{
"NDC": [
{
"NDCCode": "42571-313-86",
"PackageDescription": "1 VIAL in 1 CARTON (42571-313-86) / 4 mL in 1 VIAL",
"NDC11Code": "42571-0313-86",
"ProductNDC": "42571-313",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verapamil Hydrochloride",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190304",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211370",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190304",
"SamplePackage": "N",
"IndicationAndUsage": "Verapamil Hydrochloride Injection, USP is indicated for the following: 1 Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong-Levine [L-G-L] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to verapamil hydrochloride administration.",
"Description": "Verapamil Hydrochloride is calcium antagonist or slow channel inhibitor. Verapamil Hydrochloride Injection, USP is available in 5 mg/2 mL and 10 mg/4 mL single dose vials (for intravenous administration). Each 1 mL of solution contains 2.5 mg verapamil HCl and 8.5 mg sodium chloride in water for injection. Hydrochloric acid and/or sodium hydroxide is used for pH adjustment. The pH of the solution is 4.9 (4.0 to 6.5). Protect contents from light. Verapamil Hydrochloride Injection, USP vials are sterile. The structural formula of verapamil HCl USP is given below :. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)ethyl] methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Molecular weight: 491.07 Molecular formula: C 27H 38N 2O 4HCL. Verapamil HCl USP is an almost white, crystalline powder practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil HCl is not chemically related to other antiarrhythmic drugs."
},
{
"NDCCode": "42571-437-66",
"PackageDescription": "25 VIAL in 1 CARTON (42571-437-66) / 4 mL in 1 VIAL (42571-437-86) ",
"NDC11Code": "42571-0437-66",
"ProductNDC": "42571-437",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Furosemide",
"NonProprietaryName": "Furosemide",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20231116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218188",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "FUROSEMIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/4mL",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231116",
"SamplePackage": "N",
"IndicationAndUsage": "Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations. Edema:Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired. Furosemide is indicated as adjunctive therapy in acute pulmonary edema. The intravenous administration of furosemide is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema. If gastrointestinal absorption is impaired or oral medication is not practical for any reason, furosemide is indicated by the intravenous or intramuscular route. Parenteral use should be replaced with oral furosemide as soon as practical.",
"Description": "Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-chloro -N-furfuryl-5-sulfamoylanthranilic acid. Furosemide Injection USP, 10 mg/mL is a sterile, non-pyrogenic solution in vials for intravenous and intramuscular injection. Furosemide, USP is a white to slightly yellowish, odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows. Each mL contains: Furosemide, USP 10 mg, water for injection q.s., sodium chloride for isotonicity, sodium hydroxide and, if necessary, hydrochloric acid to adjust pH between 8.0 and 9.3."
},
{
"NDCCode": "66582-313-86",
"PackageDescription": "5000 TABLET in 1 BOTTLE (66582-313-86) ",
"NDC11Code": "66582-0313-86",
"ProductNDC": "66582-313",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vytorin",
"NonProprietaryName": "Ezetimibe And Simvastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040723",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021687",
"LabelerName": "Merck Sharp & Dohme Corp.",
"SubstanceName": "EZETIMIBE; SIMVASTATIN",
"StrengthNumber": "10; 40",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20040723",
"SamplePackage": "N"
},
{
"NDCCode": "42571-313-75",
"PackageDescription": "1 VIAL in 1 CARTON (42571-313-75) / 2 mL in 1 VIAL",
"NDC11Code": "42571-0313-75",
"ProductNDC": "42571-313",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verapamil Hydrochloride",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190304",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211370",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190304",
"SamplePackage": "N",
"IndicationAndUsage": "Verapamil Hydrochloride Injection, USP is indicated for the following: 1 Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong-Levine [L-G-L] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to verapamil hydrochloride administration.",
"Description": "Verapamil Hydrochloride is calcium antagonist or slow channel inhibitor. Verapamil Hydrochloride Injection, USP is available in 5 mg/2 mL and 10 mg/4 mL single dose vials (for intravenous administration). Each 1 mL of solution contains 2.5 mg verapamil HCl and 8.5 mg sodium chloride in water for injection. Hydrochloric acid and/or sodium hydroxide is used for pH adjustment. The pH of the solution is 4.9 (4.0 to 6.5). Protect contents from light. Verapamil Hydrochloride Injection, USP vials are sterile. The structural formula of verapamil HCl USP is given below :. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)ethyl] methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Molecular weight: 491.07 Molecular formula: C 27H 38N 2O 4HCL. Verapamil HCl USP is an almost white, crystalline powder practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil HCl is not chemically related to other antiarrhythmic drugs."
},
{
"NDCCode": "42571-313-87",
"PackageDescription": "25 VIAL in 1 CARTON (42571-313-87) / 2 mL in 1 VIAL",
"NDC11Code": "42571-0313-87",
"ProductNDC": "42571-313",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verapamil Hydrochloride",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190304",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211370",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190424",
"SamplePackage": "N",
"IndicationAndUsage": "Verapamil Hydrochloride Injection, USP is indicated for the following: 1 Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong-Levine [L-G-L] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to verapamil hydrochloride administration.",
"Description": "Verapamil Hydrochloride is calcium antagonist or slow channel inhibitor. Verapamil Hydrochloride Injection, USP is available in 5 mg/2 mL and 10 mg/4 mL single dose vials (for intravenous administration). Each 1 mL of solution contains 2.5 mg verapamil HCl and 8.5 mg sodium chloride in water for injection. Hydrochloric acid and/or sodium hydroxide is used for pH adjustment. The pH of the solution is 4.9 (4.0 to 6.5). Protect contents from light. Verapamil Hydrochloride Injection, USP vials are sterile. The structural formula of verapamil HCl USP is given below :. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)ethyl] methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Molecular weight: 491.07 Molecular formula: C 27H 38N 2O 4HCL. Verapamil HCl USP is an almost white, crystalline powder practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil HCl is not chemically related to other antiarrhythmic drugs."
},
{
"NDCCode": "42571-313-96",
"PackageDescription": "5 VIAL in 1 CARTON (42571-313-96) / 4 mL in 1 VIAL",
"NDC11Code": "42571-0313-96",
"ProductNDC": "42571-313",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verapamil Hydrochloride",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190304",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211370",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190424",
"SamplePackage": "N",
"IndicationAndUsage": "Verapamil Hydrochloride Injection, USP is indicated for the following: 1 Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong-Levine [L-G-L] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to verapamil hydrochloride administration.",
"Description": "Verapamil Hydrochloride is calcium antagonist or slow channel inhibitor. Verapamil Hydrochloride Injection, USP is available in 5 mg/2 mL and 10 mg/4 mL single dose vials (for intravenous administration). Each 1 mL of solution contains 2.5 mg verapamil HCl and 8.5 mg sodium chloride in water for injection. Hydrochloric acid and/or sodium hydroxide is used for pH adjustment. The pH of the solution is 4.9 (4.0 to 6.5). Protect contents from light. Verapamil Hydrochloride Injection, USP vials are sterile. The structural formula of verapamil HCl USP is given below :. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)ethyl] methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Molecular weight: 491.07 Molecular formula: C 27H 38N 2O 4HCL. Verapamil HCl USP is an almost white, crystalline powder practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil HCl is not chemically related to other antiarrhythmic drugs."
},
{
"NDCCode": "42571-313-97",
"PackageDescription": "5 VIAL in 1 CARTON (42571-313-97) / 2 mL in 1 VIAL",
"NDC11Code": "42571-0313-97",
"ProductNDC": "42571-313",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Verapamil Hydrochloride",
"NonProprietaryName": "Verapamil Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190304",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211370",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "VERAPAMIL HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190424",
"SamplePackage": "N",
"IndicationAndUsage": "Verapamil Hydrochloride Injection, USP is indicated for the following: 1 Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong-Levine [L-G-L] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to verapamil hydrochloride administration.",
"Description": "Verapamil Hydrochloride is calcium antagonist or slow channel inhibitor. Verapamil Hydrochloride Injection, USP is available in 5 mg/2 mL and 10 mg/4 mL single dose vials (for intravenous administration). Each 1 mL of solution contains 2.5 mg verapamil HCl and 8.5 mg sodium chloride in water for injection. Hydrochloric acid and/or sodium hydroxide is used for pH adjustment. The pH of the solution is 4.9 (4.0 to 6.5). Protect contents from light. Verapamil Hydrochloride Injection, USP vials are sterile. The structural formula of verapamil HCl USP is given below :. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)ethyl] methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Molecular weight: 491.07 Molecular formula: C 27H 38N 2O 4HCL. Verapamil HCl USP is an almost white, crystalline powder practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil HCl is not chemically related to other antiarrhythmic drugs."
