{
"NDC": [
{
"NDCCode": "0071-0419-24",
"PackageDescription": "1 BOTTLE in 1 CARTON (0071-0419-24) / 100 TABLET in 1 BOTTLE",
"NDC11Code": "00071-0419-24",
"ProductNDC": "0071-0419",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrostat",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20000501",
"EndMarketingDate": "20250430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021134",
"LabelerName": "Parke-Davis Div of Pfizer Inc",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": ".6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20000501",
"EndMarketingDatePackage": "20250430",
"SamplePackage": "N",
"IndicationAndUsage": "NITROSTAT is indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.",
"Description": "NITROSTAT is a stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg , or 0.6 mg nitroglycerin; as well as lactose monohydrate, NF; glyceryl monostearate, NF; pregelatinized starch, NF; calcium stearate, NF powder; and silicon dioxide, colloidal, NF. Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is. Molecular weight: 227.09."
},
{
"NDCCode": "21130-419-24",
"PackageDescription": "1 KIT in 1 KIT (21130-419-24) * 355 mL in 1 BOTTLE * 355 mL in 1 BOTTLE",
"NDC11Code": "21130-0419-24",
"ProductNDC": "21130-419",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Daytime Nighttime Cold And Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl",
"DosageFormName": "KIT",
"StartMarketingDate": "20140630",
"EndMarketingDate": "20201231",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Safeway, Inc.",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140630",
"EndMarketingDatePackage": "20201231",
"SamplePackage": "N"
},
{
"NDCCode": "43063-419-24",
"PackageDescription": "24 TABLET in 1 BOTTLE, PLASTIC (43063-419-24) ",
"NDC11Code": "43063-0419-24",
"ProductNDC": "43063-419",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040489",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20100806",
"SamplePackage": "N"
},
{
"NDCCode": "63736-419-24",
"PackageDescription": "24 LOZENGE in 1 CONTAINER (63736-419-24)",
"NDC11Code": "63736-0419-24",
"ProductNDC": "63736-419",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sucrets Herbal",
"ProprietaryNameSuffix": "Berry Pomegranate",
"NonProprietaryName": "Menthol And Pectin",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20090714",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part356",
"LabelerName": "Insight Pharmaceuticals LLC",
"SubstanceName": "MENTHOL; PECTIN",
"StrengthNumber": "5; 6",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-12-13",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "79481-0419-0",
"PackageDescription": "1 BOTTLE in 1 CARTON (79481-0419-0) / 24 TABLET, CHEWABLE in 1 BOTTLE",
"NDC11Code": "79481-0419-00",
"ProductNDC": "79481-0419",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Childrens Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20250630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076359",
"LabelerName": "Meijer, Inc.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250630",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily: 1 reduces fever, 2 relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches."
},
{
"NDCCode": "0071-0007-24",
"PackageDescription": "100 TABLET, CHEWABLE in 1 BOTTLE (0071-0007-24) ",
"NDC11Code": "00071-0007-24",
"ProductNDC": "0071-0007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dilantin Infatabs",
"NonProprietaryName": "Phenytoin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "19790226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084427",
"LabelerName": "Parke-Davis Div of Pfizer Inc",
"SubstanceName": "PHENYTOIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19790226",
"SamplePackage": "N",
"IndicationAndUsage": "DILANTIN INFATABS are indicated for the treatment of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.",
"Description": "DILANTIN (phenytoin) is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is 5,5-diphenyl-2,4 imidazolidinedione, having the following structural formula:. Each DILANTIN INFATAB, chewable tablet for oral administration, contains 50 mg phenytoin, USP. Also contains: D&C yellow No. 10, Aluminum Lake; FD&C yellow No. 6, Aluminum Lake; flavor; saccharin sodium, USP; confectioner's sugar, NF; talc, USP; magnesium stearate, NF; and purified water, USP."
},
{
"NDCCode": "0071-0237-24",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0071-0237-24) ",
"NDC11Code": "00071-0237-24",
"ProductNDC": "0071-0237",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zarontin",
"NonProprietaryName": "Ethosuximide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20000922",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA012380",
"LabelerName": "Parke-Davis Div of Pfizer Inc",
"SubstanceName": "ETHOSUXIMIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-05-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20000922",
"SamplePackage": "N",
"IndicationAndUsage": "Zarontin is indicated for the control of absence (petit mal) epilepsy.",
"Description": "Zarontin (ethosuximide) is an anticonvulsant succinimide, chemically designated as alpha-ethyl-alpha-methyl-succinimide, with the following structural formula. Each Zarontin capsule contains 250 mg ethosuximide, USP. Also contains: polyethylene glycol 400, NF. The capsule contains D&C yellow No. 10; FD&C red No. 3; gelatin, NF; glycerin, USP; and sorbitol."
},
{
"NDCCode": "0071-0369-24",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0071-0369-24) ",
"NDC11Code": "00071-0369-24",
"ProductNDC": "0071-0369",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dilantin",
"NonProprietaryName": "Extended Phenytoin Sodium",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19760827",
"EndMarketingDate": "20260331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084349",
"LabelerName": "Parke-Davis Div of Pfizer Inc",
"SubstanceName": "PHENYTOIN SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19760827",
"EndMarketingDatePackage": "20251130",
"SamplePackage": "N",
"IndicationAndUsage": "DILANTIN is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.",
"Description": "DILANTIN (phenytoin) is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is 5,5-diphenyl-2,4 imidazolidinedione, having the following structural formula. Each 30 mg DILANTIN- (extended phenytoin sodium capsule, USP) for oral administration contains 30 mg phenytoin sodium, USP. Also contains lactose monohydrate, NF; confectioner's sugar, NF; talc, USP; and magnesium stearate, NF. The capsule shell cap and body components contain titanium dioxide (cap and body); gelatin (cap and body); D&C yellow No. 10 (cap); FD&C red No. 3 (cap). Product in vivo performance is characterized by a slow and extended rate of absorption with peak blood concentrations expected in 4 to 12 hours as contrasted to Prompt Phenytoin Sodium Capsules, USP with a rapid rate of absorption with peak blood concentration expected in 1½ to 3 hours. Each 100 mg DILANTIN- 100 mg (extended phenytoin sodium capsule, USP) for oral administration contains 100 mg phenytoin sodium. Also contains lactose monohydrate, NF; confectioner's sugar, NF; talc, USP; and magnesium stearate, NF. The capsule body contains titanium dioxide, USP and gelatin, NF. The capsule cap contains FD&C red No. 28; FD&C yellow No. 6; and gelatin NF. Product in vivo performance is characterized by a slow and extended rate of absorption with peak blood concentrations expected in 4 to 12 hours as contrasted to Prompt Phenytoin Sodium Capsules, USP with a rapid rate of absorption with peak blood concentration expected in 1½ to 3 hours."
