{
"NDC": [
{
"NDCCode": "70748-129-06",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (70748-129-06) ",
"NDC11Code": "70748-0129-06",
"ProductNDC": "70748-129",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Leflunomide",
"NonProprietaryName": "Leflunomide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211863",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "LEFLUNOMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antirheumatic Agent [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200831",
"SamplePackage": "N",
"IndicationAndUsage": "Leflunomide is a pyrimidine synthesis inhibitor indicated for the treatment of adults with active rheumatoid arthritis. (1).",
"Description": "Leflunomide USP is a pyrimidine synthesis inhibitor. The chemical name for leflunomide is N-(4´-trifluoromethylphenyl)-5-methylisoxazole-4-carboxamide. It has an empirical formula C12H9F3N2O2, a molecular weight of 270.2 and the following structural formula. Leflunomide USP is available for oral administration as film coated tablets containing 10 mg and 20 mg of active drug. Combined with leflunomide are the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, corn starch, HPMC 2910/Hypromellose USP (6 mPas), Titanium Dioxide USP, Macrogol/PEG 6000 NF, Talc USP and Iron Oxide Yellow NF (20 mg tablet only)."
},
{
"NDCCode": "17511-129-06",
"PackageDescription": "25 mg in 1 DRUM (17511-129-06) ",
"NDC11Code": "17511-0129-06",
"ProductNDC": "17511-129",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Diflunisal",
"DosageFormName": "TABLET",
"StartMarketingDate": "20181010",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "COHANCE LIFESCIENCES LIMITED",
"SubstanceName": "DIFLUNISAL",
"StrengthNumber": "500",
"StrengthUnit": "mg/500mg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "10-OCT-18"
},
{
"NDCCode": "37803-129-06",
"PackageDescription": "25 g in 1 BOTTLE (37803-129-06)",
"NDC11Code": "37803-0129-06",
"ProductNDC": "37803-129",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Amitriptyline Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20150707",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Apotheca Supply Inc.",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "43269-129-06",
"PackageDescription": "1 KIT in 1 BOX (43269-129-06) * 59 mL in 1 BOTTLE, DISPENSING * 59 mL in 1 BOTTLE, DISPENSING * 59 mL in 1 BOTTLE, DISPENSING",
"NDC11Code": "43269-0129-06",
"ProductNDC": "43269-129",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "KIT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201007",
"EndMarketingDate": "20221007",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "SJ Creations, Inc.",
"Status": "Deprecated",
"LastUpdate": "2022-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201007",
"EndMarketingDatePackage": "20221007",
"SamplePackage": "N"
},
{
"NDCCode": "51079-129-06",
"PackageDescription": "50 BLISTER PACK in 1 CARTON (51079-129-06) > 1 TABLET, CHEWABLE in 1 BLISTER PACK (51079-129-01) ",
"NDC11Code": "51079-0129-06",
"ProductNDC": "51079-129",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenytoin",
"NonProprietaryName": "Phenytoin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20121218",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200691",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "PHENYTOIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20121218",
"SamplePackage": "N"
},
{
"NDCCode": "53247-129-06",
"PackageDescription": "1 TUBE in 1 CARTON (53247-129-06) / 130 g in 1 TUBE",
"NDC11Code": "53247-0129-06",
"ProductNDC": "53247-129",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nature Mint Anticavity",
"NonProprietaryName": "Sodium Monofluorophosphate",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20080101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Bob Barker Company Inc.",
"SubstanceName": "SODIUM MONOFLUOROPHOSPHATE",
"StrengthNumber": "7.6",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2024-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080101",
"SamplePackage": "N",
"IndicationAndUsage": "Helps protect against cavities."
},
{
"NDCCode": "58159-129-06",
"PackageDescription": "5 kg in 1 DRUM (58159-129-06) ",
"NDC11Code": "58159-0129-06",
"ProductNDC": "58159-129",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Inositol",
"DosageFormName": "POWDER",
"StartMarketingDate": "20250909",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "NURAY CHEMICALS PRIVATE LIMITED",
"SubstanceName": "INOSITOL",
"StrengthNumber": "35",
"StrengthUnit": "kg/35kg",
"Status": "Unfinished",
"LastUpdate": "2025-09-19",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "09-SEP-25"
},
{
"NDCCode": "59310-129-06",
"PackageDescription": "1 POUCH in 1 CARTON (59310-129-06) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER",
"NDC11Code": "59310-0129-06",
"ProductNDC": "59310-129",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Airduo Digihaler",
"NonProprietaryName": "Fluticasone Propionate And Salmeterol",
"DosageFormName": "POWDER, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20200915",
"EndMarketingDate": "20250731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208799",
"LabelerName": "Teva Respiratory, LLC",
"SubstanceName": "FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE",
"StrengthNumber": "113; 14",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200915",
"EndMarketingDatePackage": "20250731",
"SamplePackage": "N",
"IndicationAndUsage": "AirDuo® Digihaler® is indicated for the treatment of asthma in adult and pediatric patients aged 12 years and older. AirDuo Digihaler should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta2-adrenergic agonist (LABA). Limitations of Use:. AirDuo Digihaler is not indicated for the relief of acute bronchospasm.",
"Description": "AirDuo Digihaler 55/14 mcg, AirDuo Digihaler 113/14 mcg and AirDuo Digihaler 232/14 mcg are combinations of fluticasone propionate and salmeterol. Fluticasone Propionate. One active component of AirDuo Digihaler is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11ß,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17ß-carbothioate, 17-propionate, and the following chemical structure. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. Salmeterol Xinafoate. The other active component of AirDuo Digihaler is salmeterol xinafoate, a beta2–adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1‑hydroxy‑2‑naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α -[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure. Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. AirDuo Digihaler. AirDuo Digihaler is a multidose dry powder inhaler (MDPI) with an electronic module, for oral inhalation only. It contains fluticasone propionate, salmeterol xinafoate, and lactose monohydrate (which may contain milk proteins). The opening of the mouthpiece cover meters 5.5 mg of the formulation from the device reservoir, which contains 55 mcg, 113 mcg, or 232 mcg of fluticasone propionate, and 14 mcg of salmeterol base (equivalent to 20.3 mcg of salmeterol xinafoate). Patient inhalation through the mouthpiece causes the deagglomeration and aerosolization of the drug particles as the formulation moves through the cyclone component of the device. This is followed by dispersion into the airstream. Under standardized in vitro test conditions, the AirDuo Digihaler inhaler delivers 49 mcg, 100 mcg, or 202 mcg of fluticasone propionate and 12.75 mcg of salmeterol base (equivalent to 18.5 mcg of salmeterol xinafoate), with lactose from the mouthpiece when tested at a flow rate of 85 L/min for 1.4 seconds. The amount of drug delivered to the lung will depend on patient factors such as inspiratory flow profiles. In adult subjects (N=50, aged 18 to 45 years) with asthma, mean peak inspiratory flow (PIF) through the MDPI was 108.28 L/min (range: 70.37 to 129.24 L/min). In adolescent subjects (N=50, aged 12 to 17 years) with asthma, mean peak inspiratory flow (PIF) through the MDPI was 106.72 L/min (range: 73.64 to 125.51 L/min). AirDuo Digihaler includes a QR code (on the top of the inhaler), and contains a built-in electronic module which automatically detects, records and stores data on inhaler events, including peak inspiratory flow rate (L/min). AirDuo Digihaler may pair with and transmit data to the mobile App where inhaler events are categorized."
