{
"NDC": [
{
"NDCCode": "58118-0506-8",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (58118-0506-8)",
"NDC11Code": "58118-0506-08",
"ProductNDC": "58118-0506",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19970701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074644",
"LabelerName": "Clinical Solutions Wholesale",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-07-03"
},
{
"NDCCode": "58118-0506-0",
"PackageDescription": "1 TABLET in 1 PACKET (58118-0506-0)",
"NDC11Code": "58118-0506-00",
"ProductNDC": "58118-0506",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19970701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074644",
"LabelerName": "Clinical Solutions Wholesale",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-07-03"
},
{
"NDCCode": "58118-0506-1",
"PackageDescription": "180 TABLET in 1 BOTTLE (58118-0506-1)",
"NDC11Code": "58118-0506-01",
"ProductNDC": "58118-0506",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19970701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074644",
"LabelerName": "Clinical Solutions Wholesale",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-07-03"
},
{
"NDCCode": "58118-0506-3",
"PackageDescription": "30 TABLET in 1 BOTTLE (58118-0506-3)",
"NDC11Code": "58118-0506-03",
"ProductNDC": "58118-0506",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19970701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074644",
"LabelerName": "Clinical Solutions Wholesale",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-07-03"
},
{
"NDCCode": "58118-0506-9",
"PackageDescription": "90 TABLET in 1 BOTTLE (58118-0506-9)",
"NDC11Code": "58118-0506-09",
"ProductNDC": "58118-0506",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metoprolol Tartrate",
"NonProprietaryName": "Metoprolol Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19970701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074644",
"LabelerName": "Clinical Solutions Wholesale",
"SubstanceName": "METOPROLOL TARTRATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-07-03"
},
{
"NDCCode": "30142-506-73",
"PackageDescription": "8 BLISTER PACK in 1 CARTON (30142-506-73) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "30142-0506-73",
"ProductNDC": "30142-506",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fast Cold And Flu Relief",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20170622",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Kroger Company",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 200; 5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20170622",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these common cold and flu symptoms:. nasal congestion. headache. cough. minor aches and pains. sore throat. temporarily reduces fever. helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
},
{
"NDCCode": "30400-506-01",
"PackageDescription": "283 g in 1 BOTTLE (30400-506-01) ",
"NDC11Code": "30400-0506-01",
"ProductNDC": "30400-506",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Medicated Body",
"ProprietaryNameSuffix": "Powder",
"NonProprietaryName": "Menthol",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200901",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Jell Pharmaceuticals Pvt Ltd",
"SubstanceName": "MENTHOL",
"StrengthNumber": ".42",
"StrengthUnit": "g/283g",
"Status": "Deprecated",
"LastUpdate": "2026-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200901",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of the pain and itch associated with: 1 minor cuts, 2 scrapes, 3 sunburn, 4 insect bites, 5 prickly heat, 6 rashes, 7 minor burns, 8 minor skin irritations, 9 dries the oozing of poison ivy, oak and sumac."
},
{
"NDCCode": "42291-506-01",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-506-01) ",
"NDC11Code": "42291-0506-01",
"ProductNDC": "42291-506",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190621",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019123",
"LabelerName": "AvKARE",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190621",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium chloride extended-release is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.",
"Description": "Potassium chloride extended-release tablets, USP are a solid oral dosage form of potassium chloride. Each contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq of potassium in a wax matrix tablet. Potassium chloride extended-release tablets, USP, are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, granular powder or colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Inactive Ingredients: Hydrogenated vegetable oil, magnesium stearate, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc and titanium dioxide. Yellow tablets also contain D&C Yellow No. 10 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. Blue tablets also contain FD&C Blue No. 1 Aluminum Lake and FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "42291-506-50",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-506-50) ",
"NDC11Code": "42291-0506-50",
"ProductNDC": "42291-506",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190621",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019123",
"LabelerName": "AvKARE",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190621",
"SamplePackage": "N",
"IndicationAndUsage": "Potassium chloride extended-release is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.",
"Description": "Potassium chloride extended-release tablets, USP are a solid oral dosage form of potassium chloride. Each contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq of potassium in a wax matrix tablet. Potassium chloride extended-release tablets, USP, are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, granular powder or colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Inactive Ingredients: Hydrogenated vegetable oil, magnesium stearate, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc and titanium dioxide. Yellow tablets also contain D&C Yellow No. 10 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. Blue tablets also contain FD&C Blue No. 1 Aluminum Lake and FD&C Blue No. 2 Aluminum Lake."
},
{
"NDCCode": "43353-506-60",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (43353-506-60)",
"NDC11Code": "43353-0506-60",
"ProductNDC": "43353-506",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090810",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075927",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "250",
"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": "Carefully consider the potential benefits and risks of naproxen tablets other treatment options before deciding to use naproxen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen is indicated: 1 For the relief of the signs and symptoms of rheumatoid arthritis , 2 For the relief of the signs and symptoms of osteoarthritis , 3 For the relief of the signs and symptoms of ankylosing spondylitis , 4 For the relief of the signs and symptoms of juvenile arthritis .",
"Description": "Naproxen is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble in chloroform, practically insoluble in water at low pH and freely soluable in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Each naproxen tablet intended for oral administration contains 250 mg or 375 mg or 500 mg of naproxen. In addition, each tablet contains following inactive ingredients: colloidal silicon dioxide, magnesium stearate, pollyvinylpyrrolidone, povidone, croscarmellose sodium and sodium starch glycolate."
},
{
"NDCCode": "43353-506-70",
"PackageDescription": "120 TABLET in 1 BOTTLE, PLASTIC (43353-506-70)",
"NDC11Code": "43353-0506-70",
"ProductNDC": "43353-506",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090810",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075927",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "250",
"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": "Carefully consider the potential benefits and risks of naproxen tablets other treatment options before deciding to use naproxen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen is indicated: 1 For the relief of the signs and symptoms of rheumatoid arthritis , 2 For the relief of the signs and symptoms of osteoarthritis , 3 For the relief of the signs and symptoms of ankylosing spondylitis , 4 For the relief of the signs and symptoms of juvenile arthritis .",
"Description": "Naproxen is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble in chloroform, practically insoluble in water at low pH and freely soluable in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Each naproxen tablet intended for oral administration contains 250 mg or 375 mg or 500 mg of naproxen. In addition, each tablet contains following inactive ingredients: colloidal silicon dioxide, magnesium stearate, pollyvinylpyrrolidone, povidone, croscarmellose sodium and sodium starch glycolate."
},
{
"NDCCode": "43353-506-80",
"PackageDescription": "180 TABLET in 1 BOTTLE, PLASTIC (43353-506-80)",
"NDC11Code": "43353-0506-80",
"ProductNDC": "43353-506",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090810",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075927",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "250",
"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": "Carefully consider the potential benefits and risks of naproxen tablets other treatment options before deciding to use naproxen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen is indicated: 1 For the relief of the signs and symptoms of rheumatoid arthritis , 2 For the relief of the signs and symptoms of osteoarthritis , 3 For the relief of the signs and symptoms of ankylosing spondylitis , 4 For the relief of the signs and symptoms of juvenile arthritis .",
"Description": "Naproxen is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble in chloroform, practically insoluble in water at low pH and freely soluable in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Each naproxen tablet intended for oral administration contains 250 mg or 375 mg or 500 mg of naproxen. In addition, each tablet contains following inactive ingredients: colloidal silicon dioxide, magnesium stearate, pollyvinylpyrrolidone, povidone, croscarmellose sodium and sodium starch glycolate."
