{
"NDC": [
{
"NDCCode": "68788-0435-8",
"PackageDescription": "120 TABLET in 1 BOTTLE (68788-0435-8) ",
"NDC11Code": "68788-0435-08",
"ProductNDC": "68788-0435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075967",
"LabelerName": "Preferred Pharmaceuticals, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "850",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC],Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-10-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20110118",
"SamplePackage": "N"
},
{
"NDCCode": "58118-0435-8",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (58118-0435-8)",
"NDC11Code": "58118-0435-08",
"ProductNDC": "58118-0435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090603",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079148",
"LabelerName": "Clinical Solutions Wholesale",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "850",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC],Biguanides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-08-08"
},
{
"NDCCode": "71335-0435-8",
"PackageDescription": "6 CAPSULE in 1 BOTTLE (71335-0435-8) ",
"NDC11Code": "71335-0435-08",
"ProductNDC": "71335-0435",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Diphenhydramine Hydrochloride",
"NonProprietaryName": "Diphenhydramine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20090102",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191114",
"SamplePackage": "N",
"IndicationAndUsage": "25 MG: 1 Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nosesneezingitchy, watery eyesitchy throat and nose, 2 Temporarily relieves these symptoms due to the common cold: runny nosesneezing."
},
{
"NDCCode": "68788-0435-1",
"PackageDescription": "100 TABLET in 1 BOTTLE (68788-0435-1) ",
"NDC11Code": "68788-0435-01",
"ProductNDC": "68788-0435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075967",
"LabelerName": "Preferred Pharmaceuticals, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "850",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC],Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-10-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20110118",
"SamplePackage": "N"
},
{
"NDCCode": "68788-0435-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (68788-0435-3) ",
"NDC11Code": "68788-0435-03",
"ProductNDC": "68788-0435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075967",
"LabelerName": "Preferred Pharmaceuticals, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "850",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC],Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-10-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20110118",
"SamplePackage": "N"
},
{
"NDCCode": "68788-0435-6",
"PackageDescription": "60 TABLET in 1 BOTTLE (68788-0435-6) ",
"NDC11Code": "68788-0435-06",
"ProductNDC": "68788-0435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075967",
"LabelerName": "Preferred Pharmaceuticals, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "850",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC],Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-10-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20110118",
"SamplePackage": "N"
},
{
"NDCCode": "68788-0435-9",
"PackageDescription": "90 TABLET in 1 BOTTLE (68788-0435-9) ",
"NDC11Code": "68788-0435-09",
"ProductNDC": "68788-0435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075967",
"LabelerName": "Preferred Pharmaceuticals, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "850",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC],Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-10-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20110118",
"SamplePackage": "N"
},
{
"NDCCode": "0597-0435-96",
"PackageDescription": "1 BAG in 1 CARTON (0597-0435-96) / 60 PELLET in 1 BAG",
"NDC11Code": "00597-0435-96",
"ProductNDC": "0597-0435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pradaxa",
"NonProprietaryName": "Dabigatran Etexilate",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220316",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214358",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
"SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220316",
"SamplePackage": "N",
"IndicationAndUsage": "PRADAXA Oral Pellets are a direct thrombin inhibitor indicated: : 1 For the treatment of venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.1), 2 To reduce the risk of recurrence of VTE in pediatric patients aged 3 months to less than 12 years of age who have been previously treated (1.2).",
"Description": "PRADAXA Oral Pellets contain dabigatran etexilate mesylate, a direct thrombin inhibitor. The chemical name of dabigatran etexilate mesylate is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate and it has a molecular formula of C34H41N7O5 ∙ CH4O3S and molecular weight of 723.86 for the mesylate salt and 627.75 for the free base. The structural formula is. Dabigatran etexilate mesylate is a yellow-white to yellow powder. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. A saturated solution in pure water has a solubility of 1.8 mg/mL. Each packet of PRADAXA Oral Pellets contains 20 mg, 30 mg, 40 mg, 50 mg, 110 mg, or 150 mg dabigatran etexilate (equivalent to 23.06 mg, 34.59 mg, 46.12 mg, 57.65 mg, 126.83 mg, or 172.95 mg dabigatran etexilate mesylate) along with the following inactive ingredients: acacia, dimethicone, hydroxypropyl cellulose, hypromellose, talc, and tartaric acid."
},
{
"NDCCode": "43742-0435-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43742-0435-1) ",
"NDC11Code": "43742-0435-01",
"ProductNDC": "43742-0435",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "B Complex Mix",
"NonProprietaryName": "Magnesium Orotate, Beta Vulgaris, Ascorbic Acid, Citricum Acidum, Cysteinum, Pulsatilla (vulgaris), Adenine, Amygdalin, Adenosinum Triphosphoricum Dinatrum, Cholinum, Cyanocobalamin, Folic Acid, Inositol, Niacin, P-aminobenzoic Acid, Pangamic Acid, Pantothenic Acid, Pyridoxinum Hydrochloricum, Riboflavinum, Sulphur, Thiaminum Hydrochloricum, Natrum Oxalaceticum, Oroticum Acidum, Manganum Phosphoricum, Mutabile Bacillus (bach), Morgan Bacillus (pure)",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20141008",
"EndMarketingDate": "20211025",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Deseret Biologicals, Inc.",
"SubstanceName": "MAGNESIUM OROTATE; BETA VULGARIS; ASCORBIC ACID; ANHYDROUS CITRIC ACID; CYSTEINE; PULSATILLA VULGARIS; ADENINE; AMYGDALIN; ADENOSINE TRIPHOSPHATE DISODIUM; CHOLINE HYDROXIDE; CYANOCOBALAMIN; FOLIC ACID; INOSITOL; NIACIN; AMINOBENZOIC ACID; PANGAMIC ACID; PANTOTHENIC ACID; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SULFUR; THIAMINE HYDROCHLORIDE; SODIUM DIETHYL OXALACETATE; OROTIC ACID MONOHYDRATE; MANGANESE PHOSPHATE, DIBASIC; ESCHERICHIA COLI; PROTEUS MORGANII",
"StrengthNumber": "12; 2; 3; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 7; 8; 10; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2021-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20141008",
"EndMarketingDatePackage": "20211025",
"SamplePackage": "N"
},
{
"NDCCode": "44567-435-24",
"PackageDescription": "24 POUCH in 1 CARTON (44567-435-24) / 1 BAG in 1 POUCH / 50 mL in 1 BAG",
"NDC11Code": "44567-0435-24",
"ProductNDC": "44567-435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20160414",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090343",
"LabelerName": "WG Critical Care, LLC",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160414",
"SamplePackage": "N",
"IndicationAndUsage": "Levofloxacin Injection in 5% dextrose is indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Levofloxacin Injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form).",
"Description": "Levofloxacin Injection is a synthetic broad-spectrum antibacterial agent for intravenous administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4- benzoxazine-6-carboxylic acid hemihydrate. Figure 1 : The Chemical Structure of Levofloxacin. The empirical formula is C18H20FN3O4 ● ½ H2O and the molecular weight is 370.38. Levofloxacin is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg per mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg per mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg per mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3>Cu+2>Zn+2>Mg+2>Ca+2."
},
{
"NDCCode": "52959-435-02",
"PackageDescription": "120 TABLET in 1 BOTTLE (52959-435-02)",
"NDC11Code": "52959-0435-02",
"ProductNDC": "52959-435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methadone Hydrochloride",
"NonProprietaryName": "Methadone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090519",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040517",
"LabelerName": "H.J. Harkins Company Inc.",
"SubstanceName": "METHADONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the treatment of moderate to severe pain not responsive to non-narcotic analgesics. For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.",
"Description": "Methadone Hydrochloride Tablets USP for oral administration, each contain 5 mg or 10 mg of methadone hydrochloride. Methadone hydrochloride is a white, crystalline material that is water-soluble. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-heptanone hydrochloride. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. The tablets also contain lactose monohydrate, magnesium stearate, microcrystalline cellulose and silicon dioxide."
