{
"NDC": [
{
"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": "83324-313-96",
"PackageDescription": "96 TABLET, CHEWABLE in 1 BOTTLE (83324-313-96) ",
"NDC11Code": "83324-0313-96",
"ProductNDC": "83324-313",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Quality Choice",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Antacid Tablets (calcium Carbonate)",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20241111",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "QUALITY CHOICE (Chain drug Marketing Assoiciation)",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241111",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 heartburn, 2 sour stomach, 3 acid indigestion, 4 upset stomach associated with these symptoms."
},
{
"NDCCode": "42571-132-52",
"PackageDescription": "96 CARTON in 1 CARTON (42571-132-52) / 1 TRAY in 1 CARTON / 8 AMPULE in 1 TRAY / 5 mL in 1 AMPULE (42571-132-21) ",
"NDC11Code": "42571-0132-52",
"ProductNDC": "42571-132",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cromolyn Sodium",
"NonProprietaryName": "Cromolyn Sodium",
"DosageFormName": "SOLUTION, CONCENTRATE",
"RouteName": "ORAL",
"StartMarketingDate": "20130504",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202745",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "CROMOLYN SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Decreased Histamine Release [PE], Mast Cell Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2024-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130504",
"SamplePackage": "N",
"IndicationAndUsage": "Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL is indicated in the management of patients with mastocytosis. Use of this product has been associated with improvement in diarrhea, flushing, headaches, vomiting, urticaria, abdominal pain, nausea, and itching in some patients.",
"Description": "Each 5 mL ampule of Cromolyn Sodium Oral Solution (Concentrate) contains 100 mg cromolyn sodium, USP, in Water for Injection. Cromolyn sodium is a hygroscopic, white powder having little odor. It may leave a slightly bitter aftertaste. Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL is clear, colorless, and sterile. It is intended for oral use. Chemically, cromolyn sodium is disodium 5,5’-[(2-hydroxytrimethylene)dioxy]bis[4-oxo-4H-1-benzopyran-2-carboxylate]. The molecular formula is C 23H 14Na 2O 11; the molecular weight is 512.34. Its chemical structure is:. Pharmacologic Category: Mast cell stabilizer Therapeutic Category: Antiallergic."
},
{
"NDCCode": "42571-346-96",
"PackageDescription": "5 VIAL in 1 BOX (42571-346-96) / 3 mL in 1 VIAL",
"NDC11Code": "42571-0346-96",
"ProductNDC": "42571-346",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Caffeine Citrate",
"NonProprietaryName": "Caffeine Citrate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20200201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213202",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "CAFFEINE CITRATE",
"StrengthNumber": "60",
"StrengthUnit": "mg/3mL",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]",
"Status": "Active",
"LastUpdate": "2026-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260423",
"SamplePackage": "N",
"IndicationAndUsage": "Caffeine citrate is indicated for the short term treatment of apnea of prematurity in infants between 28 and <33 weeks gestational age.",
"Description": "Caffeine Citrate Oral Solution, USP is clear, colorless, sterile, non-pyrogenic, preservative-free, aqueous solutions adjusted to pH 4.7. Each mL contains 20 mg caffeine citrate (equivalent to 10 mg of caffeine base) prepared in solution by the addition of 10 mg caffeine anhydrous to 5 mg citric acid monohydrate, 8.3 mg trisodium citrate dihydrate and Water for Injection. Caffeine USP, a central nervous system stimulant, is an odorless white crystalline powder or granule, with a bitter taste. It is sparingly soluble in water and in ethanol at room temperature. The chemical name of caffeine is 3,7-dihydro-1,3,7-trimethyl-1H-purine-2,6-dione. In the presence of citric acid it forms caffeine citrate salt in solution. The structural formula and molecular weight of caffeine citrate follows."