},
{
"NDCCode": "67751-129-06",
"PackageDescription": "3 POUCH in 1 CARTON (67751-129-06) / 2 TABLET in 1 POUCH",
"NDC11Code": "67751-0129-06",
"ProductNDC": "67751-129",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bayer Genuine Aspirin",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160601",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Navajo Manufacturing Company Inc.",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250422",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves: 1 headache, 2 muscle pain, 3 toothache, 4 menstrual pain, 5 pain and fever of colds, 6 minor pain of arthritis."
},
{
"NDCCode": "69677-129-06",
"PackageDescription": "6 TABLET in 1 BLISTER PACK (69677-129-06) ",
"NDC11Code": "69677-0129-06",
"ProductNDC": "69677-129",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin Monohydrate",
"NonProprietaryName": "Azithromycin Monohydrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150818",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065398",
"LabelerName": "MAS MANAGEMENT GROUP, INC.",
"SubstanceName": "AZITHROMYCIN MONOHYDRATE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Azithromycin tablets are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see DOSAGE AND ADMINISTRATION (2)].",
"Description": "Azithromycin tablets USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula. Azithromycin, as the monohydrate, is a white to almost white crystalline powder with a molecular formula of C38H72N2O12H2O and a molecular weight of 767.00. Azithromycin is supplied as tablets containing azithromycin monohydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl methyl cellulose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, titanium dioxide, triacetin and D&C Red #30. Organic Impurities Test Pending."
},
{
"NDCCode": "69939-129-06",
"PackageDescription": "500 g in 1 BOTTLE (69939-129-06)",
"NDC11Code": "69939-0129-06",
"ProductNDC": "69939-129",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Orbitol Whitening",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "MOUTHWASH",
"RouteName": "ORAL",
"StartMarketingDate": "20160413",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "COSMOPHARM LTD",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".15",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-08-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "71709-129-06",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (71709-129-06) ",
"NDC11Code": "71709-0129-06",
"ProductNDC": "71709-129",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metronidazole",
"NonProprietaryName": "Metronidazole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180718",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA070040",
"LabelerName": "Metcure Pharmaceuticals, Inc.",
"SubstanceName": "METRONIDAZOLE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180718",
"SamplePackage": "N",
"IndicationAndUsage": "Symptomatic Trichomoniasis. Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with metronidazole tablets in cases of reinfection. Amebiasis. Metronidazole tablets are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, Metronidazole tablets therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections. Metronidazole tablets are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole tablets therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole tablets. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B.fragilis group (B.fragilis, B.distasonis, B.ovatus, B.thetaiotaomicron, B.vulgatus), Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcusspecies, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B.fragilis group, Clostridium species, Peptococcusspecies, Peptostreptococcus species, and Fusobacterium species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group and Clostridium species. BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroides species including the B. fragilis group. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. ENDOCARDITIS caused by Bacteroides species including the B.fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole and other antibacterial drugs, metronidazole should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Metronidazole tablets USP, 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula. Metronidazole tablets, USP contain 250 mg or 500 mg of metronidazole, USP. Inactive ingredients include anhydrous lactose, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate, colloidal silicon dioxide and stearic acid. The film coating contains hypromelloses, hydroxypropyl cellulose, titanium dioxide, ethyl cellulose, shellac, diacetylated monoglycerides and propylene glycol."
},
{
"NDCCode": "72288-129-06",
"PackageDescription": "6 CAN in 1 CARTON (72288-129-06) > 60 g in 1 CAN",
"NDC11Code": "72288-0129-06",
"ProductNDC": "72288-129",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Basic Care Hair Regrowth Treatment",
"NonProprietaryName": "Minoxidil",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091344",
"LabelerName": "Amazon.com Services LLC",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2022-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201214",
"SamplePackage": "N",
"IndicationAndUsage": "to regrow hair on the top of the scalp (see pictures on side of this carton)."
},
{
"NDCCode": "76436-129-06",
"PackageDescription": "170 g in 1 JAR (76436-129-06)",
"NDC11Code": "76436-0129-06",
"ProductNDC": "76436-129",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sof Skin Baby Petroleum",
"NonProprietaryName": "Petrolatum",
"DosageFormName": "JELLY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20070327",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Viny Health and Beauty Inc",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "99.9",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2017-11-01"
},
{
"NDCCode": "77598-129-06",
"PackageDescription": "1000 mL in 1 BOTTLE (77598-129-06) ",
"NDC11Code": "77598-0129-06",
"ProductNDC": "77598-129",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "At-mosphere",
"NonProprietaryName": "Sanitizing Gel",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200515",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Guangzhou Ouzhuang Biological Technology Co Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200515",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "70748-101-06",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70748-101-06) ",
"NDC11Code": "70748-0101-06",
"ProductNDC": "70748-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"NonProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260417",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211579",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260417",
"SamplePackage": "N",
"IndicationAndUsage": "Dapagliflozin and metformin hydrochloride extended-release tablets are 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 hydrochloride 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, (CV) death and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 CV 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 CV disease or multiple CV risk factors.",
"Description": "Dapagliflozin and metformin hydrochloride extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as, (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl) tetrahydro-2H-pyran-3,4,5-triol. The empirical formula is C21H25ClO6 and the formula weight is 408.88. The structural formula is. Metformin hydrochloride. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a white crystalline powder with a molecular formula of C4H11N5HCl and a molecular weight of 165.6. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, and methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is. Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets. Dapagliflozin and metformin hydrochloride extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin hydrochloride, 5 mg dapagliflozin and 1000 mg metformin hydrochloride, 10 mg dapagliflozin and 500 mg metformin hydrochloride, or 10 mg dapagliflozin and 1000 mg metformin hydrochloride. Each film-coated tablet of dapagliflozin and metformin hydrochloride extended-release tablet contains the following inactive ingredients: crospovidone, colloidal silicon dioxide, hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, povidone, sodium carboxymethyl cellulose, sodium stearyl fumarate. The film coatings contain the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide. Additionally, the film coating for the dapagliflozin and metformin hydrochloride extended-release tablets 5 mg/500 mg tablets contains iron oxide red and iron oxide yellow. The film coating for the dapagliflozin and metformin hydrochloride extended-release tablets 5 mg/1000 mg contains iron oxide red and iron oxide black. The film coating for the dapagliflozin and metformin hydrochloride extended-release tablets 10 mg/500 mg contains iron oxide red and iron oxide yellow. The film coating for the dapagliflozin and metformin hydrochloride extended-release tablets 10 mg/1000 mg tablets contains D & C Yellow #10 Aluminum lake, FD & C Yellow #6/ sunset yellow FCF aluminum lake, FD & C Blue #2/ indigo carmine aluminum lake."