},
{
"NDCCode": "42571-302-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (42571-302-01) ",
"NDC11Code": "42571-0302-01",
"ProductNDC": "42571-302",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlordiazepoxide And Amitriptyline Hydrochloride",
"NonProprietaryName": "Chlordiazepoxide And Amitriptyline Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211925",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE",
"StrengthNumber": "5; 12.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS], Tricyclic Antidepressant [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220401",
"SamplePackage": "N",
"IndicationAndUsage": "Chlordiazepoxide and amitriptyline hydrochloride tablets are indicated for the treatment of patients with moderate to severe depression associated with moderate to severe anxiety. The therapeutic response to chlordiazepoxide and amitriptyline hydrochloride tablet occurs earlier and with fewer treatment failures than when either amitriptyline or chlordiazepoxide is used alone. Symptoms likely to respond in the first week of treatment include: insomnia, feelings of guilt or worthlessness, agitation, psychic and somatic anxiety, suicidal ideation and anorexia.",
"Description": "Chlordiazepoxide and amitriptyline hydrochloride tablets, USP combine for oral administration, chlordiazepoxide, an agent for the relief of anxiety and tension, and amitriptyline, an antidepressant. It is available in as white, round, biconvex film-coated tablets debossed 'CA2'on one side and the other side is plain, each containing 10 mg chlordiazepoxide and 25 mg amitriptyline (as the hydrochloride salt); and in green, round, biconvex, film-coated tablets debossed 'CA1 'on one side and the other side is plain, each containing 5 mg chlordiazepoxide and 12.5 mg amitriptyline (as the hydrochloride salt). Each tablet also contains hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide, sodium starch glycolate, talc and titanium dioxide. In addition, the 10 mg/25 mg tablet contains polyethylene glycol 400 and 5 mg/12.5 mg tablet contains D&C YELLOW NO.10, FD&C BLUE NO.1, FD & C YELLOW NO. 6 and polyethylene glycol 6000. Chlordiazepoxide USP is a benzodiazepine with the formula 7-chloro-2-(methyl-amino)-5-phenyl- 3H-1,4-benzodiazepine 4-oxide. It is a slightly yellow crystalline material and is insoluble in water. The molecular weight is 299.76. Amitriptyline Hydrochloride USP is a dibenzocycloheptadiene derivative. The formula is 10,11-dihydro- N,N-dimethyl-5H-dibenzo [a,d] cycloheptene-Δ 5,γ-propylamine hydrochloride. It is a white or practically white crystalline compound that is freely soluble in water. The molecular weight is 313.87."
},
{
"NDCCode": "42571-302-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (42571-302-05) ",
"NDC11Code": "42571-0302-05",
"ProductNDC": "42571-302",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlordiazepoxide And Amitriptyline Hydrochloride",
"NonProprietaryName": "Chlordiazepoxide And Amitriptyline Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211925",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE",
"StrengthNumber": "5; 12.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS], Tricyclic Antidepressant [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220401",
"SamplePackage": "N",
"IndicationAndUsage": "Chlordiazepoxide and amitriptyline hydrochloride tablets are indicated for the treatment of patients with moderate to severe depression associated with moderate to severe anxiety. The therapeutic response to chlordiazepoxide and amitriptyline hydrochloride tablet occurs earlier and with fewer treatment failures than when either amitriptyline or chlordiazepoxide is used alone. Symptoms likely to respond in the first week of treatment include: insomnia, feelings of guilt or worthlessness, agitation, psychic and somatic anxiety, suicidal ideation and anorexia.",
"Description": "Chlordiazepoxide and amitriptyline hydrochloride tablets, USP combine for oral administration, chlordiazepoxide, an agent for the relief of anxiety and tension, and amitriptyline, an antidepressant. It is available in as white, round, biconvex film-coated tablets debossed 'CA2'on one side and the other side is plain, each containing 10 mg chlordiazepoxide and 25 mg amitriptyline (as the hydrochloride salt); and in green, round, biconvex, film-coated tablets debossed 'CA1 'on one side and the other side is plain, each containing 5 mg chlordiazepoxide and 12.5 mg amitriptyline (as the hydrochloride salt). Each tablet also contains hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide, sodium starch glycolate, talc and titanium dioxide. In addition, the 10 mg/25 mg tablet contains polyethylene glycol 400 and 5 mg/12.5 mg tablet contains D&C YELLOW NO.10, FD&C BLUE NO.1, FD & C YELLOW NO. 6 and polyethylene glycol 6000. Chlordiazepoxide USP is a benzodiazepine with the formula 7-chloro-2-(methyl-amino)-5-phenyl- 3H-1,4-benzodiazepine 4-oxide. It is a slightly yellow crystalline material and is insoluble in water. The molecular weight is 299.76. Amitriptyline Hydrochloride USP is a dibenzocycloheptadiene derivative. The formula is 10,11-dihydro- N,N-dimethyl-5H-dibenzo [a,d] cycloheptene-Δ 5,γ-propylamine hydrochloride. It is a white or practically white crystalline compound that is freely soluble in water. The molecular weight is 313.87."
},
{
"NDCCode": "42571-303-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (42571-303-01) ",
"NDC11Code": "42571-0303-01",
"ProductNDC": "42571-303",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlordiazepoxide And Amitriptyline Hydrochloride",
"NonProprietaryName": "Chlordiazepoxide And Amitriptyline Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211925",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE",
"StrengthNumber": "10; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS], Tricyclic Antidepressant [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220401",
"SamplePackage": "N",
"IndicationAndUsage": "Chlordiazepoxide and amitriptyline hydrochloride tablets are indicated for the treatment of patients with moderate to severe depression associated with moderate to severe anxiety. The therapeutic response to chlordiazepoxide and amitriptyline hydrochloride tablet occurs earlier and with fewer treatment failures than when either amitriptyline or chlordiazepoxide is used alone. Symptoms likely to respond in the first week of treatment include: insomnia, feelings of guilt or worthlessness, agitation, psychic and somatic anxiety, suicidal ideation and anorexia.",
"Description": "Chlordiazepoxide and amitriptyline hydrochloride tablets, USP combine for oral administration, chlordiazepoxide, an agent for the relief of anxiety and tension, and amitriptyline, an antidepressant. It is available in as white, round, biconvex film-coated tablets debossed 'CA2'on one side and the other side is plain, each containing 10 mg chlordiazepoxide and 25 mg amitriptyline (as the hydrochloride salt); and in green, round, biconvex, film-coated tablets debossed 'CA1 'on one side and the other side is plain, each containing 5 mg chlordiazepoxide and 12.5 mg amitriptyline (as the hydrochloride salt). Each tablet also contains hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide, sodium starch glycolate, talc and titanium dioxide. In addition, the 10 mg/25 mg tablet contains polyethylene glycol 400 and 5 mg/12.5 mg tablet contains D&C YELLOW NO.10, FD&C BLUE NO.1, FD & C YELLOW NO. 6 and polyethylene glycol 6000. Chlordiazepoxide USP is a benzodiazepine with the formula 7-chloro-2-(methyl-amino)-5-phenyl- 3H-1,4-benzodiazepine 4-oxide. It is a slightly yellow crystalline material and is insoluble in water. The molecular weight is 299.76. Amitriptyline Hydrochloride USP is a dibenzocycloheptadiene derivative. The formula is 10,11-dihydro- N,N-dimethyl-5H-dibenzo [a,d] cycloheptene-Δ 5,γ-propylamine hydrochloride. It is a white or practically white crystalline compound that is freely soluble in water. The molecular weight is 313.87."