},
{
"NDCCode": "0071-0401-24",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0071-0401-24) ",
"NDC11Code": "00071-0401-24",
"ProductNDC": "0071-0401",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Neurontin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19981009",
"EndMarketingDate": "20260731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020882",
"LabelerName": "Parke-Davis Div of Pfizer Inc",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19981009",
"EndMarketingDatePackage": "20260731",
"SamplePackage": "N",
"IndicationAndUsage": "NEURONTIN® is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in NEURONTIN capsules, tablets, and oral solution is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each NEURONTIN capsule contains 100 mg, 300 mg, or 400 mg of gabapentin and the following inactive ingredients: lactose, cornstarch, talc, gelatin, titanium dioxide, FD&C Blue No. 2, yellow iron oxide (300 mg and 400 mg only), and red iron oxide (400 mg only). Each NEURONTIN tablet contains 600 mg or 800 mg of gabapentin and the following inactive ingredients: poloxamer 407, copovidone, cornstarch, magnesium stearate, hydroxypropyl cellulose, talc, and candelilla wax. NEURONTIN oral solution contains 250 mg of gabapentin per 5 mL (50 mg per mL) and the following inactive ingredients: glycerin, xylitol, purified water, and artificial cool strawberry anise flavor."
},
{
"NDCCode": "0071-0417-24",
"PackageDescription": "1 BOTTLE in 1 CARTON (0071-0417-24) / 100 TABLET in 1 BOTTLE",
"NDC11Code": "00071-0417-24",
"ProductNDC": "0071-0417",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrostat",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20000501",
"EndMarketingDate": "20260228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021134",
"LabelerName": "Parke-Davis Div of Pfizer Inc",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": ".3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20000501",
"EndMarketingDatePackage": "20260228",
"SamplePackage": "N",
"IndicationAndUsage": "NITROSTAT is indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.",
"Description": "NITROSTAT is a stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg , or 0.6 mg nitroglycerin; as well as lactose monohydrate, NF; glyceryl monostearate, NF; pregelatinized starch, NF; calcium stearate, NF powder; and silicon dioxide, colloidal, NF. Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is. Molecular weight: 227.09."
},
{
"NDCCode": "0071-0418-24",
"PackageDescription": "1 BOTTLE in 1 CARTON (0071-0418-24) / 100 TABLET in 1 BOTTLE",
"NDC11Code": "00071-0418-24",
"ProductNDC": "0071-0418",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrostat",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20000501",
"EndMarketingDate": "20250228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021134",
"LabelerName": "Parke-Davis Div of Pfizer Inc",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": ".4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20000501",
"EndMarketingDatePackage": "20250228",
"SamplePackage": "N",
"IndicationAndUsage": "NITROSTAT is indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.",
"Description": "NITROSTAT is a stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg , or 0.6 mg nitroglycerin; as well as lactose monohydrate, NF; glyceryl monostearate, NF; pregelatinized starch, NF; calcium stearate, NF powder; and silicon dioxide, colloidal, NF. Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is. Molecular weight: 227.09."
},
{
"NDCCode": "0071-0513-24",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0071-0513-24) ",
"NDC11Code": "00071-0513-24",
"ProductNDC": "0071-0513",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Neurontin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19981009",
"EndMarketingDate": "20260630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020882",
"LabelerName": "Parke-Davis Div of Pfizer Inc",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19981009",
"EndMarketingDatePackage": "20260630",
"SamplePackage": "N",
"IndicationAndUsage": "NEURONTIN® is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in NEURONTIN capsules, tablets, and oral solution is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each NEURONTIN capsule contains 100 mg, 300 mg, or 400 mg of gabapentin and the following inactive ingredients: lactose, cornstarch, talc, gelatin, titanium dioxide, FD&C Blue No. 2, yellow iron oxide (300 mg and 400 mg only), and red iron oxide (400 mg only). Each NEURONTIN tablet contains 600 mg or 800 mg of gabapentin and the following inactive ingredients: poloxamer 407, copovidone, cornstarch, magnesium stearate, hydroxypropyl cellulose, talc, and candelilla wax. NEURONTIN oral solution contains 250 mg of gabapentin per 5 mL (50 mg per mL) and the following inactive ingredients: glycerin, xylitol, purified water, and artificial cool strawberry anise flavor."
},
{
"NDCCode": "0071-0525-24",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0071-0525-24) ",
"NDC11Code": "00071-0525-24",
"ProductNDC": "0071-0525",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celontin",
"NonProprietaryName": "Methsuximide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19570208",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA010596",
"LabelerName": "Parke-Davis Div of Pfizer Inc",
"SubstanceName": "METHSUXIMIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19570208",
"SamplePackage": "N",
"IndicationAndUsage": "Celontin is indicated for the control of absence (petit mal) seizures that are refractory to other drugs.",
"Description": "Celontin (methsuximide) is an anticonvulsant succinimide, chemically designated as N,2-Dimethyl-2-phenylsuccinimide, with the following structural formula. Each Celontin capsule contains 300 mg methsuximide, USP. Also contains starch, NF. The capsule contains colloidal silicon dioxide, NF; D&C yellow No. 10; FD&C yellow No. 6; gelatin, NF; and sodium lauryl sulfate, NF."
},
{
"NDCCode": "0071-0803-24",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0071-0803-24) ",
"NDC11Code": "00071-0803-24",
"ProductNDC": "0071-0803",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Neurontin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19931230",
"EndMarketingDate": "20260731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020235",
"LabelerName": "Parke-Davis Div of Pfizer Inc",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19931230",
"EndMarketingDatePackage": "20260731",
"SamplePackage": "N",
"IndicationAndUsage": "NEURONTIN® is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in NEURONTIN capsules, tablets, and oral solution is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each NEURONTIN capsule contains 100 mg, 300 mg, or 400 mg of gabapentin and the following inactive ingredients: lactose, cornstarch, talc, gelatin, titanium dioxide, FD&C Blue No. 2, yellow iron oxide (300 mg and 400 mg only), and red iron oxide (400 mg only). Each NEURONTIN tablet contains 600 mg or 800 mg of gabapentin and the following inactive ingredients: poloxamer 407, copovidone, cornstarch, magnesium stearate, hydroxypropyl cellulose, talc, and candelilla wax. NEURONTIN oral solution contains 250 mg of gabapentin per 5 mL (50 mg per mL) and the following inactive ingredients: glycerin, xylitol, purified water, and artificial cool strawberry anise flavor."
