{
"NDC": [
{
"NDCCode": "69336-350-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (69336-350-30)",
"NDC11Code": "69336-0350-30",
"ProductNDC": "69336-350",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methazel",
"NonProprietaryName": "Methazel",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20151012",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sterling-Knight Pharmaceuticals, LLC",
"SubstanceName": "FOLIC ACID; PYRIDOXAL 5-PHOSPHATE; METHYLCOBALAMIN; COENZYME Q10, (2Z)-; ALPHA LIPOIC ACID; ACETYLCYSTEINE",
"StrengthNumber": "1; 50; 2.5; 25; 50; 50",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-04-16",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "69336-101-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (69336-101-30)",
"NDC11Code": "69336-0101-30",
"ProductNDC": "69336-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151223",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077918",
"LabelerName": "STERLING KNIGHT PHARMACEUTICALS, LLC",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Meloxicam is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) ( 1.1) , 2 Rheumatoid Arthritis (RA) ( 1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients 2 years of age or older ( 1.3) .",
"Description": "Meloxicam, an oxicam derivative, is a member of the enolic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each pastel yellow Meloxicam Tablets, USP contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2 and it has the following structural formula. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam.The inactive ingredients in Meloxicam Tablets, USP include Colloidal Silicon Dioxide, Sodium Starch Glycolate, Lactose, Magnesium Stearate, Microcrystalline Cellulose, Povidone K-30, and Sodium Citrate."
},
{
"NDCCode": "69336-102-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (69336-102-30)",
"NDC11Code": "69336-0102-30",
"ProductNDC": "69336-102",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077918",
"LabelerName": "STERLING KNIGHT PHARMACEUTICALS, LLC",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Meloxicam is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) ( 1.1) , 2 Rheumatoid Arthritis (RA) ( 1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients 2 years of age or older ( 1.3) .",
"Description": "Meloxicam, an oxicam derivative, is a member of the enolic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each pastel yellow Meloxicam Tablets, USP contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2 and it has the following structural formula. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam.The inactive ingredients in Meloxicam Tablets, USP include Colloidal Silicon Dioxide, Sodium Starch Glycolate, Lactose, Magnesium Stearate, Microcrystalline Cellulose, Povidone K-30, and Sodium Citrate."
},
{
"NDCCode": "69336-106-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (69336-106-30)",
"NDC11Code": "69336-0106-30",
"ProductNDC": "69336-106",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20161104",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078428",
"LabelerName": "Sterling Knight Pharmaceuticals,LLC",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Gabapentin capsules, USP are 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 gabapentin capsules, USP is gabapentin, USP 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, USP 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 gabapentin, USP capsule contains 100 mg, 300 mg, or 400 mg of gabapentin and the following inactive ingredients: magnesium stearate, pregelatinized starch (corn), starch (corn) and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate and titanium dioxide. The 300 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, and iron oxide yellow. The 400 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, FD&C Yellow No.6 and FD&C Blue No.1."
},
{
"NDCCode": "69336-107-30",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69336-107-30)",
"NDC11Code": "69336-0107-30",
"ProductNDC": "69336-107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20161031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201921",
"LabelerName": "Sterling Knight Pharmaceuticals LLC",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Lansoprazole delayed-release capsule is a proton pump inhibitor (PPI) indicated for: 1 Short-Term Treatment of Active Duodenal Ulcer (1.1), 2 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence (1.2), 3 Maintenance of Healed Duodenal Ulcers (1.3), 4 Short-Term Treatment of Active Benign Gastric Ulcer (1.4), 5 Healing of nonsteroidal anti-inflammatory drugs (NSAID)- Associated Gastric Ulcer (1.5), 6 Risk Reduction of NSAID-Associated Gastric Ulcer (1.6), 7 Gastroesophageal Reflux Disease (GERD) (1.7), 8 Maintenance of Healing of Erosive Esophagitis (EE) (1.8), 9 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (ZES) (1.9) .",
"Description": "Lansoprazole delayed-release capsules 15 mg and 30 mg contain lansoprazole as the active ingredient, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsule form, for oral administration in two strengths 15 mg and 30 mg. Lansoprazole delayed-release capsules are available in two strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains lansoprazole delayed-release pellets 8.5% consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: acetone, hypromellose, isopropyl alcohol, light magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, sugar spheres, talc and titanium dioxide."
},
{
"NDCCode": "69336-112-30",
"PackageDescription": "30 CAPSULE in 1 PACKAGE (69336-112-30)",
"NDC11Code": "69336-0112-30",
"ProductNDC": "69336-112",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Not Applicable",
"NonProprietaryName": "Omeprazole Sodium Bicarbonate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170713",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207476",
"LabelerName": "Sterling Knight Pharmaceuticals LLC",
"SubstanceName": "OMEPRAZOLE; SODIUM BICARBONATE",
"StrengthNumber": "40; 1100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Omeprazole and sodium bicarbonate is a proton pump inhibitor indicated for: 1 Short-term treatment of active duodenal ulcer (1.1), 2 Short-term treatment of active benign gastric ulcer (1.2), 3 Treatment of gastroesophageal reflux disease (GERD) (1.3), 4 Maintenance of healing of erosive esophagitis (1.4).",
"Description": "Omeprazole and sodium bicarbonate is a combination of omeprazole, a proton-pump inhibitor, and sodium bicarbonate, an antacid. Omeprazole is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole, a racemic mixture of two enantiomers that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole, USP is a white or almost white powder which melts with decomposition at about 155°C. Soluble in dichloromethane, practically insoluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole and sodium bicarbonate is supplied as immediate-release capsules. Each capsule contains either 40 mg or 20 mg of omeprazole and 1100 mg of sodium bicarbonate with the following excipients: croscarmellose sodium and sodium stearyl fumarate. The capsules consist of gelatin and titanium dioxide. In addition the 20 mg/1100 mg capsule shell contains sodium lauryl sulfate and the 40 mg/1100 mg capsule shell contains FD&C Blue 1. The capsules are printed with edible ink containing black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, potassium hydroxide, shellac and strong ammonia solution."
},
{
"NDCCode": "69336-129-30",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69336-129-30) ",
"NDC11Code": "69336-0129-30",
"ProductNDC": "69336-129",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esomeprazole Strontium",
"NonProprietaryName": "Esomeprazole Strontium",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200625",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA202342",
"LabelerName": "Sterling-Knight Pharmaceuticals, LLC",
"SubstanceName": "ESOMEPRAZOLE STRONTIUM",
"StrengthNumber": "49.3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200625",
"SamplePackage": "N",
"IndicationAndUsage": "Esomeprazole strontium is a proton pump inhibitor indicated for adults for: 1 Treatment of gastroesophageal reflux disease (GERD) (1.1), 2 Risk reduction of NSAID-associated gastric ulcer (1.2), 3 H. pylori eradication to reduce the risk of duodenal ulcer recurrence (1.3), 4 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4).",
"Description": "The active ingredient in the proton pump inhibitor esomeprazole strontium delayed-release capsules is bis(5‑ methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) strontium tetrahydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. The molecular formula of esomeprazole strontium is (C17H18N3O3S)2·Sr·4H2O with molecular weight of 848.50. The structural formula is. The strontium salt is a white or almost white crystalline powder. Each molecule contains 4 moles of water of solvation and is soluble in water. Esomeprazole strontium is supplied in delayed-release capsules. Each delayed-release capsule contains 24.65 mg esomeprazole strontium equivalent to 20 mg esomeprazole or 49.3 mg esomeprazole strontium equivalent to 40 mg esomeprazole, in the form of enteric-coated granules with the following inactive ingredients: calcium carbonate, hypromellose, methacrylic acid copolymer dispersion, mono- and diglycerides, polysorbate 80, sugar spheres, talc, triethyl citrate. The 24.65 mg capsule shells have the following inactive ingredients: gelatin, titanium dioxide, synthetic iron oxide. The 49.3 mg capsule shells have the following inactive ingredients: gelatin, titanium dioxide, FD&C Blue #1, FD&C Red #40, FD&C Yellow #6. Each 24.65 mg capsule contains 2.6 mg of strontium. Each 49.3 mg capsule contains 5.1 mg of strontium."