},
{
"NDCCode": "70748-103-06",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70748-103-06) ",
"NDC11Code": "70748-0103-06",
"ProductNDC": "70748-103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"NonProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260417",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211579",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "10; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260417",
"SamplePackage": "N",
"IndicationAndUsage": "Dapagliflozin and metformin hydrochloride extended-release tablets are 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 hydrochloride 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, (CV) death and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 CV 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 CV disease or multiple CV risk factors.",
"Description": "Dapagliflozin and metformin hydrochloride extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as, (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl) tetrahydro-2H-pyran-3,4,5-triol. The empirical formula is C21H25ClO6 and the formula weight is 408.88. The structural formula is. Metformin hydrochloride. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a white crystalline powder with a molecular formula of C4H11N5HCl and a molecular weight of 165.6. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, and methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is. Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets. Dapagliflozin and metformin hydrochloride extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin hydrochloride, 5 mg dapagliflozin and 1000 mg metformin hydrochloride, 10 mg dapagliflozin and 500 mg metformin hydrochloride, or 10 mg dapagliflozin and 1000 mg metformin hydrochloride. Each film-coated tablet of dapagliflozin and metformin hydrochloride extended-release tablet contains the following inactive ingredients: crospovidone, colloidal silicon dioxide, hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, povidone, sodium carboxymethyl cellulose, sodium stearyl fumarate. The film coatings contain the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide. Additionally, the film coating for the dapagliflozin and metformin hydrochloride extended-release tablets 5 mg/500 mg tablets contains iron oxide red and iron oxide yellow. The film coating for the dapagliflozin and metformin hydrochloride extended-release tablets 5 mg/1000 mg contains iron oxide red and iron oxide black. The film coating for the dapagliflozin and metformin hydrochloride extended-release tablets 10 mg/500 mg contains iron oxide red and iron oxide yellow. The film coating for the dapagliflozin and metformin hydrochloride extended-release tablets 10 mg/1000 mg tablets contains D & C Yellow #10 Aluminum lake, FD & C Yellow #6/ sunset yellow FCF aluminum lake, FD & C Blue #2/ indigo carmine aluminum lake."
},
{
"NDCCode": "70748-104-06",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70748-104-06) ",
"NDC11Code": "70748-0104-06",
"ProductNDC": "70748-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"NonProprietaryName": "Dapagliflozin And Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20260417",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211579",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE",
"StrengthNumber": "10; 1000",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS], Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260417",
"SamplePackage": "N",
"IndicationAndUsage": "Dapagliflozin and metformin hydrochloride extended-release tablets are 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 hydrochloride 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, (CV) death and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 CV 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 CV disease or multiple CV risk factors.",
"Description": "Dapagliflozin and metformin hydrochloride extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as, (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl) tetrahydro-2H-pyran-3,4,5-triol. The empirical formula is C21H25ClO6 and the formula weight is 408.88. The structural formula is. Metformin hydrochloride. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a white crystalline powder with a molecular formula of C4H11N5HCl and a molecular weight of 165.6. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, and methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is. Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets. Dapagliflozin and metformin hydrochloride extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin hydrochloride, 5 mg dapagliflozin and 1000 mg metformin hydrochloride, 10 mg dapagliflozin and 500 mg metformin hydrochloride, or 10 mg dapagliflozin and 1000 mg metformin hydrochloride. Each film-coated tablet of dapagliflozin and metformin hydrochloride extended-release tablet contains the following inactive ingredients: crospovidone, colloidal silicon dioxide, hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, povidone, sodium carboxymethyl cellulose, sodium stearyl fumarate. The film coatings contain the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide. Additionally, the film coating for the dapagliflozin and metformin hydrochloride extended-release tablets 5 mg/500 mg tablets contains iron oxide red and iron oxide yellow. The film coating for the dapagliflozin and metformin hydrochloride extended-release tablets 5 mg/1000 mg contains iron oxide red and iron oxide black. The film coating for the dapagliflozin and metformin hydrochloride extended-release tablets 10 mg/500 mg contains iron oxide red and iron oxide yellow. The film coating for the dapagliflozin and metformin hydrochloride extended-release tablets 10 mg/1000 mg tablets contains D & C Yellow #10 Aluminum lake, FD & C Yellow #6/ sunset yellow FCF aluminum lake, FD & C Blue #2/ indigo carmine aluminum lake."
},
{
"NDCCode": "70748-105-06",
"PackageDescription": "30 TABLET in 1 BOTTLE (70748-105-06) ",
"NDC11Code": "70748-0105-06",
"ProductNDC": "70748-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapagliflozin",
"NonProprietaryName": "Dapagliflozin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211531",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "DAPAGLIFLOZIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260408",
"SamplePackage": "N",
"IndicationAndUsage": "Dapagliflozin is indicated: : 1 To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular (CV) disease or multiple CV risk factors., 2 As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Dapagliflozin, an inhibitor of SGLT2, is described chemically as (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl) tetrahydro-2H-pyran-3,4,5-triol. The empirical formula is C21H25ClO6 and the molecular weight is 408.88. The structural formula is. Dapagliflozin tablets USP are available as a film-coated tablet for oral administration containing 5 mg dapagliflozin or 10 mg dapagliflozin, and the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose anhydrous, microcrystalline cellulose, povidone, and sodium stearyl fumarate. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide."
},
{
"NDCCode": "70748-106-06",
"PackageDescription": "30 TABLET in 1 BOTTLE (70748-106-06) ",
"NDC11Code": "70748-0106-06",
"ProductNDC": "70748-106",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dapagliflozin",
"NonProprietaryName": "Dapagliflozin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211531",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "DAPAGLIFLOZIN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260408",
"SamplePackage": "N",
"IndicationAndUsage": "Dapagliflozin is indicated: : 1 To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular (CV) disease or multiple CV risk factors., 2 As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Dapagliflozin, an inhibitor of SGLT2, is described chemically as (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl) tetrahydro-2H-pyran-3,4,5-triol. The empirical formula is C21H25ClO6 and the molecular weight is 408.88. The structural formula is. Dapagliflozin tablets USP are available as a film-coated tablet for oral administration containing 5 mg dapagliflozin or 10 mg dapagliflozin, and the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose anhydrous, microcrystalline cellulose, povidone, and sodium stearyl fumarate. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide."