},
{
"NDCCode": "43353-506-94",
"PackageDescription": "360 TABLET in 1 BOTTLE, PLASTIC (43353-506-94)",
"NDC11Code": "43353-0506-94",
"ProductNDC": "43353-506",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090810",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075927",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "250",
"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": "Carefully consider the potential benefits and risks of naproxen tablets other treatment options before deciding to use naproxen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen is indicated: 1 For the relief of the signs and symptoms of rheumatoid arthritis , 2 For the relief of the signs and symptoms of osteoarthritis , 3 For the relief of the signs and symptoms of ankylosing spondylitis , 4 For the relief of the signs and symptoms of juvenile arthritis .",
"Description": "Naproxen is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble in chloroform, practically insoluble in water at low pH and freely soluable in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Each naproxen tablet intended for oral administration contains 250 mg or 375 mg or 500 mg of naproxen. In addition, each tablet contains following inactive ingredients: colloidal silicon dioxide, magnesium stearate, pollyvinylpyrrolidone, povidone, croscarmellose sodium and sodium starch glycolate."
},
{
"NDCCode": "43857-0506-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43857-0506-1) ",
"NDC11Code": "43857-0506-01",
"ProductNDC": "43857-0506",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Adaptagen",
"NonProprietaryName": "Aralia Quinquefolia, Avena Sativa, Capsicum Annuum, Ginkgo Biloba, Glycyrrhiza Glabra, Hydrocotyle Asiatica, Thiaminum Hydrochloricum, Ascorbicum Acidum, Riboflavinum, Glandula Suprarenalis Suis, Spleen (suis), Thyroidinum (suis), Cuprum Gluconate, Iodium, Ledum Palustre, Molybdenum Metallicum, Natrum Carbonicum, Phosphoricum Acidum, Picricum Acidum, Selenium Metallicum, Sepia, Vanadium Metallicum, Adenosinum Triphosphoricum Dinatrum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20190208",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "BioActive Nutritional, Inc.",
"SubstanceName": "AMERICAN GINSENG; AVENA SATIVA FLOWERING TOP; CAPSICUM; GINKGO; GLYCYRRHIZA GLABRA; CENTELLA ASIATICA; THIAMINE HYDROCHLORIDE; ASCORBIC ACID; RIBOFLAVIN; SUS SCROFA ADRENAL GLAND; SUS SCROFA SPLEEN; SUS SCROFA THYROID; COPPER GLUCONATE; IODINE; LEDUM PALUSTRE TWIG; MOLYBDENUM; SODIUM CARBONATE; PHOSPHORIC ACID; PICRIC ACID; SELENIUM; SEPIA OFFICINALIS JUICE; VANADIUM; ADENOSINE TRIPHOSPHATE DISODIUM",
"StrengthNumber": "3; 3; 3; 3; 3; 3; 4; 6; 6; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Vegetable Proteins [CS], Vitamin C [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190208",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of tiredness, weakness, general fatigue, exhaustion, weakness of memory.**. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "51668-506-01",
"PackageDescription": "30 mL in 1 CONTAINER (51668-506-01)",
"NDC11Code": "51668-0506-01",
"ProductNDC": "51668-506",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Koh Gen Do Aqua Foundation",
"ProprietaryNameSuffix": "Oc-3",
"NonProprietaryName": "Aqua Foundation",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20111103",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Koh Gen Do USA, Inc",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "1.8; 1.38",
"StrengthUnit": "mL/30mL; mL/30mL",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "54838-506-15",
"PackageDescription": "15 mL in 1 BOTTLE, PLASTIC (54838-506-15) ",
"NDC11Code": "54838-0506-15",
"ProductNDC": "54838-506",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hyosyne",
"NonProprietaryName": "Hyoscyamine Sulfate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "19971001",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "HYOSCYAMINE SULFATE",
"StrengthNumber": ".125",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2024-04-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19971001",
"SamplePackage": "N",
"IndicationAndUsage": "Hyoscyamine sulfate is effective as adjunctive therapy in the treatment of peptic ulcer. It can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon,mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Also used in the treatment of infant colic (elixir and drops). Hyoscyamine sulfate is indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.",
"Description": "HYOSYNE ORAL DROPS (Hyoscyamine Sulfate Oral Solution) contain 0.125 mg hyoscyamine sulfate per mL with 5% v/v alcohol for oral administration. HYOSYNE ELIXIR (Hyoscyamine Sulfate Elixir) contains 0.125 mg hyoscyamine sulfate per 5 mL with 20% v/v alcohol for oral administration. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C17H23NO3)2 H2SO4 2H2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, (α-(hydroxymethyl)-, 8-methyl-8-azabicyclo [3.2.1.] oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the following structure. HYOSYNE ORAL DROPS also contain as inactive ingredients: Alcohol, citric acid, FD&C red #40, FD&C yellow #6, flavor, glycerin, sodium benzoate, sodium citrate, sorbitol solution, sucrose, and water. HYOSYNE ELIXIR also contain as inactive ingredients: Alcohol, citric acid, FD&C red #40, FD&C yellow #6, flavor, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, and sucrose."
},
{
"NDCCode": "60923-506-15",
"PackageDescription": "1 KIT in 1 CARTON (60923-506-15) * 10 mL in 1 VIAL, SINGLE-USE (60923-562-01) * 15 POUCH in 1 BOX / 1 SWAB in 1 POUCH",
"NDC11Code": "60923-0506-15",
"ProductNDC": "60923-506",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Elevidys",
"NonProprietaryName": "Delandistrogene Moxeparvovec-rokl",
"DosageFormName": "KIT",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230622",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125781",
"LabelerName": "Sarepta Therapeutics, Inc.",
"Status": "Active",
"LastUpdate": "2026-08-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230622",
"SamplePackage": "N",
"IndicationAndUsage": "ELEVIDYS is indicated for the treatment of patients 4 years of age and older with Duchenne muscular dystrophy (DMD), who are ambulatory and have a confirmed mutation in the DMD gene [see Clinical Pharmacology (12.2), Clinical Studies (14)].",
"Description": "ELEVIDYS (delandistrogene moxeparvovec-rokl) is a recombinant gene therapy designed to deliver the gene encoding the ELEVIDYS micro-dystrophin protein. ELEVIDYS is a non-replicating, recombinant, adeno-associated virus serotype rh74 (AAVrh74) based vector containing the ELEVIDYS micro-dystrophin transgene under the control of the MHCK7 promoter. The genome within the ELEVIDYS AAVrh74 vector contains no viral genes and consequently is incapable of replication or reversion to a replicating form. The micro-dystrophin protein expressed by ELEVIDYS is a shortened version (138 kDa, compared to 427 kDa size of dystrophin expressed in normal muscle cells) that contains selected domains of dystrophin expressed in normal muscle cells. ELEVIDYS is a preservative-free, sterile, clear, colorless liquid that may have some opalescence and may contain white to off-white particles. ELEVIDYS is a suspension for intravenous infusion with a nominal concentration of 1.33 ×1013 vg/mL and supplied in a single-dose 10 mL vial. Each vial contains an extractable volume of 10 mL and the following excipients: 200mM sodium chloride, 13 mM tromethamine HCl, 7 mM tromethamine, 1mM magnesium chloride, 0.001% poloxamer 188, with a pH of 8.0 ± 0.3."
},
{
"NDCCode": "63304-506-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (63304-506-01) ",
"NDC11Code": "63304-0506-01",
"ProductNDC": "63304-506",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pentazocine And Naloxone",
"NonProprietaryName": "Pentazocine And Naloxone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075523",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "PENTAZOCINE; NALOXONE HYDROCHLORIDE",
"StrengthNumber": "50; .5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Competitive Opioid Antagonists [MoA], Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist/Antagonist [EPC], Partial Opioid Agonists [MoA]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2018-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180731",
"SamplePackage": "N",
"IndicationAndUsage": "Pentazocine and Naloxone Hydrochloride Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses, reserve Pentazocine and Naloxone Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia .",
"Description": "Pentazocine and Naloxone Hydrochloride Tablets, USP contain pentazocine hydrochloride, USP, a partial opioid agonist, equivalent to 50 mg base and is a member of the benzazocine series (also known as the benzomorphan series), and naloxone hydrochloride, USP, an opioid antagonist equivalent to 0.5 mg base. Pentazocine and Naloxone Hydrochloride Tablets, USP are an analgesic for oral administration. Chemically, pentazocine hydrochloride is (2R*,6R*,11R*)- 1, 2, 3, 4, 5, 6- Hexahydro-6,11-dimethyl-3-(3-methyl-2-butenyl)-2,6-methano-3-benzazocin-8-ol hydrochloride, a white, crystalline substance soluble in acidic aqueous solutions, and has the following structural formula. Chemically, naloxone hydrochloride is 17-Allyl-4,5a-epoxy-3,14-dihydroxy‑ morphinan-6-one hydrochloride. It is a slightly off-white powder, and is soluble in water and dilute acids, and has the following structural formula. Each tablet, for oral administration, contains pentazocine hydrochloride, USP, equivalent to 50 mg of pentazocine, and naloxone hydrochloride, USP, equivalent to 0.5 mg of naloxone. In addition, each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Corn Starch, Dibasic Calcium Phosphate, D&C Yellow #10. Aluminum lake, Magnesium Stearate, Microcrystalline Cellulose, Sodium Lauryl Sulfate."
