{
"NDC": [
{
"NDCCode": "15370-403-30",
"PackageDescription": "30 POUCH in 1 CARTON (15370-403-30) / 1 FILM, SOLUBLE in 1 POUCH (15370-403-01) ",
"NDC11Code": "15370-0403-30",
"ProductNDC": "15370-403",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Opipza",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "FILM, SOLUBLE",
"RouteName": "ORAL",
"StartMarketingDate": "20241101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216655",
"LabelerName": "Carwin Pharmaceutical Associates, LLC",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241101",
"SamplePackage": "N",
"IndicationAndUsage": "OPIPZA is indicated for the: 1 treatment of schizophrenia in patients ages 13 years and older, 2 adjunctive treatment of major depressive disorder (MDD) in adults, 3 treatment of irritability associated with autistic disorder in pediatric patients 6 years and older, 4 treatment of Tourette's disorder in pediatric patients 6 years and older.",
"Description": "OPIPZA contains aripiprazole, an atypical antipsychotic drug. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. Aripiprazole has a pKa of 6.2. It is freely soluble in dichloromethane, sparingly soluble in toluene, and insoluble in methanol and water. The empirical formula is C23H27Cl2N3O2 with a molecular weight of 448.38. The chemical structure is. OPIPZA is for oral administration and is available in 2 mg, 5 mg, and 10 mg strengths. Inactive ingredients include hydroxypropyl cellulose, sodium lauryl sulfate, and sucralose. Imprinting ink contains glycerin, FD&C Blue No.1, polysorbate 20, and propylene glycol."
},
{
"NDCCode": "15370-103-30",
"PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE (15370-103-30) ",
"NDC11Code": "15370-0103-30",
"ProductNDC": "15370-103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quflora Pediatric",
"NonProprietaryName": "Vitamin A Acetate, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Dl-, Thiamine Hydrochloride, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Levomefolic Acid, Folic Acid, Cyanocobalamin, Magnesium Oxide, Cupric Sulfate, And Sodium Fluoride",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20140106",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "CarWin Pharmaceutical Associates, LLC",
"SubstanceName": "VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL, DL-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLIC ACID; FOLIC ACID; CYANOCOBALAMIN; MAGNESIUM OXIDE; CUPRIC SULFATE; SODIUM FLUORIDE",
"StrengthNumber": "1200; 60; 400; 15; 1.2; 1.3; 5; 1.5; 108; 100; 4; 15; 1; .25",
"StrengthUnit": "[iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calculi Dissolution Agent [EPC], Folate Analog [EPC], Folic Acid [CS], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140106",
"SamplePackage": "N",
"IndicationAndUsage": "Quflora Pediatric Chewable Tablets with 0.5 mg Fluoride is a prescription dietary fluoride supplement providing twelve essential vitamins and minerals.",
"Description": "Quflora Pediatric Chewable Tablets with 0.5 mg Fluoride is a yellow round tablet imprinted \"104\"."
},
{
"NDCCode": "15370-104-30",
"PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE (15370-104-30) ",
"NDC11Code": "15370-0104-30",
"ProductNDC": "15370-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quflora Pediatric",
"NonProprietaryName": "Vitamin A Acetate, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Dl-, Thiamine Hydrochloride, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Levomefolic Acid, Folic Acid, Cyanocobalamin, Magnesium Oxide, Cupric Sulfate, And Sodium Fluoride",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20140106",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "CarWin Pharmaceutical Associates, LLC",
"SubstanceName": "VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL, DL-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLIC ACID; FOLIC ACID; CYANOCOBALAMIN; MAGNESIUM OXIDE; CUPRIC SULFATE; SODIUM FLUORIDE",
"StrengthNumber": "1200; 60; 400; 15; 1.2; 1.3; 5; 1.5; 108; 100; 4; 15; 1; .5",
"StrengthUnit": "[iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calculi Dissolution Agent [EPC], Folate Analog [EPC], Folic Acid [CS], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140106",
"SamplePackage": "N",
"IndicationAndUsage": "Quflora Pediatric Chewable Tablets with 0.5 mg Fluoride is a prescription dietary fluoride supplement providing twelve essential vitamins and minerals.",
"Description": "Quflora Pediatric Chewable Tablets with 0.5 mg Fluoride is a yellow round tablet imprinted \"104\"."
