{
"NDC": [
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{
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},
{
"NDCCode": "0603-0823-58",
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"ProductNDC": "0603-0823",
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},
{
"NDCCode": "0603-0823-81",
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"ProductNDC": "0603-0823",
"ProductTypeName": "HUMAN OTC DRUG",
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"LabelerName": "Qualitest Pharmaceuticals",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2019-11-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19971201",
"EndMarketingDatePackage": "20191031",
"SamplePackage": "N"
},
{
"NDCCode": "0603-0839-94",
"PackageDescription": "118 mL in 1 BOTTLE, PLASTIC (0603-0839-94)",
"NDC11Code": "00603-0839-94",
"ProductNDC": "0603-0839",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Childrens Qpap",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19980301",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Qualitest Pharmaceuticals",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "160",
"StrengthUnit": "mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0603-0840-94",
"PackageDescription": "118 mL in 1 BOTTLE, PLASTIC (0603-0840-94)",
"NDC11Code": "00603-0840-94",
"ProductNDC": "0603-0840",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Childrens Qpap",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "SOLUTION",
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"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Qualitest Pharmaceuticals",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "160",
"StrengthUnit": "mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0603-0851-94",
"PackageDescription": "118 mL in 1 BOTTLE, PLASTIC (0603-0851-94)",
"NDC11Code": "00603-0851-94",
"ProductNDC": "0603-0851",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Q Tapp Cold And Allergy",
"NonProprietaryName": "Brompheniramine Maleate And Pseudoephedrine Hcl",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20020403",
"EndMarketingDate": "20170930",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Qualitest Pharmaceuticals",
"SubstanceName": "BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "1; 15",
"StrengthUnit": "mg/5mL; mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2017-10-03"
},
{
"NDCCode": "0603-0852-94",
"PackageDescription": "118 mL in 1 BOTTLE, PLASTIC (0603-0852-94)",
"NDC11Code": "00603-0852-94",
"ProductNDC": "0603-0852",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Q Tapp Cold And Cough",
"NonProprietaryName": "Brompheniramine Maleate And Dextromethorphan Hbr And Pseudoephedrine Hcl",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
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"EndMarketingDate": "20180131",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Qualitest Pharmaceuticals",
"SubstanceName": "BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "1; 5; 15",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2018-02-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0603-0855-94",
"PackageDescription": "118 mL in 1 BOTTLE, PLASTIC (0603-0855-94)",
"NDC11Code": "00603-0855-94",
"ProductNDC": "0603-0855",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Q Tussin Dm",
"NonProprietaryName": "Dextromethorphan Hbr And Guaifenesin",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "19950401",
"EndMarketingDate": "20180331",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Qualitest Pharmaceuticals",
"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
"StrengthNumber": "10; 100",
"StrengthUnit": "mg/5mL; mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2018-04-03",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0603-0857-94",
"PackageDescription": "118 mL in 1 BOTTLE, PLASTIC (0603-0857-94)",
"NDC11Code": "00603-0857-94",
"ProductNDC": "0603-0857",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Qtussin",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19971001",
"EndMarketingDate": "20180720",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Qualitest Pharmaceuticals",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "0603-0863-94",
"PackageDescription": "118 mL in 1 BOTTLE, PLASTIC (0603-0863-94)",
"NDC11Code": "00603-0863-94",
"ProductNDC": "0603-0863",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Q-tapp",
"NonProprietaryName": "Brompheniramine Maleate And Pseudoephedrine Hydrochloride",
"DosageFormName": "ELIXIR",
"RouteName": "ORAL",
"StartMarketingDate": "20010405",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Qualitest Pharmaceuticals",
"SubstanceName": "BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "1; 15",
"StrengthUnit": "mg/5mL; mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0603-0864-94",
"PackageDescription": "118 mL in 1 BOTTLE, PLASTIC (0603-0864-94)",
"NDC11Code": "00603-0864-94",
"ProductNDC": "0603-0864",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Q-tapp Dm Elixir",
"NonProprietaryName": "Brompheniramine Maleate And Pseudoephedrine Hydrochloride And Dextromethorphan Hydrobromide",
"DosageFormName": "ELIXIR",
"RouteName": "ORAL",
"StartMarketingDate": "20010405",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Qualitest Pharmaceuticals",
"SubstanceName": "BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "1; 15; 5",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2016-12-14"
},
{
"NDCCode": "37000-603-94",
"PackageDescription": "946 mL in 1 BAG (37000-603-94) ",