},
{
"NDCCode": "70748-130-06",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (70748-130-06) ",
"NDC11Code": "70748-0130-06",
"ProductNDC": "70748-130",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Leflunomide",
"NonProprietaryName": "Leflunomide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211863",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "LEFLUNOMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antirheumatic Agent [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200831",
"SamplePackage": "N",
"IndicationAndUsage": "Leflunomide is a pyrimidine synthesis inhibitor indicated for the treatment of adults with active rheumatoid arthritis. (1).",
"Description": "Leflunomide USP is a pyrimidine synthesis inhibitor. The chemical name for leflunomide is N-(4´-trifluoromethylphenyl)-5-methylisoxazole-4-carboxamide. It has an empirical formula C12H9F3N2O2, a molecular weight of 270.2 and the following structural formula. Leflunomide USP is available for oral administration as film coated tablets containing 10 mg and 20 mg of active drug. Combined with leflunomide are the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, corn starch, HPMC 2910/Hypromellose USP (6 mPas), Titanium Dioxide USP, Macrogol/PEG 6000 NF, Talc USP and Iron Oxide Yellow NF (20 mg tablet only)."
},
{
"NDCCode": "70748-131-06",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (70748-131-06) ",
"NDC11Code": "70748-0131-06",
"ProductNDC": "70748-131",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sildenafil",
"NonProprietaryName": "Sildenafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190927",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212051",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20190927",
"SamplePackage": "N"
},
{
"NDCCode": "70748-132-06",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (70748-132-06) ",
"NDC11Code": "70748-0132-06",
"ProductNDC": "70748-132",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sildenafil",
"NonProprietaryName": "Sildenafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190927",
"EndMarketingDate": "20240131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212051",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190927",
"EndMarketingDatePackage": "20240131",
"SamplePackage": "N",
"IndicationAndUsage": "Sildenafil tablet is indicated for the treatment of erectile dysfunction.",
"Description": "Sildenafil tablets USP, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3- d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula. Sildenafil citrate is a white or almost white, slightly hygroscopic, crystalline powder with a solubility of 4.904 mg/mL in water and a molecular weight of 666.7. Sildenafil tablets are formulated as white to off white, round, film coated tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide."
},
{
"NDCCode": "70748-133-06",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (70748-133-06) ",
"NDC11Code": "70748-0133-06",
"ProductNDC": "70748-133",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sildenafil",
"NonProprietaryName": "Sildenafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190927",
"EndMarketingDate": "20240131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212051",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190927",
"EndMarketingDatePackage": "20240131",
"SamplePackage": "N",
"IndicationAndUsage": "Sildenafil tablet is indicated for the treatment of erectile dysfunction.",
"Description": "Sildenafil tablets USP, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3- d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula. Sildenafil citrate is a white or almost white, slightly hygroscopic, crystalline powder with a solubility of 4.904 mg/mL in water and a molecular weight of 666.7. Sildenafil tablets are formulated as white to off white, round, film coated tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide."
},
{
"NDCCode": "70748-211-06",
"PackageDescription": "1 BOTTLE in 1 CARTON (70748-211-06) / 30 TABLET in 1 BOTTLE",
"NDC11Code": "70748-0211-06",
"ProductNDC": "70748-211",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dasatinib",
"NonProprietaryName": "Dasatinib",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214350",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "DASATINIB",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260130",
"SamplePackage": "N",
"IndicationAndUsage": "Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.",
"Description": "Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide. The molecular formula is C22H26ClN7O2S, which corresponds to a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Dasatinib tablets are white to off-white, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, methacrylic acid copolymer, microcrystalline cellulose, magnesium stearate, talc. The tablet coating consists of hypromellose, medium chain triglycerides, titanium dioxide."
},
{
"NDCCode": "70748-212-06",
"PackageDescription": "1 BOTTLE in 1 CARTON (70748-212-06) / 30 TABLET in 1 BOTTLE",
"NDC11Code": "70748-0212-06",
"ProductNDC": "70748-212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dasatinib",
"NonProprietaryName": "Dasatinib",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214350",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "DASATINIB",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260130",
"SamplePackage": "N",
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"Description": "Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide. The molecular formula is C22H26ClN7O2S, which corresponds to a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Dasatinib tablets are white to off-white, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, methacrylic acid copolymer, microcrystalline cellulose, magnesium stearate, talc. The tablet coating consists of hypromellose, medium chain triglycerides, titanium dioxide."
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{
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"PackageDescription": "1 BOTTLE in 1 CARTON (70748-213-06) / 30 TABLET in 1 BOTTLE",
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"ProductNDC": "70748-213",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dasatinib",
"NonProprietaryName": "Dasatinib",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214350",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "DASATINIB",
"StrengthNumber": "140",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
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"IndicationAndUsage": "Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.",
"Description": "Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide. The molecular formula is C22H26ClN7O2S, which corresponds to a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Dasatinib tablets are white to off-white, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, methacrylic acid copolymer, microcrystalline cellulose, magnesium stearate, talc. The tablet coating consists of hypromellose, medium chain triglycerides, titanium dioxide."
},
{
"NDCCode": "70748-236-06",
"PackageDescription": "30 TABLET in 1 BOTTLE (70748-236-06) ",
"NDC11Code": "70748-0236-06",
"ProductNDC": "70748-236",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azilsartan Medoxomil",
"NonProprietaryName": "Azilsartan Medoxomil",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214489",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "AZILSARTAN KAMEDOXOMIL",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Blocker [EPC], Angiotensin 2 Type 1 Receptor Antagonists [MoA], Decreased Blood Pressure [PE]",
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"IndicationAndUsage": "Azilsartan medoxomil tablets are indicated for the treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with azilsartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality and it can be concluded that it is blood pressure reduction and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia) and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure or diabetic kidney disease). These considerations may guide selection of therapy. Azilsartan medoxomil tablets may be used alone or in combination with other antihypertensive agents.",
"Description": "Azilsartan medoxomil, a prodrug, is hydrolyzed to azilsartan in the gastrointestinal tract during absorption. Azilsartan is an angiotensin II receptor blocker. The drug substance used in the drug product formulation is the potassium salt of azilsartan medoxomil, also known by the US accepted name of azilsartan kamedoxomil and is chemically described as (5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 2-ethoxy-1-{[2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl]methyl}-1H-benzimidazole-7-carboxylate mono potassium salt. Its empirical formula is C30H23KN4O8 and its structural formula is. Azilsartan kamedoxomil is a white to off-white colored powder with a molecular weight of 606.62. It is practically insoluble in water, sparingly soluble in methanol; and soluble in N, N-Dimethylformamide. Azilsartan medoxomil is available for oral use as tablets. The tablets have a characteristic odor. Each azilsartan medoxomil tablet contains 42.68 or 85.36 mg of azilsartan kamedoxomil, which is equivalent to containing 40 mg or 80 mg respectively, of azilsartan medoxomil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose and vanillin."