},
{
"NDCCode": "69336-200-30",
"PackageDescription": "30 PACKAGE in 1 BOX (69336-200-30) > 100 g in 1 PACKAGE",
"NDC11Code": "69336-0200-30",
"ProductNDC": "69336-200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Synvexia",
"NonProprietaryName": "Lidocaine Hydrochloride And Menthol",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141114",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sterling Knight Pharmaceuticals,LLC",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; MENTHOL",
"StrengthNumber": "4; 1",
"StrengthUnit": "g/100g; g/100g",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-08-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "69336-300-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (69336-300-30)",
"NDC11Code": "69336-0300-30",
"ProductNDC": "69336-300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Durachol",
"NonProprietaryName": "Durachol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20141116",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sterling Knight Pharmaceuticals,LLC",
"SubstanceName": "CHOLECALCIFEROL; FOLIC ACID",
"StrengthNumber": "3775; 1",
"StrengthUnit": "[iU]/1; mg/1",
"Pharm_Classes": "Vitamin D [Chemical/Ingredient],Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-04-16",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Durachol is indicated for dietary management of patients with unique nutritional needs requiring increased folate levels, Vitamin D deficiency or are in need of Vitamin D supplementation and other nutritional supplementation.",
"Description": "Durachol is an orally administered prescription Vitamin for the dietary management of patients with unique nutritional needs requiring increased folate levels, Vitamin D supplementation due to Vitamin D deficiency and other nutritional supplementation. Durachol should be administered under the supervision of a licensed medical practitioner. Vitamin D3 (cholecalciferol) is a white, crystalline powder, very soluble in water, with the following structural formula. Each capsule contains:Folic Acid: 1mg, Vitamin D3 (Cholecalciferol): 3775IU. Each capsule contains the following inactive ingredients: Gelatin, cellulose, magnesium stearate, silica, FD&C Red #3, FD&C Yellow # 6."
},
{
"NDCCode": "69336-310-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (69336-310-30)",
"NDC11Code": "69336-0310-30",
"ProductNDC": "69336-310",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cifrazol",
"NonProprietaryName": "Cifrazol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20170110",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sterling Knight Pharmaceuticals,LLC",
"SubstanceName": "CHOLECALCIFEROL; FOLIC ACID",
"StrengthNumber": "3775; 1",
"StrengthUnit": "[iU]/1; mg/1",
"Pharm_Classes": "Vitamin D [Chemical/Ingredient],Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-05-30",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Cifrazol is indicated for dietary management of patients with unique nutritional needs requiring increased folate levels, Vitamin D deficiency or are in need of Vitamin D supplementation and other nutritional supplementation.",
"Description": "Cifrazol is an orally administered prescription Vitamin for the dietary management of patients with unique nutritional needs requiring increased folate levels, Vitamin D supplementation due to Vitamin D deficiency and other nutritional supplementation. Cifrazol should be administered under the supervision of a licensed medical practitioner. Vitamin D3 (cholecalciferol) is a white, crystalline powder, very soluble in water, with the following structural formula. Each capsule contains:Folic Acid: 1mg, Vitamin D3 (Cholecalciferol): 3775IU. Each capsule contains the following inactive ingredients: Gelatin,Water, Soybean Oil, Yellow Wax, Lecithin,Glycerin, FD&C Red #40, FD&C Yellow #5, Titanium Dioxide."
},
{
"NDCCode": "69336-330-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (69336-330-30) ",
"NDC11Code": "69336-0330-30",
"ProductNDC": "69336-330",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Revesta",
"NonProprietaryName": "Revesta",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20161013",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sterling Knight Pharmaceuticals,LLC",
"SubstanceName": "CHOLECALCIFEROL; FOLIC ACID",
"StrengthNumber": "5750; 1",
"StrengthUnit": "[iU]/1; mg/1",
"Pharm_Classes": "Vitamin D [CS],Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20161013",
"SamplePackage": "N",
"IndicationAndUsage": "Revesta is indicated for dietary management of patients with unique nutritional needs requiring increased folate levels, Vitamin D deficiency or are in need of Vitamin D supplementation and other nutritional supplementation.",
"Description": "Revesta is an orally administered prescription Vitamin for the dietary management of patients with unique nutritional needs requiring increased folate levels, Vitamin D supplementation due to Vitamin D deficiency and other nutritional supplementation. Revesta should be administered under the supervision of a licensed medical practitioner. Vitamin D3 (cholecalciferol) is a white, crystalline powder, very soluble in water, with the following structural formula. Each capsule contains: Folic Acid: 1mg, Vitamin D3 (Cholecalciferol): 5750IU. Each capsule contains the following inactive ingredients: soybean oil, gelatin (bovine), yellow wax, glycerin, deionized water, lecithin, titanium dioxide, FD&C Blue #1."
},
{
"NDCCode": "69336-352-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (69336-352-30) ",
"NDC11Code": "69336-0352-30",
"ProductNDC": "69336-352",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenara",
"NonProprietaryName": "Prenara",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200309",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sterling-Knight Pharmaceuticals, LLC",
"SubstanceName": "VITAMIN A; ASCORBIC ACID; VITAMIN D; THIAMINE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM; IODINE; COPPER; MAGNESIUM; ZINC",
"StrengthNumber": "1000; 100; 750; 1.8; 1.7; 20; 2.5; 1; .5; 100; .15; 2; 15; 20",
"StrengthUnit": "[iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin A [CS],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Calcium [CS],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200309",
"SamplePackage": "N",
"IndicationAndUsage": "Prenara is a prescription dietary supplement for use throughout pregnancy, during the prenatal and postnatal period for both lactating and non-lactating mothers and throughout the childbearing years.",
"Description": "Prenara is an orally administered prescription dietary supplement formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced supplementation is required and nutritional supplementation in physiologically stressful conditions for maintenance of good health is needed.Prenara is a prescription dietary supplement for use throughout pregnancy, during the prenatal and postnatal period for both lactating and non-lactating mothers and throughout the childbearing years.Prenara should be administered under the supervision of a licensed medical practitioner. Each softgel capsule contains. Other Ingredients: Soybean oil, gelatin (bovine), bees wax (yellow), lecithin, glycerin, deionized water, FD&C red #40, FD&C blue #1, titanium dioxide."
},
{
"NDCCode": "69336-353-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (69336-353-30)",
"NDC11Code": "69336-0353-30",
"ProductNDC": "69336-353",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methaver",
"NonProprietaryName": "Methaver",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20151124",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sterling-knight Pharmaceuticals,LLC",
"SubstanceName": "FOLIC ACID; RIBOFLAVIN; METHYLCOBALAMIN; THIAMINE HYDROCHLORIDE; PYRIDOXINE HYDROCHLORIDE",
"StrengthNumber": "1; 29; 2; 27; 50",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-04-20",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Methaver is indicated for the distinct nutritional requirements of patients in need of dietary supplementation as determined by a licensed medical practitioner. Methaver should be administered under the supervision o f a licensed medical practitioner.",
"Description": "Methaver is an orally administered prescription vitamin specifically formulated for the dietary management of patients with unique nutritional needs requiring increased folate levels, as well as other Vitamin B supplementation. Methaver should be administered under the supervision of a licensed medical practitioner. Each capsule contains the following ingredients. Each capsule contains:Folic Acid............................................................................1mgThiamin hydrochloride..……………………………………..27mgRiboflavin……………………………………………………..29mgPyridoxine hydrochloride..............,...................................50mgMethylcobalamin……………....….……………..……………2mg. Each capsule contains the following inactive ingredients: Lactose Monohydrate, Gelatin (bovine), Silicon Dioxide, Magnesium Stearate, Titanium Dioxide, FD&C Blue #1, FD&C Red #40. * This product is a prescription vitamin that – due to increased folate levels (AUG 2 1973 FR 20750), requires an Rx on the label because of increased risk associated with masking of B12 deficiency. As such, this product requires licensed medical supervision, an Rx status, and a National Drug Code (NDC) as required by pedigree reporting requirements. FOLAT E REGULAT ION. The term \"folate\" are B vitamins that include folic acid and any forms of active pteroylglutamates regardless of the reduction state of the molecule. Folates, or vitamin B9, are primarily hydrolyzed in the intestinal jejunum and the liver to the active circulating form of folate. Folic acid, including reduced forms1 such as folinic acid, may obscure pernicious anemia above 0.1 mg doses, and must be administered under the supervision o f a licensed medical practitioner."