},
{
"NDCCode": "52959-435-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (52959-435-30)",
"NDC11Code": "52959-0435-30",
"ProductNDC": "52959-435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methadone Hydrochloride",
"NonProprietaryName": "Methadone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090519",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040517",
"LabelerName": "H.J. Harkins Company Inc.",
"SubstanceName": "METHADONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the treatment of moderate to severe pain not responsive to non-narcotic analgesics. For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.",
"Description": "Methadone Hydrochloride Tablets USP for oral administration, each contain 5 mg or 10 mg of methadone hydrochloride. Methadone hydrochloride is a white, crystalline material that is water-soluble. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-heptanone hydrochloride. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. The tablets also contain lactose monohydrate, magnesium stearate, microcrystalline cellulose and silicon dioxide."
},
{
"NDCCode": "52959-435-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (52959-435-60)",
"NDC11Code": "52959-0435-60",
"ProductNDC": "52959-435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methadone Hydrochloride",
"NonProprietaryName": "Methadone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090519",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040517",
"LabelerName": "H.J. Harkins Company Inc.",
"SubstanceName": "METHADONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the treatment of moderate to severe pain not responsive to non-narcotic analgesics. For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.",
"Description": "Methadone Hydrochloride Tablets USP for oral administration, each contain 5 mg or 10 mg of methadone hydrochloride. Methadone hydrochloride is a white, crystalline material that is water-soluble. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-heptanone hydrochloride. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. The tablets also contain lactose monohydrate, magnesium stearate, microcrystalline cellulose and silicon dioxide."
},
{
"NDCCode": "52959-435-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (52959-435-90)",
"NDC11Code": "52959-0435-90",
"ProductNDC": "52959-435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methadone Hydrochloride",
"NonProprietaryName": "Methadone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090519",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040517",
"LabelerName": "H.J. Harkins Company Inc.",
"SubstanceName": "METHADONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the treatment of moderate to severe pain not responsive to non-narcotic analgesics. For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.",
"Description": "Methadone Hydrochloride Tablets USP for oral administration, each contain 5 mg or 10 mg of methadone hydrochloride. Methadone hydrochloride is a white, crystalline material that is water-soluble. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-heptanone hydrochloride. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. The tablets also contain lactose monohydrate, magnesium stearate, microcrystalline cellulose and silicon dioxide."
},
{
"NDCCode": "57297-435-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (57297-435-01) > 2.5 mL in 1 BOTTLE",
"NDC11Code": "57297-0435-01",
"ProductNDC": "57297-435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gatifloxacin",
"NonProprietaryName": "Gatifloxacin",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20131001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202653",
"LabelerName": "LUPIN LIMITED",
"SubstanceName": "GATIFLOXACIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Quinolone Antimicrobial [EPC],Quinolones [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Gatifloxacin ophthalmic solution, 0.5% is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms. Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group*, Streptococcus oralis*, Streptococcus pneumoniae. *Efficacy for this organism was studied in fewer than 10 infections. (1).",
"Description": "Gatifloxacin ophthalmic solution, 0.5% is an 8-methoxyfluoroquinolone anti-infective for the treatment of bacterial conjunctivitis. Its chemical name is (±) 1-Cyclopropyl-6-fluoro-8- methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid. Its molecular formula is C19H22FN3O4 and its molecular weight is 375.40. Its chemical structure is. Gatifloxacin ophthalmic solution, 0.5% is a pale yellow colored transparent, sterile, liquid with an osmolality of 260 to 330 mOsm/kg and a pH of 5.1 to 5.7. Each mL of gatifloxacin ophthalmic solution, 0.5% contains Active: gatifloxacin 0.5% (5 mg) Preservative: benzalkonium chloride 0.005% Inactives: edetate disodium, water for injection and sodium chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH."
},
{
"NDCCode": "60687-435-21",
"PackageDescription": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-435-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-435-11) ",
"NDC11Code": "60687-0435-21",
"ProductNDC": "60687-435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clarithromycin",
"NonProprietaryName": "Clarithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203584",
"LabelerName": "American Health Packaging",
"SubstanceName": "CLARITHROMYCIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200129",
"EndMarketingDatePackage": "20270630",
"SamplePackage": "N",
"IndicationAndUsage": "Clarithromycin is a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: 1 Acute Bacterial Exacerbation of Chronic Bronchitis in Adults ( 1.1) , 2 Acute Maxillary Sinusitis ( 1.2) , 3 Community-Acquired Pneumonia ( 1.3) , 4 Pharyngitis/Tonsillitis ( 1.4) , 5 Uncomplicated Skin and Skin Structure Infections ( 1.5) , 6 Acute Otitis Media in Pediatric Patients ( 1.6) , 7 Treatment and Prophylaxis of Disseminated Mycobacterial Infections ( 1.7) , 8 Helicobacter pylori Infection and Duodenal Ulcer Disease in Adults ( 1.8) .",
"Description": "Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6- 0-methylerythromycin. The molecular formula is C 38H 69NO 13, and the molecular weight is 747.96. The structural formula is:. Figure 1: Structure of Clarithromycin. Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water. Each white to off-white oval film-coated immediate-release clarithromycin tablet, USP contains 250 mg or 500 mg of clarithromycin and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, hypromellose, titanium dioxide and polyethylene glycol."
},
{
"NDCCode": "61919-435-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (61919-435-30) ",
"NDC11Code": "61919-0435-30",
"ProductNDC": "61919-435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nortriptyline Hydrochloride",
"NonProprietaryName": "Nortriptyline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074132",
"LabelerName": "Direct Rx",
"SubstanceName": "NORTRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150101",
"SamplePackage": "N",
"IndicationAndUsage": "Nortriptyline hydrochloride capsules are indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.",
"Description": "Nortriptyline hydrochloride, USP is 1-Propanamine, 3-(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is as follows. C19H21NHCl M.W. 299.8. Nortriptyline hydrochloride, USP is a white to off-white powder, having a slight, characteristic odor. It is soluble in water and in chloroform; sparingly soluble in methanol; and practically insoluble in most organic solvents. Each capsule, for oral administration, contains nortriptyline hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg or 75 mg nortriptyline. In addition, each capsule contains the following inactive ingredients: corn starch, D&C Yellow #10 aluminum lake, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, gelatin, iron oxide black, methylparaben, propylene glycol, propylparaben, shellac glaze, silicone fluid, sodium lauryl sulfate, and titanium dioxide. The 10 mg, 25 mg and 75 mg capsules also contain D&C Yellow #10, FD&C Blue #1, and FD&C Yellow #6."
},
{
"NDCCode": "61919-435-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (61919-435-60) ",
"NDC11Code": "61919-0435-60",
"ProductNDC": "61919-435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nortriptyline Hydrochloride",
"NonProprietaryName": "Nortriptyline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074132",
"LabelerName": "Direct Rx",
"SubstanceName": "NORTRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150101",
"SamplePackage": "N",
"IndicationAndUsage": "Nortriptyline hydrochloride capsules are indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.",
"Description": "Nortriptyline hydrochloride, USP is 1-Propanamine, 3-(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is as follows. C19H21NHCl M.W. 299.8. Nortriptyline hydrochloride, USP is a white to off-white powder, having a slight, characteristic odor. It is soluble in water and in chloroform; sparingly soluble in methanol; and practically insoluble in most organic solvents. Each capsule, for oral administration, contains nortriptyline hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg or 75 mg nortriptyline. In addition, each capsule contains the following inactive ingredients: corn starch, D&C Yellow #10 aluminum lake, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, gelatin, iron oxide black, methylparaben, propylene glycol, propylparaben, shellac glaze, silicone fluid, sodium lauryl sulfate, and titanium dioxide. The 10 mg, 25 mg and 75 mg capsules also contain D&C Yellow #10, FD&C Blue #1, and FD&C Yellow #6."
},
{
"NDCCode": "61919-435-90",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (61919-435-90) ",
"NDC11Code": "61919-0435-90",
"ProductNDC": "61919-435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nortriptyline Hydrochloride",
"NonProprietaryName": "Nortriptyline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074132",
"LabelerName": "Direct Rx",
"SubstanceName": "NORTRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150101",
"SamplePackage": "N",
"IndicationAndUsage": "Nortriptyline hydrochloride capsules are indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.",
"Description": "Nortriptyline hydrochloride, USP is 1-Propanamine, 3-(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is as follows. C19H21NHCl M.W. 299.8. Nortriptyline hydrochloride, USP is a white to off-white powder, having a slight, characteristic odor. It is soluble in water and in chloroform; sparingly soluble in methanol; and practically insoluble in most organic solvents. Each capsule, for oral administration, contains nortriptyline hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg or 75 mg nortriptyline. In addition, each capsule contains the following inactive ingredients: corn starch, D&C Yellow #10 aluminum lake, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, gelatin, iron oxide black, methylparaben, propylene glycol, propylparaben, shellac glaze, silicone fluid, sodium lauryl sulfate, and titanium dioxide. The 10 mg, 25 mg and 75 mg capsules also contain D&C Yellow #10, FD&C Blue #1, and FD&C Yellow #6."
