{
"NDC": [
{
"NDCCode": "83107-023-45",
"PackageDescription": "1 TUBE in 1 CARTON (83107-023-45) / 45 g in 1 TUBE",
"NDC11Code": "83107-0023-45",
"ProductNDC": "83107-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naftin",
"NonProprietaryName": "Naftifine Hydrochloride",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250729",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204286",
"LabelerName": "Legacy Pharma USA Inc.",
"SubstanceName": "NAFTIFINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Allylamine Antifungal [EPC], Allylamine [CS]",
"Status": "Active",
"LastUpdate": "2025-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250729",
"SamplePackage": "N",
"IndicationAndUsage": "NAFTIN ®Gel is an allylamine antifungal indicated for the treatment of interdigital tinea pedis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.",
"Description": "NAFTIN ®Gel is a clear to yellow gel for topical use only. Each gram of NAFTIN ®Gel contains 20 mg of naftifine hydrochloride, a synthetic allylamine antifungal compound. Chemically, naftifine HCl is (E)-N-Cinnamyl-N-methyl-1-napthalenemethylamine hydrochloride. The molecular formula is C 21H 21N∙HCl with a molecular weight of 323.86. The structural formula of naftifine hydrochloride is. NAFTIN ®Gel contains the following inactive ingredients: alcohol, benzyl alcohol, edetate disodium, hydroxyethyl cellulose, purified water, propylene glycol, polysorbate 20 and trolamine."
},
{
"NDCCode": "83107-023-60",
"PackageDescription": "1 TUBE in 1 CARTON (83107-023-60) / 60 g in 1 TUBE",
"NDC11Code": "83107-0023-60",
"ProductNDC": "83107-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naftin",
"NonProprietaryName": "Naftifine Hydrochloride",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250729",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204286",
"LabelerName": "Legacy Pharma USA Inc.",
"SubstanceName": "NAFTIFINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Allylamine Antifungal [EPC], Allylamine [CS]",
"Status": "Active",
"LastUpdate": "2025-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250729",
"SamplePackage": "N",
"IndicationAndUsage": "NAFTIN ®Gel is an allylamine antifungal indicated for the treatment of interdigital tinea pedis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.",
"Description": "NAFTIN ®Gel is a clear to yellow gel for topical use only. Each gram of NAFTIN ®Gel contains 20 mg of naftifine hydrochloride, a synthetic allylamine antifungal compound. Chemically, naftifine HCl is (E)-N-Cinnamyl-N-methyl-1-napthalenemethylamine hydrochloride. The molecular formula is C 21H 21N∙HCl with a molecular weight of 323.86. The structural formula of naftifine hydrochloride is. NAFTIN ®Gel contains the following inactive ingredients: alcohol, benzyl alcohol, edetate disodium, hydroxyethyl cellulose, purified water, propylene glycol, polysorbate 20 and trolamine."
},
{
"NDCCode": "43353-023-45",
"PackageDescription": "45 TABLET in 1 BOTTLE (43353-023-45) ",
"NDC11Code": "43353-0023-45",
"ProductNDC": "43353-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090935",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150426",
"SamplePackage": "N",
"IndicationAndUsage": "Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
"Description": "Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free."
},
{
"NDCCode": "52343-023-45",
"PackageDescription": "45 TABLET, FILM COATED in 1 BOTTLE (52343-023-45) ",
"NDC11Code": "52343-0023-45",
"ProductNDC": "52343-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077691",
"LabelerName": "ACETRIS HEALTH, LLC",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20061220",
"SamplePackage": "N"
},
{
"NDCCode": "63824-023-45",
"PackageDescription": "1 BOTTLE in 1 BLISTER PACK (63824-023-45) > 44 TABLET, EXTENDED RELEASE in 1 BOTTLE",
"NDC11Code": "63824-0023-45",
"ProductNDC": "63824-023",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucinex",
"ProprietaryNameSuffix": "Maximum Strength",
"NonProprietaryName": "Guaifenesin",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120626",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021282",
"LabelerName": "Reckitt Benckiser LLC",
"SubstanceName": "GUAIFENESIN",
"StrengthNumber": "1200",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-10-17"
},
{
"NDCCode": "67402-021-23",
"PackageDescription": "1 KIT in 1 BOX (67402-021-23) * 45 g in 1 TUBE * 7 POUCH in 1 CASE (67402-023-07) > .5 g in 1 POUCH (67402-023-01)",
"NDC11Code": "67402-0021-23",
"ProductNDC": "67402-021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Neobenz Micro Plus Pack",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "KIT",
"StartMarketingDate": "20090416",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "SkinMedica Pharmaceuticals, Inc.",
"Status": "Active",
"LastUpdate": "2014-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090416",
"SamplePackage": "N"
},
{
"NDCCode": "67544-023-45",
"PackageDescription": "45 TABLET in 1 BOTTLE, PLASTIC (67544-023-45)",
"NDC11Code": "67544-0023-45",
"ProductNDC": "67544-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"NonProprietaryName": "Hydrocodone Bitartrate And Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089160",
"LabelerName": "Aphena Pharma Solutions - Tennessee, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; ACETAMINOPHEN",
"StrengthNumber": "5; 500",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "70983-023-01",
"PackageDescription": "1 BOTTLE, WITH APPLICATOR in 1 BOX (70983-023-01) / 45 mL in 1 BOTTLE, WITH APPLICATOR",
"NDC11Code": "70983-0023-01",
"ProductNDC": "70983-023",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Extra Strength",
"NonProprietaryName": "Menthol And Methyl Salicylate",
"DosageFormName": "OIL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190513",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Saje Natural Business Inc.",
"SubstanceName": "MENTHOL; METHYL SALICYLATE",
"StrengthNumber": "94.41; 123.74",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2025-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190513",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor aches and pains of muscles and joints associated with: simple back ache arthritis strains bruise sprains.",
"Description": "Extra Strength Pain Relieving Oil Blend 0.68 fl oz (20 ml). Extra Strength Pain Relieving Oil Blend 1.5 fl oz (45 ml)."
},
{
"NDCCode": "71610-023-45",
"PackageDescription": "45 TABLET in 1 BOTTLE (71610-023-45) ",
"NDC11Code": "71610-0023-45",
"ProductNDC": "71610-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonazepam",
"NonProprietaryName": "Clonazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074869",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "CLONAZEPAM",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20171222",
"SamplePackage": "N",
"IndicationAndUsage": "Seizure Disorders: Clonazepam tablets, USP are useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam may be useful. In some studies, up to 30% of patients have shown a loss of anticonvulsant activity, often within 3 months of administration. In some cases, dosage adjustment may reestablish efficacy. Panic Disorder: Clonazepam tablets, USP are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-V. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of clonazepam was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR category of panic disorder (see CLINICAL PHARMACOLOGY, Clinical Trials). Panic disorder (DSM-V) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The effectiveness of clonazepam in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use clonazepam for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "Clonazepam USP, a benzodiazepine, is available for oral administration as scored tablets containing 0.5 mg, 1 mg or 2 mg of clonazepam. In addition, each tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The 0.5 mg tablet also contains D&C Red #30 aluminum lake. The 1 mg tablet also contains D&C Yellow #10HT aluminum lake. Chemically, clonazepam, USP is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula."
},
{
"NDCCode": "82953-023-12",
"PackageDescription": "45 mL in 1 BOTTLE, PLASTIC (82953-023-12) ",
"NDC11Code": "82953-0023-12",
"ProductNDC": "82953-023",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sunscreen",
"ProprietaryNameSuffix": "01",
"NonProprietaryName": "Avobenzone,homosalate,octocrylene,octisalate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240530",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Cosmuses Cosmetics (Ningbo) Co., Ltd.",
"SubstanceName": "OCTOCRYLENE; HOMOSALATE; AVOBENZONE; OCTISALATE",
"StrengthNumber": "3; 10; 5; 10",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Active",
"LastUpdate": "2024-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240530",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreased the risk of skin cancer and early skin aging caused by sun."
},
{
"NDCCode": "84575-023-01",
"PackageDescription": "45 mL in 1 BOTTLE (84575-023-01) ",
"NDC11Code": "84575-0023-01",
"ProductNDC": "84575-023",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aloe Hair Serum",
"NonProprietaryName": "Camphor",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240822",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Linhe Biotechnology (Shenzhen) Co., Ltd",
"SubstanceName": "CAMPHOR, (-)-",
"StrengthNumber": ".1",
"StrengthUnit": "g/45mL",
"Status": "Deprecated",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240822",
"SamplePackage": "N",
"IndicationAndUsage": "Twist or snip off the capsule neck to open, Squeeze the serum onto your fingertips, Distribute the serum to your hair, from mid-length to the ends."