},
{
"NDCCode": "69336-358-30",
"PackageDescription": "30 CAPSULE in 1 PACKAGE (69336-358-30) ",
"NDC11Code": "69336-0358-30",
"ProductNDC": "69336-358",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lexazin",
"NonProprietaryName": "Lexazin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180102",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sterling Knight Pharmaceuticals LLC",
"SubstanceName": "ASCORBIC ACID; CHOLECALCIFEROL; THIAMINE HYDROCHLORIDE; PYRIDOXAL PHOSPHATE ANHYDROUS; FOLIC ACID; METHYLCOBALAMIN; NADH; COENZYME Q10, (2Z)-",
"StrengthNumber": "125; 500; 25; 12.5; 1; 5; 5; 50",
"StrengthUnit": "mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180105",
"SamplePackage": "N"
},
{
"NDCCode": "69336-600-30",
"PackageDescription": "30 PACKAGE in 1 BOX (69336-600-30) > 100 g in 1 PACKAGE",
"NDC11Code": "69336-0600-30",
"ProductNDC": "69336-600",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Provenza",
"NonProprietaryName": "Menthol And Lidocaine",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141219",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sterling Knight Pharmaceuticals,LLC",
"SubstanceName": "MENTHOL; LIDOCAINE",
"StrengthNumber": "1; 4",
"StrengthUnit": "g/g; g/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-08-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "69336-800-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (69336-800-30)",
"NDC11Code": "69336-0800-30",
"ProductNDC": "69336-800",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Macuzin",
"NonProprietaryName": "Macuzin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150430",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Sterling-Knight Pharmaceuticals, LLC",
"SubstanceName": "FOLIC ACID; ASCORBIC ACID; .ALPHA.-TOCOPHEROL ACETATE, DL-; ZINC OXIDE; COPPER; LUTEIN; ZEAXANTHIN",
"StrengthNumber": "1; 500; 400; 80; 2; 10; 2",
"StrengthUnit": "mg/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "69336-825-01",
"PackageDescription": "1 TUBE in 1 CARTON (69336-825-01) > 30 g in 1 TUBE",
"NDC11Code": "69336-0825-01",
"ProductNDC": "69336-825",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidopril",
"NonProprietaryName": "Lidocaine 2.5% And Prilocaine 2.5%",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160707",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019941",
"LabelerName": "Sterling-knight Pharmaceuticals,LLC",
"SubstanceName": "LIDOCAINE; PRILOCAINE",
"StrengthNumber": "25; 25",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Lidocaine and prilocaine cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on: 1 normal intact skin for local analgesia., 2 genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia.",
"Description": "Lidocaine 2.5% and Prilocaine Cream, USP is an emulsion in which the oil phase is a eutectic mixture of lidocaine and prilocaine in a ratio of 1:1 by weight. This eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. It is packaged in 5 gram and 30 gram tubes. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol: water partition ratio of 43 at pH 7.4, and has the following structure. Prilocaine is chemically designated as propanamide, N-(2-methylphenyl)-2-(propylamino), has an octanol: water partition ratio of 25 at pH 7.4, and has the following structure. Each gram of lidocaine and prilocaine cream contains lidocaine 25 mg, prilocaine 25 mg, polyoxyethylene fatty acid esters (as emulsifiers), carboxypolymethylene (as a thickening agent), sodium hydroxide to adjust to a pH approximating 9, and purified water to 1 gram. Lidocaine and prilocaine cream contains no preservative, however it passes the USP antimicrobial effectiveness test due to the pH. The specific gravity of lidocaine and prilocaine cream is 1.00."
},
{
"NDCCode": "69336-826-01",
"PackageDescription": "1 TUBE in 1 CARTON (69336-826-01) > 30 g in 1 TUBE",
"NDC11Code": "69336-0826-01",
"ProductNDC": "69336-826",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidopril Xr",
"NonProprietaryName": "Lidocaine 2.5% And Prilocaine 2.5%",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160816",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019941",
"LabelerName": "Sterling-knight Pharmaceuticals,LLC",
"SubstanceName": "LIDOCAINE; PRILOCAINE",
"StrengthNumber": "25; 25",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Lidocaine and prilocaine cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on: 1 normal intact skin for local analgesia., 2 genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia.",
"Description": "Lidocaine 2.5% and Prilocaine Cream, USP is an emulsion in which the oil phase is a eutectic mixture of lidocaine and prilocaine in a ratio of 1:1 by weight. This eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. It is packaged in 5 gram and 30 gram tubes. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol: water partition ratio of 43 at pH 7.4, and has the following structure. Prilocaine is chemically designated as propanamide, N-(2-methylphenyl)-2-(propylamino), has an octanol: water partition ratio of 25 at pH 7.4, and has the following structure. Each gram of lidocaine and prilocaine cream contains lidocaine 25 mg, prilocaine 25 mg, polyoxyethylene fatty acid esters (as emulsifiers), carboxypolymethylene (as a thickening agent), sodium hydroxide to adjust to a pH approximating 9, and purified water to 1 gram. Lidocaine and prilocaine cream contains no preservative, however it passes the USP antimicrobial effectiveness test due to the pH. The specific gravity of lidocaine and prilocaine cream is 1.00."
},
{
"NDCCode": "69336-828-01",
"PackageDescription": "1 TUBE in 1 CARTON (69336-828-01) > 30 g in 1 TUBE",
"NDC11Code": "69336-0828-01",
"ProductNDC": "69336-828",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prilolid",
"NonProprietaryName": "Lidocaine 2.5% And Prilocaine 2.5%",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161005",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019941",
"LabelerName": "Sterling-knight Pharmaceuticals,LLC",
"SubstanceName": "LIDOCAINE; PRILOCAINE",
"StrengthNumber": "25; 25",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Lidocaine and prilocaine cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on: 1 normal intact skin for local analgesia., 2 genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia.",
"Description": "Lidocaine 2.5% and Prilocaine Cream, USP is an emulsion in which the oil phase is a eutectic mixture of lidocaine and prilocaine in a ratio of 1:1 by weight. This eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. It is packaged in 5 gram and 30 gram tubes. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol: water partition ratio of 43 at pH 7.4, and has the following structure. Prilocaine is chemically designated as propanamide, N-(2-methylphenyl)-2-(propylamino), has an octanol: water partition ratio of 25 at pH 7.4, and has the following structure. Each gram of lidocaine and prilocaine cream contains lidocaine 25 mg, prilocaine 25 mg, polyoxyethylene fatty acid esters (as emulsifiers), carboxypolymethylene (as a thickening agent), sodium hydroxide to adjust to a pH approximating 9, and purified water to 1 gram. Lidocaine and prilocaine cream contains no preservative, however it passes the USP antimicrobial effectiveness test due to the pH. The specific gravity of lidocaine and prilocaine cream is 1.00."
},
{
"NDCCode": "10893-350-30",
"PackageDescription": "30 mL in 1 BOTTLE, GLASS (10893-350-30) ",
"NDC11Code": "10893-0350-30",
"ProductNDC": "10893-350",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Naturasil",
"ProprietaryNameSuffix": "Neuropathy Rub",
"NonProprietaryName": "Hypericum And Arnica Montana",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120111",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nature's Innovation, Inc.",
"SubstanceName": "ARNICA MONTANA; ST. JOHN'S WORT",
"StrengthNumber": "1; 6",
"StrengthUnit": "[hp_X]/30mL; [hp_X]/30mL",
"Status": "Deprecated",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20120111",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: Symptomatic treatment of neuropathy, tingling, burning and numbness.",
"Description": "The letters HPUS indicate the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopeia of the United States."
},
{
"NDCCode": "14141-192-01",
"PackageDescription": "9 g in 1 JAR (14141-192-01) ",
"NDC11Code": "14141-0192-01",
"ProductNDC": "14141-192",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clarite Makeup For A Cleaner Appearance Spf 30 350-n",
"NonProprietaryName": "Octinoxate, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200324",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "BEL STAR S A",
"SubstanceName": "OCTINOXATE; ZINC OXIDE",
"StrengthNumber": "7.5; 7.84",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-12-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200324",
"SamplePackage": "N"
},
{
"NDCCode": "16103-350-04",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (16103-350-04) / 30 TABLET, COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "16103-0350-04",
"ProductNDC": "16103-350",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pharbetol",
"NonProprietaryName": "Acetaminophen 500mg",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180301",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Pharbest Pharmaceuticals, Inc.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-12-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180301",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to:. the common cold. headache. backache. minor pain of arthritis. toothache. muscular aches. premenstrual and menstrual cramps. temporarily reduces fever."
},
{
"NDCCode": "16729-350-10",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (16729-350-10) ",
"NDC11Code": "16729-0350-10",
"ProductNDC": "16729-350",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lurasidone Hydrochloride",
"NonProprietaryName": "Lurasidone Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208049",
"LabelerName": "Accord Healthcare, Inc.",
"SubstanceName": "LURASIDONE HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230220",
"SamplePackage": "N",
"IndicationAndUsage": "Lurasidone hydrochloride tablets are indicated for: 1 Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies ( 14.1)] . , 2 Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies ( 14.2)] . , 3 Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies ( 14.2)] . .",
"Description": "Lurasidone hydrochloride is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3a R,4 S,7 R,7a S)-2-{(1 R,2 R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2 H-isoindole-1,3-dione hydrochloride. Its molecular formula is C 28H 36N 4O 2S·HCl and its molecular weight is 529.14. The chemical structure is. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are mannitol, pregelatinized starch, croscarmellose sodium, hydroxypropyl methyl cellulose, magnesium stearate. Additionally, the 20 mg, 40 mg, 60 mg & 120 mg tablet contains hydroxylpropyl methyl cellulose 2910, talc, polyethylene glycol 6000 & titanium dioxide and 80 mg tablet contains hydroxylpropyl methyl cellulose 2910, titanium dioxide, talc, polyethylene glycol 6000, iron oxide yellow and FD&C Blue #2/indigo carmine aluminium lake."