},
{
"NDCCode": "63323-506-01",
"PackageDescription": "25 VIAL in 1 TRAY (63323-506-01) / 1 mL in 1 VIAL (63323-506-00) ",
"NDC11Code": "63323-0506-01",
"ProductNDC": "63323-506",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexamethasone Sodium Phosphate",
"NonProprietaryName": "Dexamethasone Sodium Phosphate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20030529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040491",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "DEXAMETHASONE SODIUM PHOSPHATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20030529",
"SamplePackage": "N",
"Description": "Dexamethasone Sodium Phosphate Injection, USP, is a water-soluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly. Dexamethasone Sodium Phosphate, USP chemically is Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17- dihydroxy-16-methyl-21-(phosphonooxy)-, disodium salt, (11ß, 16α). It occurs as a white to creamy white powder, is exceedingly hygroscopic, is soluble in water and its solutions have a pH between 7.0 and 8.5. It has the following structural formula. Each mL of Dexamethasone Sodium Phosphate Injection, USP (Preservative Free) contains Dexamethasone Sodium Phosphate, USP equivalent to 10 mg dexamethasone phosphate; 24.75 mg sodium citrate, dihydrate; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5. Each mL Dexamethasone Sodium Phosphate Injection, USP (Preserved) contains dexamethasone sodium phosphate, USP equivalent to 10 mg dexamethasone phosphate; 13.5 mg sodium citrate, dihydrate; 10 mg benzyl alcohol; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5."
},
{
"NDCCode": "63323-506-13",
"PackageDescription": "25 VIAL in 1 TRAY (63323-506-13) / 1 mL in 1 VIAL (63323-506-03) ",
"NDC11Code": "63323-0506-13",
"ProductNDC": "63323-506",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexamethasone Sodium Phosphate",
"NonProprietaryName": "Dexamethasone Sodium Phosphate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20030529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040491",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "DEXAMETHASONE SODIUM PHOSPHATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250106",
"SamplePackage": "N",
"Description": "Dexamethasone Sodium Phosphate Injection, USP, is a water-soluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly. Dexamethasone Sodium Phosphate, USP chemically is Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17- dihydroxy-16-methyl-21-(phosphonooxy)-, disodium salt, (11ß, 16α). It occurs as a white to creamy white powder, is exceedingly hygroscopic, is soluble in water and its solutions have a pH between 7.0 and 8.5. It has the following structural formula. Each mL of Dexamethasone Sodium Phosphate Injection, USP (Preservative Free) contains Dexamethasone Sodium Phosphate, USP equivalent to 10 mg dexamethasone phosphate; 24.75 mg sodium citrate, dihydrate; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5. Each mL Dexamethasone Sodium Phosphate Injection, USP (Preserved) contains dexamethasone sodium phosphate, USP equivalent to 10 mg dexamethasone phosphate; 13.5 mg sodium citrate, dihydrate; 10 mg benzyl alcohol; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5."
},
{
"NDCCode": "63323-506-16",
"PackageDescription": "25 VIAL in 1 TRAY (63323-506-16) / 1 mL in 1 VIAL (63323-506-41) ",
"NDC11Code": "63323-0506-16",
"ProductNDC": "63323-506",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexamethasone Sodium Phosphate",
"NonProprietaryName": "Dexamethasone Sodium Phosphate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20030529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040491",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "DEXAMETHASONE SODIUM PHOSPHATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20030529",
"SamplePackage": "N",
"Description": "Dexamethasone Sodium Phosphate Injection, USP, is a water-soluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly. Dexamethasone Sodium Phosphate, USP chemically is Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17- dihydroxy-16-methyl-21-(phosphonooxy)-, disodium salt, (11ß, 16α). It occurs as a white to creamy white powder, is exceedingly hygroscopic, is soluble in water and its solutions have a pH between 7.0 and 8.5. It has the following structural formula. Each mL of Dexamethasone Sodium Phosphate Injection, USP (Preservative Free) contains Dexamethasone Sodium Phosphate, USP equivalent to 10 mg dexamethasone phosphate; 24.75 mg sodium citrate, dihydrate; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5. Each mL Dexamethasone Sodium Phosphate Injection, USP (Preserved) contains dexamethasone sodium phosphate, USP equivalent to 10 mg dexamethasone phosphate; 13.5 mg sodium citrate, dihydrate; 10 mg benzyl alcohol; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5."
},
{
"NDCCode": "63459-506-30",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (63459-506-30) / 1 LOZENGE in 1 BLISTER PACK (63459-506-01) ",
"NDC11Code": "63459-0506-30",
"ProductNDC": "63459-506",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Actiq",
"NonProprietaryName": "Fentanyl Citrate",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL; TRANSMUCOSAL",
"StartMarketingDate": "19990120",
"EndMarketingDate": "20240531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020747",
"LabelerName": "Cephalon, LLC",
"SubstanceName": "FENTANYL CITRATE",
"StrengthNumber": "600",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19990120",
"EndMarketingDatePackage": "20240531",
"SamplePackage": "N",
"IndicationAndUsage": "ACTIQ is indicated for the management of breakthrough pain in cancer patients 16 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids when taking ACTIQ. Limitations of Use: 1 Not for use in opioid non-tolerant patients., 2 Not for use in the management of acute or postoperative pain, including headache/migraine and dental pain [see Contraindications (4)]., 3 As a part of the TIRF REMS, ACTIQ may be dispensed by outpatient pharmacies only to outpatients enrolled in the program [see Warnings and Precautions (5.7)]. For inpatient administration of ACTIQ, patient and prescriber enrollment are not required.",
"Description": "ACTIQ (fentanyl citrate) oral transmucosal lozenge is a solid formulation of fentanyl, an opioid agonist, intended for oral transmucosal administration. ACTIQ is formulated as a white to off-white solid drug matrix on a handle that is fracture resistant (ABS plastic) under normal conditions when used as directed. ACTIQ is designed to be dissolved slowly in the mouth to facilitate transmucosal absorption. The handle allows the ACTIQ unit to be removed from the mouth if signs of excessive opioid effects appear during administration. Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl) propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1) that is freely soluble in organic solvents and sparingly soluble in water (1:40). The molecular weight of the free base is 336.5 (the citrate salt is 528.6). The pKa of the tertiary nitrogens are 7.3 and 8.4. The compound has the following structural formula. Inactive Ingredients: Hydrated dextrates, citric acid, dibasic sodium phosphate, artificial berry flavor, magnesium stearate, and edible glue (modified food starch and confectioner’s sugar)."