},
{
"NDCCode": "0006-5084-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0006-5084-01) ",
"NDC11Code": "00006-5084-01",
"ProductNDC": "0006-5084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lipfendra",
"NonProprietaryName": "Lipfendra",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260715",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA220848",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "ENLICITIDE DECANOATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260715",
"SamplePackage": "N",
"IndicationAndUsage": "LIPFENDRA® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy.",
"Description": "LIPFENDRA (enlicitide) tablets for oral use contain enlicitide decanoate, a PCSK9 inhibitor. The chemical name of enlicitide decanoate is 6-({[(11S,17S,20S,23S,27S,39S,42S,63S,66R)-47-Fluoro-20-[(1R)-1-hydroxyethyl]-17-[(4-methoxyphenyl)methyl]-11,63-dimethyl-10,16,19,22,30,40,58,61,64,67,70-undecaoxo-28-oxa-1,9,15,18,21,24,31,41,51,62,65,68-dodecaazanonacyclo[37.18.11.23,6.124,42.133,37.144,51.011,15.023,27.045,50]triheptaconta-3,5,33(71),34,36,44(69),45,47,49,72-decaen-66-yl]methyl}amino)-N,N,N-trimethyl-6-oxohexan-1-aminium decanoate. Enlicitide decanoate is a white to off-white powder that is slightly soluble in water. The molecular formula is C92H129FN14O17 and the molecular weight is 1722.12 g/mol. The chemical structure of enlicitide decanoate is. LIPFENDRA is available as film-coated tablets for oral administration, each containing 20 mg of enlicitide (equivalent to 22.21 mg enlicitide decanoate) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium caprate. The film coating contains calcium carbonate, ethylene glycol and vinyl alcohol graft copolymer, glyceryl mono and dicaprylocaprate, polyvinyl alcohol, and talc. Carnauba wax is added as a polishing agent."
},
{
"NDCCode": "0006-5084-59",
"PackageDescription": "1 BOTTLE in 1 CARTON (0006-5084-59) / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5084-58) ",
"NDC11Code": "00006-5084-59",
"ProductNDC": "0006-5084",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lipfendra",
"NonProprietaryName": "Lipfendra",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260715",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA220848",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "ENLICITIDE DECANOATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260715",
"SamplePackage": "Y",
"IndicationAndUsage": "LIPFENDRA® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy.",
"Description": "LIPFENDRA (enlicitide) tablets for oral use contain enlicitide decanoate, a PCSK9 inhibitor. The chemical name of enlicitide decanoate is 6-({[(11S,17S,20S,23S,27S,39S,42S,63S,66R)-47-Fluoro-20-[(1R)-1-hydroxyethyl]-17-[(4-methoxyphenyl)methyl]-11,63-dimethyl-10,16,19,22,30,40,58,61,64,67,70-undecaoxo-28-oxa-1,9,15,18,21,24,31,41,51,62,65,68-dodecaazanonacyclo[37.18.11.23,6.124,42.133,37.144,51.011,15.023,27.045,50]triheptaconta-3,5,33(71),34,36,44(69),45,47,49,72-decaen-66-yl]methyl}amino)-N,N,N-trimethyl-6-oxohexan-1-aminium decanoate. Enlicitide decanoate is a white to off-white powder that is slightly soluble in water. The molecular formula is C92H129FN14O17 and the molecular weight is 1722.12 g/mol. The chemical structure of enlicitide decanoate is. LIPFENDRA is available as film-coated tablets for oral administration, each containing 20 mg of enlicitide (equivalent to 22.21 mg enlicitide decanoate) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium caprate. The film coating contains calcium carbonate, ethylene glycol and vinyl alcohol graft copolymer, glyceryl mono and dicaprylocaprate, polyvinyl alcohol, and talc. Carnauba wax is added as a polishing agent."
},
{
"NDCCode": "50632-023-02",
"PackageDescription": "10 VIAL in 1 CARTON (50632-023-02) / .5 mL in 1 VIAL (50632-023-04) ",
"NDC11Code": "50632-0023-02",
"ProductNDC": "50632-023",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Jynneos",
"NonProprietaryName": "Vaccinia Virus Modified Strain Ankara-bavarian Nordic Non-replicating Antigen",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20250214",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125678",
"LabelerName": "Bavarian Nordic A/S",
"SubstanceName": "VACCINIA VIRUS MODIFIED STRAIN ANKARA-BAVARIAN NORDIC NON-REPLICATING ANTIGEN",
"StrengthNumber": "50000000",
"StrengthUnit": "1/.5mL",
"Status": "Active",
"LastUpdate": "2025-04-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250214",
"SamplePackage": "N",
"IndicationAndUsage": "JYNNEOS is a vaccine indicated for prevention of smallpox and mpox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.",
"Description": "JYNNEOS (Smallpox and Mpox Vaccine, Live, Non-replicating) is a sterile injectable suspension administered subcutaneously. JYNNEOS is a live vaccine produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus. MVA-BN is grown in primary Chicken Embryo Fibroblast (CEF) cells suspended in a serum-free medium containing no material of direct animal origin, harvested from the CEF cells, purified and concentrated by several Tangential Flow Filtration (TFF) steps including benzonase digestion. Each 0.5 mL dose of JYNNEOS is formulated to contain 0.5 x 108 to 3.95 x 108 infectious units of MVA-BN live virus. Each 0.5 mL dose contains 0.61 mg of Tris (tromethamine), 4.09 mg sodium chloride, and may contain residual amounts of host-cell DNA (≤20 mcg), protein (≤500 mcg), benzonase (≤0.0025 mcg), gentamicin (≤0.400 mcg), and ciprofloxacin (≤0.005 mcg). In addition, JYNNEOS vaccine reconstituted with Diluent Component (Water for Injection) contains 9.45 mg dextran 40, 22.5 mg sucrose, and 0.054 mg potassium L-glutamate monohydrate as stabilizers. After preparation [see Dosage and Administration (2.2)], JYNNEOS is a milky, light yellow to pale white colored suspension. JYNNEOS is formulated without preservatives. The vial stoppers are not made with natural rubber latex."
},
{
"NDCCode": "51060-023-01",
"PackageDescription": "1 TUBE in 1 CARTON (51060-023-01) > 30 mL in 1 TUBE",
"NDC11Code": "51060-0023-01",
"ProductNDC": "51060-023",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bb Tinted Treatment 12-hour Primer Broad Spectrum Spf 30 Sunscreen",
"ProprietaryNameSuffix": "Tan Deep",
"NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Tarte, Inc",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "45.5; 35",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20140101",
"SamplePackage": "N"
},
{
"NDCCode": "60842-023-01",
"PackageDescription": "2 DOSE PACK in 1 CARTON (60842-023-01) / .3 mL in 1 DOSE PACK",
"NDC11Code": "60842-0023-01",
"ProductNDC": "60842-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Auvi-q",
"NonProprietaryName": "Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20121115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201739",
"LabelerName": "kaleo, Inc",
"SubstanceName": "EPINEPHRINE",
"StrengthNumber": ".3",
"StrengthUnit": "mg/.3mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20121115",
"EndMarketingDatePackage": "20251209",
"SamplePackage": "N",
"IndicationAndUsage": "AUVI-Q is indicated for the emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 7.5 kg or greater.",
"Description": "AUVI-Q (epinephrine injection, USP) 0.3 mg, 0.15 mg and 0.1 mg is an autoinjector and a combination product containing drug and device components. AUVI-Q includes audible (electronic voice instructions, beeps) and visible (LED lights) cues for use. The needle automatically retracts after the injection is complete. Each AUVI-Q 0.3 mg delivers a single dose of 0.3 mg epinephrine from epinephrine injection, USP (0.3 mL) in a sterile solution. Each AUVI-Q 0.15 mg delivers a single dose of 0.15 mg epinephrine from epinephrine injection, USP (0.15 mL) in a sterile solution. Each AUVI-Q 0.1 mg delivers a single dose of 0.1 mg epinephrine from epinephrine injection, USP (0.1 mL) in a sterile solution. AUVI-Q 0.3 mg, AUVI-Q 0.15 mg and AUVI-Q 0.1 mg each contain 0.76 mL epinephrine solution. 0.3 mL, 0.15 mL and 0.1 mL epinephrine solution is dispensed for AUVI-Q 0.3 mg, AUVI-Q 0.15 mg and AUVI-Q 0.1 mg, respectively, when activated. The remaining solution is not available for future use and should be discarded. Each 0.3 mL in AUVI-Q 0.3 mg contains 0.3 mg epinephrine, 2.3 mg sodium chloride, 0.45 mg sodium bisulfite, hydrochloric acid to adjust pH, and water for injection. The pH range is 2.2– 5.0. Each 0.15 mL in AUVI-Q 0.15 mg contains 0.15 mg epinephrine, 1.2 mg sodium chloride, 0.225 mg sodium bisulfite, hydrochloric acid to adjust pH, and water for injection. The pH range is 2.2–5.0. Each 0.1 mL in AUVI-Q 0.1 mg contains 0.1 mg epinephrine, 0.78 mg sodium chloride, 0.15 mg sodium bisulfite, hydrochloric acid to adjust pH, and water for injection. The pH range is 2.2–5.0. Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4-Dihydroxy-a-[(methylamino)methyl]benzyl alcohol with the following structure. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. AUVI-Q is not made with natural rubber latex. AUVI-Q instructional and safety systems should be thoroughly reviewed with patients and caregivers prior to use [see Patient Counseling Information (17)]."