},
{
"NDCCode": "64980-435-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (64980-435-01) ",
"NDC11Code": "64980-0435-01",
"ProductNDC": "64980-435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Midodrine Hydrochloride",
"NonProprietaryName": "Midodrine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207613",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "MIDODRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190401",
"SamplePackage": "N",
"IndicationAndUsage": "Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets can cause marked elevation of supine blood pressure (BP > 200 mmHg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. The indication is based on midodrine hydrochloride tablets's effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine hydrochloride tablets, principally improved ability to perform life activities, have not been established. Further clinical trials are underway to verify and describe the clinical benefits of midodrine hydrochloride tablets. After initiation of treatment, midodrine hydrochloride tablets should be continued only for patients who report significant symptomatic improvement.",
"Description": "Name: Midodrine Hydrochloride Tablets Dosage Form: 2.5-mg, 5-mg and 10-mg tablets for oral administration Active Ingredient: Midodrine hydrochloride, 2.5 mg, 5 mg and 10 mg Inactive Ingredients: Colloidal Silicon Dioxide NF, Croscarmellose Sodium NF, Magnesium Stearate NF, Microcrystalline Cellulose NF, Pregelatinized Starch NF and Sodium Lauryl Sulfate NF. Pharmacological Classification: Vasopressor/Antihypotensive Chemical Names (USAN: Midodrine Hydrochloride): (1) Acetamide, 2-amino-N-[2-(2,5dimethoxyphenyl)-2-hydroxyethyl]-monohydrochloride, (±)-; (2) (±)-2-amino-N-(ß-hydroxy-2,5-dimethoxyphenethyl) acetamide monohydrochloride BAN, INN, JAN: Midodrine Structural formula. Molecular formula: C12H18N2O4HCl; Molecular Weight: 290.7 Organoleptic Properties: White to off-white powder Solubility: Water: Soluble Methanol: Sparingly soluble pKa: 7.8 (0.3% aqueous solution) pH: 3.5 to 5.5 (5% aqueous solution) Melting Range: 200 to 203°C."
},
{
"NDCCode": "66184-435-01",
"PackageDescription": "30 mL in 1 CONTAINER (66184-435-01)",
"NDC11Code": "66184-0435-01",
"ProductNDC": "66184-435",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ck One 3-in-1 Face Makeup",
"ProprietaryNameSuffix": "With Spf 8 Sunscreen",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Coty US LLC",
"SubstanceName": "TITANIUM DIOXIDE; OCTINOXATE",
"StrengthNumber": "7.5; .6",
"StrengthUnit": "mL/30mL; mL/30mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "66184-435-02",
"PackageDescription": "30 mL in 1 BOX (66184-435-02)",
"NDC11Code": "66184-0435-02",
"ProductNDC": "66184-435",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ck One 3-in-1 Face Makeup",
"ProprietaryNameSuffix": "With Spf 8 Sunscreen",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Coty US LLC",
"SubstanceName": "TITANIUM DIOXIDE; OCTINOXATE",
"StrengthNumber": "7.5; .6",
"StrengthUnit": "mL/30mL; mL/30mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "66184-435-03",
"PackageDescription": "10 mL in 1 BOTTLE (66184-435-03)",
"NDC11Code": "66184-0435-03",
"ProductNDC": "66184-435",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ck One 3-in-1 Face Makeup",
"ProprietaryNameSuffix": "With Spf 8 Sunscreen",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Coty US LLC",
"SubstanceName": "TITANIUM DIOXIDE; OCTINOXATE",
"StrengthNumber": "7.5; .6",
"StrengthUnit": "mL/30mL; mL/30mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "69367-435-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69367-435-30) ",
"NDC11Code": "69367-0435-30",
"ProductNDC": "69367-435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paliperidone",
"NonProprietaryName": "Paliperidone",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20251209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218755",
"LabelerName": "Westminster Pharmaceuticals, LLC",
"SubstanceName": "PALIPERIDONE",
"StrengthNumber": "9",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251209",
"SamplePackage": "N",
"IndicationAndUsage": "Paliperidone Extended-Release Tablets are an atypical antipsychotic agent indicated for Treatment of schizophrenia (1.1): 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. (14.1), 2 Adolescents (ages 12–17): Efficacy was established in one 6-week trial. (14.1).",
"Description": "Paliperidone Extended-Release Tablets contains paliperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone Extended-Release Tablets contains a racemic mixture of (+)- and (-)-paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4Hpyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C23H27FN4O3 and its molecular weight is 426.49. The structural formula is. Paliperidone is sparingly soluble in 0.1N HCl and in methylene chloride; practically insoluble in water, in 0.1N NaOH and hexane; and slightly soluble in N, N-dimethyl formamide and in Tetrahydrofuran. Paliperidone Extended-Release Tablets are intended for oral administration and are available in 1.5 mg (blue), 3 mg (white), 6 mg (yellow), and 9 mg (beige) strengths. Paliperidone Extended-Release Tablets utilizes Osmotic Drug delivery (OROS, Push-Pull technology) system. Inactive ingredients are hydroxypropyl cellulose, butylated hydroxytoluene, polyethylene oxide, talc, sodium chloride, colloidal silicon dioxide, sodium stearyl fumarate, iron oxide red, cellulose acetate, polyethylene glycol, polyvinyl alcohol, and titanium dioxide. The 1.5 mg tablets also contain F D & C blue # 2 and the 6 mg, and 9 mg tablets also contain iron oxide yellow. The imprinting ink contains shellac, black iron oxide, propylene glycol, and ammonium hydroxide. Delivery System Components and Performance. Paliperidone Extended-Release Tablets uses osmotic pressure to deliver paliperidone at a controlled rate. The tablets contain an osmotically active bi-layer core tablet that consists of a drug layer containing the entire amount of active ingredient in a hydrophilic polymer matrix and a push layer that contains an osmotic agent in a hydrophilic, swell-able polymer matrix. The bi-layer core tablet is coated with a releasecontrolling semi-permeable membrane (SPM). The SPM allows water permeation into the core without allowing components to quickly dissipate from the core. A laser-drilled aperture is present on the drug layer side of the SPM-coated tablet and is necessary for delivery. The tablets contain a water-soluble cosmetic over-coating that is imprinted with an identifier. Once ingested, the cosmetic over-coating rapidly dissipates in the gastrointestinal tract. The SPM allows water to penetrate into the core as the osmotic agent in the push layer provides a driving force for water influx. Once hydrated, the swell-able polymer matrix in the push layer (high molecular weight polyethylene oxide) expands, exerting a pressure on the drug layer portion of the core tablet which forces it out of the laser-drilled aperture in a plug-flow fashion. As the release rate is controlled by the rate of water influx into the core (SPM permeability), the delivery is independent of pH or gastrointestinal motility. The biologically inert tablet core, containing residual push layer components, remains intact and is eliminated in the feces. Drug absorption is controlled by a combination of drug release from the tablet and subsequent dissolution in the gastrointestinal tract."