},
{
"NDCCode": "64642-506-51",
"PackageDescription": "10 kg in 1 BAG (64642-506-51)",
"NDC11Code": "64642-0506-51",
"ProductNDC": "64642-506",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "POWDER",
"StartMarketingDate": "19980201",
"EndMarketingDate": "20200124",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Ishihara Sangyo Kaisha, Ltd.",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "8.1",
"StrengthUnit": "kg/10kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "65162-506-03",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-03) ",
"NDC11Code": "65162-0506-03",
"ProductNDC": "65162-506",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20101206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091549",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101206",
"SamplePackage": "N",
"IndicationAndUsage": "Indomethacin extended-release capsules are indicated for: : 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease, 2 Moderate to severe ankylosing spondylitis , 3 Moderate to severe osteoarthritis , 4 Acute painful shoulder (bursitis and/or tendinitis).",
"Description": "Indomethacin extended-release capsules, USP are nonsteroidal anti-inflammatory drugs, available as capsules containing 75 mg of indomethacin, USP, administered for oral use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C19H16ClNO4, and it has the following chemical structure. Indomethacin, USP is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in indomethacin extended-release capsules USP, 75 mg include: ammonia, black iron oxide, butyl alcohol, corn starch, dehydrated alcohol, FD&C Blue No. 1, FD&C Green No.3, FD&C Yellow No. 5, FD&C Red No. 40, gelatin, isopropyl alcohol, lactose monohydrate, potassium hydroxide, povidone, propylene glycol, shellac, sucrose and talc. This Product meets the USP Drug Release Test 2 Specifications."
},
{
"NDCCode": "65162-506-06",
"PackageDescription": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-06) ",
"NDC11Code": "65162-0506-06",
"ProductNDC": "65162-506",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20101206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091549",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101206",
"SamplePackage": "N",
"IndicationAndUsage": "Indomethacin extended-release capsules are indicated for: : 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease, 2 Moderate to severe ankylosing spondylitis , 3 Moderate to severe osteoarthritis , 4 Acute painful shoulder (bursitis and/or tendinitis).",
"Description": "Indomethacin extended-release capsules, USP are nonsteroidal anti-inflammatory drugs, available as capsules containing 75 mg of indomethacin, USP, administered for oral use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C19H16ClNO4, and it has the following chemical structure. Indomethacin, USP is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in indomethacin extended-release capsules USP, 75 mg include: ammonia, black iron oxide, butyl alcohol, corn starch, dehydrated alcohol, FD&C Blue No. 1, FD&C Green No.3, FD&C Yellow No. 5, FD&C Red No. 40, gelatin, isopropyl alcohol, lactose monohydrate, potassium hydroxide, povidone, propylene glycol, shellac, sucrose and talc. This Product meets the USP Drug Release Test 2 Specifications."
},
{
"NDCCode": "65162-506-09",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-09) ",
"NDC11Code": "65162-0506-09",
"ProductNDC": "65162-506",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20101206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091549",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101206",
"SamplePackage": "N",
"IndicationAndUsage": "Indomethacin extended-release capsules are indicated for: : 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease, 2 Moderate to severe ankylosing spondylitis , 3 Moderate to severe osteoarthritis , 4 Acute painful shoulder (bursitis and/or tendinitis).",
"Description": "Indomethacin extended-release capsules, USP are nonsteroidal anti-inflammatory drugs, available as capsules containing 75 mg of indomethacin, USP, administered for oral use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C19H16ClNO4, and it has the following chemical structure. Indomethacin, USP is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in indomethacin extended-release capsules USP, 75 mg include: ammonia, black iron oxide, butyl alcohol, corn starch, dehydrated alcohol, FD&C Blue No. 1, FD&C Green No.3, FD&C Yellow No. 5, FD&C Red No. 40, gelatin, isopropyl alcohol, lactose monohydrate, potassium hydroxide, povidone, propylene glycol, shellac, sucrose and talc. This Product meets the USP Drug Release Test 2 Specifications."
},
{
"NDCCode": "65162-506-10",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-10) ",
"NDC11Code": "65162-0506-10",
"ProductNDC": "65162-506",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20101206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091549",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101206",
"SamplePackage": "N",
"IndicationAndUsage": "Indomethacin extended-release capsules are indicated for: : 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease, 2 Moderate to severe ankylosing spondylitis , 3 Moderate to severe osteoarthritis , 4 Acute painful shoulder (bursitis and/or tendinitis).",
"Description": "Indomethacin extended-release capsules, USP are nonsteroidal anti-inflammatory drugs, available as capsules containing 75 mg of indomethacin, USP, administered for oral use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C19H16ClNO4, and it has the following chemical structure. Indomethacin, USP is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in indomethacin extended-release capsules USP, 75 mg include: ammonia, black iron oxide, butyl alcohol, corn starch, dehydrated alcohol, FD&C Blue No. 1, FD&C Green No.3, FD&C Yellow No. 5, FD&C Red No. 40, gelatin, isopropyl alcohol, lactose monohydrate, potassium hydroxide, povidone, propylene glycol, shellac, sucrose and talc. This Product meets the USP Drug Release Test 2 Specifications."
},
{
"NDCCode": "65162-506-11",
"PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-11) ",
"NDC11Code": "65162-0506-11",
"ProductNDC": "65162-506",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin",
"NonProprietaryName": "Indomethacin",
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"RouteName": "ORAL",
"StartMarketingDate": "20101206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091549",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101206",
"SamplePackage": "N",
"IndicationAndUsage": "Indomethacin extended-release capsules are indicated for: : 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease, 2 Moderate to severe ankylosing spondylitis , 3 Moderate to severe osteoarthritis , 4 Acute painful shoulder (bursitis and/or tendinitis).",
"Description": "Indomethacin extended-release capsules, USP are nonsteroidal anti-inflammatory drugs, available as capsules containing 75 mg of indomethacin, USP, administered for oral use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C19H16ClNO4, and it has the following chemical structure. Indomethacin, USP is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in indomethacin extended-release capsules USP, 75 mg include: ammonia, black iron oxide, butyl alcohol, corn starch, dehydrated alcohol, FD&C Blue No. 1, FD&C Green No.3, FD&C Yellow No. 5, FD&C Red No. 40, gelatin, isopropyl alcohol, lactose monohydrate, potassium hydroxide, povidone, propylene glycol, shellac, sucrose and talc. This Product meets the USP Drug Release Test 2 Specifications."
},
{
"NDCCode": "65162-506-50",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-50) ",
"NDC11Code": "65162-0506-50",
"ProductNDC": "65162-506",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Indomethacin",
"NonProprietaryName": "Indomethacin",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20101206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091549",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "INDOMETHACIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101206",
"SamplePackage": "N",
"IndicationAndUsage": "Indomethacin extended-release capsules are indicated for: : 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease, 2 Moderate to severe ankylosing spondylitis , 3 Moderate to severe osteoarthritis , 4 Acute painful shoulder (bursitis and/or tendinitis).",
"Description": "Indomethacin extended-release capsules, USP are nonsteroidal anti-inflammatory drugs, available as capsules containing 75 mg of indomethacin, USP, administered for oral use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C19H16ClNO4, and it has the following chemical structure. Indomethacin, USP is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in indomethacin extended-release capsules USP, 75 mg include: ammonia, black iron oxide, butyl alcohol, corn starch, dehydrated alcohol, FD&C Blue No. 1, FD&C Green No.3, FD&C Yellow No. 5, FD&C Red No. 40, gelatin, isopropyl alcohol, lactose monohydrate, potassium hydroxide, povidone, propylene glycol, shellac, sucrose and talc. This Product meets the USP Drug Release Test 2 Specifications."