},
{
"NDCCode": "0071-0805-24",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0071-0805-24) ",
"NDC11Code": "00071-0805-24",
"ProductNDC": "0071-0805",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Neurontin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19931230",
"EndMarketingDate": "20270430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020235",
"LabelerName": "Parke-Davis Div of Pfizer Inc",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19931230",
"EndMarketingDatePackage": "20270430",
"SamplePackage": "N",
"IndicationAndUsage": "NEURONTIN® is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in NEURONTIN capsules, tablets, and oral solution is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each NEURONTIN capsule contains 100 mg, 300 mg, or 400 mg of gabapentin and the following inactive ingredients: lactose, cornstarch, talc, gelatin, titanium dioxide, FD&C Blue No. 2, yellow iron oxide (300 mg and 400 mg only), and red iron oxide (400 mg only). Each NEURONTIN tablet contains 600 mg or 800 mg of gabapentin and the following inactive ingredients: poloxamer 407, copovidone, cornstarch, magnesium stearate, hydroxypropyl cellulose, talc, and candelilla wax. NEURONTIN oral solution contains 250 mg of gabapentin per 5 mL (50 mg per mL) and the following inactive ingredients: glycerin, xylitol, purified water, and artificial cool strawberry anise flavor."
},
{
"NDCCode": "0071-0806-24",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0071-0806-24) ",
"NDC11Code": "00071-0806-24",
"ProductNDC": "0071-0806",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Neurontin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19931230",
"EndMarketingDate": "20260731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020235",
"LabelerName": "Parke-Davis Div of Pfizer Inc",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19931230",
"EndMarketingDatePackage": "20260731",
"SamplePackage": "N",
"IndicationAndUsage": "NEURONTIN® is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in NEURONTIN capsules, tablets, and oral solution is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each NEURONTIN capsule contains 100 mg, 300 mg, or 400 mg of gabapentin and the following inactive ingredients: lactose, cornstarch, talc, gelatin, titanium dioxide, FD&C Blue No. 2, yellow iron oxide (300 mg and 400 mg only), and red iron oxide (400 mg only). Each NEURONTIN tablet contains 600 mg or 800 mg of gabapentin and the following inactive ingredients: poloxamer 407, copovidone, cornstarch, magnesium stearate, hydroxypropyl cellulose, talc, and candelilla wax. NEURONTIN oral solution contains 250 mg of gabapentin per 5 mL (50 mg per mL) and the following inactive ingredients: glycerin, xylitol, purified water, and artificial cool strawberry anise flavor."
},
{
"NDCCode": "21130-071-24",
"PackageDescription": "24 BLISTER PACK in 1 CARTON (21130-071-24) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "21130-0071-24",
"ProductNDC": "21130-071",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cold And Flu Relief",
"ProprietaryNameSuffix": "Nighttime",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20160229",
"EndMarketingDate": "20250228",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Safeway, Inc.",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "325; 15; 6.25",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160229",
"EndMarketingDatePackage": "20250228",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves common cold and flu symptoms:sore throat headache minor aches and pains fever runny nose and sneezing cough due to minor throat and bronchial irritation."
},
{
"NDCCode": "41163-071-24",
"PackageDescription": "24 BLISTER PACK in 1 CARTON (41163-071-24) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "41163-0071-24",
"ProductNDC": "41163-071",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cold And Flu Relief",
"ProprietaryNameSuffix": "Nighttime Multi Symptom",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20160229",
"EndMarketingDate": "20211231",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "EQUALINE (SuperValu)",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "325; 15; 6.25",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160229",
"EndMarketingDatePackage": "20211231",
"SamplePackage": "N"
},
{
"NDCCode": "41520-071-24",
"PackageDescription": "24 BLISTER PACK in 1 CARTON (41520-071-24) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "41520-0071-24",
"ProductNDC": "41520-071",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Multi Symptom Nitetime",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20151031",
"EndMarketingDate": "20221231",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Care One (American Sales Company)",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "325; 15; 6.25",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20151031",
"EndMarketingDatePackage": "20221231",
"SamplePackage": "N"
},
{
"NDCCode": "49738-071-24",
"PackageDescription": "24 BLISTER PACK in 1 CARTON (49738-071-24) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "49738-0071-24",
"ProductNDC": "49738-071",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Multi Symptom Cold And Flu Relief",
"ProprietaryNameSuffix": "Nighttime",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20160731",
"EndMarketingDate": "20211231",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "SMART SENSE (Kmart)",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "325; 15; 6.25",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160731",
"EndMarketingDatePackage": "20211231",
"SamplePackage": "N"
},
{
"NDCCode": "60760-071-24",
"PackageDescription": "24 TABLET, COATED in 1 BOTTLE, PLASTIC (60760-071-24) ",
"NDC11Code": "60760-0071-24",
"ProductNDC": "60760-071",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Health Sense Ecpirin",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190815",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part343",
"LabelerName": "St. Mary's Medical Park Pharmacy",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20190815",
"SamplePackage": "N"
},
{
"NDCCode": "61941-0071-1",
"PackageDescription": "24 PACKAGE in 1 CASE (61941-0071-1) > 18 LOZENGE in 1 PACKAGE (61941-0071-8)",
"NDC11Code": "61941-0071-01",
"ProductNDC": "61941-0071",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cold-eeze",
"NonProprietaryName": "Zinc Gluconate",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20100201",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "ProPhase Labs, Inc.",
"SubstanceName": "ZINC GLUCONATE",
"StrengthNumber": "2",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "to reduce the duration of the common cold. reduces the severity of cold symptoms: cough, sore throat, stuffy nose, sneezing, post nasal drip and/or hoarseness."
},
{
"NDCCode": "63868-071-24",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (63868-071-24) / 12 TABLET, COATED in 1 BLISTER PACK",
"NDC11Code": "63868-0071-24",
"ProductNDC": "63868-071",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Severe Sinus Congestion And Pain",
"NonProprietaryName": "Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20091113",
"EndMarketingDate": "20261231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Chain Drug Marketing Association",
"SubstanceName": "ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 200; 5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20091113",
"EndMarketingDatePackage": "20261231",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of: sinus congestion and pressureheadachenasal congestionminor aches and pains. helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive. temporarily relieves nasal congestion due to the common cold, and hay fever or other upper respiratory allergies. temporarily reduces fever."
},
{
"NDCCode": "75594-071-24",
"PackageDescription": "1.89 L in 1 BOTTLE, PUMP (75594-071-24) ",
"NDC11Code": "75594-0071-24",
"ProductNDC": "75594-071",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aloe Gel",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200723",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Commercial Beverage Concepts, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".7",
"StrengthUnit": "L/L",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200723",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "83324-071-24",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (83324-071-24) / 24 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC",
"NDC11Code": "83324-0071-24",
"ProductNDC": "83324-071",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Childrens Pain And Fever Relief",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20241021",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Chain Drug Marketing Association, Inc.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241021",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: headachesore throatflutoothachethe common cold. temporarily reduces fever."