},
{
"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": "42571-313-86",
"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": "42571-313-87",
"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": "42571-313-97",
"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": "42571-470-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (42571-470-01) ",
"NDC11Code": "42571-0470-01",
"ProductNDC": "42571-470",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bisoprolol",
"NonProprietaryName": "Bisoprolol Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218303",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "BISOPROLOL FUMARATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260601",
"SamplePackage": "N",
"IndicationAndUsage": "Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Bisoprolol fumarate, USP is a synthetic, beta 1-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is 2-Propanol, l -[4-[[2-(1-methylethoxy)ethoxy] methyl]phenoxy]-3-[(1-methylethyl)amino] -,(±)-, (E)-2-butenedioate (2: l). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is C 40H 66N 2O 12and its structure is:. Bisoprolol fumarate, USP has a molecular weight of 766.96. It is a white or almost white, slightly hygroscopic powder which is approximately equally hydrophilic and lipophilic. It is very soluble in water and in methanol; freely soluble in glacial acetic acid, chloroform and in alcohol; and slightly soluble in acetone. Bisoprolol fumarate tablets, USP is available as 5 mg and 10 mg tablets for oral administration. Inactive ingredients include colloidal silicon dioxide, crospovidone, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch and titanium dioxide. In addition, the 5 mg tablets also contain iron oxide red and iron oxide yellow. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "42571-470-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (42571-470-05) ",
"NDC11Code": "42571-0470-05",
"ProductNDC": "42571-470",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bisoprolol",
"NonProprietaryName": "Bisoprolol Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218303",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "BISOPROLOL FUMARATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260601",
"SamplePackage": "N",
"IndicationAndUsage": "Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Bisoprolol fumarate, USP is a synthetic, beta 1-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is 2-Propanol, l -[4-[[2-(1-methylethoxy)ethoxy] methyl]phenoxy]-3-[(1-methylethyl)amino] -,(±)-, (E)-2-butenedioate (2: l). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is C 40H 66N 2O 12and its structure is:. Bisoprolol fumarate, USP has a molecular weight of 766.96. It is a white or almost white, slightly hygroscopic powder which is approximately equally hydrophilic and lipophilic. It is very soluble in water and in methanol; freely soluble in glacial acetic acid, chloroform and in alcohol; and slightly soluble in acetone. Bisoprolol fumarate tablets, USP is available as 5 mg and 10 mg tablets for oral administration. Inactive ingredients include colloidal silicon dioxide, crospovidone, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch and titanium dioxide. In addition, the 5 mg tablets also contain iron oxide red and iron oxide yellow. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "42571-470-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (42571-470-30) ",
"NDC11Code": "42571-0470-30",
"ProductNDC": "42571-470",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bisoprolol",
"NonProprietaryName": "Bisoprolol Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218303",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "BISOPROLOL FUMARATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260601",
"SamplePackage": "N",
"IndicationAndUsage": "Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Bisoprolol fumarate, USP is a synthetic, beta 1-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is 2-Propanol, l -[4-[[2-(1-methylethoxy)ethoxy] methyl]phenoxy]-3-[(1-methylethyl)amino] -,(±)-, (E)-2-butenedioate (2: l). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is C 40H 66N 2O 12and its structure is:. Bisoprolol fumarate, USP has a molecular weight of 766.96. It is a white or almost white, slightly hygroscopic powder which is approximately equally hydrophilic and lipophilic. It is very soluble in water and in methanol; freely soluble in glacial acetic acid, chloroform and in alcohol; and slightly soluble in acetone. Bisoprolol fumarate tablets, USP is available as 5 mg and 10 mg tablets for oral administration. Inactive ingredients include colloidal silicon dioxide, crospovidone, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch and titanium dioxide. In addition, the 5 mg tablets also contain iron oxide red and iron oxide yellow. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "42571-471-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (42571-471-01) ",
"NDC11Code": "42571-0471-01",
"ProductNDC": "42571-471",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bisoprolol",
"NonProprietaryName": "Bisoprolol Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218303",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "BISOPROLOL FUMARATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260601",
"SamplePackage": "N",
"IndicationAndUsage": "Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Bisoprolol fumarate, USP is a synthetic, beta 1-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is 2-Propanol, l -[4-[[2-(1-methylethoxy)ethoxy] methyl]phenoxy]-3-[(1-methylethyl)amino] -,(±)-, (E)-2-butenedioate (2: l). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is C 40H 66N 2O 12and its structure is:. Bisoprolol fumarate, USP has a molecular weight of 766.96. It is a white or almost white, slightly hygroscopic powder which is approximately equally hydrophilic and lipophilic. It is very soluble in water and in methanol; freely soluble in glacial acetic acid, chloroform and in alcohol; and slightly soluble in acetone. Bisoprolol fumarate tablets, USP is available as 5 mg and 10 mg tablets for oral administration. Inactive ingredients include colloidal silicon dioxide, crospovidone, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch and titanium dioxide. In addition, the 5 mg tablets also contain iron oxide red and iron oxide yellow. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "42571-471-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (42571-471-05) ",
"NDC11Code": "42571-0471-05",
"ProductNDC": "42571-471",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bisoprolol",
"NonProprietaryName": "Bisoprolol Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218303",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "BISOPROLOL FUMARATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260601",
"SamplePackage": "N",