},
{
"NDCCode": "65585-506-03",
"PackageDescription": "8 BAG in 1 BOX (65585-506-03) > 1000 mL in 1 BAG",
"NDC11Code": "65585-0506-03",
"ProductNDC": "65585-506",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Whiskcare 357",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20111110",
"EndMarketingDate": "20141231",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Whisk Products, Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2015-01-02"
}
]
}
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<NDC>
<NDCCode>58118-0506-8</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (58118-0506-8)</PackageDescription>
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<ProductNDC>58118-0506</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<StrengthUnit>mg/1</StrengthUnit>
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<Status>Deprecated</Status>
<LastUpdate>2017-07-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>58118-0506-0</NDCCode>
<PackageDescription>1 TABLET in 1 PACKET (58118-0506-0)</PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
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<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074644</ApplicationNumber>
<LabelerName>Clinical Solutions Wholesale</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-07-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>58118-0506-1</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE (58118-0506-1)</PackageDescription>
<NDC11Code>58118-0506-01</NDC11Code>
<ProductNDC>58118-0506</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074644</ApplicationNumber>
<LabelerName>Clinical Solutions Wholesale</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-07-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>58118-0506-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (58118-0506-3)</PackageDescription>
<NDC11Code>58118-0506-03</NDC11Code>
<ProductNDC>58118-0506</ProductNDC>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074644</ApplicationNumber>
<LabelerName>Clinical Solutions Wholesale</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-07-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>58118-0506-9</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (58118-0506-9)</PackageDescription>
<NDC11Code>58118-0506-09</NDC11Code>
<ProductNDC>58118-0506</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metoprolol Tartrate</ProprietaryName>
<NonProprietaryName>Metoprolol Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074644</ApplicationNumber>
<LabelerName>Clinical Solutions Wholesale</LabelerName>
<SubstanceName>METOPROLOL TARTRATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-07-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>30142-506-73</NDCCode>
<PackageDescription>8 BLISTER PACK in 1 CARTON (30142-506-73) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>30142-0506-73</NDC11Code>
<ProductNDC>30142-506</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fast Cold And Flu Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170622</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 200; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170622</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these common cold and flu symptoms:. nasal congestion. headache. cough. minor aches and pains. sore throat. temporarily reduces fever. helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>30400-506-01</NDCCode>
<PackageDescription>283 g in 1 BOTTLE (30400-506-01) </PackageDescription>
<NDC11Code>30400-0506-01</NDC11Code>
<ProductNDC>30400-506</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Medicated Body</ProprietaryName>
<ProprietaryNameSuffix>Powder</ProprietaryNameSuffix>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Jell Pharmaceuticals Pvt Ltd</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>.42</StrengthNumber>
<StrengthUnit>g/283g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of the pain and itch associated with: 1 minor cuts, 2 scrapes, 3 sunburn, 4 insect bites, 5 prickly heat, 6 rashes, 7 minor burns, 8 minor skin irritations, 9 dries the oozing of poison ivy, oak and sumac.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42291-506-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-506-01) </PackageDescription>
<NDC11Code>42291-0506-01</NDC11Code>
<ProductNDC>42291-506</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190621</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019123</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190621</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium chloride extended-release is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.</IndicationAndUsage>
<Description>Potassium chloride extended-release tablets, USP are a solid oral dosage form of potassium chloride. Each contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq of potassium in a wax matrix tablet. Potassium chloride extended-release tablets, USP, are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, granular powder or colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Inactive Ingredients: Hydrogenated vegetable oil, magnesium stearate, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc and titanium dioxide. Yellow tablets also contain D&C Yellow No. 10 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. Blue tablets also contain FD&C Blue No. 1 Aluminum Lake and FD&C Blue No. 2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>42291-506-50</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-506-50) </PackageDescription>
<NDC11Code>42291-0506-50</NDC11Code>
<ProductNDC>42291-506</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190621</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019123</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190621</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Potassium chloride extended-release is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.</IndicationAndUsage>
<Description>Potassium chloride extended-release tablets, USP are a solid oral dosage form of potassium chloride. Each contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq of potassium in a wax matrix tablet. Potassium chloride extended-release tablets, USP, are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, granular powder or colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. Inactive Ingredients: Hydrogenated vegetable oil, magnesium stearate, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc and titanium dioxide. Yellow tablets also contain D&C Yellow No. 10 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. Blue tablets also contain FD&C Blue No. 1 Aluminum Lake and FD&C Blue No. 2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>43353-506-60</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (43353-506-60)</PackageDescription>
<NDC11Code>43353-0506-60</NDC11Code>
<ProductNDC>43353-506</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090810</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075927</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>250</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>Carefully consider the potential benefits and risks of naproxen tablets other treatment options before deciding to use naproxen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen is indicated: 1 For the relief of the signs and symptoms of rheumatoid arthritis , 2 For the relief of the signs and symptoms of osteoarthritis , 3 For the relief of the signs and symptoms of ankylosing spondylitis , 4 For the relief of the signs and symptoms of juvenile arthritis .</IndicationAndUsage>
<Description>Naproxen is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble in chloroform, practically insoluble in water at low pH and freely soluable in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Each naproxen tablet intended for oral administration contains 250 mg or 375 mg or 500 mg of naproxen. In addition, each tablet contains following inactive ingredients: colloidal silicon dioxide, magnesium stearate, pollyvinylpyrrolidone, povidone, croscarmellose sodium and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>43353-506-70</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE, PLASTIC (43353-506-70)</PackageDescription>
<NDC11Code>43353-0506-70</NDC11Code>
<ProductNDC>43353-506</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090810</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075927</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>250</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>Carefully consider the potential benefits and risks of naproxen tablets other treatment options before deciding to use naproxen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen is indicated: 1 For the relief of the signs and symptoms of rheumatoid arthritis , 2 For the relief of the signs and symptoms of osteoarthritis , 3 For the relief of the signs and symptoms of ankylosing spondylitis , 4 For the relief of the signs and symptoms of juvenile arthritis .</IndicationAndUsage>
<Description>Naproxen is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble in chloroform, practically insoluble in water at low pH and freely soluable in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Each naproxen tablet intended for oral administration contains 250 mg or 375 mg or 500 mg of naproxen. In addition, each tablet contains following inactive ingredients: colloidal silicon dioxide, magnesium stearate, pollyvinylpyrrolidone, povidone, croscarmellose sodium and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>43353-506-80</NDCCode>
<PackageDescription>180 TABLET in 1 BOTTLE, PLASTIC (43353-506-80)</PackageDescription>
<NDC11Code>43353-0506-80</NDC11Code>