},
{
"NDCCode": "42571-303-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (42571-303-05) ",
"NDC11Code": "42571-0303-05",
"ProductNDC": "42571-303",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlordiazepoxide And Amitriptyline Hydrochloride",
"NonProprietaryName": "Chlordiazepoxide And Amitriptyline Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211925",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE",
"StrengthNumber": "10; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS], Tricyclic Antidepressant [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220401",
"SamplePackage": "N",
"IndicationAndUsage": "Chlordiazepoxide and amitriptyline hydrochloride tablets are indicated for the treatment of patients with moderate to severe depression associated with moderate to severe anxiety. The therapeutic response to chlordiazepoxide and amitriptyline hydrochloride tablet occurs earlier and with fewer treatment failures than when either amitriptyline or chlordiazepoxide is used alone. Symptoms likely to respond in the first week of treatment include: insomnia, feelings of guilt or worthlessness, agitation, psychic and somatic anxiety, suicidal ideation and anorexia.",
"Description": "Chlordiazepoxide and amitriptyline hydrochloride tablets, USP combine for oral administration, chlordiazepoxide, an agent for the relief of anxiety and tension, and amitriptyline, an antidepressant. It is available in as white, round, biconvex film-coated tablets debossed 'CA2'on one side and the other side is plain, each containing 10 mg chlordiazepoxide and 25 mg amitriptyline (as the hydrochloride salt); and in green, round, biconvex, film-coated tablets debossed 'CA1 'on one side and the other side is plain, each containing 5 mg chlordiazepoxide and 12.5 mg amitriptyline (as the hydrochloride salt). Each tablet also contains hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide, sodium starch glycolate, talc and titanium dioxide. In addition, the 10 mg/25 mg tablet contains polyethylene glycol 400 and 5 mg/12.5 mg tablet contains D&C YELLOW NO.10, FD&C BLUE NO.1, FD & C YELLOW NO. 6 and polyethylene glycol 6000. Chlordiazepoxide USP is a benzodiazepine with the formula 7-chloro-2-(methyl-amino)-5-phenyl- 3H-1,4-benzodiazepine 4-oxide. It is a slightly yellow crystalline material and is insoluble in water. The molecular weight is 299.76. Amitriptyline Hydrochloride USP is a dibenzocycloheptadiene derivative. The formula is 10,11-dihydro- N,N-dimethyl-5H-dibenzo [a,d] cycloheptene-Δ 5,γ-propylamine hydrochloride. It is a white or practically white crystalline compound that is freely soluble in water. The molecular weight is 313.87."
},
{
"NDCCode": "42571-320-05",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-320-05) ",
"NDC11Code": "42571-0320-05",
"ProductNDC": "42571-320",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"NonProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20261001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211466",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261001",
"SamplePackage": "N",
"IndicationAndUsage": "Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: : 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.",
"Description": "Dapagliflozin and metformin HCl extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1- C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1 S)-. The molecular formula is C 21H 25ClO 6and the formula weight is 408.87. The structural formula is:. Metformin HCl. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl) is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is:. Dapagliflozin and Metformin HCl Extended-Release Tablets. Dapagliflozin and metformin HCl extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/500 mg), 10 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide yellow, glyceryl dibehenate, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k30, talc. The film coatings contain the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Additionally, the film coating for the dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg tablets contains FD&C Yellow No. 6; the 5 mg/1000 mg and 10 mg/500 mg tablets contains iron oxide red and ferrosoferric oxide; and the 10 mg/1000 mg tablets contains iron oxide yellow and ferrosoferric oxide."
},
{
"NDCCode": "42571-320-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-320-30) ",
"NDC11Code": "42571-0320-30",
"ProductNDC": "42571-320",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"NonProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20261001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211466",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261001",
"SamplePackage": "N",
"IndicationAndUsage": "Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: : 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.",
"Description": "Dapagliflozin and metformin HCl extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1- C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1 S)-. The molecular formula is C 21H 25ClO 6and the formula weight is 408.87. The structural formula is:. Metformin HCl. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl) is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is:. Dapagliflozin and Metformin HCl Extended-Release Tablets. Dapagliflozin and metformin HCl extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/500 mg), 10 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide yellow, glyceryl dibehenate, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k30, talc. The film coatings contain the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Additionally, the film coating for the dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg tablets contains FD&C Yellow No. 6; the 5 mg/1000 mg and 10 mg/500 mg tablets contains iron oxide red and ferrosoferric oxide; and the 10 mg/1000 mg tablets contains iron oxide yellow and ferrosoferric oxide."
},
{
"NDCCode": "42571-320-90",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-320-90) ",
"NDC11Code": "42571-0320-90",
"ProductNDC": "42571-320",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"NonProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20261001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211466",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261001",
"SamplePackage": "N",
"IndicationAndUsage": "Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: : 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.",
"Description": "Dapagliflozin and metformin HCl extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1- C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1 S)-. The molecular formula is C 21H 25ClO 6and the formula weight is 408.87. The structural formula is:. Metformin HCl. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl) is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is:. Dapagliflozin and Metformin HCl Extended-Release Tablets. Dapagliflozin and metformin HCl extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/500 mg), 10 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide yellow, glyceryl dibehenate, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k30, talc. The film coatings contain the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Additionally, the film coating for the dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg tablets contains FD&C Yellow No. 6; the 5 mg/1000 mg and 10 mg/500 mg tablets contains iron oxide red and ferrosoferric oxide; and the 10 mg/1000 mg tablets contains iron oxide yellow and ferrosoferric oxide."
},
{
"NDCCode": "42571-321-05",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-321-05) ",
"NDC11Code": "42571-0321-05",
"ProductNDC": "42571-321",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"NonProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20261001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211466",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "10; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261001",
"SamplePackage": "N",
"IndicationAndUsage": "Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: : 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.",
"Description": "Dapagliflozin and metformin HCl extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1- C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1 S)-. The molecular formula is C 21H 25ClO 6and the formula weight is 408.87. The structural formula is:. Metformin HCl. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl) is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is:. Dapagliflozin and Metformin HCl Extended-Release Tablets. Dapagliflozin and metformin HCl extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/500 mg), 10 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide yellow, glyceryl dibehenate, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k30, talc. The film coatings contain the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Additionally, the film coating for the dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg tablets contains FD&C Yellow No. 6; the 5 mg/1000 mg and 10 mg/500 mg tablets contains iron oxide red and ferrosoferric oxide; and the 10 mg/1000 mg tablets contains iron oxide yellow and ferrosoferric oxide."
},
{
"NDCCode": "42571-321-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-321-30) ",
"NDC11Code": "42571-0321-30",
"ProductNDC": "42571-321",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"NonProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20261001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211466",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "10; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261001",
"SamplePackage": "N",
"IndicationAndUsage": "Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: : 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.",
"Description": "Dapagliflozin and metformin HCl extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1- C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1 S)-. The molecular formula is C 21H 25ClO 6and the formula weight is 408.87. The structural formula is:. Metformin HCl. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl) is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is:. Dapagliflozin and Metformin HCl Extended-Release Tablets. Dapagliflozin and metformin HCl extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/500 mg), 10 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide yellow, glyceryl dibehenate, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k30, talc. The film coatings contain the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Additionally, the film coating for the dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg tablets contains FD&C Yellow No. 6; the 5 mg/1000 mg and 10 mg/500 mg tablets contains iron oxide red and ferrosoferric oxide; and the 10 mg/1000 mg tablets contains iron oxide yellow and ferrosoferric oxide."