"NDC11Code": "37000-0603-94",
"ProductNDC": "37000-603",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Safeguard",
"ProprietaryNameSuffix": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100701",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "64",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20201207",
"SamplePackage": "N"
},
{
"NDCCode": "31722-603-12",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (31722-603-12) ",
"NDC11Code": "31722-0603-12",
"ProductNDC": "31722-603",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lopinavir And Ritonavir",
"NonProprietaryName": "Lopinavir And Ritonavir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210607",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091677",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "LOPINAVIR; RITONAVIR",
"StrengthNumber": "100; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]",
"Status": "Active",
"LastUpdate": "2021-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210607",
"SamplePackage": "N",
"IndicationAndUsage": "Lopinavir and ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: Genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir tablets. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir tablets [see Microbiology (12.4)].",
"Description": "Lopinavir and Ritonavir Tablets, USP is a co-formulation of lopinavir USP and ritonavir USP. Lopinavir USP is an inhibitor of the HIV-1 protease. As co-formulated in lopinavir and ritonavir, ritonavir USP inhibits the CYP3A-mediated metabolism of lopinavir USP, thereby providing increased plasma levels of lopinavir USP. Lopinavir USP is chemically designated as [1 S-[1 R*, ( R*),3 R*,4 R*]]- N-[4-[[(2,6-dimethylphenoxy) acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2 H)-pyrimidineacetamide. Its molecular formula is C 37H 48N 4O 5, and its molecular weight is 628.80. Lopinavir USP is a white to off-white powder. It is practically insoluble in water, freely soluble in methanol, ethanol and in isopropyl alcohol. Lopinavir USP has the following structural formula:. Ritonavir USP is chemically designated as 2,4,7,12-tetraazatridecan-13-oic acid, 10-hydroxy-2-methyl-5-(1-methylethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C 37H 48N 6O 5S 2, and its molecular weight is 720.94. Ritonavir USP is a white to off-white powder. It is freely soluble in methanol, methylene chloride, sparingly soluble in acetonitrile and practically insoluble in water. Ritonavir USP has the following structural formula:. Lopinavir and ritonavir film coated tablets USP are available for oral administration in two strengths: Yellow tablets containing 200 mg of lopinavir USP and 50 mg of ritonavir USP Yellow tablets containing 100 mg of lopinavir USP and 25 mg of ritonavir USP The yellow, 200 mg lopinavir/50 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide. The yellow, 100 mg lopinavir/25 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide."
},
{
"NDCCode": "31722-603-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (31722-603-60) ",
"NDC11Code": "31722-0603-60",
"ProductNDC": "31722-603",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lopinavir And Ritonavir",
"NonProprietaryName": "Lopinavir And Ritonavir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210607",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091677",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "LOPINAVIR; RITONAVIR",
"StrengthNumber": "100; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]",
"Status": "Active",
"LastUpdate": "2021-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210607",
"SamplePackage": "N",
"IndicationAndUsage": "Lopinavir and ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: Genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir tablets. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir tablets [see Microbiology (12.4)].",
"Description": "Lopinavir and Ritonavir Tablets, USP is a co-formulation of lopinavir USP and ritonavir USP. Lopinavir USP is an inhibitor of the HIV-1 protease. As co-formulated in lopinavir and ritonavir, ritonavir USP inhibits the CYP3A-mediated metabolism of lopinavir USP, thereby providing increased plasma levels of lopinavir USP. Lopinavir USP is chemically designated as [1 S-[1 R*, ( R*),3 R*,4 R*]]- N-[4-[[(2,6-dimethylphenoxy) acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2 H)-pyrimidineacetamide. Its molecular formula is C 37H 48N 4O 5, and its molecular weight is 628.80. Lopinavir USP is a white to off-white powder. It is practically insoluble in water, freely soluble in methanol, ethanol and in isopropyl alcohol. Lopinavir USP has the following structural formula:. Ritonavir USP is chemically designated as 2,4,7,12-tetraazatridecan-13-oic acid, 10-hydroxy-2-methyl-5-(1-methylethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C 37H 48N 6O 5S 2, and its molecular weight is 720.94. Ritonavir USP is a white to off-white powder. It is freely soluble in methanol, methylene chloride, sparingly soluble in acetonitrile and practically insoluble in water. Ritonavir USP has the following structural formula:. Lopinavir and ritonavir film coated tablets USP are available for oral administration in two strengths: Yellow tablets containing 200 mg of lopinavir USP and 50 mg of ritonavir USP Yellow tablets containing 100 mg of lopinavir USP and 25 mg of ritonavir USP The yellow, 200 mg lopinavir/50 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide. The yellow, 100 mg lopinavir/25 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide."