<ProductNDC>43353-506</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090810</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075927</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>250</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>Carefully consider the potential benefits and risks of naproxen tablets other treatment options before deciding to use naproxen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen is indicated: 1 For the relief of the signs and symptoms of rheumatoid arthritis , 2 For the relief of the signs and symptoms of osteoarthritis , 3 For the relief of the signs and symptoms of ankylosing spondylitis , 4 For the relief of the signs and symptoms of juvenile arthritis .</IndicationAndUsage>
<Description>Naproxen is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble in chloroform, practically insoluble in water at low pH and freely soluable in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Each naproxen tablet intended for oral administration contains 250 mg or 375 mg or 500 mg of naproxen. In addition, each tablet contains following inactive ingredients: colloidal silicon dioxide, magnesium stearate, pollyvinylpyrrolidone, povidone, croscarmellose sodium and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>43353-506-94</NDCCode>
<PackageDescription>360 TABLET in 1 BOTTLE, PLASTIC (43353-506-94)</PackageDescription>
<NDC11Code>43353-0506-94</NDC11Code>
<ProductNDC>43353-506</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090810</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075927</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>250</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>Carefully consider the potential benefits and risks of naproxen tablets other treatment options before deciding to use naproxen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen is indicated: 1 For the relief of the signs and symptoms of rheumatoid arthritis , 2 For the relief of the signs and symptoms of osteoarthritis , 3 For the relief of the signs and symptoms of ankylosing spondylitis , 4 For the relief of the signs and symptoms of juvenile arthritis .</IndicationAndUsage>
<Description>Naproxen is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has the following structure. Naproxen has a molecular weight of 230.26 and a molecular formula of C14H14O3. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble in chloroform, practically insoluble in water at low pH and freely soluable in water at high pH. The octanol/water partition coefficient of naproxen at pH 7.4 is 1.6 to 1.8. Each naproxen tablet intended for oral administration contains 250 mg or 375 mg or 500 mg of naproxen. In addition, each tablet contains following inactive ingredients: colloidal silicon dioxide, magnesium stearate, pollyvinylpyrrolidone, povidone, croscarmellose sodium and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>43857-0506-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (43857-0506-1) </PackageDescription>
<NDC11Code>43857-0506-01</NDC11Code>
<ProductNDC>43857-0506</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Adaptagen</ProprietaryName>
<NonProprietaryName>Aralia Quinquefolia, Avena Sativa, Capsicum Annuum, Ginkgo Biloba, Glycyrrhiza Glabra, Hydrocotyle Asiatica, Thiaminum Hydrochloricum, Ascorbicum Acidum, Riboflavinum, Glandula Suprarenalis Suis, Spleen (suis), Thyroidinum (suis), Cuprum Gluconate, Iodium, Ledum Palustre, Molybdenum Metallicum, Natrum Carbonicum, Phosphoricum Acidum, Picricum Acidum, Selenium Metallicum, Sepia, Vanadium Metallicum, Adenosinum Triphosphoricum Dinatrum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190208</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>BioActive Nutritional, Inc.</LabelerName>
<SubstanceName>AMERICAN GINSENG; AVENA SATIVA FLOWERING TOP; CAPSICUM; GINKGO; GLYCYRRHIZA GLABRA; CENTELLA ASIATICA; THIAMINE HYDROCHLORIDE; ASCORBIC ACID; RIBOFLAVIN; SUS SCROFA ADRENAL GLAND; SUS SCROFA SPLEEN; SUS SCROFA THYROID; COPPER GLUCONATE; IODINE; LEDUM PALUSTRE TWIG; MOLYBDENUM; SODIUM CARBONATE; PHOSPHORIC ACID; PICRIC ACID; SELENIUM; SEPIA OFFICINALIS JUICE; VANADIUM; ADENOSINE TRIPHOSPHATE DISODIUM</SubstanceName>
<StrengthNumber>3; 3; 3; 3; 3; 3; 4; 6; 6; 8; 8; 8; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Vegetable Proteins [CS], Vitamin C [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of tiredness, weakness, general fatigue, exhaustion, weakness of memory.**. **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51668-506-01</NDCCode>
<PackageDescription>30 mL in 1 CONTAINER (51668-506-01)</PackageDescription>
<NDC11Code>51668-0506-01</NDC11Code>
<ProductNDC>51668-506</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Koh Gen Do Aqua Foundation</ProprietaryName>
<ProprietaryNameSuffix>Oc-3</ProprietaryNameSuffix>
<NonProprietaryName>Aqua Foundation</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20111103</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Koh Gen Do USA, Inc</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>1.8; 1.38</StrengthNumber>
<StrengthUnit>mL/30mL; mL/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>54838-506-15</NDCCode>
<PackageDescription>15 mL in 1 BOTTLE, PLASTIC (54838-506-15) </PackageDescription>
<NDC11Code>54838-0506-15</NDC11Code>
<ProductNDC>54838-506</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hyosyne</ProprietaryName>
<NonProprietaryName>Hyoscyamine Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971001</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>HYOSCYAMINE SULFATE</SubstanceName>
<StrengthNumber>.125</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-04-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hyoscyamine sulfate is effective as adjunctive therapy in the treatment of peptic ulcer. It can also be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. May be used in functional intestinal disorders to reduce symptoms such as those seen in mild dysenteries, diverticulitis, and acute enterocolitis. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon,mucous colitis) and functional gastrointestinal disorders. Also used as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Also used in the treatment of infant colic (elixir and drops). Hyoscyamine sulfate is indicated along with morphine or other narcotics in symptomatic relief of biliary and renal colic; as a “drying agent” in the relief of symptoms of acute rhinitis; in the therapy of parkinsonism to reduce rigidity and tremors and to control associated sialorrhea and hyperhidrosis. May be used in the therapy of poisoning by anticholinesterase agents.</IndicationAndUsage>
<Description>HYOSYNE ORAL DROPS (Hyoscyamine Sulfate Oral Solution) contain 0.125 mg hyoscyamine sulfate per mL with 5% v/v alcohol for oral administration. HYOSYNE ELIXIR (Hyoscyamine Sulfate Elixir) contains 0.125 mg hyoscyamine sulfate per 5 mL with 20% v/v alcohol for oral administration. Hyoscyamine sulfate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids. The empirical formula is (C17H23NO3)2 H2SO4 2H2O and the molecular weight is 712.85. Chemically, it is benzeneacetic acid, (α-(hydroxymethyl)-, 8-methyl-8-azabicyclo [3.2.1.] oct-3-yl ester, [3(S)-endo]-, sulfate (2:1), dihydrate with the following structure. HYOSYNE ORAL DROPS also contain as inactive ingredients: Alcohol, citric acid, FD&C red #40, FD&C yellow #6, flavor, glycerin, sodium benzoate, sodium citrate, sorbitol solution, sucrose, and water. HYOSYNE ELIXIR also contain as inactive ingredients: Alcohol, citric acid, FD&C red #40, FD&C yellow #6, flavor, glycerin, purified water, sodium benzoate, sodium citrate, sorbitol solution, and sucrose.</Description>
</NDC>
<NDC>
<NDCCode>60923-506-15</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (60923-506-15) * 10 mL in 1 VIAL, SINGLE-USE (60923-562-01) * 15 POUCH in 1 BOX / 1 SWAB in 1 POUCH</PackageDescription>
<NDC11Code>60923-0506-15</NDC11Code>
<ProductNDC>60923-506</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Elevidys</ProprietaryName>
<NonProprietaryName>Delandistrogene Moxeparvovec-rokl</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230622</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125781</ApplicationNumber>
<LabelerName>Sarepta Therapeutics, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-08-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230622</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ELEVIDYS is indicated for the treatment of patients 4 years of age and older with Duchenne muscular dystrophy (DMD), who are ambulatory and have a confirmed mutation in the DMD gene [see Clinical Pharmacology (12.2), Clinical Studies (14)].</IndicationAndUsage>
<Description>ELEVIDYS (delandistrogene moxeparvovec-rokl) is a recombinant gene therapy designed to deliver the gene encoding the ELEVIDYS micro-dystrophin protein. ELEVIDYS is a non-replicating, recombinant, adeno-associated virus serotype rh74 (AAVrh74) based vector containing the ELEVIDYS micro-dystrophin transgene under the control of the MHCK7 promoter. The genome within the ELEVIDYS AAVrh74 vector contains no viral genes and consequently is incapable of replication or reversion to a replicating form. The micro-dystrophin protein expressed by ELEVIDYS is a shortened version (138 kDa, compared to 427 kDa size of dystrophin expressed in normal muscle cells) that contains selected domains of dystrophin expressed in normal muscle cells. ELEVIDYS is a preservative-free, sterile, clear, colorless liquid that may have some opalescence and may contain white to off-white particles. ELEVIDYS is a suspension for intravenous infusion with a nominal concentration of 1.33 ×1013 vg/mL and supplied in a single-dose 10 mL vial. Each vial contains an extractable volume of 10 mL and the following excipients: 200mM sodium chloride, 13 mM tromethamine HCl, 7 mM tromethamine, 1mM magnesium chloride, 0.001% poloxamer 188, with a pH of 8.0 ± 0.3.</Description>