},
{
"NDCCode": "42571-321-90",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-321-90) ",
"NDC11Code": "42571-0321-90",
"ProductNDC": "42571-321",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"NonProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20261001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211466",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "10; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261001",
"SamplePackage": "N",
"IndicationAndUsage": "Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: : 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.",
"Description": "Dapagliflozin and metformin HCl extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1- C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1 S)-. The molecular formula is C 21H 25ClO 6and the formula weight is 408.87. The structural formula is:. Metformin HCl. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl) is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is:. Dapagliflozin and Metformin HCl Extended-Release Tablets. Dapagliflozin and metformin HCl extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/500 mg), 10 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide yellow, glyceryl dibehenate, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k30, talc. The film coatings contain the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Additionally, the film coating for the dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg tablets contains FD&C Yellow No. 6; the 5 mg/1000 mg and 10 mg/500 mg tablets contains iron oxide red and ferrosoferric oxide; and the 10 mg/1000 mg tablets contains iron oxide yellow and ferrosoferric oxide."
},
{
"NDCCode": "42571-322-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-322-30) ",
"NDC11Code": "42571-0322-30",
"ProductNDC": "42571-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"NonProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20261001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211466",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "5; 1000",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: : 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.",
"Description": "Dapagliflozin and metformin HCl extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1- C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1 S)-. The molecular formula is C 21H 25ClO 6and the formula weight is 408.87. The structural formula is:. Metformin HCl. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl) is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is:. Dapagliflozin and Metformin HCl Extended-Release Tablets. Dapagliflozin and metformin HCl extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/500 mg), 10 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide yellow, glyceryl dibehenate, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k30, talc. The film coatings contain the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Additionally, the film coating for the dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg tablets contains FD&C Yellow No. 6; the 5 mg/1000 mg and 10 mg/500 mg tablets contains iron oxide red and ferrosoferric oxide; and the 10 mg/1000 mg tablets contains iron oxide yellow and ferrosoferric oxide."
},
{
"NDCCode": "42571-322-60",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-322-60) ",
"NDC11Code": "42571-0322-60",
"ProductNDC": "42571-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"NonProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20261001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211466",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "5; 1000",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20261001",
"SamplePackage": "N",
"IndicationAndUsage": "Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: : 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.",
"Description": "Dapagliflozin and metformin HCl extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1- C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1 S)-. The molecular formula is C 21H 25ClO 6and the formula weight is 408.87. The structural formula is:. Metformin HCl. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl) is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is:. Dapagliflozin and Metformin HCl Extended-Release Tablets. Dapagliflozin and metformin HCl extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/500 mg), 10 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide yellow, glyceryl dibehenate, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k30, talc. The film coatings contain the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Additionally, the film coating for the dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg tablets contains FD&C Yellow No. 6; the 5 mg/1000 mg and 10 mg/500 mg tablets contains iron oxide red and ferrosoferric oxide; and the 10 mg/1000 mg tablets contains iron oxide yellow and ferrosoferric oxide."
},
{
"NDCCode": "42571-322-90",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-322-90) ",
"NDC11Code": "42571-0322-90",
"ProductNDC": "42571-322",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"NonProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20261001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211466",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "5; 1000",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20261001",
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"IndicationAndUsage": "Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: : 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.",
"Description": "Dapagliflozin and metformin HCl extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1- C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1 S)-. The molecular formula is C 21H 25ClO 6and the formula weight is 408.87. The structural formula is:. Metformin HCl. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl) is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is:. Dapagliflozin and Metformin HCl Extended-Release Tablets. Dapagliflozin and metformin HCl extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/500 mg), 10 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide yellow, glyceryl dibehenate, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k30, talc. The film coatings contain the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Additionally, the film coating for the dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg tablets contains FD&C Yellow No. 6; the 5 mg/1000 mg and 10 mg/500 mg tablets contains iron oxide red and ferrosoferric oxide; and the 10 mg/1000 mg tablets contains iron oxide yellow and ferrosoferric oxide."
},
{
"NDCCode": "42571-323-04",
"PackageDescription": "400 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-323-04) ",
"NDC11Code": "42571-0323-04",
"ProductNDC": "42571-323",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"NonProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20261001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211466",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "10; 1000",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: : 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.",
"Description": "Dapagliflozin and metformin HCl extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1- C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1 S)-. The molecular formula is C 21H 25ClO 6and the formula weight is 408.87. The structural formula is:. Metformin HCl. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl) is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is:. Dapagliflozin and Metformin HCl Extended-Release Tablets. Dapagliflozin and metformin HCl extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/500 mg), 10 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide yellow, glyceryl dibehenate, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k30, talc. The film coatings contain the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Additionally, the film coating for the dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg tablets contains FD&C Yellow No. 6; the 5 mg/1000 mg and 10 mg/500 mg tablets contains iron oxide red and ferrosoferric oxide; and the 10 mg/1000 mg tablets contains iron oxide yellow and ferrosoferric oxide."
},
{
"NDCCode": "42571-323-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-323-30) ",
"NDC11Code": "42571-0323-30",
"ProductNDC": "42571-323",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"NonProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20261001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211466",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "10; 1000",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
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"IndicationAndUsage": "Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: : 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.",
"Description": "Dapagliflozin and metformin HCl extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1- C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1 S)-. The molecular formula is C 21H 25ClO 6and the formula weight is 408.87. The structural formula is:. Metformin HCl. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl) is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is:. Dapagliflozin and Metformin HCl Extended-Release Tablets. Dapagliflozin and metformin HCl extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/500 mg), 10 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide yellow, glyceryl dibehenate, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k30, talc. The film coatings contain the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Additionally, the film coating for the dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg tablets contains FD&C Yellow No. 6; the 5 mg/1000 mg and 10 mg/500 mg tablets contains iron oxide red and ferrosoferric oxide; and the 10 mg/1000 mg tablets contains iron oxide yellow and ferrosoferric oxide."
},
{
"NDCCode": "42571-323-90",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-323-90) ",
"NDC11Code": "42571-0323-90",
"ProductNDC": "42571-323",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"NonProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20261001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211466",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "10; 1000",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: : 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.",
"Description": "Dapagliflozin and metformin HCl extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1- C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1 S)-. The molecular formula is C 21H 25ClO 6and the formula weight is 408.87. The structural formula is:. Metformin HCl. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl) is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is:. Dapagliflozin and Metformin HCl Extended-Release Tablets. Dapagliflozin and metformin HCl extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/500 mg), 10 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide yellow, glyceryl dibehenate, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k30, talc. The film coatings contain the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Additionally, the film coating for the dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg tablets contains FD&C Yellow No. 6; the 5 mg/1000 mg and 10 mg/500 mg tablets contains iron oxide red and ferrosoferric oxide; and the 10 mg/1000 mg tablets contains iron oxide yellow and ferrosoferric oxide."
},
{
"NDCCode": "0008-0833-21",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0833-21) ",
"NDC11Code": "00008-0833-21",
"ProductNDC": "0008-0833",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Effexor",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19971101",
"EndMarketingDate": "20251031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020699",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19971101",
"EndMarketingDatePackage": "20251031",
"SamplePackage": "N",
"IndicationAndUsage": "Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].",
"Description": "Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide."
},
{
"NDCCode": "0008-0833-22",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0833-22) ",
"NDC11Code": "00008-0833-22",
"ProductNDC": "0008-0833",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Effexor",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19971101",
"EndMarketingDate": "20251031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020699",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19971101",
"EndMarketingDatePackage": "20251031",
"SamplePackage": "N",
"IndicationAndUsage": "Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].",
"Description": "Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide."
},
{
"NDCCode": "0008-0836-21",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0836-21) ",
"NDC11Code": "00008-0836-21",
"ProductNDC": "0008-0836",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Effexor",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19971101",
"EndMarketingDate": "20260630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020699",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19971101",
"EndMarketingDatePackage": "20260630",
"SamplePackage": "N",
"IndicationAndUsage": "Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].",
"Description": "Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide."
},
{
"NDCCode": "0008-0836-22",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0836-22) ",
"NDC11Code": "00008-0836-22",
"ProductNDC": "0008-0836",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Effexor",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19971101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020699",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19971101",
"EndMarketingDatePackage": "20250531",
"SamplePackage": "N",
"IndicationAndUsage": "Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].",
"Description": "Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide."