},
{
"NDCCode": "60842-023-02",
"PackageDescription": "2 DOSE PACK in 1 CARTON (60842-023-02) / .3 mL in 1 DOSE PACK",
"NDC11Code": "60842-0023-02",
"ProductNDC": "60842-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Auvi-q",
"NonProprietaryName": "Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20121115",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201739",
"LabelerName": "kaleo, Inc",
"SubstanceName": "EPINEPHRINE",
"StrengthNumber": ".3",
"StrengthUnit": "mg/.3mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240910",
"SamplePackage": "N",
"IndicationAndUsage": "AUVI-Q is indicated for the emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 7.5 kg or greater.",
"Description": "AUVI-Q (epinephrine injection, USP) 0.3 mg, 0.15 mg and 0.1 mg is an autoinjector and a combination product containing drug and device components. AUVI-Q includes audible (electronic voice instructions, beeps) and visible (LED lights) cues for use. The needle automatically retracts after the injection is complete. Each AUVI-Q 0.3 mg delivers a single dose of 0.3 mg epinephrine from epinephrine injection, USP (0.3 mL) in a sterile solution. Each AUVI-Q 0.15 mg delivers a single dose of 0.15 mg epinephrine from epinephrine injection, USP (0.15 mL) in a sterile solution. Each AUVI-Q 0.1 mg delivers a single dose of 0.1 mg epinephrine from epinephrine injection, USP (0.1 mL) in a sterile solution. AUVI-Q 0.3 mg, AUVI-Q 0.15 mg and AUVI-Q 0.1 mg each contain 0.76 mL epinephrine solution. 0.3 mL, 0.15 mL and 0.1 mL epinephrine solution is dispensed for AUVI-Q 0.3 mg, AUVI-Q 0.15 mg and AUVI-Q 0.1 mg, respectively, when activated. The remaining solution is not available for future use and should be discarded. Each 0.3 mL in AUVI-Q 0.3 mg contains 0.3 mg epinephrine, 2.3 mg sodium chloride, 0.45 mg sodium bisulfite, hydrochloric acid to adjust pH, and water for injection. The pH range is 2.2– 5.0. Each 0.15 mL in AUVI-Q 0.15 mg contains 0.15 mg epinephrine, 1.2 mg sodium chloride, 0.225 mg sodium bisulfite, hydrochloric acid to adjust pH, and water for injection. The pH range is 2.2–5.0. Each 0.1 mL in AUVI-Q 0.1 mg contains 0.1 mg epinephrine, 0.78 mg sodium chloride, 0.15 mg sodium bisulfite, hydrochloric acid to adjust pH, and water for injection. The pH range is 2.2–5.0. Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4-Dihydroxy-a-[(methylamino)methyl]benzyl alcohol with the following structure. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. AUVI-Q is not made with natural rubber latex. AUVI-Q instructional and safety systems should be thoroughly reviewed with patients and caregivers prior to use [see Patient Counseling Information (17)]."
},
{
"NDCCode": "65862-023-01",
"PackageDescription": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-023-01) ",
"NDC11Code": "65862-0023-01",
"ProductNDC": "65862-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mirtazapine",
"NonProprietaryName": "Mirtazapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20060228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077376",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "MIRTAZAPINE",
"StrengthNumber": "45",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20060228",
"SamplePackage": "N",
"IndicationAndUsage": "Mirtazapine orally disintegrating tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "Mirtazapine orally disintegrating tablet, USP contains mirtazapine USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1-a] pyrido [2,3-c][2] benzazepine and has the molecular formula of C17H19N3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture. Mirtazapine is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine orally disintegrating tablets, USP are available for oral administration as an orally disintegrating tablet containing 15 mg, 30 mg or 45 mg of mirtazapine USP. Mirtazapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, natural and artificial peppermint flavor, and strawberry guarana flavor."
},
{
"NDCCode": "65862-023-06",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (65862-023-06) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "65862-0023-06",
"ProductNDC": "65862-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mirtazapine",
"NonProprietaryName": "Mirtazapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20060228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077376",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "MIRTAZAPINE",
"StrengthNumber": "45",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20060228",
"SamplePackage": "N",
"IndicationAndUsage": "Mirtazapine orally disintegrating tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "Mirtazapine orally disintegrating tablet, USP contains mirtazapine USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1-a] pyrido [2,3-c][2] benzazepine and has the molecular formula of C17H19N3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture. Mirtazapine is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine orally disintegrating tablets, USP are available for oral administration as an orally disintegrating tablet containing 15 mg, 30 mg or 45 mg of mirtazapine USP. Mirtazapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, natural and artificial peppermint flavor, and strawberry guarana flavor."
},
{
"NDCCode": "65862-023-30",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-023-30) ",
"NDC11Code": "65862-0023-30",
"ProductNDC": "65862-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mirtazapine",
"NonProprietaryName": "Mirtazapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20060228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077376",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "MIRTAZAPINE",
"StrengthNumber": "45",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20060228",
"SamplePackage": "N",
"IndicationAndUsage": "Mirtazapine orally disintegrating tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "Mirtazapine orally disintegrating tablet, USP contains mirtazapine USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1-a] pyrido [2,3-c][2] benzazepine and has the molecular formula of C17H19N3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture. Mirtazapine is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine orally disintegrating tablets, USP are available for oral administration as an orally disintegrating tablet containing 15 mg, 30 mg or 45 mg of mirtazapine USP. Mirtazapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, natural and artificial peppermint flavor, and strawberry guarana flavor."
},
{
"NDCCode": "65862-023-35",
"PackageDescription": "3500 TABLET, ORALLY DISINTEGRATING in 1 BAG (65862-023-35) ",
"NDC11Code": "65862-0023-35",
"ProductNDC": "65862-023",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Mirtazapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"StartMarketingDate": "20051208",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "MIRTAZAPINE",
"StrengthNumber": "45",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-01-27",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "08-DEC-05"
},
{
"NDCCode": "65862-023-60",
"PackageDescription": "60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-023-60) ",
"NDC11Code": "65862-0023-60",
"ProductNDC": "65862-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mirtazapine",
"NonProprietaryName": "Mirtazapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20060228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077376",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "MIRTAZAPINE",
"StrengthNumber": "45",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20060228",
"SamplePackage": "N",
"IndicationAndUsage": "Mirtazapine orally disintegrating tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "Mirtazapine orally disintegrating tablet, USP contains mirtazapine USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1-a] pyrido [2,3-c][2] benzazepine and has the molecular formula of C17H19N3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture. Mirtazapine is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine orally disintegrating tablets, USP are available for oral administration as an orally disintegrating tablet containing 15 mg, 30 mg or 45 mg of mirtazapine USP. Mirtazapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, natural and artificial peppermint flavor, and strawberry guarana flavor."
},
{
"NDCCode": "65862-023-90",
"PackageDescription": "90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-023-90) ",
"NDC11Code": "65862-0023-90",
"ProductNDC": "65862-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mirtazapine",
"NonProprietaryName": "Mirtazapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20060228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077376",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "MIRTAZAPINE",
"StrengthNumber": "45",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-07-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20060228",
"SamplePackage": "N",
"IndicationAndUsage": "Mirtazapine orally disintegrating tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "Mirtazapine orally disintegrating tablet, USP contains mirtazapine USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1-a] pyrido [2,3-c][2] benzazepine and has the molecular formula of C17H19N3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture. Mirtazapine is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine orally disintegrating tablets, USP are available for oral administration as an orally disintegrating tablet containing 15 mg, 30 mg or 45 mg of mirtazapine USP. Mirtazapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, natural and artificial peppermint flavor, and strawberry guarana flavor."