},
{
"NDCCode": "0173-0823-18",
"PackageDescription": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0173-0823-18) ",
"NDC11Code": "00173-0823-18",
"ProductNDC": "0173-0823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rythmol",
"ProprietaryNameSuffix": "Sr",
"NonProprietaryName": "Propafenone Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110317",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021416",
"LabelerName": "GlaxoSmithKline LLC",
"SubstanceName": "PROPAFENONE HYDROCHLORIDE",
"StrengthNumber": "225",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110317",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N",
"IndicationAndUsage": "RYTHMOL SR is indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations: 1 The use of RYTHMOL SR in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use RYTHMOL SR to control ventricular rate during AF., 2 Some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional atrioventricular (AV) nodal refractory period is recommended., 3 The effect of propafenone on mortality has not been determined [see Boxed Warning].",
"Description": "RYTHMOL SR (propafenone hydrochloride) is an antiarrhythmic drug supplied in extended-release capsules of 225, 325, and 425 mg for oral administration. Chemically, propafenone hydrochloride is 2’-[2-hydroxy-3-(propylamino)-propoxy]-3-phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3HCl. Propafenone HCl has some structural similarities to beta-blocking agents. The structural formula of propafenone HCl is given below. Propafenone HCl occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20°C), chloroform, and ethanol. RYTHMOL SR capsules are filled with cylindrical-shaped 2 x 2 mm microtablets containing propafenone and the following inactive ingredients: antifoam, gelatin, hypromellose, magnesium stearate, red iron oxide, shellac, sodium dodecyl sulfate, sodium lauryl sulfate, soy lecithin, and titanium dioxide."
},
{
"NDCCode": "0220-0823-41",
"PackageDescription": "6 [hp_C] in 1 TUBE (0220-0823-41) ",
"NDC11Code": "00220-0823-41",
"ProductNDC": "0220-0823",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Benzoicum Acidum",
"NonProprietaryName": "Benzoic Acid",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "19830303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Boiron",
"SubstanceName": "BENZOIC ACID",
"StrengthNumber": "6",
"StrengthUnit": "[hp_C]/6[hp_C]",
"Pharm_Classes": "Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19830303",
"SamplePackage": "N",
"IndicationAndUsage": "Relieves minor arthritis pain in the wrists *. Uses: See symptoms on front panel."
},
{
"NDCCode": "0245-0823-04",
"PackageDescription": "28 BLISTER PACK in 1 CARTON (0245-0823-04) / 1 TABLET in 1 BLISTER PACK (0245-0823-89) ",
"NDC11Code": "00245-0823-04",
"ProductNDC": "0245-0823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Torpenz",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214182",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251021",
"SamplePackage": "N",
"IndicationAndUsage": "1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer. TORPENZ tablets are indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole.",
"Description": "TORPENZ (everolimus) tablets are a kinase inhibitor. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy- 15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.0 4,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.2 g/mol. The structural formula is:. TORPENZ tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate."
},
{
"NDCCode": "0245-0823-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (0245-0823-30) ",
"NDC11Code": "00245-0823-30",
"ProductNDC": "0245-0823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Torpenz",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20211001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214182",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240624",
"SamplePackage": "N",
"IndicationAndUsage": "1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer. TORPENZ tablets are indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole.",
"Description": "TORPENZ (everolimus) tablets are a kinase inhibitor. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy- 15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.0 4,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.2 g/mol. The structural formula is:. TORPENZ tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate."
},
{
"NDCCode": "0268-0823-05",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (0268-0823-05) ",
"NDC11Code": "00268-0823-05",
"ProductNDC": "0268-0823",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Aspergillus Fumigatus",
"NonProprietaryName": "Aspergillus Fumigatus",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19650101",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103753",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "ASPERGILLUS FUMIGATUS",
"StrengthNumber": ".02",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Non-Standardized Fungal Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19650101",
"SamplePackage": "N"
},
{
"NDCCode": "0363-0823-34",
"PackageDescription": "1 TUBE in 1 CARTON (0363-0823-34) > 14 g in 1 TUBE",
"NDC11Code": "00363-0823-34",
"ProductNDC": "0363-0823",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Triple Antibiotic With Pain Relief",
"ProprietaryNameSuffix": "Maximum Strength",
"NonProprietaryName": "Bacitracin Zinc,neomycin Sulfate, Polymyxin B Sulfate, Pramoxine Hydrochloride",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100312",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "Walgreen Company",
"SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "500; 3.5; 10000; 10",
"StrengthUnit": "[USP'U]/g; mg/g; [USP'U]/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2017-12-20",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0363-0823-56",
"PackageDescription": "1 TUBE in 1 CARTON (0363-0823-56) > 28 g in 1 TUBE",
"NDC11Code": "00363-0823-56",
"ProductNDC": "0363-0823",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Triple Antibiotic With Pain Relief",
"ProprietaryNameSuffix": "Maximum Strength",
"NonProprietaryName": "Bacitracin Zinc,neomycin Sulfate, Polymyxin B Sulfate, Pramoxine Hydrochloride",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100312",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "Walgreen Company",
"SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "500; 3.5; 10000; 10",
"StrengthUnit": "[USP'U]/g; mg/g; [USP'U]/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-05-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20100312",