},
{
"NDCCode": "17312-419-14",
"PackageDescription": "2 BLISTER PACK in 1 PACKAGE (17312-419-14) / 24 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "17312-0419-14",
"ProductNDC": "17312-419",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Natural Eyes Aging Eye Relief",
"ProprietaryNameSuffix": "Fast Dissolving Tables",
"NonProprietaryName": "Calcarea Phosphorica, Calendula Officinalis, Carboneum Sulphuratum, Cineraria Maritima, Conium Maculatum, Euphrasia Officinalis, Selenium Metallicum, Zincum Metallicum",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20250316",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "TRP Company",
"SubstanceName": "ZINC; TRIBASIC CALCIUM PHOSPHATE; SELENIUM; CONIUM MACULATUM FLOWERING TOP; CARBON DISULFIDE; JACOBAEA MARITIMA; EUPHRASIA STRICTA; CALENDULA OFFICINALIS FLOWERING TOP",
"StrengthNumber": "9; 10; 9; 3; 6; 6; 3; 1",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Active",
"LastUpdate": "2025-03-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250317",
"SamplePackage": "N",
"IndicationAndUsage": "Uses* According to homeopathic indications these ingredients provide temporary relief from eye irritation after serious causes have been ruled out by a physician. *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "44911-0419-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (44911-0419-1) ",
"NDC11Code": "44911-0419-01",
"ProductNDC": "44911-0419",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Liverex I",
"NonProprietaryName": "Ginkgo Biloba, Fel Tauri, Gallbladder (suis), Hepar Suis), Thyroidinum (suis), Germanium Sesquioxide, Alpha-ketoglutaricum Acidum, Citricum Acidum, Fumaricum Acidum, Malicum Acidum, Manganum Metallicum, Pyruvic Acid, Succinicum Acidum, Naphthochinonum, Arsenicum Metallicum, Sulphur, Aconiticum Acidum, Cis, Lycopodium Clavatum, Natrum Oxalaceticum, Phosphorus",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170228",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Energique, Inc.",
"SubstanceName": "GINKGO; BOS TAURUS BILE; SUS SCROFA GALLBLADDER; PORK LIVER; THYROID; GERMANIUM SESQUIOXIDE; OXOGLURIC ACID; ANHYDROUS CITRIC ACID; FUMARIC ACID; MALIC ACID; MANGANESE; PYRUVIC ACID; SUCCINIC ACID; 1,4-NAPHTHOQUINONE; ARSENIC; SULFUR; ACONITIC ACID, (Z)-; LYCOPODIUM CLAVATUM SPORE; SODIUM DIETHYL OXALACETATE; PHOSPHORUS",
"StrengthNumber": "6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 9; 12; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]",
"Status": "Active",
"LastUpdate": "2023-07-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170228",
"SamplePackage": "N",
"IndicationAndUsage": "May temporarily relieve abdominal pain and nausea.**. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "55111-419-05",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-419-05) ",
"NDC11Code": "55111-0419-05",
"ProductNDC": "55111-419",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180906",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202383",
"LabelerName": "Dr.Reddy's Laboratories Limited",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180906",
"SamplePackage": "N",
"Description": "Lamotrigine extended-release tablets, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine USP is slightly soluble in acetone and in methanol. The structural formula is. Lamotrigine extended-release tablets, USP are supplied for oral administration as 25 mg (yellow), 50 mg (light green), 100 mg (orange), 200 mg (blue), 250 mg (purple) and 300 mg (grey) tablets. Each tablet contains the labeled amount of lamotrigine USP and the following inactive ingredients: D&C Red # 27 (250 mg), FD&C BLUE No. 2 (200 mg and 250 mg), hypromellose, iron oxide black (50 mg and 300 mg), iron oxide yellow (25 mg, 50 mg and 100 mg), iron oxide red (100 mg), lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol 400, talc, titanium dioxide and triethyl citrate. Tablets are printed with edible black ink which contains iron oxide black and shellac glaze. Lamotrigine extended-release tablets, USP contains modified release, erodible matrix as the core. The core tablet is coated with a modified enteric coat to enable a controlled release of drug in the acidic environment of the stomach. The combination of modified-release core and the modified enteric coating are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels. Meets USP Dissolution Test 2."
},
{
"NDCCode": "55111-419-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-419-30) ",
"NDC11Code": "55111-0419-30",
"ProductNDC": "55111-419",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180906",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202383",
"LabelerName": "Dr.Reddy's Laboratories Limited",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180906",
"SamplePackage": "N",
"Description": "Lamotrigine extended-release tablets, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine USP is slightly soluble in acetone and in methanol. The structural formula is. Lamotrigine extended-release tablets, USP are supplied for oral administration as 25 mg (yellow), 50 mg (light green), 100 mg (orange), 200 mg (blue), 250 mg (purple) and 300 mg (grey) tablets. Each tablet contains the labeled amount of lamotrigine USP and the following inactive ingredients: D&C Red # 27 (250 mg), FD&C BLUE No. 2 (200 mg and 250 mg), hypromellose, iron oxide black (50 mg and 300 mg), iron oxide yellow (25 mg, 50 mg and 100 mg), iron oxide red (100 mg), lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol 400, talc, titanium dioxide and triethyl citrate. Tablets are printed with edible black ink which contains iron oxide black and shellac glaze. Lamotrigine extended-release tablets, USP contains modified release, erodible matrix as the core. The core tablet is coated with a modified enteric coat to enable a controlled release of drug in the acidic environment of the stomach. The combination of modified-release core and the modified enteric coating are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels. Meets USP Dissolution Test 2."