},
{
"NDCCode": "70748-237-06",
"PackageDescription": "30 TABLET in 1 BOTTLE (70748-237-06) ",
"NDC11Code": "70748-0237-06",
"ProductNDC": "70748-237",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azilsartan Medoxomil",
"NonProprietaryName": "Azilsartan Medoxomil",
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"StartMarketingDate": "20260514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214489",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "AZILSARTAN KAMEDOXOMIL",
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"StrengthUnit": "mg/1",
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"IndicationAndUsage": "Azilsartan medoxomil tablets are indicated for the treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with azilsartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality and it can be concluded that it is blood pressure reduction and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia) and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure or diabetic kidney disease). These considerations may guide selection of therapy. Azilsartan medoxomil tablets may be used alone or in combination with other antihypertensive agents.",
"Description": "Azilsartan medoxomil, a prodrug, is hydrolyzed to azilsartan in the gastrointestinal tract during absorption. Azilsartan is an angiotensin II receptor blocker. The drug substance used in the drug product formulation is the potassium salt of azilsartan medoxomil, also known by the US accepted name of azilsartan kamedoxomil and is chemically described as (5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 2-ethoxy-1-{[2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl]methyl}-1H-benzimidazole-7-carboxylate mono potassium salt. Its empirical formula is C30H23KN4O8 and its structural formula is. Azilsartan kamedoxomil is a white to off-white colored powder with a molecular weight of 606.62. It is practically insoluble in water, sparingly soluble in methanol; and soluble in N, N-Dimethylformamide. Azilsartan medoxomil is available for oral use as tablets. The tablets have a characteristic odor. Each azilsartan medoxomil tablet contains 42.68 or 85.36 mg of azilsartan kamedoxomil, which is equivalent to containing 40 mg or 80 mg respectively, of azilsartan medoxomil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose and vanillin."
},
{
"NDCCode": "70748-238-06",
"PackageDescription": "30 TABLET in 1 BOTTLE (70748-238-06) ",
"NDC11Code": "70748-0238-06",
"ProductNDC": "70748-238",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tolvaptan",
"NonProprietaryName": "Tolvaptan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250512",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216063",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "TOLVAPTAN",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vasopressin V2 Receptor Antagonist [EPC], Vasopressin V2 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-05-12",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "Tolvaptan tablets are indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).",
"Description": "Tolvaptan tablets contain tolvaptan, a selective vasopressin V2-receptor antagonist in immediate release tablets for oral administration available in 15 mg, 30 mg, 45 mg, 60 mg and 90 mg strengths. Tolvaptan is N-(4-(7-chloro-5-hydroxy-2, 3, 4, 5 - tetrahydro-1H-benzo[b]azepine-1-carbonyl)-3-methylphenyl)-2-methylbenzamide. The empirical formula is C26H25ClN2O3. Molecular weight is 448.9. The chemical structure is. Inactive ingredients include corn starch, hydroxy propyl cellulose, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose and red iron oxide."
}
]
}
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<LabelerName>SJ Creations, Inc.</LabelerName>
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<IndicationAndUsage>Helps protect against cavities.</IndicationAndUsage>
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<LastUpdate>2025-08-02</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AirDuo® Digihaler® is indicated for the treatment of asthma in adult and pediatric patients aged 12 years and older. AirDuo Digihaler should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta2-adrenergic agonist (LABA). Limitations of Use:. AirDuo Digihaler is not indicated for the relief of acute bronchospasm.</IndicationAndUsage>
<Description>AirDuo Digihaler 55/14 mcg, AirDuo Digihaler 113/14 mcg and AirDuo Digihaler 232/14 mcg are combinations of fluticasone propionate and salmeterol. Fluticasone Propionate. One active component of AirDuo Digihaler is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11ß,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17ß-carbothioate, 17-propionate, and the following chemical structure. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. Salmeterol Xinafoate. The other active component of AirDuo Digihaler is salmeterol xinafoate, a beta2–adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1‑hydroxy‑2‑naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α -[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure. Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. AirDuo Digihaler. AirDuo Digihaler is a multidose dry powder inhaler (MDPI) with an electronic module, for oral inhalation only. It contains fluticasone propionate, salmeterol xinafoate, and lactose monohydrate (which may contain milk proteins). The opening of the mouthpiece cover meters 5.5 mg of the formulation from the device reservoir, which contains 55 mcg, 113 mcg, or 232 mcg of fluticasone propionate, and 14 mcg of salmeterol base (equivalent to 20.3 mcg of salmeterol xinafoate). Patient inhalation through the mouthpiece causes the deagglomeration and aerosolization of the drug particles as the formulation moves through the cyclone component of the device. This is followed by dispersion into the airstream. Under standardized in vitro test conditions, the AirDuo Digihaler inhaler delivers 49 mcg, 100 mcg, or 202 mcg of fluticasone propionate and 12.75 mcg of salmeterol base (equivalent to 18.5 mcg of salmeterol xinafoate), with lactose from the mouthpiece when tested at a flow rate of 85 L/min for 1.4 seconds. The amount of drug delivered to the lung will depend on patient factors such as inspiratory flow profiles. In adult subjects (N=50, aged 18 to 45 years) with asthma, mean peak inspiratory flow (PIF) through the MDPI was 108.28 L/min (range: 70.37 to 129.24 L/min). In adolescent subjects (N=50, aged 12 to 17 years) with asthma, mean peak inspiratory flow (PIF) through the MDPI was 106.72 L/min (range: 73.64 to 125.51 L/min). AirDuo Digihaler includes a QR code (on the top of the inhaler), and contains a built-in electronic module which automatically detects, records and stores data on inhaler events, including peak inspiratory flow rate (L/min). AirDuo Digihaler may pair with and transmit data to the mobile App where inhaler events are categorized.</Description>
</NDC>
<NDC>
<NDCCode>67751-129-06</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (67751-129-06) / 2 TABLET in 1 POUCH</PackageDescription>
<NDC11Code>67751-0129-06</NDC11Code>
<ProductNDC>67751-129</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bayer Genuine Aspirin</ProprietaryName>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Navajo Manufacturing Company Inc.</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>325</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves: 1 headache, 2 muscle pain, 3 toothache, 4 menstrual pain, 5 pain and fever of colds, 6 minor pain of arthritis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69677-129-06</NDCCode>
<PackageDescription>6 TABLET in 1 BLISTER PACK (69677-129-06) </PackageDescription>
<NDC11Code>69677-0129-06</NDC11Code>
<ProductNDC>69677-129</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin Monohydrate</ProprietaryName>
<NonProprietaryName>Azithromycin Monohydrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150818</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065398</ApplicationNumber>
<LabelerName>MAS MANAGEMENT GROUP, INC.</LabelerName>
<SubstanceName>AZITHROMYCIN MONOHYDRATE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azithromycin tablets are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see DOSAGE AND ADMINISTRATION (2)].</IndicationAndUsage>
<Description>Azithromycin tablets USP contain the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula. Azithromycin, as the monohydrate, is a white to almost white crystalline powder with a molecular formula of C38H72N2O12H2O and a molecular weight of 767.00. Azithromycin is supplied as tablets containing azithromycin monohydrate equivalent to either 250 mg or 500 mg azithromycin and the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl methyl cellulose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, titanium dioxide, triacetin and D&C Red #30. Organic Impurities Test Pending.</Description>
</NDC>
<NDC>
<NDCCode>69939-129-06</NDCCode>
<PackageDescription>500 g in 1 BOTTLE (69939-129-06)</PackageDescription>
<NDC11Code>69939-0129-06</NDC11Code>
<ProductNDC>69939-129</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Orbitol Whitening</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>MOUTHWASH</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160413</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>COSMOPHARM LTD</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>.15</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-08-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>71709-129-06</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (71709-129-06) </PackageDescription>
<NDC11Code>71709-0129-06</NDC11Code>
<ProductNDC>71709-129</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metronidazole</ProprietaryName>