"SamplePackage": "N"
},
{
"NDCCode": "0574-0823-01",
"PackageDescription": "1 VIAL in 1 CARTON (0574-0823-01) > 3 mL in 1 VIAL (0574-0823-81)",
"NDC11Code": "00574-0823-01",
"ProductNDC": "0574-0823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Caffeine Citrate",
"NonProprietaryName": "Caffeine Citrate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20060921",
"EndMarketingDate": "20150831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077233",
"LabelerName": "Paddock Laboratories, LLC",
"SubstanceName": "CAFFEINE CITRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2015-09-04"
},
{
"NDCCode": "0713-0823-75",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (0713-0823-75) ",
"NDC11Code": "00713-0823-75",
"ProductNDC": "0713-0823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promethazine Hydrochloride And Codeine Phosphate",
"NonProprietaryName": "Promethazine Hydrochloride And Codeine Phosphate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20251219",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200386",
"LabelerName": "Cosette Pharmaceuticals, Inc.",
"SubstanceName": "PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE",
"StrengthNumber": "6.25; 10",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS]",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251219",
"SamplePackage": "N",
"IndicationAndUsage": "Promethazine HCl and Codeine Phosphate Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older. Important Limitations of Use: 1 Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)]., 2 Contraindicated in pediatric patients under 12 years of age [see Contraindications (4), Use in Specific Populations (8.4)]., 3 Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see Contraindications (4), Use in Specific Populations (8.4)]., 4 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve Promethazine HCl and Codeine Phosphate Oral Solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.",
"Description": "Promethazine HCl and Codeine Phosphate Oral Solution contains codeine, an opioid agonist, and promethazine, a phenothiazine. Each 5 mL of Promethazine HCl and Codeine Phosphate Oral Solution contains 10 mg of codeine phosphate and 6.25 mg of promethazine hydrochloride for oral administration. Promethazine HCl and Codeine Phosphate Oral Solution has a pH between 4.8 and 5.4 and contains alcohol 8% (v/v). Promethazine HCl and Codeine Phosphate Oral Solution also contains the following inactive ingredients: anhydrous citric acid, ascorbic acid, D&C Red # 33, edetate disodium, FD&C Blue #1, methylparaben, peach-mint flavor, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate anhydrous, sodium metabisulfite, sucrose. Codeine PhosphateThe chemical name for codeine phosphate is 7,8-Didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate. Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy, it is classified pharmacologically as a narcotic analgesic. The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. The molecular weight is 406.37. Its molecular formula is C18H21NO3H3PO4 ½ H2O, and it has the following chemical structure. Promethazine HydrochlorideThe chemical name for promethazine hydrochloride, a phenothiazine derivative, is (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. The molecular weight is 320.88. Its molecular formula is C17H20N2SHCl, and it has the following chemical structure."
},
{
"NDCCode": "10135-823-05",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-05) ",
"NDC11Code": "10135-0823-05",
"ProductNDC": "10135-823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202306",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260901",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin Hydrochloride Extended-Release Tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Metformin Hydrochloride Extended-Release Tablets contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below:. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets, USP contains 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin Hydrochloride Extended-Release Tablets USP, 500 mg contain the inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose and povidone. Metformin Hydrochloride Extended-Release Tablets USP, 750 mg contain the inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, red iron oxide and yellow iron oxide. System Components and Performance – Metformin Hydrochloride Extended-Release Tablets USP is based on a hydrophilic polymer matrix drug delivery system. On oral administration, fluid from the gastrointestinal tract wets and penetrates the matrix leading to the formation of a hydrogel and swelling of the polymer matrix. Drug is released slowly over time in a controlled manner, independent of pH, by a process of drug dissolution followed by drug diffusion through the hydrogel barrier formed and gradual matrix erosion. Metformin Hydrochloride Extended-Release Tablets USP meets USP Dissolution Test 6."
},
{
"NDCCode": "10135-823-10",
"PackageDescription": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-10) ",
"NDC11Code": "10135-0823-10",
"ProductNDC": "10135-823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202306",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260901",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin Hydrochloride Extended-Release Tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Metformin Hydrochloride Extended-Release Tablets contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below:. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets, USP contains 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin Hydrochloride Extended-Release Tablets USP, 500 mg contain the inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose and povidone. Metformin Hydrochloride Extended-Release Tablets USP, 750 mg contain the inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, red iron oxide and yellow iron oxide. System Components and Performance – Metformin Hydrochloride Extended-Release Tablets USP is based on a hydrophilic polymer matrix drug delivery system. On oral administration, fluid from the gastrointestinal tract wets and penetrates the matrix leading to the formation of a hydrogel and swelling of the polymer matrix. Drug is released slowly over time in a controlled manner, independent of pH, by a process of drug dissolution followed by drug diffusion through the hydrogel barrier formed and gradual matrix erosion. Metformin Hydrochloride Extended-Release Tablets USP meets USP Dissolution Test 6."