},
{
"NDCCode": "69844-023-01",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69844-023-01) ",
"NDC11Code": "69844-0023-01",
"ProductNDC": "69844-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibric Acid Delayed-release",
"NonProprietaryName": "Fenofibric Acid",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190718",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211626",
"LabelerName": "Graviti Pharmaceuticals Private Limited",
"SubstanceName": "FENOFIBRIC ACID",
"StrengthNumber": "135",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190718",
"SamplePackage": "N",
"IndicationAndUsage": "Fenofibric acid is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as adjunctive therapy to diet to. : 1 Reduce TG in patients with severe hypertriglyceridemia ( 1.1). , 2 Reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in patients with primary hypercholesterolemia or mixed dyslipidemia ( 1.2). .",
"Description": "Fenofibric acid delayed-release capsules are lipid regulating agent available as delayed release capsules for oral administration. Each delayed release capsule contains choline fenofibrate, equivalent to 45 mg or 135 mg of fenofibric acid. The chemical name for choline fenofibrate is ethanaminium, 2- hydroxy-N,N,N-trimethyl, 2-{4-(4-chlorobenzoyl)phenoxy] -2-methylpropanoate (1:1) with the following structural formula. The molecular formula is C 22H 28ClNO 5 and the molecular weight is 421.9. Choline fenofibrate is very soluble in water and freely soluble in methanol. The melting point is approximately 210°C. Choline fenofibrate is a white to off-white crystalline powder. Each delayed release capsule contains enteric coated mini-tablets comprised of choline fenofibrate and the following inactive ingredients: Colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose 2208, methacrylic acid and ethyl acrylate copolymer dispersion (sodium lauryl sulfate, polysorbate 80 and methacrylic acid and ethyl acrylate copolymer), povidone, sodium stearyl fumarate, talc and triethyl citrate. Capsule shell contains: gelatin, iron oxide black, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. Additionally, 45 mg contains: iron oxide red. 135 mg contains: FD & C blue 1, FD & C red 3, FD & C red 40. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "69844-023-02",
"PackageDescription": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69844-023-02) ",
"NDC11Code": "69844-0023-02",
"ProductNDC": "69844-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibric Acid Delayed-release",
"NonProprietaryName": "Fenofibric Acid",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190718",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211626",
"LabelerName": "Graviti Pharmaceuticals Private Limited",
"SubstanceName": "FENOFIBRIC ACID",
"StrengthNumber": "135",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190718",
"SamplePackage": "N",
"IndicationAndUsage": "Fenofibric acid is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as adjunctive therapy to diet to. : 1 Reduce TG in patients with severe hypertriglyceridemia ( 1.1). , 2 Reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in patients with primary hypercholesterolemia or mixed dyslipidemia ( 1.2). .",
"Description": "Fenofibric acid delayed-release capsules are lipid regulating agent available as delayed release capsules for oral administration. Each delayed release capsule contains choline fenofibrate, equivalent to 45 mg or 135 mg of fenofibric acid. The chemical name for choline fenofibrate is ethanaminium, 2- hydroxy-N,N,N-trimethyl, 2-{4-(4-chlorobenzoyl)phenoxy] -2-methylpropanoate (1:1) with the following structural formula. The molecular formula is C 22H 28ClNO 5 and the molecular weight is 421.9. Choline fenofibrate is very soluble in water and freely soluble in methanol. The melting point is approximately 210°C. Choline fenofibrate is a white to off-white crystalline powder. Each delayed release capsule contains enteric coated mini-tablets comprised of choline fenofibrate and the following inactive ingredients: Colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose 2208, methacrylic acid and ethyl acrylate copolymer dispersion (sodium lauryl sulfate, polysorbate 80 and methacrylic acid and ethyl acrylate copolymer), povidone, sodium stearyl fumarate, talc and triethyl citrate. Capsule shell contains: gelatin, iron oxide black, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. Additionally, 45 mg contains: iron oxide red. 135 mg contains: FD & C blue 1, FD & C red 3, FD & C red 40. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "69844-023-03",
"PackageDescription": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69844-023-03) ",
"NDC11Code": "69844-0023-03",
"ProductNDC": "69844-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibric Acid Delayed-release",
"NonProprietaryName": "Fenofibric Acid",
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"RouteName": "ORAL",
"StartMarketingDate": "20190718",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211626",
"LabelerName": "Graviti Pharmaceuticals Private Limited",
"SubstanceName": "FENOFIBRIC ACID",
"StrengthNumber": "135",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190718",
"SamplePackage": "N",
"IndicationAndUsage": "Fenofibric acid is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as adjunctive therapy to diet to. : 1 Reduce TG in patients with severe hypertriglyceridemia ( 1.1). , 2 Reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in patients with primary hypercholesterolemia or mixed dyslipidemia ( 1.2). .",
"Description": "Fenofibric acid delayed-release capsules are lipid regulating agent available as delayed release capsules for oral administration. Each delayed release capsule contains choline fenofibrate, equivalent to 45 mg or 135 mg of fenofibric acid. The chemical name for choline fenofibrate is ethanaminium, 2- hydroxy-N,N,N-trimethyl, 2-{4-(4-chlorobenzoyl)phenoxy] -2-methylpropanoate (1:1) with the following structural formula. The molecular formula is C 22H 28ClNO 5 and the molecular weight is 421.9. Choline fenofibrate is very soluble in water and freely soluble in methanol. The melting point is approximately 210°C. Choline fenofibrate is a white to off-white crystalline powder. Each delayed release capsule contains enteric coated mini-tablets comprised of choline fenofibrate and the following inactive ingredients: Colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose 2208, methacrylic acid and ethyl acrylate copolymer dispersion (sodium lauryl sulfate, polysorbate 80 and methacrylic acid and ethyl acrylate copolymer), povidone, sodium stearyl fumarate, talc and triethyl citrate. Capsule shell contains: gelatin, iron oxide black, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. Additionally, 45 mg contains: iron oxide red. 135 mg contains: FD & C blue 1, FD & C red 3, FD & C red 40. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "70983-023-02",
"PackageDescription": "20 mL in 1 BOTTLE, WITH APPLICATOR (70983-023-02) ",
"NDC11Code": "70983-0023-02",
"ProductNDC": "70983-023",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Extra Strength",
"NonProprietaryName": "Menthol And Methyl Salicylate",
"DosageFormName": "OIL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190513",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Saje Natural Business Inc.",
"SubstanceName": "MENTHOL; METHYL SALICYLATE",
"StrengthNumber": "94.41; 123.74",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2025-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221031",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor aches and pains of muscles and joints associated with: simple back ache arthritis strains bruise sprains.",
"Description": "Extra Strength Pain Relieving Oil Blend 0.68 fl oz (20 ml). Extra Strength Pain Relieving Oil Blend 1.5 fl oz (45 ml)."
},
{
"NDCCode": "83257-023-41",
"PackageDescription": "1 SYRINGE in 1 CARTON (83257-023-41) / .5 mL in 1 SYRINGE",
"NDC11Code": "83257-0023-41",
"ProductNDC": "83257-023",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Yesintek",
"NonProprietaryName": "Ustekinumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20250222",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761406",
"LabelerName": "Biocon Biologics Inc.",
"SubstanceName": "USTEKINUMAB",
"StrengthNumber": "45",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250222",
"SamplePackage": "Y",
"IndicationAndUsage": "YESINTEK is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).",
"Description": "Ustekinumab-kfce, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-kfce is produced in a murine cell line (Sp2/0). The manufacturing process contains steps for the clearance of viruses. Ustekinumab is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. YESINTEK (ustekinumab-kfce) injection is a sterile, preservative-free, clear and colorless to pale yellow solution with pH of 5.7- 6.3."