<NonProprietaryName>Metronidazole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180718</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA070040</ApplicationNumber>
<LabelerName>Metcure Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METRONIDAZOLE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Symptomatic Trichomoniasis. Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with metronidazole tablets in cases of reinfection. Amebiasis. Metronidazole tablets are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, Metronidazole tablets therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections. Metronidazole tablets are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole tablets therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole tablets. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B.fragilis group (B.fragilis, B.distasonis, B.ovatus, B.thetaiotaomicron, B.vulgatus), Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcusspecies, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B.fragilis group, Clostridium species, Peptococcusspecies, Peptostreptococcus species, and Fusobacterium species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group and Clostridium species. BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroides species including the B. fragilis group. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. ENDOCARDITIS caused by Bacteroides species including the B.fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole and other antibacterial drugs, metronidazole should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Metronidazole tablets USP, 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula. Metronidazole tablets, USP contain 250 mg or 500 mg of metronidazole, USP. Inactive ingredients include anhydrous lactose, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate, colloidal silicon dioxide and stearic acid. The film coating contains hypromelloses, hydroxypropyl cellulose, titanium dioxide, ethyl cellulose, shellac, diacetylated monoglycerides and propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>72288-129-06</NDCCode>
<PackageDescription>6 CAN in 1 CARTON (72288-129-06) > 60 g in 1 CAN</PackageDescription>
<NDC11Code>72288-0129-06</NDC11Code>
<ProductNDC>72288-129</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Basic Care Hair Regrowth Treatment</ProprietaryName>
<NonProprietaryName>Minoxidil</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091344</ApplicationNumber>
<LabelerName>Amazon.com Services LLC</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to regrow hair on the top of the scalp (see pictures on side of this carton).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76436-129-06</NDCCode>
<PackageDescription>170 g in 1 JAR (76436-129-06)</PackageDescription>
<NDC11Code>76436-0129-06</NDC11Code>
<ProductNDC>76436-129</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sof Skin Baby Petroleum</ProprietaryName>
<NonProprietaryName>Petrolatum</NonProprietaryName>
<DosageFormName>JELLY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20070327</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Viny Health and Beauty Inc</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>99.9</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-01</LastUpdate>
</NDC>
<NDC>
<NDCCode>77598-129-06</NDCCode>
<PackageDescription>1000 mL in 1 BOTTLE (77598-129-06) </PackageDescription>
<NDC11Code>77598-0129-06</NDC11Code>
<ProductNDC>77598-129</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>At-mosphere</ProprietaryName>
<NonProprietaryName>Sanitizing Gel</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200515</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Guangzhou Ouzhuang Biological Technology Co Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70748-101-06</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70748-101-06) </PackageDescription>
<NDC11Code>70748-0101-06</NDC11Code>
<ProductNDC>70748-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapagliflozin And Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Dapagliflozin And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260417</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211579</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5; 500</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>2026-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260417</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapagliflozin and metformin hydrochloride extended-release tablets are 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 hydrochloride 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, (CV) death and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 CV 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 CV disease or multiple CV risk factors.</IndicationAndUsage>
<Description>Dapagliflozin and metformin hydrochloride extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as, (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl) tetrahydro-2H-pyran-3,4,5-triol. The empirical formula is C21H25ClO6 and the formula weight is 408.88. The structural formula is. Metformin hydrochloride. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a white crystalline powder with a molecular formula of C4H11N5HCl and a molecular weight of 165.6. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, and methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is. Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets. Dapagliflozin and metformin hydrochloride extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin hydrochloride, 5 mg dapagliflozin and 1000 mg metformin hydrochloride, 10 mg dapagliflozin and 500 mg metformin hydrochloride, or 10 mg dapagliflozin and 1000 mg metformin hydrochloride. Each film-coated tablet of dapagliflozin and metformin hydrochloride extended-release tablet contains the following inactive ingredients: crospovidone, colloidal silicon dioxide, hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, povidone, sodium carboxymethyl cellulose, sodium stearyl fumarate. The film coatings contain the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide. Additionally, the film coating for the dapagliflozin and metformin hydrochloride extended-release tablets 5 mg/500 mg tablets contains iron oxide red and iron oxide yellow. The film coating for the dapagliflozin and metformin hydrochloride extended-release tablets 5 mg/1000 mg contains iron oxide red and iron oxide black. The film coating for the dapagliflozin and metformin hydrochloride extended-release tablets 10 mg/500 mg contains iron oxide red and iron oxide yellow. The film coating for the dapagliflozin and metformin hydrochloride extended-release tablets 10 mg/1000 mg tablets contains D & C Yellow #10 Aluminum lake, FD & C Yellow #6/ sunset yellow FCF aluminum lake, FD & C Blue #2/ indigo carmine aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>70748-103-06</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70748-103-06) </PackageDescription>
<NDC11Code>70748-0103-06</NDC11Code>
<ProductNDC>70748-103</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapagliflozin And Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Dapagliflozin And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260417</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211579</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10; 500</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>2026-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260417</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapagliflozin and metformin hydrochloride extended-release tablets are 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 hydrochloride 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, (CV) death and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 CV 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 CV disease or multiple CV risk factors.</IndicationAndUsage>
<Description>Dapagliflozin and metformin hydrochloride extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as, (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl) tetrahydro-2H-pyran-3,4,5-triol. The empirical formula is C21H25ClO6 and the formula weight is 408.88. The structural formula is. Metformin hydrochloride. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a white crystalline powder with a molecular formula of C4H11N5HCl and a molecular weight of 165.6. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, and methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is. Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets. Dapagliflozin and metformin hydrochloride extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin hydrochloride, 5 mg dapagliflozin and 1000 mg metformin hydrochloride, 10 mg dapagliflozin and 500 mg metformin hydrochloride, or 10 mg dapagliflozin and 1000 mg metformin hydrochloride. Each film-coated tablet of dapagliflozin and metformin hydrochloride extended-release tablet contains the following inactive ingredients: crospovidone, colloidal silicon dioxide, hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, povidone, sodium carboxymethyl cellulose, sodium stearyl fumarate. The film coatings contain the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide. Additionally, the film coating for the dapagliflozin and metformin hydrochloride extended-release tablets 5 mg/500 mg tablets contains iron oxide red and iron oxide yellow. The film coating for the dapagliflozin and metformin hydrochloride extended-release tablets 5 mg/1000 mg contains iron oxide red and iron oxide black. The film coating for the dapagliflozin and metformin hydrochloride extended-release tablets 10 mg/500 mg contains iron oxide red and iron oxide yellow. The film coating for the dapagliflozin and metformin hydrochloride extended-release tablets 10 mg/1000 mg tablets contains D & C Yellow #10 Aluminum lake, FD & C Yellow #6/ sunset yellow FCF aluminum lake, FD & C Blue #2/ indigo carmine aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>70748-104-06</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70748-104-06) </PackageDescription>