},
{
"NDCCode": "55111-419-90",
"PackageDescription": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-419-90) ",
"NDC11Code": "55111-0419-90",
"ProductNDC": "55111-419",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180906",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202383",
"LabelerName": "Dr.Reddy's Laboratories Limited",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180906",
"SamplePackage": "N",
"Description": "Lamotrigine extended-release tablets, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine USP is slightly soluble in acetone and in methanol. The structural formula is. Lamotrigine extended-release tablets, USP are supplied for oral administration as 25 mg (yellow), 50 mg (light green), 100 mg (orange), 200 mg (blue), 250 mg (purple) and 300 mg (grey) tablets. Each tablet contains the labeled amount of lamotrigine USP and the following inactive ingredients: D&C Red # 27 (250 mg), FD&C BLUE No. 2 (200 mg and 250 mg), hypromellose, iron oxide black (50 mg and 300 mg), iron oxide yellow (25 mg, 50 mg and 100 mg), iron oxide red (100 mg), lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol 400, talc, titanium dioxide and triethyl citrate. Tablets are printed with edible black ink which contains iron oxide black and shellac glaze. Lamotrigine extended-release tablets, USP contains modified release, erodible matrix as the core. The core tablet is coated with a modified enteric coat to enable a controlled release of drug in the acidic environment of the stomach. The combination of modified-release core and the modified enteric coating are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels. Meets USP Dissolution Test 2."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>0071-0419-24</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0071-0419-24) / 100 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>00071-0419-24</NDC11Code>
<ProductNDC>0071-0419</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrostat</ProprietaryName>
<NonProprietaryName>Nitroglycerin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20000501</StartMarketingDate>
<EndMarketingDate>20250430</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021134</ApplicationNumber>
<LabelerName>Parke-Davis Div of Pfizer Inc</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>.6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20000501</StartMarketingDatePackage>
<EndMarketingDatePackage>20250430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NITROSTAT is indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.</IndicationAndUsage>
<Description>NITROSTAT is a stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg , or 0.6 mg nitroglycerin; as well as lactose monohydrate, NF; glyceryl monostearate, NF; pregelatinized starch, NF; calcium stearate, NF powder; and silicon dioxide, colloidal, NF. Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is. Molecular weight: 227.09.</Description>
</NDC>
<NDC>
<NDCCode>21130-419-24</NDCCode>
<PackageDescription>1 KIT in 1 KIT (21130-419-24) * 355 mL in 1 BOTTLE * 355 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>21130-0419-24</NDC11Code>
<ProductNDC>21130-419</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Daytime Nighttime Cold And Flu</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20140630</StartMarketingDate>
<EndMarketingDate>20201231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Safeway, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140630</StartMarketingDatePackage>
<EndMarketingDatePackage>20201231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43063-419-24</NDCCode>
<PackageDescription>24 TABLET in 1 BOTTLE, PLASTIC (43063-419-24) </PackageDescription>
<NDC11Code>43063-0419-24</NDC11Code>
<ProductNDC>43063-419</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040489</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100806</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63736-419-24</NDCCode>
<PackageDescription>24 LOZENGE in 1 CONTAINER (63736-419-24)</PackageDescription>
<NDC11Code>63736-0419-24</NDC11Code>
<ProductNDC>63736-419</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sucrets Herbal</ProprietaryName>
<ProprietaryNameSuffix>Berry Pomegranate</ProprietaryNameSuffix>
<NonProprietaryName>Menthol And Pectin</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090714</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part356</ApplicationNumber>
<LabelerName>Insight Pharmaceuticals LLC</LabelerName>
<SubstanceName>MENTHOL; PECTIN</SubstanceName>
<StrengthNumber>5; 6</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-13</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>79481-0419-0</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (79481-0419-0) / 24 TABLET, CHEWABLE in 1 BOTTLE</PackageDescription>
<NDC11Code>79481-0419-00</NDC11Code>
<ProductNDC>79481-0419</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Childrens Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076359</ApplicationNumber>
<LabelerName>Meijer, Inc.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily: 1 reduces fever, 2 relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0071-0007-24</NDCCode>
<PackageDescription>100 TABLET, CHEWABLE in 1 BOTTLE (0071-0007-24) </PackageDescription>
<NDC11Code>00071-0007-24</NDC11Code>
<ProductNDC>0071-0007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dilantin Infatabs</ProprietaryName>
<NonProprietaryName>Phenytoin</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19790226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA084427</ApplicationNumber>
<LabelerName>Parke-Davis Div of Pfizer Inc</LabelerName>
<SubstanceName>PHENYTOIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19790226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DILANTIN INFATABS are indicated for the treatment of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.</IndicationAndUsage>
<Description>DILANTIN (phenytoin) is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is 5,5-diphenyl-2,4 imidazolidinedione, having the following structural formula:. Each DILANTIN INFATAB, chewable tablet for oral administration, contains 50 mg phenytoin, USP. Also contains: D&C yellow No. 10, Aluminum Lake; FD&C yellow No. 6, Aluminum Lake; flavor; saccharin sodium, USP; confectioner's sugar, NF; talc, USP; magnesium stearate, NF; and purified water, USP.</Description>
</NDC>
<NDC>
<NDCCode>0071-0237-24</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0071-0237-24) </PackageDescription>
<NDC11Code>00071-0237-24</NDC11Code>
<ProductNDC>0071-0237</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zarontin</ProprietaryName>
<NonProprietaryName>Ethosuximide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000922</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA012380</ApplicationNumber>
<LabelerName>Parke-Davis Div of Pfizer Inc</LabelerName>
<SubstanceName>ETHOSUXIMIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000922</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zarontin is indicated for the control of absence (petit mal) epilepsy.</IndicationAndUsage>
<Description>Zarontin (ethosuximide) is an anticonvulsant succinimide, chemically designated as alpha-ethyl-alpha-methyl-succinimide, with the following structural formula. Each Zarontin capsule contains 250 mg ethosuximide, USP. Also contains: polyethylene glycol 400, NF. The capsule contains D&C yellow No. 10; FD&C red No. 3; gelatin, NF; glycerin, USP; and sorbitol.</Description>
</NDC>
<NDC>
<NDCCode>0071-0369-24</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0071-0369-24) </PackageDescription>
<NDC11Code>00071-0369-24</NDC11Code>
<ProductNDC>0071-0369</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dilantin</ProprietaryName>
<NonProprietaryName>Extended Phenytoin Sodium</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19760827</StartMarketingDate>
<EndMarketingDate>20260331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA084349</ApplicationNumber>
<LabelerName>Parke-Davis Div of Pfizer Inc</LabelerName>
<SubstanceName>PHENYTOIN SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19760827</StartMarketingDatePackage>
<EndMarketingDatePackage>20251130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DILANTIN is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.</IndicationAndUsage>