},
{
"NDCCode": "0008-0837-21",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0837-21) ",
"NDC11Code": "00008-0837-21",
"ProductNDC": "0008-0837",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Effexor",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19971101",
"EndMarketingDate": "20250531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020699",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19971101",
"EndMarketingDatePackage": "20250531",
"SamplePackage": "N",
"IndicationAndUsage": "Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].",
"Description": "Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide."
},
{
"NDCCode": "0008-0837-22",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0837-22) ",
"NDC11Code": "00008-0837-22",
"ProductNDC": "0008-0837",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Effexor",
"ProprietaryNameSuffix": "Xr",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19971101",
"EndMarketingDate": "20250531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020699",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19971101",
"EndMarketingDatePackage": "20250531",
"SamplePackage": "N",
"IndicationAndUsage": "Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].",
"Description": "Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide."
},
{
"NDCCode": "0093-7384-05",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-7384-05) ",
"NDC11Code": "00093-7384-05",
"ProductNDC": "0093-7384",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076565",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "37.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120301",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].",
"Description": "Venlafaxine hydrochloride extended-release capsules, USP are an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, USP a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride, USP is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of black iron oxide, dibutyl sebacate, ethylcellulose, gelatin, polyethylene glycol, povidone, propylene glycol, shellac, sugar spheres (which contain sucrose and corn starch), FD&C Yellow No. 6, Sunset Yellow FCF, talc, and titanium dioxide. The 37.5 mg capsules also contain D&C Yellow No. 10 and potassium hydroxide, the 75 mg capsules also contain D&C Yellow No. 10 and may contain potassium hydroxide, and the 150 mg capsules also contain potassium hydroxide."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>42571-313-86</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (42571-313-86) / 4 mL in 1 VIAL</PackageDescription>
<NDC11Code>42571-0313-86</NDC11Code>
<ProductNDC>42571-313</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190304</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211370</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190304</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Verapamil Hydrochloride Injection, USP is indicated for the following: 1 Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong-Levine [L-G-L] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to verapamil hydrochloride administration.</IndicationAndUsage>
<Description>Verapamil Hydrochloride is calcium antagonist or slow channel inhibitor. Verapamil Hydrochloride Injection, USP is available in 5 mg/2 mL and 10 mg/4 mL single dose vials (for intravenous administration). Each 1 mL of solution contains 2.5 mg verapamil HCl and 8.5 mg sodium chloride in water for injection. Hydrochloric acid and/or sodium hydroxide is used for pH adjustment. The pH of the solution is 4.9 (4.0 to 6.5). Protect contents from light. Verapamil Hydrochloride Injection, USP vials are sterile. The structural formula of verapamil HCl USP is given below :. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)ethyl] methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Molecular weight: 491.07 Molecular formula: C 27H 38N 2O 4HCL. Verapamil HCl USP is an almost white, crystalline powder practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil HCl is not chemically related to other antiarrhythmic drugs.</Description>
</NDC>
<NDC>
<NDCCode>42571-437-66</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (42571-437-66) / 4 mL in 1 VIAL (42571-437-86) </PackageDescription>
<NDC11Code>42571-0437-66</NDC11Code>
<ProductNDC>42571-437</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Furosemide</ProprietaryName>
<NonProprietaryName>Furosemide</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20231116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218188</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>FUROSEMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/4mL</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations. Edema:Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired. Furosemide is indicated as adjunctive therapy in acute pulmonary edema. The intravenous administration of furosemide is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema. If gastrointestinal absorption is impaired or oral medication is not practical for any reason, furosemide is indicated by the intravenous or intramuscular route. Parenteral use should be replaced with oral furosemide as soon as practical.</IndicationAndUsage>
<Description>Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-chloro -N-furfuryl-5-sulfamoylanthranilic acid. Furosemide Injection USP, 10 mg/mL is a sterile, non-pyrogenic solution in vials for intravenous and intramuscular injection. Furosemide, USP is a white to slightly yellowish, odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows. Each mL contains: Furosemide, USP 10 mg, water for injection q.s., sodium chloride for isotonicity, sodium hydroxide and, if necessary, hydrochloric acid to adjust pH between 8.0 and 9.3.</Description>
</NDC>
<NDC>
<NDCCode>66582-313-86</NDCCode>
<PackageDescription>5000 TABLET in 1 BOTTLE (66582-313-86) </PackageDescription>
<NDC11Code>66582-0313-86</NDC11Code>
<ProductNDC>66582-313</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vytorin</ProprietaryName>
<NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040723</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021687</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme Corp.</LabelerName>
<SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
<StrengthNumber>10; 40</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Cholesterol Absorption [PE],Dietary Cholesterol Absorption Inhibitor [EPC],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42571-313-75</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (42571-313-75) / 2 mL in 1 VIAL</PackageDescription>
<NDC11Code>42571-0313-75</NDC11Code>
<ProductNDC>42571-313</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190304</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211370</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190304</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Verapamil Hydrochloride Injection, USP is indicated for the following: 1 Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong-Levine [L-G-L] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to verapamil hydrochloride administration.</IndicationAndUsage>
<Description>Verapamil Hydrochloride is calcium antagonist or slow channel inhibitor. Verapamil Hydrochloride Injection, USP is available in 5 mg/2 mL and 10 mg/4 mL single dose vials (for intravenous administration). Each 1 mL of solution contains 2.5 mg verapamil HCl and 8.5 mg sodium chloride in water for injection. Hydrochloric acid and/or sodium hydroxide is used for pH adjustment. The pH of the solution is 4.9 (4.0 to 6.5). Protect contents from light. Verapamil Hydrochloride Injection, USP vials are sterile. The structural formula of verapamil HCl USP is given below :. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)ethyl] methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Molecular weight: 491.07 Molecular formula: C 27H 38N 2O 4HCL. Verapamil HCl USP is an almost white, crystalline powder practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil HCl is not chemically related to other antiarrhythmic drugs.</Description>
</NDC>
<NDC>
<NDCCode>42571-313-87</NDCCode>
<PackageDescription>25 VIAL in 1 CARTON (42571-313-87) / 2 mL in 1 VIAL</PackageDescription>
<NDC11Code>42571-0313-87</NDC11Code>
<ProductNDC>42571-313</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190304</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211370</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Verapamil Hydrochloride Injection, USP is indicated for the following: 1 Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong-Levine [L-G-L] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to verapamil hydrochloride administration.</IndicationAndUsage>
<Description>Verapamil Hydrochloride is calcium antagonist or slow channel inhibitor. Verapamil Hydrochloride Injection, USP is available in 5 mg/2 mL and 10 mg/4 mL single dose vials (for intravenous administration). Each 1 mL of solution contains 2.5 mg verapamil HCl and 8.5 mg sodium chloride in water for injection. Hydrochloric acid and/or sodium hydroxide is used for pH adjustment. The pH of the solution is 4.9 (4.0 to 6.5). Protect contents from light. Verapamil Hydrochloride Injection, USP vials are sterile. The structural formula of verapamil HCl USP is given below :. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)ethyl] methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Molecular weight: 491.07 Molecular formula: C 27H 38N 2O 4HCL. Verapamil HCl USP is an almost white, crystalline powder practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil HCl is not chemically related to other antiarrhythmic drugs.</Description>
</NDC>
<NDC>
<NDCCode>42571-313-96</NDCCode>
<PackageDescription>5 VIAL in 1 CARTON (42571-313-96) / 4 mL in 1 VIAL</PackageDescription>
<NDC11Code>42571-0313-96</NDC11Code>
<ProductNDC>42571-313</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190304</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211370</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Verapamil Hydrochloride Injection, USP is indicated for the following: 1 Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong-Levine [L-G-L] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to verapamil hydrochloride administration.</IndicationAndUsage>
<Description>Verapamil Hydrochloride is calcium antagonist or slow channel inhibitor. Verapamil Hydrochloride Injection, USP is available in 5 mg/2 mL and 10 mg/4 mL single dose vials (for intravenous administration). Each 1 mL of solution contains 2.5 mg verapamil HCl and 8.5 mg sodium chloride in water for injection. Hydrochloric acid and/or sodium hydroxide is used for pH adjustment. The pH of the solution is 4.9 (4.0 to 6.5). Protect contents from light. Verapamil Hydrochloride Injection, USP vials are sterile. The structural formula of verapamil HCl USP is given below :. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)ethyl] methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Molecular weight: 491.07 Molecular formula: C 27H 38N 2O 4HCL. Verapamil HCl USP is an almost white, crystalline powder practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil HCl is not chemically related to other antiarrhythmic drugs.</Description>