</NDC>
<NDC>
<NDCCode>63304-506-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (63304-506-01) </PackageDescription>
<NDC11Code>63304-0506-01</NDC11Code>
<ProductNDC>63304-506</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pentazocine And Naloxone</ProprietaryName>
<NonProprietaryName>Pentazocine And Naloxone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075523</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>PENTAZOCINE; NALOXONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50; .5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Competitive Opioid Antagonists [MoA], Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist/Antagonist [EPC], Partial Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2018-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pentazocine and Naloxone Hydrochloride Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses, reserve Pentazocine and Naloxone Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] : 1 Have not been tolerated, or are not expected to be tolerated,, 2 Have not provided adequate analgesia, or are not expected to provide adequate analgesia .</IndicationAndUsage>
<Description>Pentazocine and Naloxone Hydrochloride Tablets, USP contain pentazocine hydrochloride, USP, a partial opioid agonist, equivalent to 50 mg base and is a member of the benzazocine series (also known as the benzomorphan series), and naloxone hydrochloride, USP, an opioid antagonist equivalent to 0.5 mg base. Pentazocine and Naloxone Hydrochloride Tablets, USP are an analgesic for oral administration. Chemically, pentazocine hydrochloride is (2R*,6R*,11R*)- 1, 2, 3, 4, 5, 6- Hexahydro-6,11-dimethyl-3-(3-methyl-2-butenyl)-2,6-methano-3-benzazocin-8-ol hydrochloride, a white, crystalline substance soluble in acidic aqueous solutions, and has the following structural formula. Chemically, naloxone hydrochloride is 17-Allyl-4,5a-epoxy-3,14-dihydroxy‑ morphinan-6-one hydrochloride. It is a slightly off-white powder, and is soluble in water and dilute acids, and has the following structural formula. Each tablet, for oral administration, contains pentazocine hydrochloride, USP, equivalent to 50 mg of pentazocine, and naloxone hydrochloride, USP, equivalent to 0.5 mg of naloxone. In addition, each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Corn Starch, Dibasic Calcium Phosphate, D&C Yellow #10. Aluminum lake, Magnesium Stearate, Microcrystalline Cellulose, Sodium Lauryl Sulfate.</Description>
</NDC>
<NDC>
<NDCCode>63323-506-01</NDCCode>
<PackageDescription>25 VIAL in 1 TRAY (63323-506-01) / 1 mL in 1 VIAL (63323-506-00) </PackageDescription>
<NDC11Code>63323-0506-01</NDC11Code>
<ProductNDC>63323-506</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexamethasone Sodium Phosphate</ProprietaryName>
<NonProprietaryName>Dexamethasone Sodium Phosphate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20030529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040491</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>DEXAMETHASONE SODIUM PHOSPHATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Dexamethasone Sodium Phosphate Injection, USP, is a water-soluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly. Dexamethasone Sodium Phosphate, USP chemically is Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17- dihydroxy-16-methyl-21-(phosphonooxy)-, disodium salt, (11ß, 16α). It occurs as a white to creamy white powder, is exceedingly hygroscopic, is soluble in water and its solutions have a pH between 7.0 and 8.5. It has the following structural formula. Each mL of Dexamethasone Sodium Phosphate Injection, USP (Preservative Free) contains Dexamethasone Sodium Phosphate, USP equivalent to 10 mg dexamethasone phosphate; 24.75 mg sodium citrate, dihydrate; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5. Each mL Dexamethasone Sodium Phosphate Injection, USP (Preserved) contains dexamethasone sodium phosphate, USP equivalent to 10 mg dexamethasone phosphate; 13.5 mg sodium citrate, dihydrate; 10 mg benzyl alcohol; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5.</Description>
</NDC>
<NDC>
<NDCCode>63323-506-13</NDCCode>
<PackageDescription>25 VIAL in 1 TRAY (63323-506-13) / 1 mL in 1 VIAL (63323-506-03) </PackageDescription>
<NDC11Code>63323-0506-13</NDC11Code>
<ProductNDC>63323-506</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexamethasone Sodium Phosphate</ProprietaryName>
<NonProprietaryName>Dexamethasone Sodium Phosphate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20030529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040491</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>DEXAMETHASONE SODIUM PHOSPHATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Dexamethasone Sodium Phosphate Injection, USP, is a water-soluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly. Dexamethasone Sodium Phosphate, USP chemically is Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17- dihydroxy-16-methyl-21-(phosphonooxy)-, disodium salt, (11ß, 16α). It occurs as a white to creamy white powder, is exceedingly hygroscopic, is soluble in water and its solutions have a pH between 7.0 and 8.5. It has the following structural formula. Each mL of Dexamethasone Sodium Phosphate Injection, USP (Preservative Free) contains Dexamethasone Sodium Phosphate, USP equivalent to 10 mg dexamethasone phosphate; 24.75 mg sodium citrate, dihydrate; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5. Each mL Dexamethasone Sodium Phosphate Injection, USP (Preserved) contains dexamethasone sodium phosphate, USP equivalent to 10 mg dexamethasone phosphate; 13.5 mg sodium citrate, dihydrate; 10 mg benzyl alcohol; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5.</Description>
</NDC>
<NDC>
<NDCCode>63323-506-16</NDCCode>
<PackageDescription>25 VIAL in 1 TRAY (63323-506-16) / 1 mL in 1 VIAL (63323-506-41) </PackageDescription>
<NDC11Code>63323-0506-16</NDC11Code>
<ProductNDC>63323-506</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexamethasone Sodium Phosphate</ProprietaryName>
<NonProprietaryName>Dexamethasone Sodium Phosphate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20030529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040491</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>DEXAMETHASONE SODIUM PHOSPHATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Dexamethasone Sodium Phosphate Injection, USP, is a water-soluble inorganic ester of dexamethasone which produces a rapid response even when injected intramuscularly. Dexamethasone Sodium Phosphate, USP chemically is Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17- dihydroxy-16-methyl-21-(phosphonooxy)-, disodium salt, (11ß, 16α). It occurs as a white to creamy white powder, is exceedingly hygroscopic, is soluble in water and its solutions have a pH between 7.0 and 8.5. It has the following structural formula. Each mL of Dexamethasone Sodium Phosphate Injection, USP (Preservative Free) contains Dexamethasone Sodium Phosphate, USP equivalent to 10 mg dexamethasone phosphate; 24.75 mg sodium citrate, dihydrate; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5. Each mL Dexamethasone Sodium Phosphate Injection, USP (Preserved) contains dexamethasone sodium phosphate, USP equivalent to 10 mg dexamethasone phosphate; 13.5 mg sodium citrate, dihydrate; 10 mg benzyl alcohol; and Water for Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5.</Description>
</NDC>
<NDC>
<NDCCode>63459-506-30</NDCCode>
<PackageDescription>30 BLISTER PACK in 1 CARTON (63459-506-30) / 1 LOZENGE in 1 BLISTER PACK (63459-506-01) </PackageDescription>
<NDC11Code>63459-0506-30</NDC11Code>
<ProductNDC>63459-506</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Actiq</ProprietaryName>
<NonProprietaryName>Fentanyl Citrate</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL; TRANSMUCOSAL</RouteName>
<StartMarketingDate>19990120</StartMarketingDate>
<EndMarketingDate>20240531</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020747</ApplicationNumber>
<LabelerName>Cephalon, LLC</LabelerName>
<SubstanceName>FENTANYL CITRATE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19990120</StartMarketingDatePackage>
<EndMarketingDatePackage>20240531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ACTIQ is indicated for the management of breakthrough pain in cancer patients 16 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids when taking ACTIQ. Limitations of Use: 1 Not for use in opioid non-tolerant patients., 2 Not for use in the management of acute or postoperative pain, including headache/migraine and dental pain [see Contraindications (4)]., 3 As a part of the TIRF REMS, ACTIQ may be dispensed by outpatient pharmacies only to outpatients enrolled in the program [see Warnings and Precautions (5.7)]. For inpatient administration of ACTIQ, patient and prescriber enrollment are not required.</IndicationAndUsage>
<Description>ACTIQ (fentanyl citrate) oral transmucosal lozenge is a solid formulation of fentanyl, an opioid agonist, intended for oral transmucosal administration. ACTIQ is formulated as a white to off-white solid drug matrix on a handle that is fracture resistant (ABS plastic) under normal conditions when used as directed. ACTIQ is designed to be dissolved slowly in the mouth to facilitate transmucosal absorption. The handle allows the ACTIQ unit to be removed from the mouth if signs of excessive opioid effects appear during administration. Active Ingredient: Fentanyl citrate, USP is N-(1-Phenethyl-4-piperidyl) propionanilide citrate (1:1). Fentanyl is a highly lipophilic compound (octanol-water partition coefficient at pH 7.4 is 816:1) that is freely soluble in organic solvents and sparingly soluble in water (1:40). The molecular weight of the free base is 336.5 (the citrate salt is 528.6). The pKa of the tertiary nitrogens are 7.3 and 8.4. The compound has the following structural formula. Inactive Ingredients: Hydrated dextrates, citric acid, dibasic sodium phosphate, artificial berry flavor, magnesium stearate, and edible glue (modified food starch and confectioner’s sugar).</Description>