},
{
"NDCCode": "17089-350-18",
"PackageDescription": "1 BOTTLE, DROPPER in 1 BOX (17089-350-18) / 30 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "17089-0350-18",
"ProductNDC": "17089-350",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guna-awareness",
"NonProprietaryName": "Betaine - Bufo Bufo Cutaneous Gland - Calcium Carbonate - Chromic Sulfate - Cicuta Virosa Root - Copper - Folic Acid - Gold - Cobalamin - Iron - Lachesis Muta Venom - Melatonin - Molybdenum - Neurotrophin-3 - Neurotrophin-4 - Oxytocin - Silicon Dioxide - Sus Scrofa Frontal Lobe - Sus Scrofa Temporal Lobe - Thyrotropin Alfa - Ubidecarenone - Vanadium - Zinc - Brain-derived Neurotrophic Factor Human -",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20080416",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Guna spa",
"SubstanceName": "LACHESIS MUTA VENOM; MELATONIN; MOLYBDENUM; NEUROTROPHIN-3; NEUROTROPHIN-4; OXYTOCIN; SILICON DIOXIDE; SUS SCROFA TEMPORAL LOBE; THYROTROPIN ALFA; BETAINE; VANADIUM; ZINC; GOLD; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; BUFO BUFO CUTANEOUS GLAND; CALCIUM CARBONATE; CHROMIC SULFATE; CICUTA VIROSA ROOT; COBALAMIN; UBIDECARENONE; COPPER; IRON; FOLIC ACID; SUS SCROFA FRONTAL LOBE",
"StrengthNumber": "12; 4; 3; 4; 4; 6; 12; 6; 3; 3; 6; 3; 12; 4; 12; 3; 3; 12; 3; 3; 12; 3; 3; 6",
"StrengthUnit": "[hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL",
"Pharm_Classes": "Allergens [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased Uterine Smooth Muscle Contraction or Tone [PE], Inhibit Ovum Fertilization [PE], Methylating Activity [MoA], Methylating Agent [EPC], Oxytocic [EPC], Oxytocin [CS], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Standardized Chemical Allergen [EPC], Thyroid Stimulating Hormone [EPC], Thyrotropin [CS]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181221",
"SamplePackage": "N",
"IndicationAndUsage": "Take 15 minutes before meals."
},
{
"NDCCode": "42192-350-30",
"PackageDescription": "30 TABLET, COATED in 1 BOTTLE (42192-350-30) ",
"NDC11Code": "42192-0350-30",
"ProductNDC": "42192-350",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pnv-first",
"NonProprietaryName": ".beta.-carotene, Cholecalciferol, Ascorbic Acid, .alpha.-tocopherol Acetate, Dl-, Folic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Niacinamide, Calcium Carbonate, Ferrous Fumarate, Magnesium Oxide, Zinc Oxide, Cupric Oxide And Doconexent",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130517",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Acella Pharmaceuticals, LLC",
"SubstanceName": ".BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; IRON SUCROSE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC OXIDE; CUPRIC OXIDE; OMEGA-3 FATTY ACIDS",
"StrengthNumber": "1100; 30; 1000; 20; 1.6; 1.8; 15; 1; 2.5; 12; 29; 150; 20; 25; 2; 200",
"StrengthUnit": "[iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-01-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20130517",
"SamplePackage": "N"
},
{
"NDCCode": "43386-350-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (43386-350-03)",
"NDC11Code": "43386-0350-03",
"ProductNDC": "43386-350",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Homatropine Methylbromide",
"NonProprietaryName": "Hydrocodone Bitartrate And Homatropine Methylbromide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091528",
"LabelerName": "GAVIS Pharmaceuticals, LLC",
"SubstanceName": "HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE",
"StrengthNumber": "1.5; 5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC],Opioid Agonists [MoA],Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2014-09-26"
},
{
"NDCCode": "43547-350-03",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (43547-350-03) ",
"NDC11Code": "43547-0350-03",
"ProductNDC": "43547-350",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paroxetine",
"NonProprietaryName": "Paroxetine Hydrochloride Hemihydrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220329",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203854",
"LabelerName": "Solco Healthcare US, LLC",
"SubstanceName": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220329",
"SamplePackage": "N",
"IndicationAndUsage": "Paroxetine tablets are indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD), 4 Social anxiety disorder (SAD), 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).",
"Description": "Paroxetine tablets contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is: 1 ."
},
{
"NDCCode": "43596-0165-1",
"PackageDescription": "9 g in 1 JAR (43596-0165-1) ",
"NDC11Code": "43596-0165-01",
"ProductNDC": "43596-0165",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clarite Makeup For A Cleaner Appearance Spf 30 350-n",
"NonProprietaryName": "Octinoxate, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200324",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; ZINC OXIDE",
"StrengthNumber": "7.5; 7.84",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200324",
"SamplePackage": "N"
},
{
"NDCCode": "43975-350-03",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43975-350-03) ",
"NDC11Code": "43975-0350-03",
"ProductNDC": "43975-350",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paliperidone",
"NonProprietaryName": "Paliperidone",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20191127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204452",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "PALIPERIDONE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191127",
"SamplePackage": "N",
"IndicationAndUsage": "Paliperidone is an atypical antipsychotic agent indicated for Treatment of schizophrenia ( 1.1) : 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. ( 14.1) , 2 Adolescents (ages 12-17): Efficacy was established in one 6-week trial. ( 14.1) .",
"Description": "Paliperidone extended-release tablets contain paliperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone contains a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 3and its molecular weight is 426.49. The structural formula is:. Paliperidone is sparingly soluble in 0.1N HCl and methylene chloride; practically insoluble in water, 0.1N NaOH, and hexane; and slightly soluble in N,N-dimethylformamide. Paliperidone extended-release tablets are intended for oral administration and are available in 1.5 mg (orange-brown), 3 mg (white), 6 mg (beige), and 9 mg (pink) strengths. Paliperidone extended-release tablets utilize coated matrix drug-release technology . Inactive ingredients are butylated hydroxytoluene, carbomer homopolymer, colloidal silicon dioxide, dibutyl sebacate, ethyl cellulose, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, polyethylene oxides, talc, titanium dioxide. The 1.5 mg and 6 mg tablets also contain ferric oxide yellow and ferric oxide red. The 9 mg tablets contain ferric oxide red. Delivery System Components and Performance. Paliperidone extended-release tablets uses coated matrix formulation to deliver paliperidone at a controlled rate. The delivery system which resembles the round shape tablet in appearance consists of active in a core surrounded by a semipermeable membrane. The matrix core is composed of the drug, release controlling polymers and excipients. The semipermeable membrane surrounding the core consists of polymers. Each tablet strength has a different colorant and printing markings. In an aqueous environment, such as the gastrointestinal tract, aqueous fluid enters the tablets core through semipermeable membrane that controls the rate at which aqueous medium enters the tablet core, which in turn determine the lag of drug delivery. The hydrophilic polymers of the core hydrates, swells, creating a gel containing paliperidone which in turn determine the rate of drug delivery."
},
{
"NDCCode": "46708-350-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (46708-350-30) ",
"NDC11Code": "46708-0350-30",
"ProductNDC": "46708-350",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213252",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "54",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200123",
"SamplePackage": "N",
"IndicationAndUsage": "Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: 1 To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1)., 2 For treatment of adult patients with severe hypertriglyceridemia (1.2). .",
"Description": "Fenofibrate, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate, USP is very soluble in methylene chloride; slightly soluble in alcohol; practically insoluble in water. The melting point is 79 to 82°C. Fenofibrate, USP is a white or almost white crystalline powder which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains microcrystalline cellulose, croscarmellose sodium, hypromellose, magnesium stearate, polydextrose, titanium dioxide, triacetin, polyethylene glycol 8000. Additionally, fenofibrate tablets USP, 54 mg contains D&C Yellow No. 10 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. Fenofibrate tablets, USP meets USP Dissolution Test 3."