</NDC>
<NDC>
<NDCCode>42571-313-97</NDCCode>
<PackageDescription>5 VIAL in 1 CARTON (42571-313-97) / 2 mL in 1 VIAL</PackageDescription>
<NDC11Code>42571-0313-97</NDC11Code>
<ProductNDC>42571-313</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
<NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190304</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211370</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190424</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Verapamil Hydrochloride Injection, USP is indicated for the following: 1 Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong-Levine [L-G-L] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to verapamil hydrochloride administration.</IndicationAndUsage>
<Description>Verapamil Hydrochloride is calcium antagonist or slow channel inhibitor. Verapamil Hydrochloride Injection, USP is available in 5 mg/2 mL and 10 mg/4 mL single dose vials (for intravenous administration). Each 1 mL of solution contains 2.5 mg verapamil HCl and 8.5 mg sodium chloride in water for injection. Hydrochloric acid and/or sodium hydroxide is used for pH adjustment. The pH of the solution is 4.9 (4.0 to 6.5). Protect contents from light. Verapamil Hydrochloride Injection, USP vials are sterile. The structural formula of verapamil HCl USP is given below :. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)ethyl] methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Molecular weight: 491.07 Molecular formula: C 27H 38N 2O 4HCL. Verapamil HCl USP is an almost white, crystalline powder practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil HCl is not chemically related to other antiarrhythmic drugs.</Description>
</NDC>
<NDC>
<NDCCode>42571-302-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (42571-302-01) </PackageDescription>
<NDC11Code>42571-0302-01</NDC11Code>
<ProductNDC>42571-302</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlordiazepoxide And Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Chlordiazepoxide And Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211925</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE</SubstanceName>
<StrengthNumber>5; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS], Tricyclic Antidepressant [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Chlordiazepoxide and amitriptyline hydrochloride tablets are indicated for the treatment of patients with moderate to severe depression associated with moderate to severe anxiety. The therapeutic response to chlordiazepoxide and amitriptyline hydrochloride tablet occurs earlier and with fewer treatment failures than when either amitriptyline or chlordiazepoxide is used alone. Symptoms likely to respond in the first week of treatment include: insomnia, feelings of guilt or worthlessness, agitation, psychic and somatic anxiety, suicidal ideation and anorexia.</IndicationAndUsage>
<Description>Chlordiazepoxide and amitriptyline hydrochloride tablets, USP combine for oral administration, chlordiazepoxide, an agent for the relief of anxiety and tension, and amitriptyline, an antidepressant. It is available in as white, round, biconvex film-coated tablets debossed 'CA2'on one side and the other side is plain, each containing 10 mg chlordiazepoxide and 25 mg amitriptyline (as the hydrochloride salt); and in green, round, biconvex, film-coated tablets debossed 'CA1 'on one side and the other side is plain, each containing 5 mg chlordiazepoxide and 12.5 mg amitriptyline (as the hydrochloride salt). Each tablet also contains hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide, sodium starch glycolate, talc and titanium dioxide. In addition, the 10 mg/25 mg tablet contains polyethylene glycol 400 and 5 mg/12.5 mg tablet contains D&C YELLOW NO.10, FD&C BLUE NO.1, FD & C YELLOW NO. 6 and polyethylene glycol 6000. Chlordiazepoxide USP is a benzodiazepine with the formula 7-chloro-2-(methyl-amino)-5-phenyl- 3H-1,4-benzodiazepine 4-oxide. It is a slightly yellow crystalline material and is insoluble in water. The molecular weight is 299.76. Amitriptyline Hydrochloride USP is a dibenzocycloheptadiene derivative. The formula is 10,11-dihydro- N,N-dimethyl-5H-dibenzo [a,d] cycloheptene-Δ 5,γ-propylamine hydrochloride. It is a white or practically white crystalline compound that is freely soluble in water. The molecular weight is 313.87.</Description>
</NDC>
<NDC>
<NDCCode>42571-302-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (42571-302-05) </PackageDescription>
<NDC11Code>42571-0302-05</NDC11Code>
<ProductNDC>42571-302</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlordiazepoxide And Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Chlordiazepoxide And Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211925</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE</SubstanceName>
<StrengthNumber>5; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS], Tricyclic Antidepressant [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Chlordiazepoxide and amitriptyline hydrochloride tablets are indicated for the treatment of patients with moderate to severe depression associated with moderate to severe anxiety. The therapeutic response to chlordiazepoxide and amitriptyline hydrochloride tablet occurs earlier and with fewer treatment failures than when either amitriptyline or chlordiazepoxide is used alone. Symptoms likely to respond in the first week of treatment include: insomnia, feelings of guilt or worthlessness, agitation, psychic and somatic anxiety, suicidal ideation and anorexia.</IndicationAndUsage>
<Description>Chlordiazepoxide and amitriptyline hydrochloride tablets, USP combine for oral administration, chlordiazepoxide, an agent for the relief of anxiety and tension, and amitriptyline, an antidepressant. It is available in as white, round, biconvex film-coated tablets debossed 'CA2'on one side and the other side is plain, each containing 10 mg chlordiazepoxide and 25 mg amitriptyline (as the hydrochloride salt); and in green, round, biconvex, film-coated tablets debossed 'CA1 'on one side and the other side is plain, each containing 5 mg chlordiazepoxide and 12.5 mg amitriptyline (as the hydrochloride salt). Each tablet also contains hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide, sodium starch glycolate, talc and titanium dioxide. In addition, the 10 mg/25 mg tablet contains polyethylene glycol 400 and 5 mg/12.5 mg tablet contains D&C YELLOW NO.10, FD&C BLUE NO.1, FD & C YELLOW NO. 6 and polyethylene glycol 6000. Chlordiazepoxide USP is a benzodiazepine with the formula 7-chloro-2-(methyl-amino)-5-phenyl- 3H-1,4-benzodiazepine 4-oxide. It is a slightly yellow crystalline material and is insoluble in water. The molecular weight is 299.76. Amitriptyline Hydrochloride USP is a dibenzocycloheptadiene derivative. The formula is 10,11-dihydro- N,N-dimethyl-5H-dibenzo [a,d] cycloheptene-Δ 5,γ-propylamine hydrochloride. It is a white or practically white crystalline compound that is freely soluble in water. The molecular weight is 313.87.</Description>
</NDC>
<NDC>
<NDCCode>42571-303-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (42571-303-01) </PackageDescription>
<NDC11Code>42571-0303-01</NDC11Code>
<ProductNDC>42571-303</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlordiazepoxide And Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Chlordiazepoxide And Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211925</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE</SubstanceName>
<StrengthNumber>10; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS], Tricyclic Antidepressant [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Chlordiazepoxide and amitriptyline hydrochloride tablets are indicated for the treatment of patients with moderate to severe depression associated with moderate to severe anxiety. The therapeutic response to chlordiazepoxide and amitriptyline hydrochloride tablet occurs earlier and with fewer treatment failures than when either amitriptyline or chlordiazepoxide is used alone. Symptoms likely to respond in the first week of treatment include: insomnia, feelings of guilt or worthlessness, agitation, psychic and somatic anxiety, suicidal ideation and anorexia.</IndicationAndUsage>
<Description>Chlordiazepoxide and amitriptyline hydrochloride tablets, USP combine for oral administration, chlordiazepoxide, an agent for the relief of anxiety and tension, and amitriptyline, an antidepressant. It is available in as white, round, biconvex film-coated tablets debossed 'CA2'on one side and the other side is plain, each containing 10 mg chlordiazepoxide and 25 mg amitriptyline (as the hydrochloride salt); and in green, round, biconvex, film-coated tablets debossed 'CA1 'on one side and the other side is plain, each containing 5 mg chlordiazepoxide and 12.5 mg amitriptyline (as the hydrochloride salt). Each tablet also contains hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide, sodium starch glycolate, talc and titanium dioxide. In addition, the 10 mg/25 mg tablet contains polyethylene glycol 400 and 5 mg/12.5 mg tablet contains D&C YELLOW NO.10, FD&C BLUE NO.1, FD & C YELLOW NO. 6 and polyethylene glycol 6000. Chlordiazepoxide USP is a benzodiazepine with the formula 7-chloro-2-(methyl-amino)-5-phenyl- 3H-1,4-benzodiazepine 4-oxide. It is a slightly yellow crystalline material and is insoluble in water. The molecular weight is 299.76. Amitriptyline Hydrochloride USP is a dibenzocycloheptadiene derivative. The formula is 10,11-dihydro- N,N-dimethyl-5H-dibenzo [a,d] cycloheptene-Δ 5,γ-propylamine hydrochloride. It is a white or practically white crystalline compound that is freely soluble in water. The molecular weight is 313.87.</Description>
</NDC>
<NDC>
<NDCCode>42571-303-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (42571-303-05) </PackageDescription>
<NDC11Code>42571-0303-05</NDC11Code>
<ProductNDC>42571-303</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlordiazepoxide And Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Chlordiazepoxide And Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211925</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE</SubstanceName>