},
{
"NDCCode": "85179-023-00",
"PackageDescription": "15 mL in 1 BOTTLE (85179-023-00) ",
"NDC11Code": "85179-0023-00",
"ProductNDC": "85179-023",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Poolside Frostbite Sunscreen Coconut Spf 15 Scented Lip Gloss",
"NonProprietaryName": "Homosalate, Octocrylene, Octisalate, Avobenzone",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251217",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "I World LLC",
"SubstanceName": "HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE",
"StrengthNumber": "30; 50; 40; 45",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2026-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251217",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "83107-001-15",
"PackageDescription": "150 CAPSULE in 1 BOTTLE (83107-001-15) ",
"NDC11Code": "83107-0001-15",
"ProductNDC": "83107-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zanaflex",
"NonProprietaryName": "Tizanidine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180801",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021447",
"LabelerName": "Legacy Pharma USA, Inc.",
"SubstanceName": "TIZANIDINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180801",
"SamplePackage": "N",
"IndicationAndUsage": "Zanaflex is indicated for the treatment of spasticity in adults.",
"Description": "Zanaflex ®contains tizanidine hydrochloride as the active ingredient, which is a central alpha 2-adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. It has a molecular formula of C 9H 8ClN 5S-HCl and a molecular weight of 290.2. Its structural formula is:. Tizanidine hydrochloride is a white to off-white, fine crystalline powder, which is odorless or with a faint characteristic odor. Tizanidine hydrochloride is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Zanaflex capsules are for oral administration and contain 2, 4, or 6 mg tizanidine (equivalent to 2.29 mg, 4.58 mg, and 6.87 mg tizanidine hydrochloride, respectively), and the inactive ingredients colorants, gelatin, hypromellose, silicon dioxide, sugar spheres, and titanium dioxide. Zanaflex tablets are for oral administration and contain 4 mg tizanidine (equivalent to 4.58 mg tizanidine hydrochloride), and the inactive ingredients anhydrous lactose, colloidal silicon dioxide, microcrystalline cellulose, and stearic acid."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>83107-023-45</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (83107-023-45) / 45 g in 1 TUBE</PackageDescription>
<NDC11Code>83107-0023-45</NDC11Code>
<ProductNDC>83107-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naftin</ProprietaryName>
<NonProprietaryName>Naftifine Hydrochloride</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250729</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204286</ApplicationNumber>
<LabelerName>Legacy Pharma USA Inc.</LabelerName>
<SubstanceName>NAFTIFINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Allylamine Antifungal [EPC], Allylamine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NAFTIN ®Gel is an allylamine antifungal indicated for the treatment of interdigital tinea pedis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.</IndicationAndUsage>
<Description>NAFTIN ®Gel is a clear to yellow gel for topical use only. Each gram of NAFTIN ®Gel contains 20 mg of naftifine hydrochloride, a synthetic allylamine antifungal compound. Chemically, naftifine HCl is (E)-N-Cinnamyl-N-methyl-1-napthalenemethylamine hydrochloride. The molecular formula is C 21H 21N∙HCl with a molecular weight of 323.86. The structural formula of naftifine hydrochloride is. NAFTIN ®Gel contains the following inactive ingredients: alcohol, benzyl alcohol, edetate disodium, hydroxyethyl cellulose, purified water, propylene glycol, polysorbate 20 and trolamine.</Description>
</NDC>
<NDC>
<NDCCode>83107-023-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (83107-023-60) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>83107-0023-60</NDC11Code>
<ProductNDC>83107-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naftin</ProprietaryName>
<NonProprietaryName>Naftifine Hydrochloride</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250729</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204286</ApplicationNumber>
<LabelerName>Legacy Pharma USA Inc.</LabelerName>
<SubstanceName>NAFTIFINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Allylamine Antifungal [EPC], Allylamine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NAFTIN ®Gel is an allylamine antifungal indicated for the treatment of interdigital tinea pedis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.</IndicationAndUsage>
<Description>NAFTIN ®Gel is a clear to yellow gel for topical use only. Each gram of NAFTIN ®Gel contains 20 mg of naftifine hydrochloride, a synthetic allylamine antifungal compound. Chemically, naftifine HCl is (E)-N-Cinnamyl-N-methyl-1-napthalenemethylamine hydrochloride. The molecular formula is C 21H 21N∙HCl with a molecular weight of 323.86. The structural formula of naftifine hydrochloride is. NAFTIN ®Gel contains the following inactive ingredients: alcohol, benzyl alcohol, edetate disodium, hydroxyethyl cellulose, purified water, propylene glycol, polysorbate 20 and trolamine.</Description>
</NDC>
<NDC>
<NDCCode>43353-023-45</NDCCode>
<PackageDescription>45 TABLET in 1 BOTTLE (43353-023-45) </PackageDescription>
<NDC11Code>43353-0023-45</NDC11Code>
<ProductNDC>43353-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090935</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150426</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
<Description>Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular formula is C 19H 15NaO 4, and its structural formula is represented by the following:. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each. 1 mg tablet contains: D&C Red # 30 aluminum lake. 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2. 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2. 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake. 4 mg tablet contains: FD&C Blue # 2. 5 mg tablet contains: FD&C Yellow # 6 aluminum lake. 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2. 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake. 10 mg tablet is dye free.</Description>
</NDC>
<NDC>
<NDCCode>52343-023-45</NDCCode>
<PackageDescription>45 TABLET, FILM COATED in 1 BOTTLE (52343-023-45) </PackageDescription>
<NDC11Code>52343-0023-45</NDC11Code>
<ProductNDC>52343-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077691</ApplicationNumber>
<LabelerName>ACETRIS HEALTH, LLC</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63824-023-45</NDCCode>
<PackageDescription>1 BOTTLE in 1 BLISTER PACK (63824-023-45) > 44 TABLET, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>63824-0023-45</NDC11Code>
<ProductNDC>63824-023</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mucinex</ProprietaryName>
<ProprietaryNameSuffix>Maximum Strength</ProprietaryNameSuffix>
<NonProprietaryName>Guaifenesin</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120626</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021282</ApplicationNumber>
<LabelerName>Reckitt Benckiser LLC</LabelerName>
<SubstanceName>GUAIFENESIN</SubstanceName>
<StrengthNumber>1200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-10-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>67402-021-23</NDCCode>
<PackageDescription>1 KIT in 1 BOX (67402-021-23) * 45 g in 1 TUBE * 7 POUCH in 1 CASE (67402-023-07) > .5 g in 1 POUCH (67402-023-01)</PackageDescription>
<NDC11Code>67402-0021-23</NDC11Code>
<ProductNDC>67402-021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Neobenz Micro Plus Pack</ProprietaryName>
<NonProprietaryName>Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20090416</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>SkinMedica Pharmaceuticals, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2014-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20090416</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>67544-023-45</NDCCode>
<PackageDescription>45 TABLET in 1 BOTTLE, PLASTIC (67544-023-45)</PackageDescription>
<NDC11Code>67544-0023-45</NDC11Code>
<ProductNDC>67544-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Acetaminophen</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089160</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; ACETAMINOPHEN</SubstanceName>
<StrengthNumber>5; 500</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>70983-023-01</NDCCode>
<PackageDescription>1 BOTTLE, WITH APPLICATOR in 1 BOX (70983-023-01) / 45 mL in 1 BOTTLE, WITH APPLICATOR</PackageDescription>
<NDC11Code>70983-0023-01</NDC11Code>
<ProductNDC>70983-023</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Extra Strength</ProprietaryName>
<NonProprietaryName>Menthol And Methyl Salicylate</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190513</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Saje Natural Business Inc.</LabelerName>
<SubstanceName>MENTHOL; METHYL SALICYLATE</SubstanceName>
<StrengthNumber>94.41; 123.74</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190513</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor aches and pains of muscles and joints associated with: simple back ache arthritis strains bruise sprains.</IndicationAndUsage>
<Description>Extra Strength Pain Relieving Oil Blend 0.68 fl oz (20 ml). Extra Strength Pain Relieving Oil Blend 1.5 fl oz (45 ml).</Description>
</NDC>
<NDC>
<NDCCode>71610-023-45</NDCCode>
<PackageDescription>45 TABLET in 1 BOTTLE (71610-023-45) </PackageDescription>
<NDC11Code>71610-0023-45</NDC11Code>
<ProductNDC>71610-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonazepam</ProprietaryName>
<NonProprietaryName>Clonazepam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074869</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>CLONAZEPAM</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Seizure Disorders: Clonazepam tablets, USP are useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam may be useful. In some studies, up to 30% of patients have shown a loss of anticonvulsant activity, often within 3 months of administration. In some cases, dosage adjustment may reestablish efficacy. Panic Disorder: Clonazepam tablets, USP are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-V. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of clonazepam was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR category of panic disorder (see CLINICAL PHARMACOLOGY, Clinical Trials). Panic disorder (DSM-V) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The effectiveness of clonazepam in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use clonazepam for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Clonazepam USP, a benzodiazepine, is available for oral administration as scored tablets containing 0.5 mg, 1 mg or 2 mg of clonazepam. In addition, each tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The 0.5 mg tablet also contains D&C Red #30 aluminum lake. The 1 mg tablet also contains D&C Yellow #10HT aluminum lake. Chemically, clonazepam, USP is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>82953-023-12</NDCCode>