},
{
"NDCCode": "15370-105-30",
"PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE (15370-105-30) ",
"NDC11Code": "15370-0105-30",
"ProductNDC": "15370-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quflora Pediatric",
"NonProprietaryName": "Vitamin A Acetate, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Dl-, Thiamine Hydrochloride, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Levomefolic Acid, Folic Acid, Cyanocobalamin, Magnesium Oxide, Cupric Sulfate, And Sodium Fluoride",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20140106",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "CarWin Pharmaceutical Associates, LLC",
"SubstanceName": "VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL, DL-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLIC ACID; FOLIC ACID; CYANOCOBALAMIN; MAGNESIUM OXIDE; CUPRIC SULFATE; SODIUM FLUORIDE",
"StrengthNumber": "1200; 60; 400; 15; 1.2; 1.3; 5; 1.5; 108; 100; 4; 15; 1; 1",
"StrengthUnit": "[iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calculi Dissolution Agent [EPC], Folate Analog [EPC], Folic Acid [CS], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140106",
"SamplePackage": "N",
"IndicationAndUsage": "Quflora Pediatric Chewable Tablets with 0.5 mg Fluoride is a prescription dietary fluoride supplement providing twelve essential vitamins and minerals.",
"Description": "Quflora Pediatric Chewable Tablets with 0.5 mg Fluoride is a yellow round tablet imprinted \"104\"."
},
{
"NDCCode": "15370-170-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (15370-170-30) ",
"NDC11Code": "15370-0170-30",
"ProductNDC": "15370-170",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Relafen Ds",
"NonProprietaryName": "Nabumetone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190920",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203166",
"LabelerName": "Carwin Pharmaceutical Associates, LLC",
"SubstanceName": "NABUMETONE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190920",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of nabumetone tablets and other treatment options before deciding to use nabumetone tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS]. Nabumetone tablets are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.",
"Description": "Nabumetone is a naphthylalkanone designated chemically as 4-(6-methoxy-2-naphthalenyl)-2-butanone. It has the following structure. Nabumetone is a white to off-white crystalline substance. It is nonacidic and practically insoluble in water, but soluble in alcohol and most organic solvents. It has an n-octanol:phosphate buffer partition coefficient of 2,400 at pH 7.4. Each tablet, for oral administration, contains either 500 mg, 750 mg, or 1000 mg of nabumetone. In addition, each tablet contains the following inactive ingredients: povidone, croscarmellose, magnesium stearate, sodium lauryl sulfate, and colloidal silicon dioxide. The coating contains hydroxypropyl cellulose and hypromellose."
},
{
"NDCCode": "15370-185-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (15370-185-30) ",
"NDC11Code": "15370-0185-30",
"ProductNDC": "15370-185",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Potassium",
"NonProprietaryName": "Diclofenac Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20231101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076561",
"LabelerName": "Carwin Pharmaceutical Associates, LLC",
"SubstanceName": "DICLOFENAC POTASSIUM",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231101",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac potassium tablets, and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac potassium tablets is indicated: 1 For treatment of primary dysmenorrhea, 2 For relief of mild to moderate pain, 3 For relief of the signs and symptoms of osteoarthritis, 4 For relief of the signs and symptoms of rheumatoid arthritis.",
"Description": "Diclofenac potassium tablets are a benzeneacetic acid derivative. Diclofenac potassium tablets are available as tablets of 25 mg (yellow) for oral administration. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monopotassium salt. The molecular weight is 334.25. Its molecular formula is C14H10Cl2NKO2, and it has the following structural formula. Each 25mg diclofenac potassium tablets intended for oral administration, contains 25 mg diclofenac potassium for oral administration. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hydroxyethyl cellulose, iron oxide red, magnesium stearate, methanol, polyethylene glycol, povidone, sodium bicarbonate, titanium dioxide and yellow iron oxide."
},
{
"NDCCode": "15370-250-30",
"PackageDescription": "30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (15370-250-30) ",
"NDC11Code": "15370-0250-30",
"ProductNDC": "15370-250",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tristart Dha",
"NonProprietaryName": "Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, D-, Thiamine Hydrochloride, Riboflavin, Niacin, Pyridoxine Hydrochloride, Levomefolate Magnesium, Folic Acid, Cyanocobalamin, Iron Pentacarbonyl, Potassium Iodide, Magnesium Oxide, Doconexent, And Icosapent",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20150601",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "CarWin Pharmaceutical Associates, LLC",
"SubstanceName": "ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, D-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN; NIACIN; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLATE MAGNESIUM; FOLIC ACID; CYANOCOBALAMIN; IRON PENTACARBONYL; POTASSIUM IODIDE; MAGNESIUM OXIDE; DOCONEXENT; ICOSAPENT",
"StrengthNumber": "55; 1000; 15; 1.3; 1.8; 5; 35; 600; 400; 14; 31; 200; 30; 200; 15",
"StrengthUnit": "mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calculi Dissolution Agent [EPC], Folate Analog [EPC], Folic Acid [CS], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Nicotinic Acid [EPC], Nicotinic Acids [CS], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150601",
"SamplePackage": "N",
"IndicationAndUsage": "TriStart DHA is an orally administered multivitamin/multimineral fatty acid dietary supplement indicated to improve the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. TriStart DHA can also be beneficial in improving the nutritional status of women prior to conception.This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent disease.",
"Description": "OTHER INGREDIENTS: Gelatin (bovine), Glycerin, Purified Water, Yellow Bees Wax, Caramel Powder, Soy Lecithin, Natural Orange Flavor, Ethyl Vanillin. Contains: Soy and Fish. TriStart DHA Softgel capsules are dye free, lactose, gluten and sugar free. They do not contain any artificial flavors or sweeteners. TriStart DHA contains bovine gelatin."