"IndicationAndUsage": "Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Bisoprolol fumarate, USP is a synthetic, beta 1-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is 2-Propanol, l -[4-[[2-(1-methylethoxy)ethoxy] methyl]phenoxy]-3-[(1-methylethyl)amino] -,(±)-, (E)-2-butenedioate (2: l). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is C 40H 66N 2O 12and its structure is:. Bisoprolol fumarate, USP has a molecular weight of 766.96. It is a white or almost white, slightly hygroscopic powder which is approximately equally hydrophilic and lipophilic. It is very soluble in water and in methanol; freely soluble in glacial acetic acid, chloroform and in alcohol; and slightly soluble in acetone. Bisoprolol fumarate tablets, USP is available as 5 mg and 10 mg tablets for oral administration. Inactive ingredients include colloidal silicon dioxide, crospovidone, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch and titanium dioxide. In addition, the 5 mg tablets also contain iron oxide red and iron oxide yellow. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "42571-471-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (42571-471-30) ",
"NDC11Code": "42571-0471-30",
"ProductNDC": "42571-471",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bisoprolol",
"NonProprietaryName": "Bisoprolol Fumarate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218303",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "BISOPROLOL FUMARATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260601",
"SamplePackage": "N",
"IndicationAndUsage": "Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Bisoprolol fumarate, USP is a synthetic, beta 1-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is 2-Propanol, l -[4-[[2-(1-methylethoxy)ethoxy] methyl]phenoxy]-3-[(1-methylethyl)amino] -,(±)-, (E)-2-butenedioate (2: l). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is C 40H 66N 2O 12and its structure is:. Bisoprolol fumarate, USP has a molecular weight of 766.96. It is a white or almost white, slightly hygroscopic powder which is approximately equally hydrophilic and lipophilic. It is very soluble in water and in methanol; freely soluble in glacial acetic acid, chloroform and in alcohol; and slightly soluble in acetone. Bisoprolol fumarate tablets, USP is available as 5 mg and 10 mg tablets for oral administration. Inactive ingredients include colloidal silicon dioxide, crospovidone, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch and titanium dioxide. In addition, the 5 mg tablets also contain iron oxide red and iron oxide yellow. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "11344-416-96",
"PackageDescription": "221 mL in 1 BOTTLE, PLASTIC (11344-416-96) ",
"NDC11Code": "11344-0416-96",
"ProductNDC": "11344-416",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Hand Wash",
"NonProprietaryName": "Benzalkonium Chloride 0.13%",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170327",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Vi-Jon, LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.313",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170327",
"SamplePackage": "N",
"IndicationAndUsage": "for handwashing to decrease bacteria on the skin."
},
{
"NDCCode": "11344-460-96",
"PackageDescription": "221 mL in 1 BOTTLE, PLASTIC (11344-460-96) ",
"NDC11Code": "11344-0460-96",
"ProductNDC": "11344-460",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Hand Wash",
"NonProprietaryName": "Benzalkonium Chloride 0.13%",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160527",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Vi-Jon, LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.313",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160527",
"SamplePackage": "N",
"IndicationAndUsage": "for handwashing to decrease bacteria on the skin."
},
{
"NDCCode": "33342-313-07",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-313-07) ",
"NDC11Code": "33342-0313-07",
"ProductNDC": "33342-313",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine And Donepezil",
"NonProprietaryName": "Memantine And Donepezil",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208672",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "28; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA], N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250715",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine and donepezil hydrochlorides extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily.",
"Description": "Memantine and donepezil hydrochlorides extended-release capsules contain memantine, an orally active NMDA receptor antagonist, as the hydrochloride salt and donepezil, a reversible inhibitor of the enzyme acetylcholinesterase, as the hydrochloride salt. Memantine HydrochlorideThe chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Donepezil Hydrochloride. The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. Memantine and donepezil hydrochlorides extended-release capsules. Memantine and donepezil hydrochlorides extended-release capsules for oral administration, containing 14 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (14 mg/10 mg) or 28 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (28 mg/10 mg). All doses of memantine and donepezil hydrochlorides extended-release capsules contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropylmethyl cellulose, lactose monohydrate, microcrystalline cellulose, sugar sphere, talc. The hard gelatin capsules contain gelatin, sodium lauryl sulfate and titanium dioxide; colorants are iron oxide red (28 mg/10 mg). The black ink contains black iron oxide, propylene glycol and shellac."
},
{
"NDCCode": "33342-313-10",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-313-10) ",
"NDC11Code": "33342-0313-10",
"ProductNDC": "33342-313",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine And Donepezil",
"NonProprietaryName": "Memantine And Donepezil",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208672",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "28; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA], N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250715",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine and donepezil hydrochlorides extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily.",
"Description": "Memantine and donepezil hydrochlorides extended-release capsules contain memantine, an orally active NMDA receptor antagonist, as the hydrochloride salt and donepezil, a reversible inhibitor of the enzyme acetylcholinesterase, as the hydrochloride salt. Memantine HydrochlorideThe chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Donepezil Hydrochloride. The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. Memantine and donepezil hydrochlorides extended-release capsules. Memantine and donepezil hydrochlorides extended-release capsules for oral administration, containing 14 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (14 mg/10 mg) or 28 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (28 mg/10 mg). All doses of memantine and donepezil hydrochlorides extended-release capsules contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropylmethyl cellulose, lactose monohydrate, microcrystalline cellulose, sugar sphere, talc. The hard gelatin capsules contain gelatin, sodium lauryl sulfate and titanium dioxide; colorants are iron oxide red (28 mg/10 mg). The black ink contains black iron oxide, propylene glycol and shellac."