<PackageDescription>45 mL in 1 BOTTLE, PLASTIC (82953-023-12) </PackageDescription>
<NDC11Code>82953-0023-12</NDC11Code>
<ProductNDC>82953-023</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sunscreen</ProprietaryName>
<ProprietaryNameSuffix>01</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone,homosalate,octocrylene,octisalate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240530</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Cosmuses Cosmetics (Ningbo) Co., Ltd.</LabelerName>
<SubstanceName>OCTOCRYLENE; HOMOSALATE; AVOBENZONE; OCTISALATE</SubstanceName>
<StrengthNumber>3; 10; 5; 10</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreased the risk of skin cancer and early skin aging caused by sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84575-023-01</NDCCode>
<PackageDescription>45 mL in 1 BOTTLE (84575-023-01) </PackageDescription>
<NDC11Code>84575-0023-01</NDC11Code>
<ProductNDC>84575-023</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aloe Hair Serum</ProprietaryName>
<NonProprietaryName>Camphor</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240822</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Linhe Biotechnology (Shenzhen) Co., Ltd</LabelerName>
<SubstanceName>CAMPHOR, (-)-</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/45mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Twist or snip off the capsule neck to open, Squeeze the serum onto your fingertips, Distribute the serum to your hair, from mid-length to the ends.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0006-5084-01</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0006-5084-01) </PackageDescription>
<NDC11Code>00006-5084-01</NDC11Code>
<ProductNDC>0006-5084</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lipfendra</ProprietaryName>
<NonProprietaryName>Lipfendra</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260715</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA220848</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>ENLICITIDE DECANOATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LIPFENDRA® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy.</IndicationAndUsage>
<Description>LIPFENDRA (enlicitide) tablets for oral use contain enlicitide decanoate, a PCSK9 inhibitor. The chemical name of enlicitide decanoate is 6-({[(11S,17S,20S,23S,27S,39S,42S,63S,66R)-47-Fluoro-20-[(1R)-1-hydroxyethyl]-17-[(4-methoxyphenyl)methyl]-11,63-dimethyl-10,16,19,22,30,40,58,61,64,67,70-undecaoxo-28-oxa-1,9,15,18,21,24,31,41,51,62,65,68-dodecaazanonacyclo[37.18.11.23,6.124,42.133,37.144,51.011,15.023,27.045,50]triheptaconta-3,5,33(71),34,36,44(69),45,47,49,72-decaen-66-yl]methyl}amino)-N,N,N-trimethyl-6-oxohexan-1-aminium decanoate. Enlicitide decanoate is a white to off-white powder that is slightly soluble in water. The molecular formula is C92H129FN14O17 and the molecular weight is 1722.12 g/mol. The chemical structure of enlicitide decanoate is. LIPFENDRA is available as film-coated tablets for oral administration, each containing 20 mg of enlicitide (equivalent to 22.21 mg enlicitide decanoate) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium caprate. The film coating contains calcium carbonate, ethylene glycol and vinyl alcohol graft copolymer, glyceryl mono and dicaprylocaprate, polyvinyl alcohol, and talc. Carnauba wax is added as a polishing agent.</Description>
</NDC>
<NDC>
<NDCCode>0006-5084-59</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0006-5084-59) / 7 TABLET, FILM COATED in 1 BOTTLE (0006-5084-58) </PackageDescription>
<NDC11Code>00006-5084-59</NDC11Code>
<ProductNDC>0006-5084</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lipfendra</ProprietaryName>
<NonProprietaryName>Lipfendra</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260715</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA220848</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>ENLICITIDE DECANOATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260715</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>LIPFENDRA® is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Cardiovascular outcomes trials have demonstrated that reducing LDL-C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy.</IndicationAndUsage>
<Description>LIPFENDRA (enlicitide) tablets for oral use contain enlicitide decanoate, a PCSK9 inhibitor. The chemical name of enlicitide decanoate is 6-({[(11S,17S,20S,23S,27S,39S,42S,63S,66R)-47-Fluoro-20-[(1R)-1-hydroxyethyl]-17-[(4-methoxyphenyl)methyl]-11,63-dimethyl-10,16,19,22,30,40,58,61,64,67,70-undecaoxo-28-oxa-1,9,15,18,21,24,31,41,51,62,65,68-dodecaazanonacyclo[37.18.11.23,6.124,42.133,37.144,51.011,15.023,27.045,50]triheptaconta-3,5,33(71),34,36,44(69),45,47,49,72-decaen-66-yl]methyl}amino)-N,N,N-trimethyl-6-oxohexan-1-aminium decanoate. Enlicitide decanoate is a white to off-white powder that is slightly soluble in water. The molecular formula is C92H129FN14O17 and the molecular weight is 1722.12 g/mol. The chemical structure of enlicitide decanoate is. LIPFENDRA is available as film-coated tablets for oral administration, each containing 20 mg of enlicitide (equivalent to 22.21 mg enlicitide decanoate) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium caprate. The film coating contains calcium carbonate, ethylene glycol and vinyl alcohol graft copolymer, glyceryl mono and dicaprylocaprate, polyvinyl alcohol, and talc. Carnauba wax is added as a polishing agent.</Description>
</NDC>
<NDC>
<NDCCode>50632-023-02</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (50632-023-02) / .5 mL in 1 VIAL (50632-023-04) </PackageDescription>
<NDC11Code>50632-0023-02</NDC11Code>
<ProductNDC>50632-023</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Jynneos</ProprietaryName>
<NonProprietaryName>Vaccinia Virus Modified Strain Ankara-bavarian Nordic Non-replicating Antigen</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250214</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125678</ApplicationNumber>
<LabelerName>Bavarian Nordic A/S</LabelerName>
<SubstanceName>VACCINIA VIRUS MODIFIED STRAIN ANKARA-BAVARIAN NORDIC NON-REPLICATING ANTIGEN</SubstanceName>
<StrengthNumber>50000000</StrengthNumber>
<StrengthUnit>1/.5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-04-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JYNNEOS is a vaccine indicated for prevention of smallpox and mpox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.</IndicationAndUsage>
<Description>JYNNEOS (Smallpox and Mpox Vaccine, Live, Non-replicating) is a sterile injectable suspension administered subcutaneously. JYNNEOS is a live vaccine produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus. MVA-BN is grown in primary Chicken Embryo Fibroblast (CEF) cells suspended in a serum-free medium containing no material of direct animal origin, harvested from the CEF cells, purified and concentrated by several Tangential Flow Filtration (TFF) steps including benzonase digestion. Each 0.5 mL dose of JYNNEOS is formulated to contain 0.5 x 108 to 3.95 x 108 infectious units of MVA-BN live virus. Each 0.5 mL dose contains 0.61 mg of Tris (tromethamine), 4.09 mg sodium chloride, and may contain residual amounts of host-cell DNA (≤20 mcg), protein (≤500 mcg), benzonase (≤0.0025 mcg), gentamicin (≤0.400 mcg), and ciprofloxacin (≤0.005 mcg). In addition, JYNNEOS vaccine reconstituted with Diluent Component (Water for Injection) contains 9.45 mg dextran 40, 22.5 mg sucrose, and 0.054 mg potassium L-glutamate monohydrate as stabilizers. After preparation [see Dosage and Administration (2.2)], JYNNEOS is a milky, light yellow to pale white colored suspension. JYNNEOS is formulated without preservatives. The vial stoppers are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>51060-023-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51060-023-01) > 30 mL in 1 TUBE</PackageDescription>
<NDC11Code>51060-0023-01</NDC11Code>
<ProductNDC>51060-023</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bb Tinted Treatment 12-hour Primer Broad Spectrum Spf 30 Sunscreen</ProprietaryName>
<ProprietaryNameSuffix>Tan Deep</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Tarte, Inc</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>45.5; 35</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60842-023-01</NDCCode>
<PackageDescription>2 DOSE PACK in 1 CARTON (60842-023-01) / .3 mL in 1 DOSE PACK</PackageDescription>
<NDC11Code>60842-0023-01</NDC11Code>
<ProductNDC>60842-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Auvi-q</ProprietaryName>
<NonProprietaryName>Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20121115</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201739</ApplicationNumber>
<LabelerName>kaleo, Inc</LabelerName>
<SubstanceName>EPINEPHRINE</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/.3mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121115</StartMarketingDatePackage>
<EndMarketingDatePackage>20251209</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AUVI-Q is indicated for the emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 7.5 kg or greater.</IndicationAndUsage>
<Description>AUVI-Q (epinephrine injection, USP) 0.3 mg, 0.15 mg and 0.1 mg is an autoinjector and a combination product containing drug and device components. AUVI-Q includes audible (electronic voice instructions, beeps) and visible (LED lights) cues for use. The needle automatically retracts after the injection is complete. Each AUVI-Q 0.3 mg delivers a single dose of 0.3 mg epinephrine from epinephrine injection, USP (0.3 mL) in a sterile solution. Each AUVI-Q 0.15 mg delivers a single dose of 0.15 mg epinephrine from epinephrine injection, USP (0.15 mL) in a sterile solution. Each AUVI-Q 0.1 mg delivers a single dose of 0.1 mg epinephrine from epinephrine injection, USP (0.1 mL) in a sterile solution. AUVI-Q 0.3 mg, AUVI-Q 0.15 mg and AUVI-Q 0.1 mg each contain 0.76 mL epinephrine solution. 0.3 mL, 0.15 mL and 0.1 mL epinephrine solution is dispensed for AUVI-Q 0.3 mg, AUVI-Q 0.15 mg and AUVI-Q 0.1 mg, respectively, when activated. The remaining solution is not available for future use and should be discarded. Each 0.3 mL in AUVI-Q 0.3 mg contains 0.3 mg epinephrine, 2.3 mg sodium chloride, 0.45 mg sodium bisulfite, hydrochloric acid to adjust pH, and water for injection. The pH range is 2.2– 5.0. Each 0.15 mL in AUVI-Q 0.15 mg contains 0.15 mg epinephrine, 1.2 mg sodium chloride, 0.225 mg sodium bisulfite, hydrochloric acid to adjust pH, and water for injection. The pH range is 2.2–5.0. Each 0.1 mL in AUVI-Q 0.1 mg contains 0.1 mg epinephrine, 0.78 mg sodium chloride, 0.15 mg sodium bisulfite, hydrochloric acid to adjust pH, and water for injection. The pH range is 2.2–5.0. Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4-Dihydroxy-a-[(methylamino)methyl]benzyl alcohol with the following structure. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. AUVI-Q is not made with natural rubber latex. AUVI-Q instructional and safety systems should be thoroughly reviewed with patients and caregivers prior to use [see Patient Counseling Information (17)].</Description>