<StrengthNumber>10; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS], Tricyclic Antidepressant [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Chlordiazepoxide and amitriptyline hydrochloride tablets are indicated for the treatment of patients with moderate to severe depression associated with moderate to severe anxiety. The therapeutic response to chlordiazepoxide and amitriptyline hydrochloride tablet occurs earlier and with fewer treatment failures than when either amitriptyline or chlordiazepoxide is used alone. Symptoms likely to respond in the first week of treatment include: insomnia, feelings of guilt or worthlessness, agitation, psychic and somatic anxiety, suicidal ideation and anorexia.</IndicationAndUsage>
<Description>Chlordiazepoxide and amitriptyline hydrochloride tablets, USP combine for oral administration, chlordiazepoxide, an agent for the relief of anxiety and tension, and amitriptyline, an antidepressant. It is available in as white, round, biconvex film-coated tablets debossed 'CA2'on one side and the other side is plain, each containing 10 mg chlordiazepoxide and 25 mg amitriptyline (as the hydrochloride salt); and in green, round, biconvex, film-coated tablets debossed 'CA1 'on one side and the other side is plain, each containing 5 mg chlordiazepoxide and 12.5 mg amitriptyline (as the hydrochloride salt). Each tablet also contains hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide, sodium starch glycolate, talc and titanium dioxide. In addition, the 10 mg/25 mg tablet contains polyethylene glycol 400 and 5 mg/12.5 mg tablet contains D&C YELLOW NO.10, FD&C BLUE NO.1, FD & C YELLOW NO. 6 and polyethylene glycol 6000. Chlordiazepoxide USP is a benzodiazepine with the formula 7-chloro-2-(methyl-amino)-5-phenyl- 3H-1,4-benzodiazepine 4-oxide. It is a slightly yellow crystalline material and is insoluble in water. The molecular weight is 299.76. Amitriptyline Hydrochloride USP is a dibenzocycloheptadiene derivative. The formula is 10,11-dihydro- N,N-dimethyl-5H-dibenzo [a,d] cycloheptene-Δ 5,γ-propylamine hydrochloride. It is a white or practically white crystalline compound that is freely soluble in water. The molecular weight is 313.87.</Description>
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<IndicationAndUsage>Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: : 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.</IndicationAndUsage>
<Description>Dapagliflozin and metformin HCl extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1- C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1 S)-. The molecular formula is C 21H 25ClO 6and the formula weight is 408.87. The structural formula is:. Metformin HCl. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl) is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is:. Dapagliflozin and Metformin HCl Extended-Release Tablets. Dapagliflozin and metformin HCl extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/500 mg), 10 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide yellow, glyceryl dibehenate, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k30, talc. The film coatings contain the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Additionally, the film coating for the dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg tablets contains FD&C Yellow No. 6; the 5 mg/1000 mg and 10 mg/500 mg tablets contains iron oxide red and ferrosoferric oxide; and the 10 mg/1000 mg tablets contains iron oxide yellow and ferrosoferric oxide.</Description>
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<IndicationAndUsage>Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: : 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.</IndicationAndUsage>
<Description>Dapagliflozin and metformin HCl extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1- C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1 S)-. The molecular formula is C 21H 25ClO 6and the formula weight is 408.87. The structural formula is:. Metformin HCl. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl) is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is:. Dapagliflozin and Metformin HCl Extended-Release Tablets. Dapagliflozin and metformin HCl extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/500 mg), 10 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide yellow, glyceryl dibehenate, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k30, talc. The film coatings contain the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Additionally, the film coating for the dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg tablets contains FD&C Yellow No. 6; the 5 mg/1000 mg and 10 mg/500 mg tablets contains iron oxide red and ferrosoferric oxide; and the 10 mg/1000 mg tablets contains iron oxide yellow and ferrosoferric oxide.</Description>
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<IndicationAndUsage>Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: : 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.</IndicationAndUsage>
<Description>Dapagliflozin and metformin HCl extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1- C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1 S)-. The molecular formula is C 21H 25ClO 6and the formula weight is 408.87. The structural formula is:. Metformin HCl. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl) is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is:. Dapagliflozin and Metformin HCl Extended-Release Tablets. Dapagliflozin and metformin HCl extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/500 mg), 10 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide yellow, glyceryl dibehenate, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k30, talc. The film coatings contain the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Additionally, the film coating for the dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg tablets contains FD&C Yellow No. 6; the 5 mg/1000 mg and 10 mg/500 mg tablets contains iron oxide red and ferrosoferric oxide; and the 10 mg/1000 mg tablets contains iron oxide yellow and ferrosoferric oxide.</Description>
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<IndicationAndUsage>Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: : 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.</IndicationAndUsage>
<Description>Dapagliflozin and metformin HCl extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1- C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1 S)-. The molecular formula is C 21H 25ClO 6and the formula weight is 408.87. The structural formula is:. Metformin HCl. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl) is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is:. Dapagliflozin and Metformin HCl Extended-Release Tablets. Dapagliflozin and metformin HCl extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/500 mg), 10 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide yellow, glyceryl dibehenate, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k30, talc. The film coatings contain the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Additionally, the film coating for the dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg tablets contains FD&C Yellow No. 6; the 5 mg/1000 mg and 10 mg/500 mg tablets contains iron oxide red and ferrosoferric oxide; and the 10 mg/1000 mg tablets contains iron oxide yellow and ferrosoferric oxide.</Description>
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<IndicationAndUsage>Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: : 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.</IndicationAndUsage>
<Description>Dapagliflozin and metformin HCl extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1- C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1 S)-. The molecular formula is C 21H 25ClO 6and the formula weight is 408.87. The structural formula is:. Metformin HCl. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl) is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is:. Dapagliflozin and Metformin HCl Extended-Release Tablets. Dapagliflozin and metformin HCl extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/500 mg), 10 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide yellow, glyceryl dibehenate, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k30, talc. The film coatings contain the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Additionally, the film coating for the dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg tablets contains FD&C Yellow No. 6; the 5 mg/1000 mg and 10 mg/500 mg tablets contains iron oxide red and ferrosoferric oxide; and the 10 mg/1000 mg tablets contains iron oxide yellow and ferrosoferric oxide.</Description>
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<IndicationAndUsage>Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: : 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.</IndicationAndUsage>
<Description>Dapagliflozin and metformin HCl extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1- C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1 S)-. The molecular formula is C 21H 25ClO 6and the formula weight is 408.87. The structural formula is:. Metformin HCl. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl) is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is:. Dapagliflozin and Metformin HCl Extended-Release Tablets. Dapagliflozin and metformin HCl extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/500 mg), 10 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide yellow, glyceryl dibehenate, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k30, talc. The film coatings contain the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Additionally, the film coating for the dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg tablets contains FD&C Yellow No. 6; the 5 mg/1000 mg and 10 mg/500 mg tablets contains iron oxide red and ferrosoferric oxide; and the 10 mg/1000 mg tablets contains iron oxide yellow and ferrosoferric oxide.</Description>
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<IndicationAndUsage>Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: : 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.</IndicationAndUsage>
<Description>Dapagliflozin and metformin HCl extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1- C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1 S)-. The molecular formula is C 21H 25ClO 6and the formula weight is 408.87. The structural formula is:. Metformin HCl. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl) is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is:. Dapagliflozin and Metformin HCl Extended-Release Tablets. Dapagliflozin and metformin HCl extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/500 mg), 10 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide yellow, glyceryl dibehenate, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k30, talc. The film coatings contain the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Additionally, the film coating for the dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg tablets contains FD&C Yellow No. 6; the 5 mg/1000 mg and 10 mg/500 mg tablets contains iron oxide red and ferrosoferric oxide; and the 10 mg/1000 mg tablets contains iron oxide yellow and ferrosoferric oxide.</Description>