},
{
"NDCCode": "33342-313-56",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (33342-313-56) / 14 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "33342-0313-56",
"ProductNDC": "33342-313",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine And Donepezil",
"NonProprietaryName": "Memantine And Donepezil",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208672",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "28; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA], N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250715",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine and donepezil hydrochlorides extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily.",
"Description": "Memantine and donepezil hydrochlorides extended-release capsules contain memantine, an orally active NMDA receptor antagonist, as the hydrochloride salt and donepezil, a reversible inhibitor of the enzyme acetylcholinesterase, as the hydrochloride salt. Memantine HydrochlorideThe chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Donepezil Hydrochloride. The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. Memantine and donepezil hydrochlorides extended-release capsules. Memantine and donepezil hydrochlorides extended-release capsules for oral administration, containing 14 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (14 mg/10 mg) or 28 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (28 mg/10 mg). All doses of memantine and donepezil hydrochlorides extended-release capsules contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropylmethyl cellulose, lactose monohydrate, microcrystalline cellulose, sugar sphere, talc. The hard gelatin capsules contain gelatin, sodium lauryl sulfate and titanium dioxide; colorants are iron oxide red (28 mg/10 mg). The black ink contains black iron oxide, propylene glycol and shellac."
},
{
"NDCCode": "49035-079-96",
"PackageDescription": "750 mL in 1 BOTTLE, PLASTIC (49035-079-96) ",
"NDC11Code": "49035-0079-96",
"ProductNDC": "49035-079",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Hand Wash",
"NonProprietaryName": "Benzalkonium Chloride 0.13%",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160728",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Wal-Mart, Inc",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.313",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20160728",
"SamplePackage": "N"
},
{
"NDCCode": "42571-005-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (42571-005-05) ",
"NDC11Code": "42571-0005-05",
"ProductNDC": "42571-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130613",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090383",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130613",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin tablets are indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.",
"Description": "Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S *,4S *),-8aβ]]. The molecular formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral use contain 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin, USP and the following inactive ingredients: ascorbic acid, citric acid monohydrate, hydroxypropyl cellulose, hypromellose, iron oxide yellow (5 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized maize starch, talc, and titanium dioxide. Butylated hydroxyanisole is added as a preservative."
},
{
"NDCCode": "42571-005-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (42571-005-10) ",
"NDC11Code": "42571-0005-10",
"ProductNDC": "42571-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130613",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090383",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130613",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin tablets are indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.",
"Description": "Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S *,4S *),-8aβ]]. The molecular formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral use contain 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin, USP and the following inactive ingredients: ascorbic acid, citric acid monohydrate, hydroxypropyl cellulose, hypromellose, iron oxide yellow (5 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized maize starch, talc, and titanium dioxide. Butylated hydroxyanisole is added as a preservative."
},
{
"NDCCode": "42571-005-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (42571-005-30) ",
"NDC11Code": "42571-0005-30",
"ProductNDC": "42571-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130613",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090383",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130613",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin tablets are indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.",
"Description": "Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S *,4S *),-8aβ]]. The molecular formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral use contain 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin, USP and the following inactive ingredients: ascorbic acid, citric acid monohydrate, hydroxypropyl cellulose, hypromellose, iron oxide yellow (5 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized maize starch, talc, and titanium dioxide. Butylated hydroxyanisole is added as a preservative."
},
{
"NDCCode": "42571-005-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (42571-005-60) ",
"NDC11Code": "42571-0005-60",
"ProductNDC": "42571-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130613",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090383",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130613",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin tablets are indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.",
"Description": "Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S *,4S *),-8aβ]]. The molecular formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral use contain 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin, USP and the following inactive ingredients: ascorbic acid, citric acid monohydrate, hydroxypropyl cellulose, hypromellose, iron oxide yellow (5 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized maize starch, talc, and titanium dioxide. Butylated hydroxyanisole is added as a preservative."
},
{
"NDCCode": "42571-005-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (42571-005-90) ",
"NDC11Code": "42571-0005-90",
"ProductNDC": "42571-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130613",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090383",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130613",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin tablets are indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.",
"Description": "Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S *,4S *),-8aβ]]. The molecular formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral use contain 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin, USP and the following inactive ingredients: ascorbic acid, citric acid monohydrate, hydroxypropyl cellulose, hypromellose, iron oxide yellow (5 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized maize starch, talc, and titanium dioxide. Butylated hydroxyanisole is added as a preservative."