</NDC>
<NDC>
<NDCCode>60842-023-02</NDCCode>
<PackageDescription>2 DOSE PACK in 1 CARTON (60842-023-02) / .3 mL in 1 DOSE PACK</PackageDescription>
<NDC11Code>60842-0023-02</NDC11Code>
<ProductNDC>60842-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Auvi-q</ProprietaryName>
<NonProprietaryName>Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20121115</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201739</ApplicationNumber>
<LabelerName>kaleo, Inc</LabelerName>
<SubstanceName>EPINEPHRINE</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/.3mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AUVI-Q is indicated for the emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 7.5 kg or greater.</IndicationAndUsage>
<Description>AUVI-Q (epinephrine injection, USP) 0.3 mg, 0.15 mg and 0.1 mg is an autoinjector and a combination product containing drug and device components. AUVI-Q includes audible (electronic voice instructions, beeps) and visible (LED lights) cues for use. The needle automatically retracts after the injection is complete. Each AUVI-Q 0.3 mg delivers a single dose of 0.3 mg epinephrine from epinephrine injection, USP (0.3 mL) in a sterile solution. Each AUVI-Q 0.15 mg delivers a single dose of 0.15 mg epinephrine from epinephrine injection, USP (0.15 mL) in a sterile solution. Each AUVI-Q 0.1 mg delivers a single dose of 0.1 mg epinephrine from epinephrine injection, USP (0.1 mL) in a sterile solution. AUVI-Q 0.3 mg, AUVI-Q 0.15 mg and AUVI-Q 0.1 mg each contain 0.76 mL epinephrine solution. 0.3 mL, 0.15 mL and 0.1 mL epinephrine solution is dispensed for AUVI-Q 0.3 mg, AUVI-Q 0.15 mg and AUVI-Q 0.1 mg, respectively, when activated. The remaining solution is not available for future use and should be discarded. Each 0.3 mL in AUVI-Q 0.3 mg contains 0.3 mg epinephrine, 2.3 mg sodium chloride, 0.45 mg sodium bisulfite, hydrochloric acid to adjust pH, and water for injection. The pH range is 2.2– 5.0. Each 0.15 mL in AUVI-Q 0.15 mg contains 0.15 mg epinephrine, 1.2 mg sodium chloride, 0.225 mg sodium bisulfite, hydrochloric acid to adjust pH, and water for injection. The pH range is 2.2–5.0. Each 0.1 mL in AUVI-Q 0.1 mg contains 0.1 mg epinephrine, 0.78 mg sodium chloride, 0.15 mg sodium bisulfite, hydrochloric acid to adjust pH, and water for injection. The pH range is 2.2–5.0. Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4-Dihydroxy-a-[(methylamino)methyl]benzyl alcohol with the following structure. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. AUVI-Q is not made with natural rubber latex. AUVI-Q instructional and safety systems should be thoroughly reviewed with patients and caregivers prior to use [see Patient Counseling Information (17)].</Description>
</NDC>
<NDC>
<NDCCode>65862-023-01</NDCCode>
<PackageDescription>100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-023-01) </PackageDescription>
<NDC11Code>65862-0023-01</NDC11Code>
<ProductNDC>65862-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mirtazapine</ProprietaryName>
<NonProprietaryName>Mirtazapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077376</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>MIRTAZAPINE</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-07-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mirtazapine orally disintegrating tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Mirtazapine orally disintegrating tablet, USP contains mirtazapine USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1-a] pyrido [2,3-c][2] benzazepine and has the molecular formula of C17H19N3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture. Mirtazapine is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine orally disintegrating tablets, USP are available for oral administration as an orally disintegrating tablet containing 15 mg, 30 mg or 45 mg of mirtazapine USP. Mirtazapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, natural and artificial peppermint flavor, and strawberry guarana flavor.</Description>
</NDC>
<NDC>
<NDCCode>65862-023-06</NDCCode>
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<StrengthUnit>mg/1</StrengthUnit>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mirtazapine orally disintegrating tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Mirtazapine orally disintegrating tablet, USP contains mirtazapine USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1-a] pyrido [2,3-c][2] benzazepine and has the molecular formula of C17H19N3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture. Mirtazapine is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine orally disintegrating tablets, USP are available for oral administration as an orally disintegrating tablet containing 15 mg, 30 mg or 45 mg of mirtazapine USP. Mirtazapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, natural and artificial peppermint flavor, and strawberry guarana flavor.</Description>
</NDC>
<NDC>
<NDCCode>65862-023-30</NDCCode>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mirtazapine orally disintegrating tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Mirtazapine orally disintegrating tablet, USP contains mirtazapine USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1-a] pyrido [2,3-c][2] benzazepine and has the molecular formula of C17H19N3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture. Mirtazapine is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine orally disintegrating tablets, USP are available for oral administration as an orally disintegrating tablet containing 15 mg, 30 mg or 45 mg of mirtazapine USP. Mirtazapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, natural and artificial peppermint flavor, and strawberry guarana flavor.</Description>
</NDC>
<NDC>
<NDCCode>65862-023-35</NDCCode>
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<ProductNDC>65862-023</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
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<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<StartMarketingDate>20051208</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>MIRTAZAPINE</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-01-27</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>08-DEC-05</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>65862-023-60</NDCCode>
<PackageDescription>60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-023-60) </PackageDescription>
<NDC11Code>65862-0023-60</NDC11Code>
<ProductNDC>65862-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mirtazapine</ProprietaryName>
<NonProprietaryName>Mirtazapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077376</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>MIRTAZAPINE</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-07-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mirtazapine orally disintegrating tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Mirtazapine orally disintegrating tablet, USP contains mirtazapine USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1-a] pyrido [2,3-c][2] benzazepine and has the molecular formula of C17H19N3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture. Mirtazapine is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine orally disintegrating tablets, USP are available for oral administration as an orally disintegrating tablet containing 15 mg, 30 mg or 45 mg of mirtazapine USP. Mirtazapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, natural and artificial peppermint flavor, and strawberry guarana flavor.</Description>
</NDC>
<NDC>
<NDCCode>65862-023-90</NDCCode>
<PackageDescription>90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-023-90) </PackageDescription>
<NDC11Code>65862-0023-90</NDC11Code>
<ProductNDC>65862-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mirtazapine</ProprietaryName>
<NonProprietaryName>Mirtazapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077376</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>MIRTAZAPINE</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-07-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mirtazapine orally disintegrating tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Mirtazapine orally disintegrating tablet, USP contains mirtazapine USP. Mirtazapine has a tetracyclic chemical structure and belongs to the piperazino-azepine group of compounds. It is designated 1,2,3,4,10,14b-hexahydro-2-methylpyrazino [2,1-a] pyrido [2,3-c][2] benzazepine and has the molecular formula of C17H19N3. Its molecular weight is 265.35. The structural formula is the following and it is the racemic mixture. Mirtazapine is a white to creamy white crystalline powder which is practically insoluble in water. Mirtazapine orally disintegrating tablets, USP are available for oral administration as an orally disintegrating tablet containing 15 mg, 30 mg or 45 mg of mirtazapine USP. Mirtazapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, natural and artificial peppermint flavor, and strawberry guarana flavor.</Description>
</NDC>
<NDC>
<NDCCode>69844-023-01</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69844-023-01) </PackageDescription>
<NDC11Code>69844-0023-01</NDC11Code>
<ProductNDC>69844-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibric Acid Delayed-release</ProprietaryName>
<NonProprietaryName>Fenofibric Acid</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190718</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211626</ApplicationNumber>
<LabelerName>Graviti Pharmaceuticals Private Limited</LabelerName>
<SubstanceName>FENOFIBRIC ACID</SubstanceName>
<StrengthNumber>135</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fenofibric acid is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as adjunctive therapy to diet to. : 1 Reduce TG in patients with severe hypertriglyceridemia ( 1.1). , 2 Reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in patients with primary hypercholesterolemia or mixed dyslipidemia ( 1.2). .</IndicationAndUsage>