}
]
}
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<NDCList>
<NDC>
<NDCCode>69336-350-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (69336-350-30)</PackageDescription>
<NDC11Code>69336-0350-30</NDC11Code>
<ProductNDC>69336-350</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methazel</ProprietaryName>
<NonProprietaryName>Methazel</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151012</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sterling-Knight Pharmaceuticals, LLC</LabelerName>
<SubstanceName>FOLIC ACID; PYRIDOXAL 5-PHOSPHATE; METHYLCOBALAMIN; COENZYME Q10, (2Z)-; ALPHA LIPOIC ACID; ACETYLCYSTEINE</SubstanceName>
<StrengthNumber>1; 50; 2.5; 25; 50; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Antidote [EPC],Antidote for Acetaminophen Overdose [EPC],Decreased Respiratory Secretion Viscosity [PE],Increased Glutathione Concentration [PE],Mucolytic [EPC],Reduction Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-04-16</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>69336-101-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (69336-101-30)</PackageDescription>
<NDC11Code>69336-0101-30</NDC11Code>
<ProductNDC>69336-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151223</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077918</ApplicationNumber>
<LabelerName>STERLING KNIGHT PHARMACEUTICALS, LLC</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Meloxicam is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) ( 1.1) , 2 Rheumatoid Arthritis (RA) ( 1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients 2 years of age or older ( 1.3) .</IndicationAndUsage>
<Description>Meloxicam, an oxicam derivative, is a member of the enolic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each pastel yellow Meloxicam Tablets, USP contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2 and it has the following structural formula. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam.The inactive ingredients in Meloxicam Tablets, USP include Colloidal Silicon Dioxide, Sodium Starch Glycolate, Lactose, Magnesium Stearate, Microcrystalline Cellulose, Povidone K-30, and Sodium Citrate.</Description>
</NDC>
<NDC>
<NDCCode>69336-102-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (69336-102-30)</PackageDescription>
<NDC11Code>69336-0102-30</NDC11Code>
<ProductNDC>69336-102</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077918</ApplicationNumber>
<LabelerName>STERLING KNIGHT PHARMACEUTICALS, LLC</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Meloxicam is a non-steroidal anti-inflammatory drug indicated for: 1 Osteoarthritis (OA) ( 1.1) , 2 Rheumatoid Arthritis (RA) ( 1.2) , 3 Juvenile Rheumatoid Arthritis (JRA) in patients 2 years of age or older ( 1.3) .</IndicationAndUsage>
<Description>Meloxicam, an oxicam derivative, is a member of the enolic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each pastel yellow Meloxicam Tablets, USP contains 7.5 mg or 15 mg meloxicam for oral administration. Meloxicam is chemically designated as 4-hydroxy-2-methyl- N-(5-methyl-2-thiazolyl)-2 H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The molecular weight is 351.4. Its empirical formula is C 14H 13N 3O 4S 2 and it has the following structural formula. Meloxicam is a pastel yellow solid, practically insoluble in water, with higher solubility observed in strong acids and bases. It is very slightly soluble in methanol. Meloxicam has an apparent partition coefficient (log P) app = 0.1 in n-octanol/buffer pH 7.4. Meloxicam has pKa values of 1.1 and 4.2. Meloxicam is available as a tablet for oral administration containing 7.5 mg or 15 mg meloxicam.The inactive ingredients in Meloxicam Tablets, USP include Colloidal Silicon Dioxide, Sodium Starch Glycolate, Lactose, Magnesium Stearate, Microcrystalline Cellulose, Povidone K-30, and Sodium Citrate.</Description>
</NDC>
<NDC>
<NDCCode>69336-106-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (69336-106-30)</PackageDescription>
<NDC11Code>69336-0106-30</NDC11Code>
<ProductNDC>69336-106</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161104</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078428</ApplicationNumber>
<LabelerName>Sterling Knight Pharmaceuticals,LLC</LabelerName>
<SubstanceName>GABAPENTIN</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>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Gabapentin capsules, USP are 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 gabapentin capsules, USP is gabapentin, USP 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, USP 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 gabapentin, USP capsule contains 100 mg, 300 mg, or 400 mg of gabapentin and the following inactive ingredients: magnesium stearate, pregelatinized starch (corn), starch (corn) and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate and titanium dioxide. The 300 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, and iron oxide yellow. The 400 mg capsule shell contains gelatin, sodium lauryl sulfate, titanium dioxide, FD&C Yellow No.6 and FD&C Blue No.1.</Description>
</NDC>
<NDC>
<NDCCode>69336-107-30</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69336-107-30)</PackageDescription>
<NDC11Code>69336-0107-30</NDC11Code>
<ProductNDC>69336-107</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161031</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201921</ApplicationNumber>
<LabelerName>Sterling Knight Pharmaceuticals LLC</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Lansoprazole delayed-release capsule is a proton pump inhibitor (PPI) indicated for: 1 Short-Term Treatment of Active Duodenal Ulcer (1.1), 2 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence (1.2), 3 Maintenance of Healed Duodenal Ulcers (1.3), 4 Short-Term Treatment of Active Benign Gastric Ulcer (1.4), 5 Healing of nonsteroidal anti-inflammatory drugs (NSAID)- Associated Gastric Ulcer (1.5), 6 Risk Reduction of NSAID-Associated Gastric Ulcer (1.6), 7 Gastroesophageal Reflux Disease (GERD) (1.7), 8 Maintenance of Healing of Erosive Esophagitis (EE) (1.8), 9 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (ZES) (1.9) .</IndicationAndUsage>
<Description>Lansoprazole delayed-release capsules 15 mg and 30 mg contain lansoprazole as the active ingredient, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.37. Lansoprazole has the following structure. Lansoprazole is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsule form, for oral administration in two strengths 15 mg and 30 mg. Lansoprazole delayed-release capsules are available in two strengths: 15 mg and 30 mg of lansoprazole per capsule. Each delayed-release capsule contains lansoprazole delayed-release pellets 8.5% consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: acetone, hypromellose, isopropyl alcohol, light magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, sugar spheres, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>69336-112-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 PACKAGE (69336-112-30)</PackageDescription>
<NDC11Code>69336-0112-30</NDC11Code>
<ProductNDC>69336-112</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Not Applicable</ProprietaryName>
<NonProprietaryName>Omeprazole Sodium Bicarbonate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170713</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207476</ApplicationNumber>
<LabelerName>Sterling Knight Pharmaceuticals LLC</LabelerName>
<SubstanceName>OMEPRAZOLE; SODIUM BICARBONATE</SubstanceName>
<StrengthNumber>40; 1100</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Omeprazole and sodium bicarbonate is a proton pump inhibitor indicated for: 1 Short-term treatment of active duodenal ulcer (1.1), 2 Short-term treatment of active benign gastric ulcer (1.2), 3 Treatment of gastroesophageal reflux disease (GERD) (1.3), 4 Maintenance of healing of erosive esophagitis (1.4).</IndicationAndUsage>
<Description>Omeprazole and sodium bicarbonate is a combination of omeprazole, a proton-pump inhibitor, and sodium bicarbonate, an antacid. Omeprazole is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole, a racemic mixture of two enantiomers that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole, USP is a white or almost white powder which melts with decomposition at about 155°C. Soluble in dichloromethane, practically insoluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole and sodium bicarbonate is supplied as immediate-release capsules. Each capsule contains either 40 mg or 20 mg of omeprazole and 1100 mg of sodium bicarbonate with the following excipients: croscarmellose sodium and sodium stearyl fumarate. The capsules consist of gelatin and titanium dioxide. In addition the 20 mg/1100 mg capsule shell contains sodium lauryl sulfate and the 40 mg/1100 mg capsule shell contains FD&C Blue 1. The capsules are printed with edible ink containing black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, potassium hydroxide, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>69336-129-30</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69336-129-30) </PackageDescription>
<NDC11Code>69336-0129-30</NDC11Code>
<ProductNDC>69336-129</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Esomeprazole Strontium</ProprietaryName>
<NonProprietaryName>Esomeprazole Strontium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200625</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA202342</ApplicationNumber>
<LabelerName>Sterling-Knight Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ESOMEPRAZOLE STRONTIUM</SubstanceName>
<StrengthNumber>49.3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Esomeprazole strontium is a proton pump inhibitor indicated for adults for: 1 Treatment of gastroesophageal reflux disease (GERD) (1.1), 2 Risk reduction of NSAID-associated gastric ulcer (1.2), 3 H. pylori eradication to reduce the risk of duodenal ulcer recurrence (1.3), 4 Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4).</IndicationAndUsage>
<Description>The active ingredient in the proton pump inhibitor esomeprazole strontium delayed-release capsules is bis(5‑ methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) strontium tetrahydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. The molecular formula of esomeprazole strontium is (C17H18N3O3S)2·Sr·4H2O with molecular weight of 848.50. The structural formula is. The strontium salt is a white or almost white crystalline powder. Each molecule contains 4 moles of water of solvation and is soluble in water. Esomeprazole strontium is supplied in delayed-release capsules. Each delayed-release capsule contains 24.65 mg esomeprazole strontium equivalent to 20 mg esomeprazole or 49.3 mg esomeprazole strontium equivalent to 40 mg esomeprazole, in the form of enteric-coated granules with the following inactive ingredients: calcium carbonate, hypromellose, methacrylic acid copolymer dispersion, mono- and diglycerides, polysorbate 80, sugar spheres, talc, triethyl citrate. The 24.65 mg capsule shells have the following inactive ingredients: gelatin, titanium dioxide, synthetic iron oxide. The 49.3 mg capsule shells have the following inactive ingredients: gelatin, titanium dioxide, FD&C Blue #1, FD&C Red #40, FD&C Yellow #6. Each 24.65 mg capsule contains 2.6 mg of strontium. Each 49.3 mg capsule contains 5.1 mg of strontium.</Description>