},
{
"NDCCode": "42571-010-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (42571-010-05) ",
"NDC11Code": "42571-0010-05",
"ProductNDC": "42571-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130613",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090383",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130613",
"SamplePackage": "N",
"IndicationAndUsage": "Simvastatin tablets are indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.",
"Description": "Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S *,4S *),-8aβ]]. The molecular formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral use contain 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin, USP and the following inactive ingredients: ascorbic acid, citric acid monohydrate, hydroxypropyl cellulose, hypromellose, iron oxide yellow (5 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized maize starch, talc, and titanium dioxide. Butylated hydroxyanisole is added as a preservative."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<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>83324-313-96</NDCCode>
<PackageDescription>96 TABLET, CHEWABLE in 1 BOTTLE (83324-313-96) </PackageDescription>
<NDC11Code>83324-0313-96</NDC11Code>
<ProductNDC>83324-313</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Quality Choice</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
<NonProprietaryName>Antacid Tablets (calcium Carbonate)</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241111</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>QUALITY CHOICE (Chain drug Marketing Assoiciation)</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: 1 heartburn, 2 sour stomach, 3 acid indigestion, 4 upset stomach associated with these symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42571-132-52</NDCCode>
<PackageDescription>96 CARTON in 1 CARTON (42571-132-52) / 1 TRAY in 1 CARTON / 8 AMPULE in 1 TRAY / 5 mL in 1 AMPULE (42571-132-21) </PackageDescription>
<NDC11Code>42571-0132-52</NDC11Code>
<ProductNDC>42571-132</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cromolyn Sodium</ProprietaryName>
<NonProprietaryName>Cromolyn Sodium</NonProprietaryName>
<DosageFormName>SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130504</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202745</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>CROMOLYN SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Decreased Histamine Release [PE], Mast Cell Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130504</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL is indicated in the management of patients with mastocytosis. Use of this product has been associated with improvement in diarrhea, flushing, headaches, vomiting, urticaria, abdominal pain, nausea, and itching in some patients.</IndicationAndUsage>
<Description>Each 5 mL ampule of Cromolyn Sodium Oral Solution (Concentrate) contains 100 mg cromolyn sodium, USP, in Water for Injection. Cromolyn sodium is a hygroscopic, white powder having little odor. It may leave a slightly bitter aftertaste. Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL is clear, colorless, and sterile. It is intended for oral use. Chemically, cromolyn sodium is disodium 5,5’-[(2-hydroxytrimethylene)dioxy]bis[4-oxo-4H-1-benzopyran-2-carboxylate]. The molecular formula is C 23H 14Na 2O 11; the molecular weight is 512.34. Its chemical structure is:. Pharmacologic Category: Mast cell stabilizer Therapeutic Category: Antiallergic.</Description>
</NDC>
<NDC>
<NDCCode>42571-346-96</NDCCode>
<PackageDescription>5 VIAL in 1 BOX (42571-346-96) / 3 mL in 1 VIAL</PackageDescription>
<NDC11Code>42571-0346-96</NDC11Code>
<ProductNDC>42571-346</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Caffeine Citrate</ProprietaryName>
<NonProprietaryName>Caffeine Citrate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213202</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>CAFFEINE CITRATE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/3mL</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260423</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Caffeine citrate is indicated for the short term treatment of apnea of prematurity in infants between 28 and <33 weeks gestational age.</IndicationAndUsage>
<Description>Caffeine Citrate Oral Solution, USP is clear, colorless, sterile, non-pyrogenic, preservative-free, aqueous solutions adjusted to pH 4.7. Each mL contains 20 mg caffeine citrate (equivalent to 10 mg of caffeine base) prepared in solution by the addition of 10 mg caffeine anhydrous to 5 mg citric acid monohydrate, 8.3 mg trisodium citrate dihydrate and Water for Injection. Caffeine USP, a central nervous system stimulant, is an odorless white crystalline powder or granule, with a bitter taste. It is sparingly soluble in water and in ethanol at room temperature. The chemical name of caffeine is 3,7-dihydro-1,3,7-trimethyl-1H-purine-2,6-dione. In the presence of citric acid it forms caffeine citrate salt in solution. The structural formula and molecular weight of caffeine citrate follows.</Description>
</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>42571-313-86</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>42571-313-87</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>42571-313-97</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>
</NDC>
<NDC>
<NDCCode>42571-470-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (42571-470-01) </PackageDescription>
<NDC11Code>42571-0470-01</NDC11Code>
<ProductNDC>42571-470</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bisoprolol</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218303</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Bisoprolol fumarate, USP is a synthetic, beta 1-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is 2-Propanol, l -[4-[[2-(1-methylethoxy)ethoxy] methyl]phenoxy]-3-[(1-methylethyl)amino] -,(±)-, (E)-2-butenedioate (2: l). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is C 40H 66N 2O 12and its structure is:. Bisoprolol fumarate, USP has a molecular weight of 766.96. It is a white or almost white, slightly hygroscopic powder which is approximately equally hydrophilic and lipophilic. It is very soluble in water and in methanol; freely soluble in glacial acetic acid, chloroform and in alcohol; and slightly soluble in acetone. Bisoprolol fumarate tablets, USP is available as 5 mg and 10 mg tablets for oral administration. Inactive ingredients include colloidal silicon dioxide, crospovidone, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch and titanium dioxide. In addition, the 5 mg tablets also contain iron oxide red and iron oxide yellow. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>42571-470-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (42571-470-05) </PackageDescription>