},
{
"NDCCode": "71288-435-87",
"PackageDescription": "10 SYRINGE in 1 CARTON (71288-435-87) / .8 mL in 1 SYRINGE (71288-435-86) ",
"NDC11Code": "71288-0435-87",
"ProductNDC": "71288-435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enoxaparin Sodium",
"NonProprietaryName": "Enoxaparin Sodium",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20191201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206834",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "ENOXAPARIN SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Heparin, Low-Molecular-Weight [CS], Low Molecular Weight Heparin [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191201",
"SamplePackage": "N",
"IndicationAndUsage": "Enoxaparin Sodium Injection is a low molecular weight heparin (LMWH) indicated for: : 1 Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness (1.1) , 2 Inpatient treatment of acute DVT with or without pulmonary embolism (1.2) , 3 Outpatient treatment of acute DVT without pulmonary embolism (1.2) , 4 Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction (MI) (1.3) , 5 Treatment of acute ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention (PCI) (1.4) .",
"Description": "Enoxaparin Sodium Injection, USP is a sterile aqueous solution containing enoxaparin sodium, a low molecular weight heparin. The pH of the injection is 5.5 to 7.5. Enoxaparin sodium is obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa. Its structure is characterized by a 2-O-sulfo-4-enepyranosuronic acid group at the non-reducing end and a 2-N,6-O-disulfo-D-glucosamine at the reducing end of the chain. About 20% (ranging between 15% and 25%) of the enoxaparin structure contains a 1,6-anhydro derivative on the reducing end of the polysaccharide chain. The drug substance is the sodium salt. The average molecular weight is about 4,500 daltons. The molecular weight distribution is. STRUCTURAL FORMULA. Enoxaparin Sodium Injection, USP 100 mg per mL Concentration contains 10 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1,000 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. Enoxaparin Sodium Injection, USP 150 mg per mL Concentration contains 15 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1,500 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. The Enoxaparin Sodium Injection, USP prefilled syringes and graduated prefilled syringes are preservative-free and intended for use only as a single-dose injection [see Dosage and Administration (2) and How Supplied/Storage and Handling (16)]."
},
{
"NDCCode": "71288-435-92",
"PackageDescription": "10 SYRINGE in 1 CARTON (71288-435-92) / .8 mL in 1 SYRINGE (71288-435-91) ",
"NDC11Code": "71288-0435-92",
"ProductNDC": "71288-435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Enoxaparin Sodium",
"NonProprietaryName": "Enoxaparin Sodium",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20191201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206834",
"LabelerName": "Meitheal Pharmaceuticals Inc.",
"SubstanceName": "ENOXAPARIN SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Heparin, Low-Molecular-Weight [CS], Low Molecular Weight Heparin [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191201",
"SamplePackage": "N",
"IndicationAndUsage": "Enoxaparin Sodium Injection is a low molecular weight heparin (LMWH) indicated for: : 1 Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness (1.1) , 2 Inpatient treatment of acute DVT with or without pulmonary embolism (1.2) , 3 Outpatient treatment of acute DVT without pulmonary embolism (1.2) , 4 Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction (MI) (1.3) , 5 Treatment of acute ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention (PCI) (1.4) .",
"Description": "Enoxaparin Sodium Injection, USP is a sterile aqueous solution containing enoxaparin sodium, a low molecular weight heparin. The pH of the injection is 5.5 to 7.5. Enoxaparin sodium is obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa. Its structure is characterized by a 2-O-sulfo-4-enepyranosuronic acid group at the non-reducing end and a 2-N,6-O-disulfo-D-glucosamine at the reducing end of the chain. About 20% (ranging between 15% and 25%) of the enoxaparin structure contains a 1,6-anhydro derivative on the reducing end of the polysaccharide chain. The drug substance is the sodium salt. The average molecular weight is about 4,500 daltons. The molecular weight distribution is. STRUCTURAL FORMULA. Enoxaparin Sodium Injection, USP 100 mg per mL Concentration contains 10 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1,000 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. Enoxaparin Sodium Injection, USP 150 mg per mL Concentration contains 15 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1,500 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. The Enoxaparin Sodium Injection, USP prefilled syringes and graduated prefilled syringes are preservative-free and intended for use only as a single-dose injection [see Dosage and Administration (2) and How Supplied/Storage and Handling (16)]."
},
{
"NDCCode": "72205-435-01",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72205-435-01) ",
"NDC11Code": "72205-0435-01",
"ProductNDC": "72205-435",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"NonProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260406",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211479",
"LabelerName": "Novadoz Pharmaceuticals LLC",
"SubstanceName": "DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "5; 1000",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260409",
"SamplePackage": "N",
"IndicationAndUsage": "Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.",
"Description": "Dapagliflozin and metformin HCl extended-release tablets contain two oral antihyperglycemic medications used in the management of type 2 diabetes: dapagliflozin and metformin hydrochloride USP.DapagliflozinDapagliflozin is described chemically as(1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl] phenyl]-D-glucitol. The molecular formula is C21H25ClO6 and the formula weight is 408.88. The structural formula is:. Metformin hydrochloride USPMetformin hydrochloride USP (1, 1-Dimethylbiguanide Hydrochloride) is a white crystals with a molecular formula of C4H11N5.HCl and a molecular weight of 165.62. Metformin hydrochloride USP is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene chloride. The pKa of metformin is 2.8 and 11.5. The pH of a 5% solution of metformin hydrochloride USP is 6 to 7. The structural formula is:. Dapagliflozin and metformin HCl extended-release Dapagliflozin and metformin HCl extended-release is available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin hydrochloride USP which is equivalent to 389.9 mg metformin base (Dapagliflozin and metformin HCl extended-release 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin hydrochloride USP which is equivalent to 779.86 mg metformin base (Dapagliflozin and metformin HCl extended-release 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin hydrochloride USP which is equivalent to 389.9 mg metformin base (Dapagliflozin and metformin HCl extended-release 10 mg/500 mg), or 10 mg dapagliflozin and 1,000 mg metformin hydrochloride USP which is equivalent to 779.86 mg metformin base (Dapagliflozin and metformin HCl extended-release 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release contains the following inactive ingredients: crospovidone, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium carboxy methyl cellulose and sodium lauryl sulfate. The film coatings contain the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, iron oxide red and iron oxide black."
},
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"IndicationAndUsage": "Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.",
"Description": "Dapagliflozin and metformin HCl extended-release tablets contain two oral antihyperglycemic medications used in the management of type 2 diabetes: dapagliflozin and metformin hydrochloride USP.DapagliflozinDapagliflozin is described chemically as(1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl] phenyl]-D-glucitol. The molecular formula is C21H25ClO6 and the formula weight is 408.88. The structural formula is:. Metformin hydrochloride USPMetformin hydrochloride USP (1, 1-Dimethylbiguanide Hydrochloride) is a white crystals with a molecular formula of C4H11N5.HCl and a molecular weight of 165.62. Metformin hydrochloride USP is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene chloride. The pKa of metformin is 2.8 and 11.5. The pH of a 5% solution of metformin hydrochloride USP is 6 to 7. The structural formula is:. Dapagliflozin and metformin HCl extended-release Dapagliflozin and metformin HCl extended-release is available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin hydrochloride USP which is equivalent to 389.9 mg metformin base (Dapagliflozin and metformin HCl extended-release 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin hydrochloride USP which is equivalent to 779.86 mg metformin base (Dapagliflozin and metformin HCl extended-release 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin hydrochloride USP which is equivalent to 389.9 mg metformin base (Dapagliflozin and metformin HCl extended-release 10 mg/500 mg), or 10 mg dapagliflozin and 1,000 mg metformin hydrochloride USP which is equivalent to 779.86 mg metformin base (Dapagliflozin and metformin HCl extended-release 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release contains the following inactive ingredients: crospovidone, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium carboxy methyl cellulose and sodium lauryl sulfate. The film coatings contain the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, iron oxide red and iron oxide black."
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"LabelerName": "Novadoz Pharmaceuticals LLC",
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"IndicationAndUsage": "Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.",
"Description": "Dapagliflozin and metformin HCl extended-release tablets contain two oral antihyperglycemic medications used in the management of type 2 diabetes: dapagliflozin and metformin hydrochloride USP.DapagliflozinDapagliflozin is described chemically as(1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl] phenyl]-D-glucitol. The molecular formula is C21H25ClO6 and the formula weight is 408.88. The structural formula is:. Metformin hydrochloride USPMetformin hydrochloride USP (1, 1-Dimethylbiguanide Hydrochloride) is a white crystals with a molecular formula of C4H11N5.HCl and a molecular weight of 165.62. Metformin hydrochloride USP is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene chloride. The pKa of metformin is 2.8 and 11.5. The pH of a 5% solution of metformin hydrochloride USP is 6 to 7. The structural formula is:. Dapagliflozin and metformin HCl extended-release Dapagliflozin and metformin HCl extended-release is available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin hydrochloride USP which is equivalent to 389.9 mg metformin base (Dapagliflozin and metformin HCl extended-release 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin hydrochloride USP which is equivalent to 779.86 mg metformin base (Dapagliflozin and metformin HCl extended-release 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin hydrochloride USP which is equivalent to 389.9 mg metformin base (Dapagliflozin and metformin HCl extended-release 10 mg/500 mg), or 10 mg dapagliflozin and 1,000 mg metformin hydrochloride USP which is equivalent to 779.86 mg metformin base (Dapagliflozin and metformin HCl extended-release 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release contains the following inactive ingredients: crospovidone, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium carboxy methyl cellulose and sodium lauryl sulfate. The film coatings contain the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, iron oxide red and iron oxide black."