</NDC>
<NDC>
<NDCCode>69336-200-30</NDCCode>
<PackageDescription>30 PACKAGE in 1 BOX (69336-200-30) > 100 g in 1 PACKAGE</PackageDescription>
<NDC11Code>69336-0200-30</NDC11Code>
<ProductNDC>69336-200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Synvexia</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride And Menthol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141114</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sterling Knight Pharmaceuticals,LLC</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; MENTHOL</SubstanceName>
<StrengthNumber>4; 1</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-08-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>69336-300-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (69336-300-30)</PackageDescription>
<NDC11Code>69336-0300-30</NDC11Code>
<ProductNDC>69336-300</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Durachol</ProprietaryName>
<NonProprietaryName>Durachol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141116</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sterling Knight Pharmaceuticals,LLC</LabelerName>
<SubstanceName>CHOLECALCIFEROL; FOLIC ACID</SubstanceName>
<StrengthNumber>3775; 1</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin D [Chemical/Ingredient],Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-04-16</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Durachol is indicated for dietary management of patients with unique nutritional needs requiring increased folate levels, Vitamin D deficiency or are in need of Vitamin D supplementation and other nutritional supplementation.</IndicationAndUsage>
<Description>Durachol is an orally administered prescription Vitamin for the dietary management of patients with unique nutritional needs requiring increased folate levels, Vitamin D supplementation due to Vitamin D deficiency and other nutritional supplementation. Durachol should be administered under the supervision of a licensed medical practitioner. Vitamin D3 (cholecalciferol) is a white, crystalline powder, very soluble in water, with the following structural formula. Each capsule contains:Folic Acid: 1mg, Vitamin D3 (Cholecalciferol): 3775IU. Each capsule contains the following inactive ingredients: Gelatin, cellulose, magnesium stearate, silica, FD&C Red #3, FD&C Yellow # 6.</Description>
</NDC>
<NDC>
<NDCCode>69336-310-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (69336-310-30)</PackageDescription>
<NDC11Code>69336-0310-30</NDC11Code>
<ProductNDC>69336-310</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cifrazol</ProprietaryName>
<NonProprietaryName>Cifrazol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170110</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sterling Knight Pharmaceuticals,LLC</LabelerName>
<SubstanceName>CHOLECALCIFEROL; FOLIC ACID</SubstanceName>
<StrengthNumber>3775; 1</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin D [Chemical/Ingredient],Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-05-30</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Cifrazol is indicated for dietary management of patients with unique nutritional needs requiring increased folate levels, Vitamin D deficiency or are in need of Vitamin D supplementation and other nutritional supplementation.</IndicationAndUsage>
<Description>Cifrazol is an orally administered prescription Vitamin for the dietary management of patients with unique nutritional needs requiring increased folate levels, Vitamin D supplementation due to Vitamin D deficiency and other nutritional supplementation. Cifrazol should be administered under the supervision of a licensed medical practitioner. Vitamin D3 (cholecalciferol) is a white, crystalline powder, very soluble in water, with the following structural formula. Each capsule contains:Folic Acid: 1mg, Vitamin D3 (Cholecalciferol): 3775IU. Each capsule contains the following inactive ingredients: Gelatin,Water, Soybean Oil, Yellow Wax, Lecithin,Glycerin, FD&C Red #40, FD&C Yellow #5, Titanium Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>69336-330-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (69336-330-30) </PackageDescription>
<NDC11Code>69336-0330-30</NDC11Code>
<ProductNDC>69336-330</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Revesta</ProprietaryName>
<NonProprietaryName>Revesta</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161013</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sterling Knight Pharmaceuticals,LLC</LabelerName>
<SubstanceName>CHOLECALCIFEROL; FOLIC ACID</SubstanceName>
<StrengthNumber>5750; 1</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin D [CS],Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Revesta is indicated for dietary management of patients with unique nutritional needs requiring increased folate levels, Vitamin D deficiency or are in need of Vitamin D supplementation and other nutritional supplementation.</IndicationAndUsage>
<Description>Revesta is an orally administered prescription Vitamin for the dietary management of patients with unique nutritional needs requiring increased folate levels, Vitamin D supplementation due to Vitamin D deficiency and other nutritional supplementation. Revesta should be administered under the supervision of a licensed medical practitioner. Vitamin D3 (cholecalciferol) is a white, crystalline powder, very soluble in water, with the following structural formula. Each capsule contains: Folic Acid: 1mg, Vitamin D3 (Cholecalciferol): 5750IU. Each capsule contains the following inactive ingredients: soybean oil, gelatin (bovine), yellow wax, glycerin, deionized water, lecithin, titanium dioxide, FD&C Blue #1.</Description>
</NDC>
<NDC>
<NDCCode>69336-352-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (69336-352-30) </PackageDescription>
<NDC11Code>69336-0352-30</NDC11Code>
<ProductNDC>69336-352</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prenara</ProprietaryName>
<NonProprietaryName>Prenara</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200309</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sterling-Knight Pharmaceuticals, LLC</LabelerName>
<SubstanceName>VITAMIN A; ASCORBIC ACID; VITAMIN D; THIAMINE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM; IODINE; COPPER; MAGNESIUM; ZINC</SubstanceName>
<StrengthNumber>1000; 100; 750; 1.8; 1.7; 20; 2.5; 1; .5; 100; .15; 2; 15; 20</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin A [CS],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Calcium [CS],Calcium [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prenara is a prescription dietary supplement for use throughout pregnancy, during the prenatal and postnatal period for both lactating and non-lactating mothers and throughout the childbearing years.</IndicationAndUsage>
<Description>Prenara is an orally administered prescription dietary supplement formulation for the clinical dietary management of suboptimal nutritional status in patients where advanced supplementation is required and nutritional supplementation in physiologically stressful conditions for maintenance of good health is needed.Prenara is a prescription dietary supplement for use throughout pregnancy, during the prenatal and postnatal period for both lactating and non-lactating mothers and throughout the childbearing years.Prenara should be administered under the supervision of a licensed medical practitioner. Each softgel capsule contains. Other Ingredients: Soybean oil, gelatin (bovine), bees wax (yellow), lecithin, glycerin, deionized water, FD&C red #40, FD&C blue #1, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>69336-353-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (69336-353-30)</PackageDescription>
<NDC11Code>69336-0353-30</NDC11Code>
<ProductNDC>69336-353</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methaver</ProprietaryName>
<NonProprietaryName>Methaver</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151124</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sterling-knight Pharmaceuticals,LLC</LabelerName>
<SubstanceName>FOLIC ACID; RIBOFLAVIN; METHYLCOBALAMIN; THIAMINE HYDROCHLORIDE; PYRIDOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1; 29; 2; 27; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-04-20</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Methaver is indicated for the distinct nutritional requirements of patients in need of dietary supplementation as determined by a licensed medical practitioner. Methaver should be administered under the supervision o f a licensed medical practitioner.</IndicationAndUsage>
<Description>Methaver is an orally administered prescription vitamin specifically formulated for the dietary management of patients with unique nutritional needs requiring increased folate levels, as well as other Vitamin B supplementation. Methaver should be administered under the supervision of a licensed medical practitioner. Each capsule contains the following ingredients. Each capsule contains:Folic Acid............................................................................1mgThiamin hydrochloride..……………………………………..27mgRiboflavin……………………………………………………..29mgPyridoxine hydrochloride..............,...................................50mgMethylcobalamin……………....….……………..……………2mg. Each capsule contains the following inactive ingredients: Lactose Monohydrate, Gelatin (bovine), Silicon Dioxide, Magnesium Stearate, Titanium Dioxide, FD&C Blue #1, FD&C Red #40. * This product is a prescription vitamin that – due to increased folate levels (AUG 2 1973 FR 20750), requires an Rx on the label because of increased risk associated with masking of B12 deficiency. As such, this product requires licensed medical supervision, an Rx status, and a National Drug Code (NDC) as required by pedigree reporting requirements. FOLAT E REGULAT ION. The term "folate" are B vitamins that include folic acid and any forms of active pteroylglutamates regardless of the reduction state of the molecule. Folates, or vitamin B9, are primarily hydrolyzed in the intestinal jejunum and the liver to the active circulating form of folate. Folic acid, including reduced forms1 such as folinic acid, may obscure pernicious anemia above 0.1 mg doses, and must be administered under the supervision o f a licensed medical practitioner.</Description>