<NDC11Code>42571-0470-05</NDC11Code>
<ProductNDC>42571-470</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bisoprolol</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218303</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Bisoprolol fumarate, USP is a synthetic, beta 1-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is 2-Propanol, l -[4-[[2-(1-methylethoxy)ethoxy] methyl]phenoxy]-3-[(1-methylethyl)amino] -,(±)-, (E)-2-butenedioate (2: l). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is C 40H 66N 2O 12and its structure is:. Bisoprolol fumarate, USP has a molecular weight of 766.96. It is a white or almost white, slightly hygroscopic powder which is approximately equally hydrophilic and lipophilic. It is very soluble in water and in methanol; freely soluble in glacial acetic acid, chloroform and in alcohol; and slightly soluble in acetone. Bisoprolol fumarate tablets, USP is available as 5 mg and 10 mg tablets for oral administration. Inactive ingredients include colloidal silicon dioxide, crospovidone, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch and titanium dioxide. In addition, the 5 mg tablets also contain iron oxide red and iron oxide yellow. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>42571-470-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (42571-470-30) </PackageDescription>
<NDC11Code>42571-0470-30</NDC11Code>
<ProductNDC>42571-470</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bisoprolol</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218303</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Bisoprolol fumarate, USP is a synthetic, beta 1-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is 2-Propanol, l -[4-[[2-(1-methylethoxy)ethoxy] methyl]phenoxy]-3-[(1-methylethyl)amino] -,(±)-, (E)-2-butenedioate (2: l). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is C 40H 66N 2O 12and its structure is:. Bisoprolol fumarate, USP has a molecular weight of 766.96. It is a white or almost white, slightly hygroscopic powder which is approximately equally hydrophilic and lipophilic. It is very soluble in water and in methanol; freely soluble in glacial acetic acid, chloroform and in alcohol; and slightly soluble in acetone. Bisoprolol fumarate tablets, USP is available as 5 mg and 10 mg tablets for oral administration. Inactive ingredients include colloidal silicon dioxide, crospovidone, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch and titanium dioxide. In addition, the 5 mg tablets also contain iron oxide red and iron oxide yellow. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
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<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (42571-471-01) </PackageDescription>
<NDC11Code>42571-0471-01</NDC11Code>
<ProductNDC>42571-471</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bisoprolol</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218303</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Bisoprolol fumarate, USP is a synthetic, beta 1-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is 2-Propanol, l -[4-[[2-(1-methylethoxy)ethoxy] methyl]phenoxy]-3-[(1-methylethyl)amino] -,(±)-, (E)-2-butenedioate (2: l). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is C 40H 66N 2O 12and its structure is:. Bisoprolol fumarate, USP has a molecular weight of 766.96. It is a white or almost white, slightly hygroscopic powder which is approximately equally hydrophilic and lipophilic. It is very soluble in water and in methanol; freely soluble in glacial acetic acid, chloroform and in alcohol; and slightly soluble in acetone. Bisoprolol fumarate tablets, USP is available as 5 mg and 10 mg tablets for oral administration. Inactive ingredients include colloidal silicon dioxide, crospovidone, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch and titanium dioxide. In addition, the 5 mg tablets also contain iron oxide red and iron oxide yellow. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
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<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (42571-471-05) </PackageDescription>
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<ApplicationNumber>ANDA218303</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Bisoprolol fumarate, USP is a synthetic, beta 1-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is 2-Propanol, l -[4-[[2-(1-methylethoxy)ethoxy] methyl]phenoxy]-3-[(1-methylethyl)amino] -,(±)-, (E)-2-butenedioate (2: l). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is C 40H 66N 2O 12and its structure is:. Bisoprolol fumarate, USP has a molecular weight of 766.96. It is a white or almost white, slightly hygroscopic powder which is approximately equally hydrophilic and lipophilic. It is very soluble in water and in methanol; freely soluble in glacial acetic acid, chloroform and in alcohol; and slightly soluble in acetone. Bisoprolol fumarate tablets, USP is available as 5 mg and 10 mg tablets for oral administration. Inactive ingredients include colloidal silicon dioxide, crospovidone, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch and titanium dioxide. In addition, the 5 mg tablets also contain iron oxide red and iron oxide yellow. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
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<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (42571-471-30) </PackageDescription>
<NDC11Code>42571-0471-30</NDC11Code>
<ProductNDC>42571-471</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bisoprolol</ProprietaryName>
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<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218303</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Bisoprolol fumarate, USP is a synthetic, beta 1-selective (cardioselective) adrenoceptor blocking agent. The chemical name for bisoprolol fumarate is 2-Propanol, l -[4-[[2-(1-methylethoxy)ethoxy] methyl]phenoxy]-3-[(1-methylethyl)amino] -,(±)-, (E)-2-butenedioate (2: l). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is C 40H 66N 2O 12and its structure is:. Bisoprolol fumarate, USP has a molecular weight of 766.96. It is a white or almost white, slightly hygroscopic powder which is approximately equally hydrophilic and lipophilic. It is very soluble in water and in methanol; freely soluble in glacial acetic acid, chloroform and in alcohol; and slightly soluble in acetone. Bisoprolol fumarate tablets, USP is available as 5 mg and 10 mg tablets for oral administration. Inactive ingredients include colloidal silicon dioxide, crospovidone, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch and titanium dioxide. In addition, the 5 mg tablets also contain iron oxide red and iron oxide yellow. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