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"ApplicationNumber": "part349",
"LabelerName": "Grimann, S.A. de C.V.",
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}
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<IndicationAndUsage>PRADAXA Oral Pellets are a direct thrombin inhibitor indicated: : 1 For the treatment of venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.1), 2 To reduce the risk of recurrence of VTE in pediatric patients aged 3 months to less than 12 years of age who have been previously treated (1.2).</IndicationAndUsage>
<Description>PRADAXA Oral Pellets contain dabigatran etexilate mesylate, a direct thrombin inhibitor. The chemical name of dabigatran etexilate mesylate is β-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfonate and it has a molecular formula of C34H41N7O5 ∙ CH4O3S and molecular weight of 723.86 for the mesylate salt and 627.75 for the free base. The structural formula is. Dabigatran etexilate mesylate is a yellow-white to yellow powder. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. A saturated solution in pure water has a solubility of 1.8 mg/mL. Each packet of PRADAXA Oral Pellets contains 20 mg, 30 mg, 40 mg, 50 mg, 110 mg, or 150 mg dabigatran etexilate (equivalent to 23.06 mg, 34.59 mg, 46.12 mg, 57.65 mg, 126.83 mg, or 172.95 mg dabigatran etexilate mesylate) along with the following inactive ingredients: acacia, dimethicone, hydroxypropyl cellulose, hypromellose, talc, and tartaric acid.</Description>
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<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Deseret Biologicals, Inc.</LabelerName>
<SubstanceName>MAGNESIUM OROTATE; BETA VULGARIS; ASCORBIC ACID; ANHYDROUS CITRIC ACID; CYSTEINE; PULSATILLA VULGARIS; ADENINE; AMYGDALIN; ADENOSINE TRIPHOSPHATE DISODIUM; CHOLINE HYDROXIDE; CYANOCOBALAMIN; FOLIC ACID; INOSITOL; NIACIN; AMINOBENZOIC ACID; PANGAMIC ACID; PANTOTHENIC ACID; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; SULFUR; THIAMINE HYDROCHLORIDE; SODIUM DIETHYL OXALACETATE; OROTIC ACID MONOHYDRATE; MANGANESE PHOSPHATE, DIBASIC; ESCHERICHIA COLI; PROTEUS MORGANII</SubstanceName>
<StrengthNumber>12; 2; 3; 4; 4; 4; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 7; 8; 10; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20141008</StartMarketingDatePackage>
<EndMarketingDatePackage>20211025</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>44567-435-24</NDCCode>
<PackageDescription>24 POUCH in 1 CARTON (44567-435-24) / 1 BAG in 1 POUCH / 50 mL in 1 BAG</PackageDescription>
<NDC11Code>44567-0435-24</NDC11Code>
<ProductNDC>44567-435</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20160414</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090343</ApplicationNumber>
<LabelerName>WG Critical Care, LLC</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160414</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levofloxacin Injection in 5% dextrose is indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Levofloxacin Injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form).</IndicationAndUsage>
<Description>Levofloxacin Injection is a synthetic broad-spectrum antibacterial agent for intravenous administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4- benzoxazine-6-carboxylic acid hemihydrate. Figure 1 : The Chemical Structure of Levofloxacin. The empirical formula is C18H20FN3O4 ● ½ H2O and the molecular weight is 370.38. Levofloxacin is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg per mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg per mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg per mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3>Cu+2>Zn+2>Mg+2>Ca+2.</Description>
</NDC>
<NDC>
<NDCCode>52959-435-02</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE (52959-435-02)</PackageDescription>
<NDC11Code>52959-0435-02</NDC11Code>
<ProductNDC>52959-435</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methadone Hydrochloride</ProprietaryName>
<NonProprietaryName>Methadone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090519</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040517</ApplicationNumber>
<LabelerName>H.J. Harkins Company Inc.</LabelerName>
<SubstanceName>METHADONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the treatment of moderate to severe pain not responsive to non-narcotic analgesics. For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.</IndicationAndUsage>
<Description>Methadone Hydrochloride Tablets USP for oral administration, each contain 5 mg or 10 mg of methadone hydrochloride. Methadone hydrochloride is a white, crystalline material that is water-soluble. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-heptanone hydrochloride. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. The tablets also contain lactose monohydrate, magnesium stearate, microcrystalline cellulose and silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>52959-435-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (52959-435-30)</PackageDescription>
<NDC11Code>52959-0435-30</NDC11Code>
<ProductNDC>52959-435</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methadone Hydrochloride</ProprietaryName>
<NonProprietaryName>Methadone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090519</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040517</ApplicationNumber>
<LabelerName>H.J. Harkins Company Inc.</LabelerName>
<SubstanceName>METHADONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the treatment of moderate to severe pain not responsive to non-narcotic analgesics. For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.</IndicationAndUsage>
<Description>Methadone Hydrochloride Tablets USP for oral administration, each contain 5 mg or 10 mg of methadone hydrochloride. Methadone hydrochloride is a white, crystalline material that is water-soluble. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-heptanone hydrochloride. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. The tablets also contain lactose monohydrate, magnesium stearate, microcrystalline cellulose and silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>52959-435-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (52959-435-60)</PackageDescription>
<NDC11Code>52959-0435-60</NDC11Code>
<ProductNDC>52959-435</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methadone Hydrochloride</ProprietaryName>
<NonProprietaryName>Methadone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090519</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040517</ApplicationNumber>
<LabelerName>H.J. Harkins Company Inc.</LabelerName>
<SubstanceName>METHADONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the treatment of moderate to severe pain not responsive to non-narcotic analgesics. For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.</IndicationAndUsage>
<Description>Methadone Hydrochloride Tablets USP for oral administration, each contain 5 mg or 10 mg of methadone hydrochloride. Methadone hydrochloride is a white, crystalline material that is water-soluble. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-heptanone hydrochloride. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. The tablets also contain lactose monohydrate, magnesium stearate, microcrystalline cellulose and silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>52959-435-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (52959-435-90)</PackageDescription>
<NDC11Code>52959-0435-90</NDC11Code>
<ProductNDC>52959-435</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methadone Hydrochloride</ProprietaryName>
<NonProprietaryName>Methadone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090519</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040517</ApplicationNumber>
<LabelerName>H.J. Harkins Company Inc.</LabelerName>
<SubstanceName>METHADONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the treatment of moderate to severe pain not responsive to non-narcotic analgesics. For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.</IndicationAndUsage>
<Description>Methadone Hydrochloride Tablets USP for oral administration, each contain 5 mg or 10 mg of methadone hydrochloride. Methadone hydrochloride is a white, crystalline material that is water-soluble. Methadone hydrochloride is chemically described as 6-(dimethylamino)-4,4-diphenyl-3-heptanone hydrochloride. Methadone hydrochloride has a melting point of 235°C, and a pKa of 8.25 in water at 20°C. Its octanol/water partition coefficient at pH 7.4 is 117. A solution (1:100) in water has a pH between 4.5 and 6.5. It has the following structural formula. The tablets also contain lactose monohydrate, magnesium stearate, microcrystalline cellulose and silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>57297-435-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (57297-435-01) > 2.5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>57297-0435-01</NDC11Code>
<ProductNDC>57297-435</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gatifloxacin</ProprietaryName>
<NonProprietaryName>Gatifloxacin</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20131001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202653</ApplicationNumber>
<LabelerName>LUPIN LIMITED</LabelerName>
<SubstanceName>GATIFLOXACIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC],Quinolones [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Gatifloxacin ophthalmic solution, 0.5% is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms. Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group*, Streptococcus oralis*, Streptococcus pneumoniae. *Efficacy for this organism was studied in fewer than 10 infections. (1).</IndicationAndUsage>