</NDC>
<NDC>
<NDCCode>69336-358-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 PACKAGE (69336-358-30) </PackageDescription>
<NDC11Code>69336-0358-30</NDC11Code>
<ProductNDC>69336-358</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lexazin</ProprietaryName>
<NonProprietaryName>Lexazin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180102</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sterling Knight Pharmaceuticals LLC</LabelerName>
<SubstanceName>ASCORBIC ACID; CHOLECALCIFEROL; THIAMINE HYDROCHLORIDE; PYRIDOXAL PHOSPHATE ANHYDROUS; FOLIC ACID; METHYLCOBALAMIN; NADH; COENZYME Q10, (2Z)-</SubstanceName>
<StrengthNumber>125; 500; 25; 12.5; 1; 5; 5; 50</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin C [EPC],Ascorbic Acid [Chemical/Ingredient],Vitamin D [Chemical/Ingredient],Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69336-600-30</NDCCode>
<PackageDescription>30 PACKAGE in 1 BOX (69336-600-30) > 100 g in 1 PACKAGE</PackageDescription>
<NDC11Code>69336-0600-30</NDC11Code>
<ProductNDC>69336-600</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Provenza</ProprietaryName>
<NonProprietaryName>Menthol And Lidocaine</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141219</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sterling Knight Pharmaceuticals,LLC</LabelerName>
<SubstanceName>MENTHOL; LIDOCAINE</SubstanceName>
<StrengthNumber>1; 4</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-08-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>69336-800-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (69336-800-30)</PackageDescription>
<NDC11Code>69336-0800-30</NDC11Code>
<ProductNDC>69336-800</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Macuzin</ProprietaryName>
<NonProprietaryName>Macuzin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150430</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Sterling-Knight Pharmaceuticals, LLC</LabelerName>
<SubstanceName>FOLIC ACID; ASCORBIC ACID; .ALPHA.-TOCOPHEROL ACETATE, DL-; ZINC OXIDE; COPPER; LUTEIN; ZEAXANTHIN</SubstanceName>
<StrengthNumber>1; 500; 400; 80; 2; 10; 2</StrengthNumber>
<StrengthUnit>mg/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Copper [Chemical/Ingredient],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>69336-825-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (69336-825-01) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>69336-0825-01</NDC11Code>
<ProductNDC>69336-825</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidopril</ProprietaryName>
<NonProprietaryName>Lidocaine 2.5% And Prilocaine 2.5%</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160707</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019941</ApplicationNumber>
<LabelerName>Sterling-knight Pharmaceuticals,LLC</LabelerName>
<SubstanceName>LIDOCAINE; PRILOCAINE</SubstanceName>
<StrengthNumber>25; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Lidocaine and prilocaine cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on: 1 normal intact skin for local analgesia., 2 genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia.</IndicationAndUsage>
<Description>Lidocaine 2.5% and Prilocaine Cream, USP is an emulsion in which the oil phase is a eutectic mixture of lidocaine and prilocaine in a ratio of 1:1 by weight. This eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. It is packaged in 5 gram and 30 gram tubes. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol: water partition ratio of 43 at pH 7.4, and has the following structure. Prilocaine is chemically designated as propanamide, N-(2-methylphenyl)-2-(propylamino), has an octanol: water partition ratio of 25 at pH 7.4, and has the following structure. Each gram of lidocaine and prilocaine cream contains lidocaine 25 mg, prilocaine 25 mg, polyoxyethylene fatty acid esters (as emulsifiers), carboxypolymethylene (as a thickening agent), sodium hydroxide to adjust to a pH approximating 9, and purified water to 1 gram. Lidocaine and prilocaine cream contains no preservative, however it passes the USP antimicrobial effectiveness test due to the pH. The specific gravity of lidocaine and prilocaine cream is 1.00.</Description>
</NDC>
<NDC>
<NDCCode>69336-826-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (69336-826-01) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>69336-0826-01</NDC11Code>
<ProductNDC>69336-826</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidopril Xr</ProprietaryName>
<NonProprietaryName>Lidocaine 2.5% And Prilocaine 2.5%</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160816</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019941</ApplicationNumber>
<LabelerName>Sterling-knight Pharmaceuticals,LLC</LabelerName>
<SubstanceName>LIDOCAINE; PRILOCAINE</SubstanceName>
<StrengthNumber>25; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Lidocaine and prilocaine cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on: 1 normal intact skin for local analgesia., 2 genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia.</IndicationAndUsage>
<Description>Lidocaine 2.5% and Prilocaine Cream, USP is an emulsion in which the oil phase is a eutectic mixture of lidocaine and prilocaine in a ratio of 1:1 by weight. This eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. It is packaged in 5 gram and 30 gram tubes. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol: water partition ratio of 43 at pH 7.4, and has the following structure. Prilocaine is chemically designated as propanamide, N-(2-methylphenyl)-2-(propylamino), has an octanol: water partition ratio of 25 at pH 7.4, and has the following structure. Each gram of lidocaine and prilocaine cream contains lidocaine 25 mg, prilocaine 25 mg, polyoxyethylene fatty acid esters (as emulsifiers), carboxypolymethylene (as a thickening agent), sodium hydroxide to adjust to a pH approximating 9, and purified water to 1 gram. Lidocaine and prilocaine cream contains no preservative, however it passes the USP antimicrobial effectiveness test due to the pH. The specific gravity of lidocaine and prilocaine cream is 1.00.</Description>
</NDC>
<NDC>
<NDCCode>69336-828-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (69336-828-01) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>69336-0828-01</NDC11Code>
<ProductNDC>69336-828</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prilolid</ProprietaryName>
<NonProprietaryName>Lidocaine 2.5% And Prilocaine 2.5%</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161005</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019941</ApplicationNumber>
<LabelerName>Sterling-knight Pharmaceuticals,LLC</LabelerName>
<SubstanceName>LIDOCAINE; PRILOCAINE</SubstanceName>
<StrengthNumber>25; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Lidocaine and prilocaine cream (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on: 1 normal intact skin for local analgesia., 2 genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia.</IndicationAndUsage>
<Description>Lidocaine 2.5% and Prilocaine Cream, USP is an emulsion in which the oil phase is a eutectic mixture of lidocaine and prilocaine in a ratio of 1:1 by weight. This eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. It is packaged in 5 gram and 30 gram tubes. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol: water partition ratio of 43 at pH 7.4, and has the following structure. Prilocaine is chemically designated as propanamide, N-(2-methylphenyl)-2-(propylamino), has an octanol: water partition ratio of 25 at pH 7.4, and has the following structure. Each gram of lidocaine and prilocaine cream contains lidocaine 25 mg, prilocaine 25 mg, polyoxyethylene fatty acid esters (as emulsifiers), carboxypolymethylene (as a thickening agent), sodium hydroxide to adjust to a pH approximating 9, and purified water to 1 gram. Lidocaine and prilocaine cream contains no preservative, however it passes the USP antimicrobial effectiveness test due to the pH. The specific gravity of lidocaine and prilocaine cream is 1.00.</Description>
</NDC>
<NDC>
<NDCCode>10893-350-30</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, GLASS (10893-350-30) </PackageDescription>
<NDC11Code>10893-0350-30</NDC11Code>
<ProductNDC>10893-350</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Naturasil</ProprietaryName>
<ProprietaryNameSuffix>Neuropathy Rub</ProprietaryNameSuffix>
<NonProprietaryName>Hypericum And Arnica Montana</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120111</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nature's Innovation, Inc.</LabelerName>
<SubstanceName>ARNICA MONTANA; ST. JOHN'S WORT</SubstanceName>
<StrengthNumber>1; 6</StrengthNumber>
<StrengthUnit>[hp_X]/30mL; [hp_X]/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: Symptomatic treatment of neuropathy, tingling, burning and numbness.</IndicationAndUsage>
<Description>The letters HPUS indicate the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopeia of the United States.</Description>
</NDC>
<NDC>
<NDCCode>14141-192-01</NDCCode>
<PackageDescription>9 g in 1 JAR (14141-192-01) </PackageDescription>
<NDC11Code>14141-0192-01</NDC11Code>
<ProductNDC>14141-192</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Clarite Makeup For A Cleaner Appearance Spf 30 350-n</ProprietaryName>
<NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200324</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>BEL STAR S A</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>7.5; 7.84</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>16103-350-04</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (16103-350-04) / 30 TABLET, COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>16103-0350-04</NDC11Code>
<ProductNDC>16103-350</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pharbetol</ProprietaryName>
<NonProprietaryName>Acetaminophen 500mg</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Pharbest Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to:. the common cold. headache. backache. minor pain of arthritis. toothache. muscular aches. premenstrual and menstrual cramps. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16729-350-10</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (16729-350-10) </PackageDescription>
<NDC11Code>16729-0350-10</NDC11Code>
<ProductNDC>16729-350</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lurasidone Hydrochloride</ProprietaryName>
<NonProprietaryName>Lurasidone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208049</ApplicationNumber>
<LabelerName>Accord Healthcare, Inc.</LabelerName>
<SubstanceName>LURASIDONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lurasidone hydrochloride tablets are indicated for: 1 Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies ( 14.1)] . , 2 Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies ( 14.2)] . , 3 Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies ( 14.2)] . .</IndicationAndUsage>