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<NDC11Code>11344-0416-96</NDC11Code>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Hand Wash</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride 0.13%</NonProprietaryName>
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<RouteName>TOPICAL</RouteName>
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<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Vi-Jon, LLC</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.313</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170327</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for handwashing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
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<PackageDescription>221 mL in 1 BOTTLE, PLASTIC (11344-460-96) </PackageDescription>
<NDC11Code>11344-0460-96</NDC11Code>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Hand Wash</ProprietaryName>
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<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160527</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Vi-Jon, LLC</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.313</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-02-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for handwashing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>33342-313-07</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-313-07) </PackageDescription>
<NDC11Code>33342-0313-07</NDC11Code>
<ProductNDC>33342-313</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine And Donepezil</ProprietaryName>
<NonProprietaryName>Memantine And Donepezil</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208672</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>28; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA], N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine and donepezil hydrochlorides extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily.</IndicationAndUsage>
<Description>Memantine and donepezil hydrochlorides extended-release capsules contain memantine, an orally active NMDA receptor antagonist, as the hydrochloride salt and donepezil, a reversible inhibitor of the enzyme acetylcholinesterase, as the hydrochloride salt. Memantine HydrochlorideThe chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Donepezil Hydrochloride. The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. Memantine and donepezil hydrochlorides extended-release capsules. Memantine and donepezil hydrochlorides extended-release capsules for oral administration, containing 14 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (14 mg/10 mg) or 28 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (28 mg/10 mg). All doses of memantine and donepezil hydrochlorides extended-release capsules contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropylmethyl cellulose, lactose monohydrate, microcrystalline cellulose, sugar sphere, talc. The hard gelatin capsules contain gelatin, sodium lauryl sulfate and titanium dioxide; colorants are iron oxide red (28 mg/10 mg). The black ink contains black iron oxide, propylene glycol and shellac.</Description>
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<ApplicationNumber>ANDA208672</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
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<StrengthNumber>28; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA], N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-17</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine and donepezil hydrochlorides extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily.</IndicationAndUsage>
<Description>Memantine and donepezil hydrochlorides extended-release capsules contain memantine, an orally active NMDA receptor antagonist, as the hydrochloride salt and donepezil, a reversible inhibitor of the enzyme acetylcholinesterase, as the hydrochloride salt. Memantine HydrochlorideThe chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Donepezil Hydrochloride. The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. Memantine and donepezil hydrochlorides extended-release capsules. Memantine and donepezil hydrochlorides extended-release capsules for oral administration, containing 14 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (14 mg/10 mg) or 28 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (28 mg/10 mg). All doses of memantine and donepezil hydrochlorides extended-release capsules contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropylmethyl cellulose, lactose monohydrate, microcrystalline cellulose, sugar sphere, talc. The hard gelatin capsules contain gelatin, sodium lauryl sulfate and titanium dioxide; colorants are iron oxide red (28 mg/10 mg). The black ink contains black iron oxide, propylene glycol and shellac.</Description>
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<PackageDescription>10 BLISTER PACK in 1 CARTON (33342-313-56) / 14 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
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<ProductNDC>33342-313</ProductNDC>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208672</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
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<StrengthNumber>28; 10</StrengthNumber>
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<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA], N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
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<LastUpdate>2025-07-17</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine and donepezil hydrochlorides extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily.</IndicationAndUsage>
<Description>Memantine and donepezil hydrochlorides extended-release capsules contain memantine, an orally active NMDA receptor antagonist, as the hydrochloride salt and donepezil, a reversible inhibitor of the enzyme acetylcholinesterase, as the hydrochloride salt. Memantine HydrochlorideThe chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Donepezil Hydrochloride. The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. Memantine and donepezil hydrochlorides extended-release capsules. Memantine and donepezil hydrochlorides extended-release capsules for oral administration, containing 14 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (14 mg/10 mg) or 28 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (28 mg/10 mg). All doses of memantine and donepezil hydrochlorides extended-release capsules contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropylmethyl cellulose, lactose monohydrate, microcrystalline cellulose, sugar sphere, talc. The hard gelatin capsules contain gelatin, sodium lauryl sulfate and titanium dioxide; colorants are iron oxide red (28 mg/10 mg). The black ink contains black iron oxide, propylene glycol and shellac.</Description>