<Description>DILANTIN (phenytoin) is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is 5,5-diphenyl-2,4 imidazolidinedione, having the following structural formula. Each 30 mg DILANTIN- (extended phenytoin sodium capsule, USP) for oral administration contains 30 mg phenytoin sodium, USP. Also contains lactose monohydrate, NF; confectioner's sugar, NF; talc, USP; and magnesium stearate, NF. The capsule shell cap and body components contain titanium dioxide (cap and body); gelatin (cap and body); D&C yellow No. 10 (cap); FD&C red No. 3 (cap). Product in vivo performance is characterized by a slow and extended rate of absorption with peak blood concentrations expected in 4 to 12 hours as contrasted to Prompt Phenytoin Sodium Capsules, USP with a rapid rate of absorption with peak blood concentration expected in 1½ to 3 hours. Each 100 mg DILANTIN- 100 mg (extended phenytoin sodium capsule, USP) for oral administration contains 100 mg phenytoin sodium. Also contains lactose monohydrate, NF; confectioner's sugar, NF; talc, USP; and magnesium stearate, NF. The capsule body contains titanium dioxide, USP and gelatin, NF. The capsule cap contains FD&C red No. 28; FD&C yellow No. 6; and gelatin NF. Product in vivo performance is characterized by a slow and extended rate of absorption with peak blood concentrations expected in 4 to 12 hours as contrasted to Prompt Phenytoin Sodium Capsules, USP with a rapid rate of absorption with peak blood concentration expected in 1½ to 3 hours.</Description>
</NDC>
<NDC>
<NDCCode>0071-0401-24</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0071-0401-24) </PackageDescription>
<NDC11Code>00071-0401-24</NDC11Code>
<ProductNDC>0071-0401</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Neurontin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19981009</StartMarketingDate>
<EndMarketingDate>20260731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020882</ApplicationNumber>
<LabelerName>Parke-Davis Div of Pfizer Inc</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19981009</StartMarketingDatePackage>
<EndMarketingDatePackage>20260731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NEURONTIN® is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in NEURONTIN capsules, tablets, and oral solution is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each NEURONTIN capsule contains 100 mg, 300 mg, or 400 mg of gabapentin and the following inactive ingredients: lactose, cornstarch, talc, gelatin, titanium dioxide, FD&C Blue No. 2, yellow iron oxide (300 mg and 400 mg only), and red iron oxide (400 mg only). Each NEURONTIN tablet contains 600 mg or 800 mg of gabapentin and the following inactive ingredients: poloxamer 407, copovidone, cornstarch, magnesium stearate, hydroxypropyl cellulose, talc, and candelilla wax. NEURONTIN oral solution contains 250 mg of gabapentin per 5 mL (50 mg per mL) and the following inactive ingredients: glycerin, xylitol, purified water, and artificial cool strawberry anise flavor.</Description>
</NDC>
<NDC>
<NDCCode>0071-0417-24</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0071-0417-24) / 100 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>00071-0417-24</NDC11Code>
<ProductNDC>0071-0417</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrostat</ProprietaryName>
<NonProprietaryName>Nitroglycerin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20000501</StartMarketingDate>
<EndMarketingDate>20260228</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021134</ApplicationNumber>
<LabelerName>Parke-Davis Div of Pfizer Inc</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20000501</StartMarketingDatePackage>
<EndMarketingDatePackage>20260228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NITROSTAT is indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.</IndicationAndUsage>
<Description>NITROSTAT is a stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg , or 0.6 mg nitroglycerin; as well as lactose monohydrate, NF; glyceryl monostearate, NF; pregelatinized starch, NF; calcium stearate, NF powder; and silicon dioxide, colloidal, NF. Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is. Molecular weight: 227.09.</Description>
</NDC>
<NDC>
<NDCCode>0071-0418-24</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0071-0418-24) / 100 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>00071-0418-24</NDC11Code>
<ProductNDC>0071-0418</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrostat</ProprietaryName>
<NonProprietaryName>Nitroglycerin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20000501</StartMarketingDate>
<EndMarketingDate>20250228</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021134</ApplicationNumber>
<LabelerName>Parke-Davis Div of Pfizer Inc</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20000501</StartMarketingDatePackage>
<EndMarketingDatePackage>20250228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NITROSTAT is indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.</IndicationAndUsage>
<Description>NITROSTAT is a stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg , or 0.6 mg nitroglycerin; as well as lactose monohydrate, NF; glyceryl monostearate, NF; pregelatinized starch, NF; calcium stearate, NF powder; and silicon dioxide, colloidal, NF. Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is. Molecular weight: 227.09.</Description>
</NDC>
<NDC>
<NDCCode>0071-0513-24</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0071-0513-24) </PackageDescription>
<NDC11Code>00071-0513-24</NDC11Code>
<ProductNDC>0071-0513</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Neurontin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19981009</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020882</ApplicationNumber>
<LabelerName>Parke-Davis Div of Pfizer Inc</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19981009</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NEURONTIN® is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in NEURONTIN capsules, tablets, and oral solution is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each NEURONTIN capsule contains 100 mg, 300 mg, or 400 mg of gabapentin and the following inactive ingredients: lactose, cornstarch, talc, gelatin, titanium dioxide, FD&C Blue No. 2, yellow iron oxide (300 mg and 400 mg only), and red iron oxide (400 mg only). Each NEURONTIN tablet contains 600 mg or 800 mg of gabapentin and the following inactive ingredients: poloxamer 407, copovidone, cornstarch, magnesium stearate, hydroxypropyl cellulose, talc, and candelilla wax. NEURONTIN oral solution contains 250 mg of gabapentin per 5 mL (50 mg per mL) and the following inactive ingredients: glycerin, xylitol, purified water, and artificial cool strawberry anise flavor.</Description>
</NDC>
<NDC>
<NDCCode>0071-0525-24</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0071-0525-24) </PackageDescription>
<NDC11Code>00071-0525-24</NDC11Code>
<ProductNDC>0071-0525</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celontin</ProprietaryName>
<NonProprietaryName>Methsuximide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19570208</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA010596</ApplicationNumber>
<LabelerName>Parke-Davis Div of Pfizer Inc</LabelerName>
<SubstanceName>METHSUXIMIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19570208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celontin is indicated for the control of absence (petit mal) seizures that are refractory to other drugs.</IndicationAndUsage>
<Description>Celontin (methsuximide) is an anticonvulsant succinimide, chemically designated as N,2-Dimethyl-2-phenylsuccinimide, with the following structural formula. Each Celontin capsule contains 300 mg methsuximide, USP. Also contains starch, NF. The capsule contains colloidal silicon dioxide, NF; D&C yellow No. 10; FD&C yellow No. 6; gelatin, NF; and sodium lauryl sulfate, NF.</Description>
</NDC>
<NDC>
<NDCCode>0071-0803-24</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0071-0803-24) </PackageDescription>
<NDC11Code>00071-0803-24</NDC11Code>
<ProductNDC>0071-0803</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Neurontin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19931230</StartMarketingDate>
<EndMarketingDate>20260731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020235</ApplicationNumber>
<LabelerName>Parke-Davis Div of Pfizer Inc</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19931230</StartMarketingDatePackage>
<EndMarketingDatePackage>20260731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NEURONTIN® is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in NEURONTIN capsules, tablets, and oral solution is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each NEURONTIN capsule contains 100 mg, 300 mg, or 400 mg of gabapentin and the following inactive ingredients: lactose, cornstarch, talc, gelatin, titanium dioxide, FD&C Blue No. 2, yellow iron oxide (300 mg and 400 mg only), and red iron oxide (400 mg only). Each NEURONTIN tablet contains 600 mg or 800 mg of gabapentin and the following inactive ingredients: poloxamer 407, copovidone, cornstarch, magnesium stearate, hydroxypropyl cellulose, talc, and candelilla wax. NEURONTIN oral solution contains 250 mg of gabapentin per 5 mL (50 mg per mL) and the following inactive ingredients: glycerin, xylitol, purified water, and artificial cool strawberry anise flavor.</Description>