},
{
"NDCCode": "10135-823-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-30) ",
"NDC11Code": "10135-0823-30",
"ProductNDC": "10135-823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202306",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260901",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin Hydrochloride Extended-Release Tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Metformin Hydrochloride Extended-Release Tablets contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below:. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets, USP contains 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin Hydrochloride Extended-Release Tablets USP, 500 mg contain the inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose and povidone. Metformin Hydrochloride Extended-Release Tablets USP, 750 mg contain the inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, red iron oxide and yellow iron oxide. System Components and Performance – Metformin Hydrochloride Extended-Release Tablets USP is based on a hydrophilic polymer matrix drug delivery system. On oral administration, fluid from the gastrointestinal tract wets and penetrates the matrix leading to the formation of a hydrogel and swelling of the polymer matrix. Drug is released slowly over time in a controlled manner, independent of pH, by a process of drug dissolution followed by drug diffusion through the hydrogel barrier formed and gradual matrix erosion. Metformin Hydrochloride Extended-Release Tablets USP meets USP Dissolution Test 6."
},
{
"NDCCode": "10135-823-32",
"PackageDescription": "180 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-32) ",
"NDC11Code": "10135-0823-32",
"ProductNDC": "10135-823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202306",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260901",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin Hydrochloride Extended-Release Tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Metformin Hydrochloride Extended-Release Tablets contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below:. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets, USP contains 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin Hydrochloride Extended-Release Tablets USP, 500 mg contain the inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose and povidone. Metformin Hydrochloride Extended-Release Tablets USP, 750 mg contain the inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, red iron oxide and yellow iron oxide. System Components and Performance – Metformin Hydrochloride Extended-Release Tablets USP is based on a hydrophilic polymer matrix drug delivery system. On oral administration, fluid from the gastrointestinal tract wets and penetrates the matrix leading to the formation of a hydrogel and swelling of the polymer matrix. Drug is released slowly over time in a controlled manner, independent of pH, by a process of drug dissolution followed by drug diffusion through the hydrogel barrier formed and gradual matrix erosion. Metformin Hydrochloride Extended-Release Tablets USP meets USP Dissolution Test 6."
},
{
"NDCCode": "10135-823-33",
"PackageDescription": "360 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-33) ",
"NDC11Code": "10135-0823-33",
"ProductNDC": "10135-823",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202306",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260901",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin Hydrochloride Extended-Release Tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
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{
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"Description": "Metformin Hydrochloride Extended-Release Tablets contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below:. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets, USP contains 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin Hydrochloride Extended-Release Tablets USP, 500 mg contain the inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose and povidone. Metformin Hydrochloride Extended-Release Tablets USP, 750 mg contain the inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, red iron oxide and yellow iron oxide. System Components and Performance – Metformin Hydrochloride Extended-Release Tablets USP is based on a hydrophilic polymer matrix drug delivery system. On oral administration, fluid from the gastrointestinal tract wets and penetrates the matrix leading to the formation of a hydrogel and swelling of the polymer matrix. Drug is released slowly over time in a controlled manner, independent of pH, by a process of drug dissolution followed by drug diffusion through the hydrogel barrier formed and gradual matrix erosion. Metformin Hydrochloride Extended-Release Tablets USP meets USP Dissolution Test 6."