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<PackageDescription>750 mL in 1 BOTTLE, PLASTIC (49035-079-96) </PackageDescription>
<NDC11Code>49035-0079-96</NDC11Code>
<ProductNDC>49035-079</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Hand Wash</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride 0.13%</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160728</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Wal-Mart, Inc</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.313</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>42571-005-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (42571-005-05) </PackageDescription>
<NDC11Code>42571-0005-05</NDC11Code>
<ProductNDC>42571-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130613</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090383</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Simvastatin tablets are indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S *,4S *),-8aβ]]. The molecular formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral use contain 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin, USP and the following inactive ingredients: ascorbic acid, citric acid monohydrate, hydroxypropyl cellulose, hypromellose, iron oxide yellow (5 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized maize starch, talc, and titanium dioxide. Butylated hydroxyanisole is added as a preservative.</Description>
</NDC>
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<NDCCode>42571-005-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (42571-005-10) </PackageDescription>
<NDC11Code>42571-0005-10</NDC11Code>
<ProductNDC>42571-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130613</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090383</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Simvastatin tablets are indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S *,4S *),-8aβ]]. The molecular formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral use contain 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin, USP and the following inactive ingredients: ascorbic acid, citric acid monohydrate, hydroxypropyl cellulose, hypromellose, iron oxide yellow (5 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized maize starch, talc, and titanium dioxide. Butylated hydroxyanisole is added as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>42571-005-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (42571-005-30) </PackageDescription>
<NDC11Code>42571-0005-30</NDC11Code>
<ProductNDC>42571-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130613</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090383</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Simvastatin tablets are indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S *,4S *),-8aβ]]. The molecular formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral use contain 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin, USP and the following inactive ingredients: ascorbic acid, citric acid monohydrate, hydroxypropyl cellulose, hypromellose, iron oxide yellow (5 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized maize starch, talc, and titanium dioxide. Butylated hydroxyanisole is added as a preservative.</Description>
</NDC>
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<PackageDescription>60 TABLET in 1 BOTTLE (42571-005-60) </PackageDescription>
<NDC11Code>42571-0005-60</NDC11Code>
<ProductNDC>42571-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130613</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090383</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Simvastatin tablets are indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S *,4S *),-8aβ]]. The molecular formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral use contain 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin, USP and the following inactive ingredients: ascorbic acid, citric acid monohydrate, hydroxypropyl cellulose, hypromellose, iron oxide yellow (5 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized maize starch, talc, and titanium dioxide. Butylated hydroxyanisole is added as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>42571-005-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (42571-005-90) </PackageDescription>
<NDC11Code>42571-0005-90</NDC11Code>
<ProductNDC>42571-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130613</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090383</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Simvastatin tablets are indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S *,4S *),-8aβ]]. The molecular formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral use contain 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin, USP and the following inactive ingredients: ascorbic acid, citric acid monohydrate, hydroxypropyl cellulose, hypromellose, iron oxide yellow (5 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized maize starch, talc, and titanium dioxide. Butylated hydroxyanisole is added as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>42571-010-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (42571-010-05) </PackageDescription>
<NDC11Code>42571-0010-05</NDC11Code>
<ProductNDC>42571-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130613</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090383</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Simvastatin tablets are indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S *,4S *),-8aβ]]. The molecular formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets, USP for oral use contain 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin, USP and the following inactive ingredients: ascorbic acid, citric acid monohydrate, hydroxypropyl cellulose, hypromellose, iron oxide yellow (5 mg), lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized maize starch, talc, and titanium dioxide. Butylated hydroxyanisole is added as a preservative.</Description>
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