<Description>Gatifloxacin ophthalmic solution, 0.5% is an 8-methoxyfluoroquinolone anti-infective for the treatment of bacterial conjunctivitis. Its chemical name is (±) 1-Cyclopropyl-6-fluoro-8- methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid. Its molecular formula is C19H22FN3O4 and its molecular weight is 375.40. Its chemical structure is. Gatifloxacin ophthalmic solution, 0.5% is a pale yellow colored transparent, sterile, liquid with an osmolality of 260 to 330 mOsm/kg and a pH of 5.1 to 5.7. Each mL of gatifloxacin ophthalmic solution, 0.5% contains Active: gatifloxacin 0.5% (5 mg) Preservative: benzalkonium chloride 0.005% Inactives: edetate disodium, water for injection and sodium chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>60687-435-21</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-435-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-435-11) </PackageDescription>
<NDC11Code>60687-0435-21</NDC11Code>
<ProductNDC>60687-435</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clarithromycin</ProprietaryName>
<NonProprietaryName>Clarithromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203584</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>CLARITHROMYCIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200129</StartMarketingDatePackage>
<EndMarketingDatePackage>20270630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clarithromycin is a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: 1 Acute Bacterial Exacerbation of Chronic Bronchitis in Adults ( 1.1) , 2 Acute Maxillary Sinusitis ( 1.2) , 3 Community-Acquired Pneumonia ( 1.3) , 4 Pharyngitis/Tonsillitis ( 1.4) , 5 Uncomplicated Skin and Skin Structure Infections ( 1.5) , 6 Acute Otitis Media in Pediatric Patients ( 1.6) , 7 Treatment and Prophylaxis of Disseminated Mycobacterial Infections ( 1.7) , 8 Helicobacter pylori Infection and Duodenal Ulcer Disease in Adults ( 1.8) .</IndicationAndUsage>
<Description>Clarithromycin is a semi-synthetic macrolide antimicrobial for oral use. Chemically, it is 6- 0-methylerythromycin. The molecular formula is C 38H 69NO 13, and the molecular weight is 747.96. The structural formula is:. Figure 1: Structure of Clarithromycin. Clarithromycin is a white to off-white crystalline powder. It is soluble in acetone, slightly soluble in methanol, ethanol, and acetonitrile, and practically insoluble in water. Each white to off-white oval film-coated immediate-release clarithromycin tablet, USP contains 250 mg or 500 mg of clarithromycin and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, hypromellose, titanium dioxide and polyethylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>61919-435-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (61919-435-30) </PackageDescription>
<NDC11Code>61919-0435-30</NDC11Code>
<ProductNDC>61919-435</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nortriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Nortriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074132</ApplicationNumber>
<LabelerName>Direct Rx</LabelerName>
<SubstanceName>NORTRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nortriptyline hydrochloride capsules are indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Nortriptyline hydrochloride, USP is 1-Propanamine, 3-(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is as follows. C19H21NHCl M.W. 299.8. Nortriptyline hydrochloride, USP is a white to off-white powder, having a slight, characteristic odor. It is soluble in water and in chloroform; sparingly soluble in methanol; and practically insoluble in most organic solvents. Each capsule, for oral administration, contains nortriptyline hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg or 75 mg nortriptyline. In addition, each capsule contains the following inactive ingredients: corn starch, D&C Yellow #10 aluminum lake, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, gelatin, iron oxide black, methylparaben, propylene glycol, propylparaben, shellac glaze, silicone fluid, sodium lauryl sulfate, and titanium dioxide. The 10 mg, 25 mg and 75 mg capsules also contain D&C Yellow #10, FD&C Blue #1, and FD&C Yellow #6.</Description>
</NDC>
<NDC>
<NDCCode>61919-435-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (61919-435-60) </PackageDescription>
<NDC11Code>61919-0435-60</NDC11Code>
<ProductNDC>61919-435</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nortriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Nortriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074132</ApplicationNumber>
<LabelerName>Direct Rx</LabelerName>
<SubstanceName>NORTRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nortriptyline hydrochloride capsules are indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Nortriptyline hydrochloride, USP is 1-Propanamine, 3-(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is as follows. C19H21NHCl M.W. 299.8. Nortriptyline hydrochloride, USP is a white to off-white powder, having a slight, characteristic odor. It is soluble in water and in chloroform; sparingly soluble in methanol; and practically insoluble in most organic solvents. Each capsule, for oral administration, contains nortriptyline hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg or 75 mg nortriptyline. In addition, each capsule contains the following inactive ingredients: corn starch, D&C Yellow #10 aluminum lake, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, gelatin, iron oxide black, methylparaben, propylene glycol, propylparaben, shellac glaze, silicone fluid, sodium lauryl sulfate, and titanium dioxide. The 10 mg, 25 mg and 75 mg capsules also contain D&C Yellow #10, FD&C Blue #1, and FD&C Yellow #6.</Description>
</NDC>
<NDC>
<NDCCode>61919-435-90</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (61919-435-90) </PackageDescription>
<NDC11Code>61919-0435-90</NDC11Code>
<ProductNDC>61919-435</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nortriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Nortriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074132</ApplicationNumber>
<LabelerName>Direct Rx</LabelerName>
<SubstanceName>NORTRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nortriptyline hydrochloride capsules are indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Nortriptyline hydrochloride, USP is 1-Propanamine, 3-(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is as follows. C19H21NHCl M.W. 299.8. Nortriptyline hydrochloride, USP is a white to off-white powder, having a slight, characteristic odor. It is soluble in water and in chloroform; sparingly soluble in methanol; and practically insoluble in most organic solvents. Each capsule, for oral administration, contains nortriptyline hydrochloride, USP equivalent to 10 mg, 25 mg, 50 mg or 75 mg nortriptyline. In addition, each capsule contains the following inactive ingredients: corn starch, D&C Yellow #10 aluminum lake, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, gelatin, iron oxide black, methylparaben, propylene glycol, propylparaben, shellac glaze, silicone fluid, sodium lauryl sulfate, and titanium dioxide. The 10 mg, 25 mg and 75 mg capsules also contain D&C Yellow #10, FD&C Blue #1, and FD&C Yellow #6.</Description>
</NDC>
<NDC>
<NDCCode>64980-435-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (64980-435-01) </PackageDescription>
<NDC11Code>64980-0435-01</NDC11Code>
<ProductNDC>64980-435</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Midodrine Hydrochloride</ProprietaryName>
<NonProprietaryName>Midodrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207613</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>MIDODRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets can cause marked elevation of supine blood pressure (BP > 200 mmHg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. The indication is based on midodrine hydrochloride tablets's effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine hydrochloride tablets, principally improved ability to perform life activities, have not been established. Further clinical trials are underway to verify and describe the clinical benefits of midodrine hydrochloride tablets. After initiation of treatment, midodrine hydrochloride tablets should be continued only for patients who report significant symptomatic improvement.</IndicationAndUsage>
<Description>Name: Midodrine Hydrochloride Tablets Dosage Form: 2.5-mg, 5-mg and 10-mg tablets for oral administration Active Ingredient: Midodrine hydrochloride, 2.5 mg, 5 mg and 10 mg Inactive Ingredients: Colloidal Silicon Dioxide NF, Croscarmellose Sodium NF, Magnesium Stearate NF, Microcrystalline Cellulose NF, Pregelatinized Starch NF and Sodium Lauryl Sulfate NF. Pharmacological Classification: Vasopressor/Antihypotensive Chemical Names (USAN: Midodrine Hydrochloride): (1) Acetamide, 2-amino-N-[2-(2,5dimethoxyphenyl)-2-hydroxyethyl]-monohydrochloride, (±)-; (2) (±)-2-amino-N-(ß-hydroxy-2,5-dimethoxyphenethyl) acetamide monohydrochloride BAN, INN, JAN: Midodrine Structural formula. Molecular formula: C12H18N2O4HCl; Molecular Weight: 290.7 Organoleptic Properties: White to off-white powder Solubility: Water: Soluble Methanol: Sparingly soluble pKa: 7.8 (0.3% aqueous solution) pH: 3.5 to 5.5 (5% aqueous solution) Melting Range: 200 to 203°C.</Description>
</NDC>
<NDC>
<NDCCode>66184-435-01</NDCCode>
<PackageDescription>30 mL in 1 CONTAINER (66184-435-01)</PackageDescription>
<NDC11Code>66184-0435-01</NDC11Code>
<ProductNDC>66184-435</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ck One 3-in-1 Face Makeup</ProprietaryName>
<ProprietaryNameSuffix>With Spf 8 Sunscreen</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Coty US LLC</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; OCTINOXATE</SubstanceName>
<StrengthNumber>7.5; .6</StrengthNumber>
<StrengthUnit>mL/30mL; mL/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66184-435-02</NDCCode>
<PackageDescription>30 mL in 1 BOX (66184-435-02)</PackageDescription>