}
]
}
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<ProprietaryName>Safeguard</ProprietaryName>
<ProprietaryNameSuffix>Hand Sanitizer</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>64</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<NonProprietaryName>Lopinavir And Ritonavir</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20210607</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091677</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LOPINAVIR; RITONAVIR</SubstanceName>
<StrengthNumber>100; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-06-08</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Lopinavir and ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: Genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir tablets. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir tablets [see Microbiology (12.4)].</IndicationAndUsage>
<Description>Lopinavir and Ritonavir Tablets, USP is a co-formulation of lopinavir USP and ritonavir USP. Lopinavir USP is an inhibitor of the HIV-1 protease. As co-formulated in lopinavir and ritonavir, ritonavir USP inhibits the CYP3A-mediated metabolism of lopinavir USP, thereby providing increased plasma levels of lopinavir USP. Lopinavir USP is chemically designated as [1 S-[1 R*, ( R*),3 R*,4 R*]]- N-[4-[[(2,6-dimethylphenoxy) acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2 H)-pyrimidineacetamide. Its molecular formula is C 37H 48N 4O 5, and its molecular weight is 628.80. Lopinavir USP is a white to off-white powder. It is practically insoluble in water, freely soluble in methanol, ethanol and in isopropyl alcohol. Lopinavir USP has the following structural formula:. Ritonavir USP is chemically designated as 2,4,7,12-tetraazatridecan-13-oic acid, 10-hydroxy-2-methyl-5-(1-methylethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C 37H 48N 6O 5S 2, and its molecular weight is 720.94. Ritonavir USP is a white to off-white powder. It is freely soluble in methanol, methylene chloride, sparingly soluble in acetonitrile and practically insoluble in water. Ritonavir USP has the following structural formula:. Lopinavir and ritonavir film coated tablets USP are available for oral administration in two strengths: Yellow tablets containing 200 mg of lopinavir USP and 50 mg of ritonavir USP Yellow tablets containing 100 mg of lopinavir USP and 25 mg of ritonavir USP The yellow, 200 mg lopinavir/50 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide. The yellow, 100 mg lopinavir/25 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide.</Description>
</NDC>
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<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (31722-603-60) </PackageDescription>
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<ProductNDC>31722-603</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lopinavir And Ritonavir</ProprietaryName>
<NonProprietaryName>Lopinavir And Ritonavir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210607</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091677</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LOPINAVIR; RITONAVIR</SubstanceName>
<StrengthNumber>100; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inducers [MoA], Cytochrome P450 3A Inhibitor [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], HIV Protease Inhibitors [MoA], HIV Protease Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protease Inhibitor [EPC], Protease Inhibitor [EPC], UDP Glucuronosyltransferases Inducers [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210607</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lopinavir and ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 14 days and older. Limitations of Use: Genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir tablets. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir tablets [see Microbiology (12.4)].</IndicationAndUsage>
<Description>Lopinavir and Ritonavir Tablets, USP is a co-formulation of lopinavir USP and ritonavir USP. Lopinavir USP is an inhibitor of the HIV-1 protease. As co-formulated in lopinavir and ritonavir, ritonavir USP inhibits the CYP3A-mediated metabolism of lopinavir USP, thereby providing increased plasma levels of lopinavir USP. Lopinavir USP is chemically designated as [1 S-[1 R*, ( R*),3 R*,4 R*]]- N-[4-[[(2,6-dimethylphenoxy) acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-alpha-(1-methylethyl)-2-oxo-1(2 H)-pyrimidineacetamide. Its molecular formula is C 37H 48N 4O 5, and its molecular weight is 628.80. Lopinavir USP is a white to off-white powder. It is practically insoluble in water, freely soluble in methanol, ethanol and in isopropyl alcohol. Lopinavir USP has the following structural formula:. Ritonavir USP is chemically designated as 2,4,7,12-tetraazatridecan-13-oic acid, 10-hydroxy-2-methyl-5-(1-methylethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-dioxo-8,11-bis(phenylmethyl)-5-thiazolylmethyl ester, [5S-(5R*,8R*,10R*,11R*)]. Its molecular formula is C 37H 48N 6O 5S 2, and its molecular weight is 720.94. Ritonavir USP is a white to off-white powder. It is freely soluble in methanol, methylene chloride, sparingly soluble in acetonitrile and practically insoluble in water. Ritonavir USP has the following structural formula:. Lopinavir and ritonavir film coated tablets USP are available for oral administration in two strengths: Yellow tablets containing 200 mg of lopinavir USP and 50 mg of ritonavir USP Yellow tablets containing 100 mg of lopinavir USP and 25 mg of ritonavir USP The yellow, 200 mg lopinavir/50 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide. The yellow, 100 mg lopinavir/25 mg ritonavir, tablets contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate, sorbitan monolaurate and opadry yellow which contains colloidal anhydrous silica, hypromellose, hydroxypropyl cellulose, iron oxide yellow, polyethylene glycol, polysorbate 80, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0173-0823-18</NDCCode>
<PackageDescription>60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0173-0823-18) </PackageDescription>
<NDC11Code>00173-0823-18</NDC11Code>
<ProductNDC>0173-0823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rythmol</ProprietaryName>
<ProprietaryNameSuffix>Sr</ProprietaryNameSuffix>
<NonProprietaryName>Propafenone Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110317</StartMarketingDate>