<NDC11Code>70748-0104-06</NDC11Code>
<ProductNDC>70748-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapagliflozin And Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Dapagliflozin And Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260417</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211579</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10; 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>2026-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260417</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapagliflozin and metformin hydrochloride extended-release tablets are 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 hydrochloride 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, (CV) death and hospitalization for heart failure in patients with chronic kidney disease at risk of progression., 2 CV 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 CV disease or multiple CV risk factors.</IndicationAndUsage>
<Description>Dapagliflozin and metformin hydrochloride extended-release tablets contain: dapagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Dapagliflozin. Dapagliflozin is described chemically as, (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl) tetrahydro-2H-pyran-3,4,5-triol. The empirical formula is C21H25ClO6 and the formula weight is 408.88. The structural formula is. Metformin hydrochloride. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is a white crystalline powder with a molecular formula of C4H11N5HCl and a molecular weight of 165.6. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, and is practically insoluble in acetone, and methylene chloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is. Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets. Dapagliflozin and metformin hydrochloride extended-release tablets are available for oral administration as tablets containing 5 mg dapagliflozin and 500 mg metformin hydrochloride, 5 mg dapagliflozin and 1000 mg metformin hydrochloride, 10 mg dapagliflozin and 500 mg metformin hydrochloride, or 10 mg dapagliflozin and 1000 mg metformin hydrochloride. Each film-coated tablet of dapagliflozin and metformin hydrochloride extended-release tablet contains the following inactive ingredients: crospovidone, colloidal silicon dioxide, hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, povidone, sodium carboxymethyl cellulose, sodium stearyl fumarate. The film coatings contain the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide. Additionally, the film coating for the dapagliflozin and metformin hydrochloride extended-release tablets 5 mg/500 mg tablets contains iron oxide red and iron oxide yellow. The film coating for the dapagliflozin and metformin hydrochloride extended-release tablets 5 mg/1000 mg contains iron oxide red and iron oxide black. The film coating for the dapagliflozin and metformin hydrochloride extended-release tablets 10 mg/500 mg contains iron oxide red and iron oxide yellow. The film coating for the dapagliflozin and metformin hydrochloride extended-release tablets 10 mg/1000 mg tablets contains D & C Yellow #10 Aluminum lake, FD & C Yellow #6/ sunset yellow FCF aluminum lake, FD & C Blue #2/ indigo carmine aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>70748-105-06</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (70748-105-06) </PackageDescription>
<NDC11Code>70748-0105-06</NDC11Code>
<ProductNDC>70748-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapagliflozin</ProprietaryName>
<NonProprietaryName>Dapagliflozin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211531</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DAPAGLIFLOZIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260408</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapagliflozin is indicated: : 1 To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular (CV) disease or multiple CV risk factors., 2 As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Dapagliflozin, an inhibitor of SGLT2, is described chemically as (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl) tetrahydro-2H-pyran-3,4,5-triol. The empirical formula is C21H25ClO6 and the molecular weight is 408.88. The structural formula is. Dapagliflozin tablets USP are available as a film-coated tablet for oral administration containing 5 mg dapagliflozin or 10 mg dapagliflozin, and the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose anhydrous, microcrystalline cellulose, povidone, and sodium stearyl fumarate. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>70748-106-06</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (70748-106-06) </PackageDescription>
<NDC11Code>70748-0106-06</NDC11Code>
<ProductNDC>70748-106</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dapagliflozin</ProprietaryName>
<NonProprietaryName>Dapagliflozin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211531</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DAPAGLIFLOZIN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260408</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dapagliflozin is indicated: : 1 To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular (CV) disease or multiple CV risk factors., 2 As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Dapagliflozin, an inhibitor of SGLT2, is described chemically as (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl) tetrahydro-2H-pyran-3,4,5-triol. The empirical formula is C21H25ClO6 and the molecular weight is 408.88. The structural formula is. Dapagliflozin tablets USP are available as a film-coated tablet for oral administration containing 5 mg dapagliflozin or 10 mg dapagliflozin, and the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose anhydrous, microcrystalline cellulose, povidone, and sodium stearyl fumarate. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>70748-130-06</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (70748-130-06) </PackageDescription>
<NDC11Code>70748-0130-06</NDC11Code>
<ProductNDC>70748-130</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Leflunomide</ProprietaryName>
<NonProprietaryName>Leflunomide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211863</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LEFLUNOMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antirheumatic Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Leflunomide is a pyrimidine synthesis inhibitor indicated for the treatment of adults with active rheumatoid arthritis. (1).</IndicationAndUsage>
<Description>Leflunomide USP is a pyrimidine synthesis inhibitor. The chemical name for leflunomide is N-(4´-trifluoromethylphenyl)-5-methylisoxazole-4-carboxamide. It has an empirical formula C12H9F3N2O2, a molecular weight of 270.2 and the following structural formula. Leflunomide USP is available for oral administration as film coated tablets containing 10 mg and 20 mg of active drug. Combined with leflunomide are the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, corn starch, HPMC 2910/Hypromellose USP (6 mPas), Titanium Dioxide USP, Macrogol/PEG 6000 NF, Talc USP and Iron Oxide Yellow NF (20 mg tablet only).</Description>
</NDC>
<NDC>
<NDCCode>70748-131-06</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (70748-131-06) </PackageDescription>
<NDC11Code>70748-0131-06</NDC11Code>
<ProductNDC>70748-131</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sildenafil</ProprietaryName>
<NonProprietaryName>Sildenafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190927</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212051</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70748-132-06</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (70748-132-06) </PackageDescription>
<NDC11Code>70748-0132-06</NDC11Code>
<ProductNDC>70748-132</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sildenafil</ProprietaryName>
<NonProprietaryName>Sildenafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190927</StartMarketingDate>
<EndMarketingDate>20240131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212051</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190927</StartMarketingDatePackage>
<EndMarketingDatePackage>20240131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sildenafil tablet is indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Sildenafil tablets USP, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3- d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula. Sildenafil citrate is a white or almost white, slightly hygroscopic, crystalline powder with a solubility of 4.904 mg/mL in water and a molecular weight of 666.7. Sildenafil tablets are formulated as white to off white, round, film coated tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70748-133-06</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (70748-133-06) </PackageDescription>
<NDC11Code>70748-0133-06</NDC11Code>
<ProductNDC>70748-133</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sildenafil</ProprietaryName>
<NonProprietaryName>Sildenafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190927</StartMarketingDate>
<EndMarketingDate>20240131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212051</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190927</StartMarketingDatePackage>