<Description>Fenofibric acid delayed-release capsules are lipid regulating agent available as delayed release capsules for oral administration. Each delayed release capsule contains choline fenofibrate, equivalent to 45 mg or 135 mg of fenofibric acid. The chemical name for choline fenofibrate is ethanaminium, 2- hydroxy-N,N,N-trimethyl, 2-{4-(4-chlorobenzoyl)phenoxy] -2-methylpropanoate (1:1) with the following structural formula. The molecular formula is C 22H 28ClNO 5 and the molecular weight is 421.9. Choline fenofibrate is very soluble in water and freely soluble in methanol. The melting point is approximately 210°C. Choline fenofibrate is a white to off-white crystalline powder. Each delayed release capsule contains enteric coated mini-tablets comprised of choline fenofibrate and the following inactive ingredients: Colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose 2208, methacrylic acid and ethyl acrylate copolymer dispersion (sodium lauryl sulfate, polysorbate 80 and methacrylic acid and ethyl acrylate copolymer), povidone, sodium stearyl fumarate, talc and triethyl citrate. Capsule shell contains: gelatin, iron oxide black, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. Additionally, 45 mg contains: iron oxide red. 135 mg contains: FD & C blue 1, FD & C red 3, FD & C red 40. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>69844-023-02</NDCCode>
<PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69844-023-02) </PackageDescription>
<NDC11Code>69844-0023-02</NDC11Code>
<ProductNDC>69844-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibric Acid Delayed-release</ProprietaryName>
<NonProprietaryName>Fenofibric Acid</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190718</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211626</ApplicationNumber>
<LabelerName>Graviti Pharmaceuticals Private Limited</LabelerName>
<SubstanceName>FENOFIBRIC ACID</SubstanceName>
<StrengthNumber>135</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fenofibric acid is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as adjunctive therapy to diet to. : 1 Reduce TG in patients with severe hypertriglyceridemia ( 1.1). , 2 Reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in patients with primary hypercholesterolemia or mixed dyslipidemia ( 1.2). .</IndicationAndUsage>
<Description>Fenofibric acid delayed-release capsules are lipid regulating agent available as delayed release capsules for oral administration. Each delayed release capsule contains choline fenofibrate, equivalent to 45 mg or 135 mg of fenofibric acid. The chemical name for choline fenofibrate is ethanaminium, 2- hydroxy-N,N,N-trimethyl, 2-{4-(4-chlorobenzoyl)phenoxy] -2-methylpropanoate (1:1) with the following structural formula. The molecular formula is C 22H 28ClNO 5 and the molecular weight is 421.9. Choline fenofibrate is very soluble in water and freely soluble in methanol. The melting point is approximately 210°C. Choline fenofibrate is a white to off-white crystalline powder. Each delayed release capsule contains enteric coated mini-tablets comprised of choline fenofibrate and the following inactive ingredients: Colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose 2208, methacrylic acid and ethyl acrylate copolymer dispersion (sodium lauryl sulfate, polysorbate 80 and methacrylic acid and ethyl acrylate copolymer), povidone, sodium stearyl fumarate, talc and triethyl citrate. Capsule shell contains: gelatin, iron oxide black, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. Additionally, 45 mg contains: iron oxide red. 135 mg contains: FD & C blue 1, FD & C red 3, FD & C red 40. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>69844-023-03</NDCCode>
<PackageDescription>1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69844-023-03) </PackageDescription>
<NDC11Code>69844-0023-03</NDC11Code>
<ProductNDC>69844-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibric Acid Delayed-release</ProprietaryName>
<NonProprietaryName>Fenofibric Acid</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190718</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211626</ApplicationNumber>
<LabelerName>Graviti Pharmaceuticals Private Limited</LabelerName>
<SubstanceName>FENOFIBRIC ACID</SubstanceName>
<StrengthNumber>135</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fenofibric acid is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as adjunctive therapy to diet to. : 1 Reduce TG in patients with severe hypertriglyceridemia ( 1.1). , 2 Reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in patients with primary hypercholesterolemia or mixed dyslipidemia ( 1.2). .</IndicationAndUsage>
<Description>Fenofibric acid delayed-release capsules are lipid regulating agent available as delayed release capsules for oral administration. Each delayed release capsule contains choline fenofibrate, equivalent to 45 mg or 135 mg of fenofibric acid. The chemical name for choline fenofibrate is ethanaminium, 2- hydroxy-N,N,N-trimethyl, 2-{4-(4-chlorobenzoyl)phenoxy] -2-methylpropanoate (1:1) with the following structural formula. The molecular formula is C 22H 28ClNO 5 and the molecular weight is 421.9. Choline fenofibrate is very soluble in water and freely soluble in methanol. The melting point is approximately 210°C. Choline fenofibrate is a white to off-white crystalline powder. Each delayed release capsule contains enteric coated mini-tablets comprised of choline fenofibrate and the following inactive ingredients: Colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose 2208, methacrylic acid and ethyl acrylate copolymer dispersion (sodium lauryl sulfate, polysorbate 80 and methacrylic acid and ethyl acrylate copolymer), povidone, sodium stearyl fumarate, talc and triethyl citrate. Capsule shell contains: gelatin, iron oxide black, iron oxide yellow, sodium lauryl sulfate and titanium dioxide. Additionally, 45 mg contains: iron oxide red. 135 mg contains: FD & C blue 1, FD & C red 3, FD & C red 40. The imprinting ink contains: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>70983-023-02</NDCCode>
<PackageDescription>20 mL in 1 BOTTLE, WITH APPLICATOR (70983-023-02) </PackageDescription>
<NDC11Code>70983-0023-02</NDC11Code>
<ProductNDC>70983-023</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Extra Strength</ProprietaryName>
<NonProprietaryName>Menthol And Methyl Salicylate</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190513</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Saje Natural Business Inc.</LabelerName>
<SubstanceName>MENTHOL; METHYL SALICYLATE</SubstanceName>
<StrengthNumber>94.41; 123.74</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor aches and pains of muscles and joints associated with: simple back ache arthritis strains bruise sprains.</IndicationAndUsage>
<Description>Extra Strength Pain Relieving Oil Blend 0.68 fl oz (20 ml). Extra Strength Pain Relieving Oil Blend 1.5 fl oz (45 ml).</Description>
</NDC>
<NDC>
<NDCCode>83257-023-41</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (83257-023-41) / .5 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>83257-0023-41</NDC11Code>
<ProductNDC>83257-023</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Yesintek</ProprietaryName>
<NonProprietaryName>Ustekinumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250222</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761406</ApplicationNumber>
<LabelerName>Biocon Biologics Inc.</LabelerName>
<SubstanceName>USTEKINUMAB</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250222</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>YESINTEK is a human interleukin-12 and -23 antagonist indicated for the treatment of. Adult patients with: 1 moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. (1.1), 2 active psoriatic arthritis (PsA). (1.2), 3 moderately to severely active Crohn’s disease (CD). (1.3), 4 moderately to severely active ulcerative colitis. (1.4).</IndicationAndUsage>
<Description>Ustekinumab-kfce, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-kfce is produced in a murine cell line (Sp2/0). The manufacturing process contains steps for the clearance of viruses. Ustekinumab is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons. YESINTEK (ustekinumab-kfce) injection is a sterile, preservative-free, clear and colorless to pale yellow solution with pH of 5.7- 6.3.</Description>
</NDC>
<NDC>
<NDCCode>85179-023-00</NDCCode>
<PackageDescription>15 mL in 1 BOTTLE (85179-023-00) </PackageDescription>
<NDC11Code>85179-0023-00</NDC11Code>
<ProductNDC>85179-023</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Poolside Frostbite Sunscreen Coconut Spf 15 Scented Lip Gloss</ProprietaryName>
<NonProprietaryName>Homosalate, Octocrylene, Octisalate, Avobenzone</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251217</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>I World LLC</LabelerName>
<SubstanceName>HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE</SubstanceName>
<StrengthNumber>30; 50; 40; 45</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83107-001-15</NDCCode>
<PackageDescription>150 CAPSULE in 1 BOTTLE (83107-001-15) </PackageDescription>
<NDC11Code>83107-0001-15</NDC11Code>
<ProductNDC>83107-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zanaflex</ProprietaryName>
<NonProprietaryName>Tizanidine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180801</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021447</ApplicationNumber>
<LabelerName>Legacy Pharma USA, Inc.</LabelerName>
<SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zanaflex is indicated for the treatment of spasticity in adults.</IndicationAndUsage>
<Description>Zanaflex ®contains tizanidine hydrochloride as the active ingredient, which is a central alpha 2-adrenergic agonist. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiadiazole monohydrochloride. It has a molecular formula of C 9H 8ClN 5S-HCl and a molecular weight of 290.2. Its structural formula is:. Tizanidine hydrochloride is a white to off-white, fine crystalline powder, which is odorless or with a faint characteristic odor. Tizanidine hydrochloride is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Zanaflex capsules are for oral administration and contain 2, 4, or 6 mg tizanidine (equivalent to 2.29 mg, 4.58 mg, and 6.87 mg tizanidine hydrochloride, respectively), and the inactive ingredients colorants, gelatin, hypromellose, silicon dioxide, sugar spheres, and titanium dioxide. Zanaflex tablets are for oral administration and contain 4 mg tizanidine (equivalent to 4.58 mg tizanidine hydrochloride), and the inactive ingredients anhydrous lactose, colloidal silicon dioxide, microcrystalline cellulose, and stearic acid.</Description>
</NDC>
</NDCList>