<EndMarketingDate>20241231</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021416</ApplicationNumber>
<LabelerName>GlaxoSmithKline LLC</LabelerName>
<SubstanceName>PROPAFENONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>225</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110317</StartMarketingDatePackage>
<EndMarketingDatePackage>20241231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RYTHMOL SR is indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations: 1 The use of RYTHMOL SR in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use RYTHMOL SR to control ventricular rate during AF., 2 Some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional atrioventricular (AV) nodal refractory period is recommended., 3 The effect of propafenone on mortality has not been determined [see Boxed Warning].</IndicationAndUsage>
<Description>RYTHMOL SR (propafenone hydrochloride) is an antiarrhythmic drug supplied in extended-release capsules of 225, 325, and 425 mg for oral administration. Chemically, propafenone hydrochloride is 2’-[2-hydroxy-3-(propylamino)-propoxy]-3-phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3HCl. Propafenone HCl has some structural similarities to beta-blocking agents. The structural formula of propafenone HCl is given below. Propafenone HCl occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20°C), chloroform, and ethanol. RYTHMOL SR capsules are filled with cylindrical-shaped 2 x 2 mm microtablets containing propafenone and the following inactive ingredients: antifoam, gelatin, hypromellose, magnesium stearate, red iron oxide, shellac, sodium dodecyl sulfate, sodium lauryl sulfate, soy lecithin, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0220-0823-41</NDCCode>
<PackageDescription>6 [hp_C] in 1 TUBE (0220-0823-41) </PackageDescription>
<NDC11Code>00220-0823-41</NDC11Code>
<ProductNDC>0220-0823</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Benzoicum Acidum</ProprietaryName>
<NonProprietaryName>Benzoic Acid</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19830303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Boiron</LabelerName>
<SubstanceName>BENZOIC ACID</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_C]/6[hp_C]</StrengthUnit>
<Pharm_Classes>Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19830303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Relieves minor arthritis pain in the wrists *. Uses: See symptoms on front panel.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0245-0823-04</NDCCode>
<PackageDescription>28 BLISTER PACK in 1 CARTON (0245-0823-04) / 1 TABLET in 1 BLISTER PACK (0245-0823-89) </PackageDescription>
<NDC11Code>00245-0823-04</NDC11Code>
<ProductNDC>0245-0823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Torpenz</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214182</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251021</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer. TORPENZ tablets are indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole.</IndicationAndUsage>
<Description>TORPENZ (everolimus) tablets are a kinase inhibitor. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy- 15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.0 4,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.2 g/mol. The structural formula is:. TORPENZ tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>0245-0823-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0245-0823-30) </PackageDescription>
<NDC11Code>00245-0823-30</NDC11Code>
<ProductNDC>0245-0823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Torpenz</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214182</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240624</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer. TORPENZ tablets are indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole.</IndicationAndUsage>
<Description>TORPENZ (everolimus) tablets are a kinase inhibitor. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy- 15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.0 4,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C 53H 83NO 14and the molecular weight is 958.2 g/mol. The structural formula is:. TORPENZ tablets for oral administration contains 2.5 mg, 5 mg, 7.5 mg, or 10 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>0268-0823-05</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (0268-0823-05) </PackageDescription>
<NDC11Code>00268-0823-05</NDC11Code>
<ProductNDC>0268-0823</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Aspergillus Fumigatus</ProprietaryName>
<NonProprietaryName>Aspergillus Fumigatus</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19650101</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>ASPERGILLUS FUMIGATUS</SubstanceName>
<StrengthNumber>.02</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19650101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0363-0823-34</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0363-0823-34) > 14 g in 1 TUBE</PackageDescription>
<NDC11Code>00363-0823-34</NDC11Code>
<ProductNDC>0363-0823</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Triple Antibiotic With Pain Relief</ProprietaryName>
<ProprietaryNameSuffix>Maximum Strength</ProprietaryNameSuffix>
<NonProprietaryName>Bacitracin Zinc,neomycin Sulfate, Polymyxin B Sulfate, Pramoxine Hydrochloride</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100312</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>Walgreen Company</LabelerName>
<SubstanceName>BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500; 3.5; 10000; 10</StrengthNumber>
<StrengthUnit>[USP'U]/g; mg/g; [USP'U]/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-20</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0363-0823-56</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0363-0823-56) > 28 g in 1 TUBE</PackageDescription>
<NDC11Code>00363-0823-56</NDC11Code>
<ProductNDC>0363-0823</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Triple Antibiotic With Pain Relief</ProprietaryName>
<ProprietaryNameSuffix>Maximum Strength</ProprietaryNameSuffix>
<NonProprietaryName>Bacitracin Zinc,neomycin Sulfate, Polymyxin B Sulfate, Pramoxine Hydrochloride</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100312</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>Walgreen Company</LabelerName>
<SubstanceName>BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500; 3.5; 10000; 10</StrengthNumber>