</NDC>
<NDC>
<NDCCode>0071-0805-24</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0071-0805-24) </PackageDescription>
<NDC11Code>00071-0805-24</NDC11Code>
<ProductNDC>0071-0805</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Neurontin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19931230</StartMarketingDate>
<EndMarketingDate>20270430</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020235</ApplicationNumber>
<LabelerName>Parke-Davis Div of Pfizer Inc</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19931230</StartMarketingDatePackage>
<EndMarketingDatePackage>20270430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NEURONTIN® is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in NEURONTIN capsules, tablets, and oral solution is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each NEURONTIN capsule contains 100 mg, 300 mg, or 400 mg of gabapentin and the following inactive ingredients: lactose, cornstarch, talc, gelatin, titanium dioxide, FD&C Blue No. 2, yellow iron oxide (300 mg and 400 mg only), and red iron oxide (400 mg only). Each NEURONTIN tablet contains 600 mg or 800 mg of gabapentin and the following inactive ingredients: poloxamer 407, copovidone, cornstarch, magnesium stearate, hydroxypropyl cellulose, talc, and candelilla wax. NEURONTIN oral solution contains 250 mg of gabapentin per 5 mL (50 mg per mL) and the following inactive ingredients: glycerin, xylitol, purified water, and artificial cool strawberry anise flavor.</Description>
</NDC>
<NDC>
<NDCCode>0071-0806-24</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0071-0806-24) </PackageDescription>
<NDC11Code>00071-0806-24</NDC11Code>
<ProductNDC>0071-0806</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Neurontin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19931230</StartMarketingDate>
<EndMarketingDate>20260731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020235</ApplicationNumber>
<LabelerName>Parke-Davis Div of Pfizer Inc</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19931230</StartMarketingDatePackage>
<EndMarketingDatePackage>20260731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NEURONTIN® is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in NEURONTIN capsules, tablets, and oral solution is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each NEURONTIN capsule contains 100 mg, 300 mg, or 400 mg of gabapentin and the following inactive ingredients: lactose, cornstarch, talc, gelatin, titanium dioxide, FD&C Blue No. 2, yellow iron oxide (300 mg and 400 mg only), and red iron oxide (400 mg only). Each NEURONTIN tablet contains 600 mg or 800 mg of gabapentin and the following inactive ingredients: poloxamer 407, copovidone, cornstarch, magnesium stearate, hydroxypropyl cellulose, talc, and candelilla wax. NEURONTIN oral solution contains 250 mg of gabapentin per 5 mL (50 mg per mL) and the following inactive ingredients: glycerin, xylitol, purified water, and artificial cool strawberry anise flavor.</Description>
</NDC>
<NDC>
<NDCCode>21130-071-24</NDCCode>
<PackageDescription>24 BLISTER PACK in 1 CARTON (21130-071-24) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>21130-0071-24</NDC11Code>
<ProductNDC>21130-071</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cold And Flu Relief</ProprietaryName>
<ProprietaryNameSuffix>Nighttime</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160229</StartMarketingDate>
<EndMarketingDate>20250228</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Safeway, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>325; 15; 6.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160229</StartMarketingDatePackage>
<EndMarketingDatePackage>20250228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold and flu symptoms:sore throat headache minor aches and pains fever runny nose and sneezing cough due to minor throat and bronchial irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>41163-071-24</NDCCode>
<PackageDescription>24 BLISTER PACK in 1 CARTON (41163-071-24) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>41163-0071-24</NDC11Code>
<ProductNDC>41163-071</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cold And Flu Relief</ProprietaryName>
<ProprietaryNameSuffix>Nighttime Multi Symptom</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160229</StartMarketingDate>
<EndMarketingDate>20211231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>EQUALINE (SuperValu)</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>325; 15; 6.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160229</StartMarketingDatePackage>
<EndMarketingDatePackage>20211231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>41520-071-24</NDCCode>
<PackageDescription>24 BLISTER PACK in 1 CARTON (41520-071-24) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>41520-0071-24</NDC11Code>
<ProductNDC>41520-071</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Multi Symptom Nitetime</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151031</StartMarketingDate>
<EndMarketingDate>20221231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Care One (American Sales Company)</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>325; 15; 6.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20151031</StartMarketingDatePackage>
<EndMarketingDatePackage>20221231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49738-071-24</NDCCode>
<PackageDescription>24 BLISTER PACK in 1 CARTON (49738-071-24) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>49738-0071-24</NDC11Code>
<ProductNDC>49738-071</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Multi Symptom Cold And Flu Relief</ProprietaryName>
<ProprietaryNameSuffix>Nighttime</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160731</StartMarketingDate>
<EndMarketingDate>20211231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>SMART SENSE (Kmart)</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>325; 15; 6.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160731</StartMarketingDatePackage>
<EndMarketingDatePackage>20211231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60760-071-24</NDCCode>
<PackageDescription>24 TABLET, COATED in 1 BOTTLE, PLASTIC (60760-071-24) </PackageDescription>
<NDC11Code>60760-0071-24</NDC11Code>
<ProductNDC>60760-071</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Health Sense Ecpirin</ProprietaryName>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190815</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>St. Mary's Medical Park Pharmacy</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>325</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>61941-0071-1</NDCCode>
<PackageDescription>24 PACKAGE in 1 CASE (61941-0071-1) > 18 LOZENGE in 1 PACKAGE (61941-0071-8)</PackageDescription>
<NDC11Code>61941-0071-01</NDC11Code>
<ProductNDC>61941-0071</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cold-eeze</ProprietaryName>
<NonProprietaryName>Zinc Gluconate</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>ProPhase Labs, Inc.</LabelerName>
<SubstanceName>ZINC GLUCONATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>to reduce the duration of the common cold. reduces the severity of cold symptoms: cough, sore throat, stuffy nose, sneezing, post nasal drip and/or hoarseness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63868-071-24</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (63868-071-24) / 12 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>63868-0071-24</NDC11Code>
<ProductNDC>63868-071</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Severe Sinus Congestion And Pain</ProprietaryName>
<NonProprietaryName>Acetaminophen, Guaifenesin, And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091113</StartMarketingDate>
<EndMarketingDate>20261231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Chain Drug Marketing Association</LabelerName>
<SubstanceName>ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 200; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20091113</StartMarketingDatePackage>
<EndMarketingDatePackage>20261231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of: sinus congestion and pressureheadachenasal congestionminor aches and pains. helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive. temporarily relieves nasal congestion due to the common cold, and hay fever or other upper respiratory allergies. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75594-071-24</NDCCode>
<PackageDescription>1.89 L in 1 BOTTLE, PUMP (75594-071-24) </PackageDescription>
<NDC11Code>75594-0071-24</NDC11Code>