<Description>Lurasidone hydrochloride is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3a R,4 S,7 R,7a S)-2-{(1 R,2 R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2 H-isoindole-1,3-dione hydrochloride. Its molecular formula is C 28H 36N 4O 2S·HCl and its molecular weight is 529.14. The chemical structure is. Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg, or 120 mg of lurasidone hydrochloride. Inactive ingredients are mannitol, pregelatinized starch, croscarmellose sodium, hydroxypropyl methyl cellulose, magnesium stearate. Additionally, the 20 mg, 40 mg, 60 mg & 120 mg tablet contains hydroxylpropyl methyl cellulose 2910, talc, polyethylene glycol 6000 & titanium dioxide and 80 mg tablet contains hydroxylpropyl methyl cellulose 2910, titanium dioxide, talc, polyethylene glycol 6000, iron oxide yellow and FD&C Blue #2/indigo carmine aluminium lake.</Description>
</NDC>
<NDC>
<NDCCode>17089-350-18</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 BOX (17089-350-18) / 30 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>17089-0350-18</NDC11Code>
<ProductNDC>17089-350</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guna-awareness</ProprietaryName>
<NonProprietaryName>Betaine - Bufo Bufo Cutaneous Gland - Calcium Carbonate - Chromic Sulfate - Cicuta Virosa Root - Copper - Folic Acid - Gold - Cobalamin - Iron - Lachesis Muta Venom - Melatonin - Molybdenum - Neurotrophin-3 - Neurotrophin-4 - Oxytocin - Silicon Dioxide - Sus Scrofa Frontal Lobe - Sus Scrofa Temporal Lobe - Thyrotropin Alfa - Ubidecarenone - Vanadium - Zinc - Brain-derived Neurotrophic Factor Human -</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080416</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Guna spa</LabelerName>
<SubstanceName>LACHESIS MUTA VENOM; MELATONIN; MOLYBDENUM; NEUROTROPHIN-3; NEUROTROPHIN-4; OXYTOCIN; SILICON DIOXIDE; SUS SCROFA TEMPORAL LOBE; THYROTROPIN ALFA; BETAINE; VANADIUM; ZINC; GOLD; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; BUFO BUFO CUTANEOUS GLAND; CALCIUM CARBONATE; CHROMIC SULFATE; CICUTA VIROSA ROOT; COBALAMIN; UBIDECARENONE; COPPER; IRON; FOLIC ACID; SUS SCROFA FRONTAL LOBE</SubstanceName>
<StrengthNumber>12; 4; 3; 4; 4; 6; 12; 6; 3; 3; 6; 3; 12; 4; 12; 3; 3; 12; 3; 3; 12; 3; 3; 6</StrengthNumber>
<StrengthUnit>[hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased Uterine Smooth Muscle Contraction or Tone [PE], Inhibit Ovum Fertilization [PE], Methylating Activity [MoA], Methylating Agent [EPC], Oxytocic [EPC], Oxytocin [CS], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Standardized Chemical Allergen [EPC], Thyroid Stimulating Hormone [EPC], Thyrotropin [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Take 15 minutes before meals.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42192-350-30</NDCCode>
<PackageDescription>30 TABLET, COATED in 1 BOTTLE (42192-350-30) </PackageDescription>
<NDC11Code>42192-0350-30</NDC11Code>
<ProductNDC>42192-350</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pnv-first</ProprietaryName>
<NonProprietaryName>.beta.-carotene, Cholecalciferol, Ascorbic Acid, .alpha.-tocopherol Acetate, Dl-, Folic Acid, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin, Niacinamide, Calcium Carbonate, Ferrous Fumarate, Magnesium Oxide, Zinc Oxide, Cupric Oxide And Doconexent</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130517</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Acella Pharmaceuticals, LLC</LabelerName>
<SubstanceName>.BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; FOLIC ACID; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN; IRON SUCROSE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC OXIDE; CUPRIC OXIDE; OMEGA-3 FATTY ACIDS</SubstanceName>
<StrengthNumber>1100; 30; 1000; 20; 1.6; 1.8; 15; 1; 2.5; 12; 29; 150; 20; 25; 2; 200</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Iron [Chemical/Ingredient],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43386-350-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (43386-350-03)</PackageDescription>
<NDC11Code>43386-0350-03</NDC11Code>
<ProductNDC>43386-350</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Homatropine Methylbromide</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Homatropine Methylbromide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091528</ApplicationNumber>
<LabelerName>GAVIS Pharmaceuticals, LLC</LabelerName>
<SubstanceName>HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE</SubstanceName>
<StrengthNumber>1.5; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC],Opioid Agonists [MoA],Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2014-09-26</LastUpdate>
</NDC>
<NDC>
<NDCCode>43547-350-03</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (43547-350-03) </PackageDescription>
<NDC11Code>43547-0350-03</NDC11Code>
<ProductNDC>43547-350</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paroxetine</ProprietaryName>
<NonProprietaryName>Paroxetine Hydrochloride Hemihydrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220329</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203854</ApplicationNumber>
<LabelerName>Solco Healthcare US, LLC</LabelerName>
<SubstanceName>PAROXETINE HYDROCHLORIDE HEMIHYDRATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paroxetine tablets are indicated in adults for the treatment of: 1 Major depressive disorder (MDD), 2 Obsessive compulsive disorder (OCD), 3 Panic disorder (PD), 4 Social anxiety disorder (SAD), 5 Generalized anxiety disorder (GAD), 6 Posttraumatic stress disorder (PTSD).</IndicationAndUsage>
<Description>Paroxetine tablets contain paroxetine hydrochloride, an SSRI. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'- methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C19H20FNO3HCl1/2H2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is: 1 .</Description>
</NDC>
<NDC>
<NDCCode>43596-0165-1</NDCCode>
<PackageDescription>9 g in 1 JAR (43596-0165-1) </PackageDescription>
<NDC11Code>43596-0165-01</NDC11Code>
<ProductNDC>43596-0165</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Clarite Makeup For A Cleaner Appearance Spf 30 350-n</ProprietaryName>
<NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200324</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>7.5; 7.84</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43975-350-03</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43975-350-03) </PackageDescription>
<NDC11Code>43975-0350-03</NDC11Code>
<ProductNDC>43975-350</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paliperidone</ProprietaryName>
<NonProprietaryName>Paliperidone</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204452</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PALIPERIDONE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paliperidone is an atypical antipsychotic agent indicated for Treatment of schizophrenia ( 1.1) : 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. ( 14.1) , 2 Adolescents (ages 12-17): Efficacy was established in one 6-week trial. ( 14.1) .</IndicationAndUsage>
<Description>Paliperidone extended-release tablets contain paliperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone contains a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 3and its molecular weight is 426.49. The structural formula is:. Paliperidone is sparingly soluble in 0.1N HCl and methylene chloride; practically insoluble in water, 0.1N NaOH, and hexane; and slightly soluble in N,N-dimethylformamide. Paliperidone extended-release tablets are intended for oral administration and are available in 1.5 mg (orange-brown), 3 mg (white), 6 mg (beige), and 9 mg (pink) strengths. Paliperidone extended-release tablets utilize coated matrix drug-release technology . Inactive ingredients are butylated hydroxytoluene, carbomer homopolymer, colloidal silicon dioxide, dibutyl sebacate, ethyl cellulose, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, polyethylene oxides, talc, titanium dioxide. The 1.5 mg and 6 mg tablets also contain ferric oxide yellow and ferric oxide red. The 9 mg tablets contain ferric oxide red. Delivery System Components and Performance. Paliperidone extended-release tablets uses coated matrix formulation to deliver paliperidone at a controlled rate. The delivery system which resembles the round shape tablet in appearance consists of active in a core surrounded by a semipermeable membrane. The matrix core is composed of the drug, release controlling polymers and excipients. The semipermeable membrane surrounding the core consists of polymers. Each tablet strength has a different colorant and printing markings. In an aqueous environment, such as the gastrointestinal tract, aqueous fluid enters the tablets core through semipermeable membrane that controls the rate at which aqueous medium enters the tablet core, which in turn determine the lag of drug delivery. The hydrophilic polymers of the core hydrates, swells, creating a gel containing paliperidone which in turn determine the rate of drug delivery.</Description>
</NDC>
<NDC>
<NDCCode>46708-350-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (46708-350-30) </PackageDescription>
<NDC11Code>46708-0350-30</NDC11Code>
<ProductNDC>46708-350</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fenofibrate</ProprietaryName>
<NonProprietaryName>Fenofibrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213252</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
<StrengthNumber>54</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fenofibrate is a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as an adjunct to diet: 1 To reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (1.1)., 2 For treatment of adult patients with severe hypertriglyceridemia (1.2). .</IndicationAndUsage>
<Description>Fenofibrate, USP is a lipid regulating agent available as tablets for oral administration. Each tablet contains 54 mg or 160 mg of fenofibrate, USP. The chemical name for fenofibrate, USP is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate, USP is very soluble in methylene chloride; slightly soluble in alcohol; practically insoluble in water. The melting point is 79 to 82°C. Fenofibrate, USP is a white or almost white crystalline powder which is stable under ordinary conditions. Inactive Ingredients. Each tablet contains microcrystalline cellulose, croscarmellose sodium, hypromellose, magnesium stearate, polydextrose, titanium dioxide, triacetin, polyethylene glycol 8000. Additionally, fenofibrate tablets USP, 54 mg contains D&C Yellow No. 10 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. Fenofibrate tablets, USP meets USP Dissolution Test 3.</Description>
</NDC>
</NDCList>