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<IndicationAndUsage>Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: : 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.</IndicationAndUsage>
<Description>Dapagliflozin and metformin HCl extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1- C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1 S)-. The molecular formula is C 21H 25ClO 6and the formula weight is 408.87. The structural formula is:. Metformin HCl. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl) is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is:. Dapagliflozin and Metformin HCl Extended-Release Tablets. Dapagliflozin and metformin HCl extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/500 mg), 10 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide yellow, glyceryl dibehenate, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k30, talc. The film coatings contain the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Additionally, the film coating for the dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg tablets contains FD&C Yellow No. 6; the 5 mg/1000 mg and 10 mg/500 mg tablets contains iron oxide red and ferrosoferric oxide; and the 10 mg/1000 mg tablets contains iron oxide yellow and ferrosoferric oxide.</Description>
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<IndicationAndUsage>Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: : 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.</IndicationAndUsage>
<Description>Dapagliflozin and metformin HCl extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1- C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1 S)-. The molecular formula is C 21H 25ClO 6and the formula weight is 408.87. The structural formula is:. Metformin HCl. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl) is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is:. Dapagliflozin and Metformin HCl Extended-Release Tablets. Dapagliflozin and metformin HCl extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/500 mg), 10 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide yellow, glyceryl dibehenate, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k30, talc. The film coatings contain the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Additionally, the film coating for the dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg tablets contains FD&C Yellow No. 6; the 5 mg/1000 mg and 10 mg/500 mg tablets contains iron oxide red and ferrosoferric oxide; and the 10 mg/1000 mg tablets contains iron oxide yellow and ferrosoferric oxide.</Description>
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<IndicationAndUsage>Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: : 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.</IndicationAndUsage>
<Description>Dapagliflozin and metformin HCl extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1- C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1 S)-. The molecular formula is C 21H 25ClO 6and the formula weight is 408.87. The structural formula is:. Metformin HCl. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl) is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is:. Dapagliflozin and Metformin HCl Extended-Release Tablets. Dapagliflozin and metformin HCl extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/500 mg), 10 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide yellow, glyceryl dibehenate, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k30, talc. The film coatings contain the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Additionally, the film coating for the dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg tablets contains FD&C Yellow No. 6; the 5 mg/1000 mg and 10 mg/500 mg tablets contains iron oxide red and ferrosoferric oxide; and the 10 mg/1000 mg tablets contains iron oxide yellow and ferrosoferric oxide.</Description>
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<Description>Dapagliflozin and metformin HCl extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1- C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1 S)-. The molecular formula is C 21H 25ClO 6and the formula weight is 408.87. The structural formula is:. Metformin HCl. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl) is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is:. Dapagliflozin and Metformin HCl Extended-Release Tablets. Dapagliflozin and metformin HCl extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/500 mg), 10 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide yellow, glyceryl dibehenate, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k30, talc. The film coatings contain the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Additionally, the film coating for the dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg tablets contains FD&C Yellow No. 6; the 5 mg/1000 mg and 10 mg/500 mg tablets contains iron oxide red and ferrosoferric oxide; and the 10 mg/1000 mg tablets contains iron oxide yellow and ferrosoferric oxide.</Description>
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<IndicationAndUsage>Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: : 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.</IndicationAndUsage>
<Description>Dapagliflozin and metformin HCl extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as D-glucitol, 1,5-anhydro-1- C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, (1 S)-. The molecular formula is C 21H 25ClO 6and the formula weight is 408.87. The structural formula is:. Metformin HCl. Metformin HCl ( N,N-dimethylimidodicarbonimidic diamide HCl) is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. Metformin HCl is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin HCl is 6.68. The structural formula is:. Dapagliflozin and Metformin HCl Extended-Release Tablets. Dapagliflozin and metformin HCl extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin HCl which is equivalent to 389.9 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/500 mg), 10 mg dapagliflozin and 1,000 mg metformin HCl which is equivalent to 779.86 mg metformin base (dapagliflozin and metformin HCl extended-release tablets 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release tablets contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, ferric oxide yellow, glyceryl dibehenate, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone k30, talc. The film coatings contain the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Additionally, the film coating for the dapagliflozin and metformin HCl extended-release tablets 5 mg/500 mg tablets contains FD&C Yellow No. 6; the 5 mg/1000 mg and 10 mg/500 mg tablets contains iron oxide red and ferrosoferric oxide; and the 10 mg/1000 mg tablets contains iron oxide yellow and ferrosoferric oxide.</Description>
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<NDC>
<NDCCode>0008-0833-21</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0833-21) </PackageDescription>
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<ProductNDC>0008-0833</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
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<EndMarketingDate>20251031</EndMarketingDate>
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<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
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<NDC>
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<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0833-22) </PackageDescription>
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<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0008-0836-21</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0836-21) </PackageDescription>
<NDC11Code>00008-0836-21</NDC11Code>
<ProductNDC>0008-0836</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0008-0836-22</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0836-22) </PackageDescription>
<NDC11Code>00008-0836-22</NDC11Code>
<ProductNDC>0008-0836</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<EndMarketingDatePackage>20250531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0008-0837-21</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0837-21) </PackageDescription>
<NDC11Code>00008-0837-21</NDC11Code>
<ProductNDC>0008-0837</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<EndMarketingDate>20250531</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<EndMarketingDatePackage>20250531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0008-0837-22</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0837-22) </PackageDescription>
<NDC11Code>00008-0837-22</NDC11Code>
<ProductNDC>0008-0837</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Effexor</ProprietaryName>
<ProprietaryNameSuffix>Xr</ProprietaryNameSuffix>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971101</StartMarketingDate>
<EndMarketingDate>20250531</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020699</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19971101</StartMarketingDatePackage>
<EndMarketingDatePackage>20250531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Effexor XR is indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0093-7384-05</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-7384-05) </PackageDescription>
<NDC11Code>00093-7384-05</NDC11Code>
<ProductNDC>0093-7384</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076565</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>37.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: 1 Major Depressive Disorder (MDD) [see Clinical Studies (14.1)], 2 Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2)], 3 Social Anxiety Disorder (SAD) [see Clinical Studies (14.3)], 4 Panic Disorder (PD) [see Clinical Studies (14.4)].</IndicationAndUsage>
<Description>Venlafaxine hydrochloride extended-release capsules, USP are an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, USP a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride, USP is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of black iron oxide, dibutyl sebacate, ethylcellulose, gelatin, polyethylene glycol, povidone, propylene glycol, shellac, sugar spheres (which contain sucrose and corn starch), FD&C Yellow No. 6, Sunset Yellow FCF, talc, and titanium dioxide. The 37.5 mg capsules also contain D&C Yellow No. 10 and potassium hydroxide, the 75 mg capsules also contain D&C Yellow No. 10 and may contain potassium hydroxide, and the 150 mg capsules also contain potassium hydroxide.</Description>
</NDC>
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