<StrengthUnit>[USP'U]/g; mg/g; [USP'U]/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-05-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0574-0823-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0574-0823-01) > 3 mL in 1 VIAL (0574-0823-81)</PackageDescription>
<NDC11Code>00574-0823-01</NDC11Code>
<ProductNDC>0574-0823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Caffeine Citrate</ProprietaryName>
<NonProprietaryName>Caffeine Citrate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20060921</StartMarketingDate>
<EndMarketingDate>20150831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077233</ApplicationNumber>
<LabelerName>Paddock Laboratories, LLC</LabelerName>
<SubstanceName>CAFFEINE CITRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-09-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>0713-0823-75</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (0713-0823-75) </PackageDescription>
<NDC11Code>00713-0823-75</NDC11Code>
<ProductNDC>0713-0823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promethazine Hydrochloride And Codeine Phosphate</ProprietaryName>
<NonProprietaryName>Promethazine Hydrochloride And Codeine Phosphate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251219</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200386</ApplicationNumber>
<LabelerName>Cosette Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>6.25; 10</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Promethazine HCl and Codeine Phosphate Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older. Important Limitations of Use: 1 Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)]., 2 Contraindicated in pediatric patients under 12 years of age [see Contraindications (4), Use in Specific Populations (8.4)]., 3 Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see Contraindications (4), Use in Specific Populations (8.4)]., 4 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve Promethazine HCl and Codeine Phosphate Oral Solution for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.</IndicationAndUsage>
<Description>Promethazine HCl and Codeine Phosphate Oral Solution contains codeine, an opioid agonist, and promethazine, a phenothiazine. Each 5 mL of Promethazine HCl and Codeine Phosphate Oral Solution contains 10 mg of codeine phosphate and 6.25 mg of promethazine hydrochloride for oral administration. Promethazine HCl and Codeine Phosphate Oral Solution has a pH between 4.8 and 5.4 and contains alcohol 8% (v/v). Promethazine HCl and Codeine Phosphate Oral Solution also contains the following inactive ingredients: anhydrous citric acid, ascorbic acid, D&C Red # 33, edetate disodium, FD&C Blue #1, methylparaben, peach-mint flavor, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate anhydrous, sodium metabisulfite, sucrose. Codeine PhosphateThe chemical name for codeine phosphate is 7,8-Didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate. Codeine is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy, it is classified pharmacologically as a narcotic analgesic. The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate is freely soluble in water and slightly soluble in alcohol. The molecular weight is 406.37. Its molecular formula is C18H21NO3H3PO4 ½ H2O, and it has the following chemical structure. Promethazine HydrochlorideThe chemical name for promethazine hydrochloride, a phenothiazine derivative, is (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. The molecular weight is 320.88. Its molecular formula is C17H20N2SHCl, and it has the following chemical structure.</Description>
</NDC>
<NDC>
<NDCCode>10135-823-05</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-823-05) </PackageDescription>
<NDC11Code>10135-0823-05</NDC11Code>
<ProductNDC>10135-823</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202306</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin Hydrochloride Extended-Release Tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
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<Description>Metformin Hydrochloride Extended-Release Tablets contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below:. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets, USP contains 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin Hydrochloride Extended-Release Tablets USP, 500 mg contain the inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose and povidone. Metformin Hydrochloride Extended-Release Tablets USP, 750 mg contain the inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, red iron oxide and yellow iron oxide. System Components and Performance – Metformin Hydrochloride Extended-Release Tablets USP is based on a hydrophilic polymer matrix drug delivery system. On oral administration, fluid from the gastrointestinal tract wets and penetrates the matrix leading to the formation of a hydrogel and swelling of the polymer matrix. Drug is released slowly over time in a controlled manner, independent of pH, by a process of drug dissolution followed by drug diffusion through the hydrogel barrier formed and gradual matrix erosion. Metformin Hydrochloride Extended-Release Tablets USP meets USP Dissolution Test 6.</Description>
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<Description>Metformin Hydrochloride Extended-Release Tablets contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below:. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets, USP contains 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin Hydrochloride Extended-Release Tablets USP, 500 mg contain the inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose and povidone. Metformin Hydrochloride Extended-Release Tablets USP, 750 mg contain the inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, red iron oxide and yellow iron oxide. System Components and Performance – Metformin Hydrochloride Extended-Release Tablets USP is based on a hydrophilic polymer matrix drug delivery system. On oral administration, fluid from the gastrointestinal tract wets and penetrates the matrix leading to the formation of a hydrogel and swelling of the polymer matrix. Drug is released slowly over time in a controlled manner, independent of pH, by a process of drug dissolution followed by drug diffusion through the hydrogel barrier formed and gradual matrix erosion. Metformin Hydrochloride Extended-Release Tablets USP meets USP Dissolution Test 6.</Description>
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