<NDC11Code>66184-0435-02</NDC11Code>
<ProductNDC>66184-435</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ck One 3-in-1 Face Makeup</ProprietaryName>
<ProprietaryNameSuffix>With Spf 8 Sunscreen</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Coty US LLC</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; OCTINOXATE</SubstanceName>
<StrengthNumber>7.5; .6</StrengthNumber>
<StrengthUnit>mL/30mL; mL/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66184-435-03</NDCCode>
<PackageDescription>10 mL in 1 BOTTLE (66184-435-03)</PackageDescription>
<NDC11Code>66184-0435-03</NDC11Code>
<ProductNDC>66184-435</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ck One 3-in-1 Face Makeup</ProprietaryName>
<ProprietaryNameSuffix>With Spf 8 Sunscreen</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Coty US LLC</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; OCTINOXATE</SubstanceName>
<StrengthNumber>7.5; .6</StrengthNumber>
<StrengthUnit>mL/30mL; mL/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69367-435-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69367-435-30) </PackageDescription>
<NDC11Code>69367-0435-30</NDC11Code>
<ProductNDC>69367-435</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paliperidone</ProprietaryName>
<NonProprietaryName>Paliperidone</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218755</ApplicationNumber>
<LabelerName>Westminster Pharmaceuticals, LLC</LabelerName>
<SubstanceName>PALIPERIDONE</SubstanceName>
<StrengthNumber>9</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paliperidone Extended-Release Tablets are an atypical antipsychotic agent indicated for Treatment of schizophrenia (1.1): 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. (14.1), 2 Adolescents (ages 12–17): Efficacy was established in one 6-week trial. (14.1).</IndicationAndUsage>
<Description>Paliperidone Extended-Release Tablets contains paliperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone Extended-Release Tablets contains a racemic mixture of (+)- and (-)-paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4Hpyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C23H27FN4O3 and its molecular weight is 426.49. The structural formula is. Paliperidone is sparingly soluble in 0.1N HCl and in methylene chloride; practically insoluble in water, in 0.1N NaOH and hexane; and slightly soluble in N, N-dimethyl formamide and in Tetrahydrofuran. Paliperidone Extended-Release Tablets are intended for oral administration and are available in 1.5 mg (blue), 3 mg (white), 6 mg (yellow), and 9 mg (beige) strengths. Paliperidone Extended-Release Tablets utilizes Osmotic Drug delivery (OROS, Push-Pull technology) system. Inactive ingredients are hydroxypropyl cellulose, butylated hydroxytoluene, polyethylene oxide, talc, sodium chloride, colloidal silicon dioxide, sodium stearyl fumarate, iron oxide red, cellulose acetate, polyethylene glycol, polyvinyl alcohol, and titanium dioxide. The 1.5 mg tablets also contain F D & C blue # 2 and the 6 mg, and 9 mg tablets also contain iron oxide yellow. The imprinting ink contains shellac, black iron oxide, propylene glycol, and ammonium hydroxide. Delivery System Components and Performance. Paliperidone Extended-Release Tablets uses osmotic pressure to deliver paliperidone at a controlled rate. The tablets contain an osmotically active bi-layer core tablet that consists of a drug layer containing the entire amount of active ingredient in a hydrophilic polymer matrix and a push layer that contains an osmotic agent in a hydrophilic, swell-able polymer matrix. The bi-layer core tablet is coated with a releasecontrolling semi-permeable membrane (SPM). The SPM allows water permeation into the core without allowing components to quickly dissipate from the core. A laser-drilled aperture is present on the drug layer side of the SPM-coated tablet and is necessary for delivery. The tablets contain a water-soluble cosmetic over-coating that is imprinted with an identifier. Once ingested, the cosmetic over-coating rapidly dissipates in the gastrointestinal tract. The SPM allows water to penetrate into the core as the osmotic agent in the push layer provides a driving force for water influx. Once hydrated, the swell-able polymer matrix in the push layer (high molecular weight polyethylene oxide) expands, exerting a pressure on the drug layer portion of the core tablet which forces it out of the laser-drilled aperture in a plug-flow fashion. As the release rate is controlled by the rate of water influx into the core (SPM permeability), the delivery is independent of pH or gastrointestinal motility. The biologically inert tablet core, containing residual push layer components, remains intact and is eliminated in the feces. Drug absorption is controlled by a combination of drug release from the tablet and subsequent dissolution in the gastrointestinal tract.</Description>
</NDC>
<NDC>
<NDCCode>71288-435-87</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (71288-435-87) / .8 mL in 1 SYRINGE (71288-435-86) </PackageDescription>
<NDC11Code>71288-0435-87</NDC11Code>
<ProductNDC>71288-435</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enoxaparin Sodium</ProprietaryName>
<NonProprietaryName>Enoxaparin Sodium</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20191201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206834</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ENOXAPARIN SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Heparin, Low-Molecular-Weight [CS], Low Molecular Weight Heparin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Enoxaparin Sodium Injection is a low molecular weight heparin (LMWH) indicated for: : 1 Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness (1.1) , 2 Inpatient treatment of acute DVT with or without pulmonary embolism (1.2) , 3 Outpatient treatment of acute DVT without pulmonary embolism (1.2) , 4 Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction (MI) (1.3) , 5 Treatment of acute ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention (PCI) (1.4) .</IndicationAndUsage>
<Description>Enoxaparin Sodium Injection, USP is a sterile aqueous solution containing enoxaparin sodium, a low molecular weight heparin. The pH of the injection is 5.5 to 7.5. Enoxaparin sodium is obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa. Its structure is characterized by a 2-O-sulfo-4-enepyranosuronic acid group at the non-reducing end and a 2-N,6-O-disulfo-D-glucosamine at the reducing end of the chain. About 20% (ranging between 15% and 25%) of the enoxaparin structure contains a 1,6-anhydro derivative on the reducing end of the polysaccharide chain. The drug substance is the sodium salt. The average molecular weight is about 4,500 daltons. The molecular weight distribution is. STRUCTURAL FORMULA. Enoxaparin Sodium Injection, USP 100 mg per mL Concentration contains 10 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1,000 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. Enoxaparin Sodium Injection, USP 150 mg per mL Concentration contains 15 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1,500 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. The Enoxaparin Sodium Injection, USP prefilled syringes and graduated prefilled syringes are preservative-free and intended for use only as a single-dose injection [see Dosage and Administration (2) and How Supplied/Storage and Handling (16)].</Description>
</NDC>
<NDC>
<NDCCode>71288-435-92</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (71288-435-92) / .8 mL in 1 SYRINGE (71288-435-91) </PackageDescription>
<NDC11Code>71288-0435-92</NDC11Code>
<ProductNDC>71288-435</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Enoxaparin Sodium</ProprietaryName>
<NonProprietaryName>Enoxaparin Sodium</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20191201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206834</ApplicationNumber>
<LabelerName>Meitheal Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ENOXAPARIN SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Heparin, Low-Molecular-Weight [CS], Low Molecular Weight Heparin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Enoxaparin Sodium Injection is a low molecular weight heparin (LMWH) indicated for: : 1 Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness (1.1) , 2 Inpatient treatment of acute DVT with or without pulmonary embolism (1.2) , 3 Outpatient treatment of acute DVT without pulmonary embolism (1.2) , 4 Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction (MI) (1.3) , 5 Treatment of acute ST-segment elevation myocardial infarction (STEMI) managed medically or with subsequent percutaneous coronary intervention (PCI) (1.4) .</IndicationAndUsage>
<Description>Enoxaparin Sodium Injection, USP is a sterile aqueous solution containing enoxaparin sodium, a low molecular weight heparin. The pH of the injection is 5.5 to 7.5. Enoxaparin sodium is obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa. Its structure is characterized by a 2-O-sulfo-4-enepyranosuronic acid group at the non-reducing end and a 2-N,6-O-disulfo-D-glucosamine at the reducing end of the chain. About 20% (ranging between 15% and 25%) of the enoxaparin structure contains a 1,6-anhydro derivative on the reducing end of the polysaccharide chain. The drug substance is the sodium salt. The average molecular weight is about 4,500 daltons. The molecular weight distribution is. STRUCTURAL FORMULA. Enoxaparin Sodium Injection, USP 100 mg per mL Concentration contains 10 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1,000 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. Enoxaparin Sodium Injection, USP 150 mg per mL Concentration contains 15 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1,500 IU [with reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard]) per 0.1 mL Water for Injection. The Enoxaparin Sodium Injection, USP prefilled syringes and graduated prefilled syringes are preservative-free and intended for use only as a single-dose injection [see Dosage and Administration (2) and How Supplied/Storage and Handling (16)].</Description>