<ProductNDC>75594-071</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aloe Gel</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200723</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Commercial Beverage Concepts, LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>L/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200723</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83324-071-24</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (83324-071-24) / 24 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>83324-0071-24</NDC11Code>
<ProductNDC>83324-071</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Childrens Pain And Fever Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241021</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Chain Drug Marketing Association, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241021</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: headachesore throatflutoothachethe common cold. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17312-419-14</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 PACKAGE (17312-419-14) / 24 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>17312-0419-14</NDC11Code>
<ProductNDC>17312-419</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Natural Eyes Aging Eye Relief</ProprietaryName>
<ProprietaryNameSuffix>Fast Dissolving Tables</ProprietaryNameSuffix>
<NonProprietaryName>Calcarea Phosphorica, Calendula Officinalis, Carboneum Sulphuratum, Cineraria Maritima, Conium Maculatum, Euphrasia Officinalis, Selenium Metallicum, Zincum Metallicum</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250316</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>TRP Company</LabelerName>
<SubstanceName>ZINC; TRIBASIC CALCIUM PHOSPHATE; SELENIUM; CONIUM MACULATUM FLOWERING TOP; CARBON DISULFIDE; JACOBAEA MARITIMA; EUPHRASIA STRICTA; CALENDULA OFFICINALIS FLOWERING TOP</SubstanceName>
<StrengthNumber>9; 10; 9; 3; 6; 6; 3; 1</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-03-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250317</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses* According to homeopathic indications these ingredients provide temporary relief from eye irritation after serious causes have been ruled out by a physician. *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>44911-0419-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (44911-0419-1) </PackageDescription>
<NDC11Code>44911-0419-01</NDC11Code>
<ProductNDC>44911-0419</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Liverex I</ProprietaryName>
<NonProprietaryName>Ginkgo Biloba, Fel Tauri, Gallbladder (suis), Hepar Suis), Thyroidinum (suis), Germanium Sesquioxide, Alpha-ketoglutaricum Acidum, Citricum Acidum, Fumaricum Acidum, Malicum Acidum, Manganum Metallicum, Pyruvic Acid, Succinicum Acidum, Naphthochinonum, Arsenicum Metallicum, Sulphur, Aconiticum Acidum, Cis, Lycopodium Clavatum, Natrum Oxalaceticum, Phosphorus</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170228</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Energique, Inc.</LabelerName>
<SubstanceName>GINKGO; BOS TAURUS BILE; SUS SCROFA GALLBLADDER; PORK LIVER; THYROID; GERMANIUM SESQUIOXIDE; OXOGLURIC ACID; ANHYDROUS CITRIC ACID; FUMARIC ACID; MALIC ACID; MANGANESE; PYRUVIC ACID; SUCCINIC ACID; 1,4-NAPHTHOQUINONE; ARSENIC; SULFUR; ACONITIC ACID, (Z)-; LYCOPODIUM CLAVATUM SPORE; SODIUM DIETHYL OXALACETATE; PHOSPHORUS</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 8; 8; 8; 8; 8; 8; 8; 8; 9; 12; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-07-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>May temporarily relieve abdominal pain and nausea.**. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55111-419-05</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-419-05) </PackageDescription>
<NDC11Code>55111-0419-05</NDC11Code>
<ProductNDC>55111-419</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180906</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202383</ApplicationNumber>
<LabelerName>Dr.Reddy's Laboratories Limited</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180906</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Lamotrigine extended-release tablets, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine USP is slightly soluble in acetone and in methanol. The structural formula is. Lamotrigine extended-release tablets, USP are supplied for oral administration as 25 mg (yellow), 50 mg (light green), 100 mg (orange), 200 mg (blue), 250 mg (purple) and 300 mg (grey) tablets. Each tablet contains the labeled amount of lamotrigine USP and the following inactive ingredients: D&C Red # 27 (250 mg), FD&C BLUE No. 2 (200 mg and 250 mg), hypromellose, iron oxide black (50 mg and 300 mg), iron oxide yellow (25 mg, 50 mg and 100 mg), iron oxide red (100 mg), lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol 400, talc, titanium dioxide and triethyl citrate. Tablets are printed with edible black ink which contains iron oxide black and shellac glaze. Lamotrigine extended-release tablets, USP contains modified release, erodible matrix as the core. The core tablet is coated with a modified enteric coat to enable a controlled release of drug in the acidic environment of the stomach. The combination of modified-release core and the modified enteric coating are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55111-419-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-419-30) </PackageDescription>
<NDC11Code>55111-0419-30</NDC11Code>
<ProductNDC>55111-419</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180906</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202383</ApplicationNumber>
<LabelerName>Dr.Reddy's Laboratories Limited</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180906</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Lamotrigine extended-release tablets, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine USP is slightly soluble in acetone and in methanol. The structural formula is. Lamotrigine extended-release tablets, USP are supplied for oral administration as 25 mg (yellow), 50 mg (light green), 100 mg (orange), 200 mg (blue), 250 mg (purple) and 300 mg (grey) tablets. Each tablet contains the labeled amount of lamotrigine USP and the following inactive ingredients: D&C Red # 27 (250 mg), FD&C BLUE No. 2 (200 mg and 250 mg), hypromellose, iron oxide black (50 mg and 300 mg), iron oxide yellow (25 mg, 50 mg and 100 mg), iron oxide red (100 mg), lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol 400, talc, titanium dioxide and triethyl citrate. Tablets are printed with edible black ink which contains iron oxide black and shellac glaze. Lamotrigine extended-release tablets, USP contains modified release, erodible matrix as the core. The core tablet is coated with a modified enteric coat to enable a controlled release of drug in the acidic environment of the stomach. The combination of modified-release core and the modified enteric coating are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>55111-419-90</NDCCode>
<PackageDescription>90 TABLET, EXTENDED RELEASE in 1 BOTTLE (55111-419-90) </PackageDescription>
<NDC11Code>55111-0419-90</NDC11Code>
<ProductNDC>55111-419</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180906</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202383</ApplicationNumber>
<LabelerName>Dr.Reddy's Laboratories Limited</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180906</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Lamotrigine extended-release tablets, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine's chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine USP is slightly soluble in acetone and in methanol. The structural formula is. Lamotrigine extended-release tablets, USP are supplied for oral administration as 25 mg (yellow), 50 mg (light green), 100 mg (orange), 200 mg (blue), 250 mg (purple) and 300 mg (grey) tablets. Each tablet contains the labeled amount of lamotrigine USP and the following inactive ingredients: D&C Red # 27 (250 mg), FD&C BLUE No. 2 (200 mg and 250 mg), hypromellose, iron oxide black (50 mg and 300 mg), iron oxide yellow (25 mg, 50 mg and 100 mg), iron oxide red (100 mg), lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol 400, talc, titanium dioxide and triethyl citrate. Tablets are printed with edible black ink which contains iron oxide black and shellac glaze. Lamotrigine extended-release tablets, USP contains modified release, erodible matrix as the core. The core tablet is coated with a modified enteric coat to enable a controlled release of drug in the acidic environment of the stomach. The combination of modified-release core and the modified enteric coating are designed to control the dissolution rate of lamotrigine over a period of approximately 12 to 15 hours, leading to a gradual increase in serum lamotrigine levels. Meets USP Dissolution Test 2.</Description>
</NDC>
</NDCList>