<EndMarketingDatePackage>20240131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sildenafil tablet is indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Sildenafil tablets USP, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3- d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula. Sildenafil citrate is a white or almost white, slightly hygroscopic, crystalline powder with a solubility of 4.904 mg/mL in water and a molecular weight of 666.7. Sildenafil tablets are formulated as white to off white, round, film coated tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70748-211-06</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (70748-211-06) / 30 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>70748-0211-06</NDC11Code>
<ProductNDC>70748-211</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dasatinib</ProprietaryName>
<NonProprietaryName>Dasatinib</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214350</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DASATINIB</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.</IndicationAndUsage>
<Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide. The molecular formula is C22H26ClN7O2S, which corresponds to a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Dasatinib tablets are white to off-white, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, methacrylic acid copolymer, microcrystalline cellulose, magnesium stearate, talc. The tablet coating consists of hypromellose, medium chain triglycerides, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70748-212-06</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (70748-212-06) / 30 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>70748-0212-06</NDC11Code>
<ProductNDC>70748-212</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dasatinib</ProprietaryName>
<NonProprietaryName>Dasatinib</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214350</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DASATINIB</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.</IndicationAndUsage>
<Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide. The molecular formula is C22H26ClN7O2S, which corresponds to a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Dasatinib tablets are white to off-white, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, methacrylic acid copolymer, microcrystalline cellulose, magnesium stearate, talc. The tablet coating consists of hypromellose, medium chain triglycerides, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70748-213-06</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (70748-213-06) / 30 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>70748-0213-06</NDC11Code>
<ProductNDC>70748-213</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dasatinib</ProprietaryName>
<NonProprietaryName>Dasatinib</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214350</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DASATINIB</SubstanceName>
<StrengthNumber>140</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with: 1 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase., 2 chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib., 3 Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.</IndicationAndUsage>
<Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide. The molecular formula is C22H26ClN7O2S, which corresponds to a molecular weight of 488.01. Dasatinib has the following chemical structure. Dasatinib is a white to off-white powder. The drug substance is insoluble in water and slightly soluble in ethanol and methanol. Dasatinib tablets are white to off-white, film-coated tablets containing dasatinib, with the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, methacrylic acid copolymer, microcrystalline cellulose, magnesium stearate, talc. The tablet coating consists of hypromellose, medium chain triglycerides, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70748-236-06</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (70748-236-06) </PackageDescription>
<NDC11Code>70748-0236-06</NDC11Code>
<ProductNDC>70748-236</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azilsartan Medoxomil</ProprietaryName>
<NonProprietaryName>Azilsartan Medoxomil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214489</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AZILSARTAN KAMEDOXOMIL</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Blocker [EPC], Angiotensin 2 Type 1 Receptor Antagonists [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azilsartan medoxomil tablets are indicated for the treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with azilsartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality and it can be concluded that it is blood pressure reduction and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia) and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure or diabetic kidney disease). These considerations may guide selection of therapy. Azilsartan medoxomil tablets may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Azilsartan medoxomil, a prodrug, is hydrolyzed to azilsartan in the gastrointestinal tract during absorption. Azilsartan is an angiotensin II receptor blocker. The drug substance used in the drug product formulation is the potassium salt of azilsartan medoxomil, also known by the US accepted name of azilsartan kamedoxomil and is chemically described as (5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 2-ethoxy-1-{[2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl]methyl}-1H-benzimidazole-7-carboxylate mono potassium salt. Its empirical formula is C30H23KN4O8 and its structural formula is. Azilsartan kamedoxomil is a white to off-white colored powder with a molecular weight of 606.62. It is practically insoluble in water, sparingly soluble in methanol; and soluble in N, N-Dimethylformamide. Azilsartan medoxomil is available for oral use as tablets. The tablets have a characteristic odor. Each azilsartan medoxomil tablet contains 42.68 or 85.36 mg of azilsartan kamedoxomil, which is equivalent to containing 40 mg or 80 mg respectively, of azilsartan medoxomil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose and vanillin.</Description>
</NDC>
<NDC>
<NDCCode>70748-237-06</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (70748-237-06) </PackageDescription>
<NDC11Code>70748-0237-06</NDC11Code>
<ProductNDC>70748-237</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azilsartan Medoxomil</ProprietaryName>
<NonProprietaryName>Azilsartan Medoxomil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214489</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AZILSARTAN KAMEDOXOMIL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Blocker [EPC], Angiotensin 2 Type 1 Receptor Antagonists [MoA], Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Azilsartan medoxomil tablets are indicated for the treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with azilsartan medoxomil tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality and it can be concluded that it is blood pressure reduction and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia) and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure or diabetic kidney disease). These considerations may guide selection of therapy. Azilsartan medoxomil tablets may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Azilsartan medoxomil, a prodrug, is hydrolyzed to azilsartan in the gastrointestinal tract during absorption. Azilsartan is an angiotensin II receptor blocker. The drug substance used in the drug product formulation is the potassium salt of azilsartan medoxomil, also known by the US accepted name of azilsartan kamedoxomil and is chemically described as (5-Methyl-2-oxo-1,3-dioxol-4-yl)methyl 2-ethoxy-1-{[2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl]methyl}-1H-benzimidazole-7-carboxylate mono potassium salt. Its empirical formula is C30H23KN4O8 and its structural formula is. Azilsartan kamedoxomil is a white to off-white colored powder with a molecular weight of 606.62. It is practically insoluble in water, sparingly soluble in methanol; and soluble in N, N-Dimethylformamide. Azilsartan medoxomil is available for oral use as tablets. The tablets have a characteristic odor. Each azilsartan medoxomil tablet contains 42.68 or 85.36 mg of azilsartan kamedoxomil, which is equivalent to containing 40 mg or 80 mg respectively, of azilsartan medoxomil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose and vanillin.</Description>
</NDC>
<NDC>
<NDCCode>70748-238-06</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (70748-238-06) </PackageDescription>
<NDC11Code>70748-0238-06</NDC11Code>
<ProductNDC>70748-238</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tolvaptan</ProprietaryName>
<NonProprietaryName>Tolvaptan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250512</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216063</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TOLVAPTAN</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vasopressin V2 Receptor Antagonist [EPC], Vasopressin V2 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250512</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tolvaptan tablets are indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).</IndicationAndUsage>
<Description>Tolvaptan tablets contain tolvaptan, a selective vasopressin V2-receptor antagonist in immediate release tablets for oral administration available in 15 mg, 30 mg, 45 mg, 60 mg and 90 mg strengths. Tolvaptan is N-(4-(7-chloro-5-hydroxy-2, 3, 4, 5 - tetrahydro-1H-benzo[b]azepine-1-carbonyl)-3-methylphenyl)-2-methylbenzamide. The empirical formula is C26H25ClN2O3. Molecular weight is 448.9. The chemical structure is. Inactive ingredients include corn starch, hydroxy propyl cellulose, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose and red iron oxide.</Description>
</NDC>
</NDCList>