</NDC>
<NDC>
<NDCCode>72205-435-01</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72205-435-01) </PackageDescription>
<NDC11Code>72205-0435-01</NDC11Code>
<ProductNDC>72205-435</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapagliflozin And Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Dapagliflozin And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260406</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211479</ApplicationNumber>
<LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
<SubstanceName>DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 1000</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.</IndicationAndUsage>
<Description>Dapagliflozin and metformin HCl extended-release tablets contain two oral antihyperglycemic medications used in the management of type 2 diabetes: dapagliflozin and metformin hydrochloride USP.DapagliflozinDapagliflozin is described chemically as(1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl] phenyl]-D-glucitol. The molecular formula is C21H25ClO6 and the formula weight is 408.88. The structural formula is:. Metformin hydrochloride USPMetformin hydrochloride USP (1, 1-Dimethylbiguanide Hydrochloride) is a white crystals with a molecular formula of C4H11N5.HCl and a molecular weight of 165.62. Metformin hydrochloride USP is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene chloride. The pKa of metformin is 2.8 and 11.5. The pH of a 5% solution of metformin hydrochloride USP is 6 to 7. The structural formula is:. Dapagliflozin and metformin HCl extended-release Dapagliflozin and metformin HCl extended-release is available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin hydrochloride USP which is equivalent to 389.9 mg metformin base (Dapagliflozin and metformin HCl extended-release 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin hydrochloride USP which is equivalent to 779.86 mg metformin base (Dapagliflozin and metformin HCl extended-release 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin hydrochloride USP which is equivalent to 389.9 mg metformin base (Dapagliflozin and metformin HCl extended-release 10 mg/500 mg), or 10 mg dapagliflozin and 1,000 mg metformin hydrochloride USP which is equivalent to 779.86 mg metformin base (Dapagliflozin and metformin HCl extended-release 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release contains the following inactive ingredients: crospovidone, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium carboxy methyl cellulose and sodium lauryl sulfate. The film coatings contain the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, iron oxide red and iron oxide black.</Description>
</NDC>
<NDC>
<NDCCode>72205-435-02</NDCCode>
<PackageDescription>400 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72205-435-02) </PackageDescription>
<NDC11Code>72205-0435-02</NDC11Code>
<ProductNDC>72205-435</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapagliflozin And Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Dapagliflozin And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260406</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211479</ApplicationNumber>
<LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
<SubstanceName>DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 1000</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.</IndicationAndUsage>
<Description>Dapagliflozin and metformin HCl extended-release tablets contain two oral antihyperglycemic medications used in the management of type 2 diabetes: dapagliflozin and metformin hydrochloride USP.DapagliflozinDapagliflozin is described chemically as(1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl] phenyl]-D-glucitol. The molecular formula is C21H25ClO6 and the formula weight is 408.88. The structural formula is:. Metformin hydrochloride USPMetformin hydrochloride USP (1, 1-Dimethylbiguanide Hydrochloride) is a white crystals with a molecular formula of C4H11N5.HCl and a molecular weight of 165.62. Metformin hydrochloride USP is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene chloride. The pKa of metformin is 2.8 and 11.5. The pH of a 5% solution of metformin hydrochloride USP is 6 to 7. The structural formula is:. Dapagliflozin and metformin HCl extended-release Dapagliflozin and metformin HCl extended-release is available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin hydrochloride USP which is equivalent to 389.9 mg metformin base (Dapagliflozin and metformin HCl extended-release 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin hydrochloride USP which is equivalent to 779.86 mg metformin base (Dapagliflozin and metformin HCl extended-release 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin hydrochloride USP which is equivalent to 389.9 mg metformin base (Dapagliflozin and metformin HCl extended-release 10 mg/500 mg), or 10 mg dapagliflozin and 1,000 mg metformin hydrochloride USP which is equivalent to 779.86 mg metformin base (Dapagliflozin and metformin HCl extended-release 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release contains the following inactive ingredients: crospovidone, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium carboxy methyl cellulose and sodium lauryl sulfate. The film coatings contain the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, iron oxide red and iron oxide black.</Description>
</NDC>
<NDC>
<NDCCode>72205-435-03</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72205-435-03) </PackageDescription>
<NDC11Code>72205-0435-03</NDC11Code>
<ProductNDC>72205-435</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapagliflozin And Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Dapagliflozin And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260406</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211479</ApplicationNumber>
<LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
<SubstanceName>DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 1000</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapagliflozin and metformin HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin HCl extended-release tablets, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: 1 Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 Cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in patients with heart failure., 3 Hospitalization for heart failure in patients with type 2 diabetes mellitus and either established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.</IndicationAndUsage>
<Description>Dapagliflozin and metformin HCl extended-release tablets contain two oral antihyperglycemic medications used in the management of type 2 diabetes: dapagliflozin and metformin hydrochloride USP.DapagliflozinDapagliflozin is described chemically as(1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl] phenyl]-D-glucitol. The molecular formula is C21H25ClO6 and the formula weight is 408.88. The structural formula is:. Metformin hydrochloride USPMetformin hydrochloride USP (1, 1-Dimethylbiguanide Hydrochloride) is a white crystals with a molecular formula of C4H11N5.HCl and a molecular weight of 165.62. Metformin hydrochloride USP is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene chloride. The pKa of metformin is 2.8 and 11.5. The pH of a 5% solution of metformin hydrochloride USP is 6 to 7. The structural formula is:. Dapagliflozin and metformin HCl extended-release Dapagliflozin and metformin HCl extended-release is available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin hydrochloride USP which is equivalent to 389.9 mg metformin base (Dapagliflozin and metformin HCl extended-release 5 mg/500 mg), 5 mg dapagliflozin and 1,000 mg metformin hydrochloride USP which is equivalent to 779.86 mg metformin base (Dapagliflozin and metformin HCl extended-release 5 mg/1,000 mg), 10 mg dapagliflozin and 500 mg metformin hydrochloride USP which is equivalent to 389.9 mg metformin base (Dapagliflozin and metformin HCl extended-release 10 mg/500 mg), or 10 mg dapagliflozin and 1,000 mg metformin hydrochloride USP which is equivalent to 779.86 mg metformin base (Dapagliflozin and metformin HCl extended-release 10 mg/1,000 mg). Each film-coated tablet of dapagliflozin and metformin HCl extended-release contains the following inactive ingredients: crospovidone, hypromellose, iron oxide red, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium carboxy methyl cellulose and sodium lauryl sulfate. The film coatings contain the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, iron oxide red and iron oxide black.</Description>
</NDC>
<NDC>
<NDCCode>81660-435-01</NDCCode>
<PackageDescription>1 U in 1 BOTTLE, GLASS (81660-435-01) </PackageDescription>
<NDC11Code>81660-0435-01</NDC11Code>
<ProductNDC>81660-435</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Derofen Miel</ProprietaryName>
<NonProprietaryName>Guaifenesin .beta.-isomer</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210505</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part349</ApplicationNumber>
<LabelerName>Grimann, S.A. de C.V.</LabelerName>
<SubstanceName>PROPYLENE GLYCOL</SubstanceName>
<StrengthNumber>11.8</StrengthNumber>
<StrengthUnit>g/U</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Therapeutic indications: Indicated for the symptomatic treatment of manifestations related to allergic rhinitis such as: sneezing, runny nose and watery eyes. Also indicated for chronic hives and other manifestations of allergic dermatological disorder.</IndicationAndUsage>
</NDC>
</NDCList>