</NDC>
<NDC>
<NDCCode>64642-506-51</NDCCode>
<PackageDescription>10 kg in 1 BAG (64642-506-51)</PackageDescription>
<NDC11Code>64642-0506-51</NDC11Code>
<ProductNDC>64642-506</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19980201</StartMarketingDate>
<EndMarketingDate>20200124</EndMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Ishihara Sangyo Kaisha, Ltd.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>8.1</StrengthNumber>
<StrengthUnit>kg/10kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>65162-506-03</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-03) </PackageDescription>
<NDC11Code>65162-0506-03</NDC11Code>
<ProductNDC>65162-506</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091549</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indomethacin extended-release capsules are indicated for: : 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease, 2 Moderate to severe ankylosing spondylitis , 3 Moderate to severe osteoarthritis , 4 Acute painful shoulder (bursitis and/or tendinitis).</IndicationAndUsage>
<Description>Indomethacin extended-release capsules, USP are nonsteroidal anti-inflammatory drugs, available as capsules containing 75 mg of indomethacin, USP, administered for oral use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C19H16ClNO4, and it has the following chemical structure. Indomethacin, USP is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in indomethacin extended-release capsules USP, 75 mg include: ammonia, black iron oxide, butyl alcohol, corn starch, dehydrated alcohol, FD&C Blue No. 1, FD&C Green No.3, FD&C Yellow No. 5, FD&C Red No. 40, gelatin, isopropyl alcohol, lactose monohydrate, potassium hydroxide, povidone, propylene glycol, shellac, sucrose and talc. This Product meets the USP Drug Release Test 2 Specifications.</Description>
</NDC>
<NDC>
<NDCCode>65162-506-06</NDCCode>
<PackageDescription>60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-06) </PackageDescription>
<NDC11Code>65162-0506-06</NDC11Code>
<ProductNDC>65162-506</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091549</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indomethacin extended-release capsules are indicated for: : 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease, 2 Moderate to severe ankylosing spondylitis , 3 Moderate to severe osteoarthritis , 4 Acute painful shoulder (bursitis and/or tendinitis).</IndicationAndUsage>
<Description>Indomethacin extended-release capsules, USP are nonsteroidal anti-inflammatory drugs, available as capsules containing 75 mg of indomethacin, USP, administered for oral use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C19H16ClNO4, and it has the following chemical structure. Indomethacin, USP is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in indomethacin extended-release capsules USP, 75 mg include: ammonia, black iron oxide, butyl alcohol, corn starch, dehydrated alcohol, FD&C Blue No. 1, FD&C Green No.3, FD&C Yellow No. 5, FD&C Red No. 40, gelatin, isopropyl alcohol, lactose monohydrate, potassium hydroxide, povidone, propylene glycol, shellac, sucrose and talc. This Product meets the USP Drug Release Test 2 Specifications.</Description>
</NDC>
<NDC>
<NDCCode>65162-506-09</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-09) </PackageDescription>
<NDC11Code>65162-0506-09</NDC11Code>
<ProductNDC>65162-506</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091549</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indomethacin extended-release capsules are indicated for: : 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease, 2 Moderate to severe ankylosing spondylitis , 3 Moderate to severe osteoarthritis , 4 Acute painful shoulder (bursitis and/or tendinitis).</IndicationAndUsage>
<Description>Indomethacin extended-release capsules, USP are nonsteroidal anti-inflammatory drugs, available as capsules containing 75 mg of indomethacin, USP, administered for oral use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C19H16ClNO4, and it has the following chemical structure. Indomethacin, USP is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in indomethacin extended-release capsules USP, 75 mg include: ammonia, black iron oxide, butyl alcohol, corn starch, dehydrated alcohol, FD&C Blue No. 1, FD&C Green No.3, FD&C Yellow No. 5, FD&C Red No. 40, gelatin, isopropyl alcohol, lactose monohydrate, potassium hydroxide, povidone, propylene glycol, shellac, sucrose and talc. This Product meets the USP Drug Release Test 2 Specifications.</Description>
</NDC>
<NDC>
<NDCCode>65162-506-10</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-10) </PackageDescription>
<NDC11Code>65162-0506-10</NDC11Code>
<ProductNDC>65162-506</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091549</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indomethacin extended-release capsules are indicated for: : 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease, 2 Moderate to severe ankylosing spondylitis , 3 Moderate to severe osteoarthritis , 4 Acute painful shoulder (bursitis and/or tendinitis).</IndicationAndUsage>
<Description>Indomethacin extended-release capsules, USP are nonsteroidal anti-inflammatory drugs, available as capsules containing 75 mg of indomethacin, USP, administered for oral use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C19H16ClNO4, and it has the following chemical structure. Indomethacin, USP is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in indomethacin extended-release capsules USP, 75 mg include: ammonia, black iron oxide, butyl alcohol, corn starch, dehydrated alcohol, FD&C Blue No. 1, FD&C Green No.3, FD&C Yellow No. 5, FD&C Red No. 40, gelatin, isopropyl alcohol, lactose monohydrate, potassium hydroxide, povidone, propylene glycol, shellac, sucrose and talc. This Product meets the USP Drug Release Test 2 Specifications.</Description>
</NDC>
<NDC>
<NDCCode>65162-506-11</NDCCode>
<PackageDescription>1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-11) </PackageDescription>
<NDC11Code>65162-0506-11</NDC11Code>
<ProductNDC>65162-506</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091549</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indomethacin extended-release capsules are indicated for: : 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease, 2 Moderate to severe ankylosing spondylitis , 3 Moderate to severe osteoarthritis , 4 Acute painful shoulder (bursitis and/or tendinitis).</IndicationAndUsage>
<Description>Indomethacin extended-release capsules, USP are nonsteroidal anti-inflammatory drugs, available as capsules containing 75 mg of indomethacin, USP, administered for oral use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C19H16ClNO4, and it has the following chemical structure. Indomethacin, USP is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in indomethacin extended-release capsules USP, 75 mg include: ammonia, black iron oxide, butyl alcohol, corn starch, dehydrated alcohol, FD&C Blue No. 1, FD&C Green No.3, FD&C Yellow No. 5, FD&C Red No. 40, gelatin, isopropyl alcohol, lactose monohydrate, potassium hydroxide, povidone, propylene glycol, shellac, sucrose and talc. This Product meets the USP Drug Release Test 2 Specifications.</Description>
</NDC>
<NDC>
<NDCCode>65162-506-50</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-506-50) </PackageDescription>
<NDC11Code>65162-0506-50</NDC11Code>
<ProductNDC>65162-506</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Indomethacin</ProprietaryName>
<NonProprietaryName>Indomethacin</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091549</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>INDOMETHACIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indomethacin extended-release capsules are indicated for: : 1 Moderate to severe rheumatoid arthritis including acute flares of chronic disease, 2 Moderate to severe ankylosing spondylitis , 3 Moderate to severe osteoarthritis , 4 Acute painful shoulder (bursitis and/or tendinitis).</IndicationAndUsage>
<Description>Indomethacin extended-release capsules, USP are nonsteroidal anti-inflammatory drugs, available as capsules containing 75 mg of indomethacin, USP, administered for oral use. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C19H16ClNO4, and it has the following chemical structure. Indomethacin, USP is a white to yellow crystalline powder. It is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali. The inactive ingredients in indomethacin extended-release capsules USP, 75 mg include: ammonia, black iron oxide, butyl alcohol, corn starch, dehydrated alcohol, FD&C Blue No. 1, FD&C Green No.3, FD&C Yellow No. 5, FD&C Red No. 40, gelatin, isopropyl alcohol, lactose monohydrate, potassium hydroxide, povidone, propylene glycol, shellac, sucrose and talc. This Product meets the USP Drug Release Test 2 Specifications.</Description>
</NDC>
<NDC>
<NDCCode>65585-506-03</NDCCode>
<PackageDescription>8 BAG in 1 BOX (65585-506-03) > 1000 mL in 1 BAG</PackageDescription>
<NDC11Code>65585-0506-03</NDC11Code>
<ProductNDC>65585-506</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Whiskcare 357</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20111110</StartMarketingDate>
<EndMarketingDate>20141231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Whisk Products, Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-01-02</LastUpdate>
</NDC>
</NDCList>