},
{
"NDCCode": "15370-265-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (15370-265-30)",
"NDC11Code": "15370-0265-30",
"ProductNDC": "15370-265",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nufera",
"NonProprietaryName": "Ascorbic Acid, Cholecalciferol, Pyridoxine Hydrochloride, Levomefolate Magnesium, Folic Acid, Cyanocobalamin, And Iron Pentacarbonyl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151216",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "CarWin Pharmaceutical Associates, LLC",
"SubstanceName": "ASCORBIC ACID; CHOLECALCIFEROL; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLATE MAGNESIUM; FOLIC ACID; CYANOCOBALAMIN; IRON PENTACARBONYL",
"StrengthNumber": "170; 1000; 15; 600; 400; 16; 125",
"StrengthUnit": "mg/1; [iU]/1; mg/1; ug/1; ug/1; ug/1; mg/1",
"Pharm_Classes": "Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "15370-305-30",
"PackageDescription": "30 POUCH in 1 CARTON (15370-305-30) / .79 g in 1 POUCH (15370-305-01) ",
"NDC11Code": "15370-0305-30",
"ProductNDC": "15370-305",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pokonza",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20230919",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208019",
"LabelerName": "Carwin Pharmaceutical Associates, LLC",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": ".75",
"StrengthUnit": "g/.79g",
"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": "2024-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240318",
"SamplePackage": "N",
"IndicationAndUsage": "POKONZA (Potassium Chloride for Oral Solution, USP) 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 is a white crystalline or colorless solid. It is soluble in water and slightly soluble in alcohol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55. Each pouch of POKONZA (Potassium Chloride for Oral Solution, USP) is a light pink to orange powder containing: 1 10 mEq: contains 0.75 g of potassium chloride, USP, which is equivalent to potassium 10 mEq and chloride 10 mEq and the following inactive ingredients: citric acid anhydrous, colloidal silicon dioxide, FD&C Yellow #6, natural and artificial orange flavor, and sucralose."
},
{
"NDCCode": "15370-306-30",
"PackageDescription": "30 POUCH in 1 CARTON (15370-306-30) / 1.185 g in 1 POUCH",
"NDC11Code": "15370-0306-30",
"ProductNDC": "15370-306",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pokonza",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20251209",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208019",
"LabelerName": "Carwin Pharmaceutical Associates, LLC",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "1.125",
"StrengthUnit": "g/1.185g",
"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": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251209",
"SamplePackage": "N",
"IndicationAndUsage": "POKONZA® (Potasium Chloride for Oral Solution, USP) 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 is a white crystalline or colorless solid. It is soluble in water and slightly soluble in alcohol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55. Each pouch of POKONZA® (Potassium Chloride for Oral Solution, USP) is a light pink to orange powder containing: 1 10 mEq: contains 0.75 g of potassium chloride, USP, which is equivalent to potassium 10 mEq and chloride 10 mEq and the following inactive ingredients: citric acid anhydrous, colloidal silicon dioxide, FD&C Yellow #6, natural and artificial orange flavor, and sucralose., 2 15 mEq: contains 1.185 g of potassium chloride, USP, which is equivalent to potassium 15 mEq and chloride 15 mEq and the following inactive ingredients: citric acid anhydrous, colloidal silicon dioxide, FD&C Yellow #6, natural and artificial orange flavor, and sucralose."
},
{
"NDCCode": "15370-401-30",
"PackageDescription": "30 POUCH in 1 CARTON (15370-401-30) / 1 FILM, SOLUBLE in 1 POUCH (15370-401-01) ",
"NDC11Code": "15370-0401-30",
"ProductNDC": "15370-401",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Opipza",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "FILM, SOLUBLE",
"RouteName": "ORAL",
"StartMarketingDate": "20241101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216655",
"LabelerName": "Carwin Pharmaceutical Associates, LLC",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241101",
"SamplePackage": "N",
"IndicationAndUsage": "OPIPZA is indicated for the: 1 treatment of schizophrenia in patients ages 13 years and older, 2 adjunctive treatment of major depressive disorder (MDD) in adults, 3 treatment of irritability associated with autistic disorder in pediatric patients 6 years and older, 4 treatment of Tourette's disorder in pediatric patients 6 years and older.",
"Description": "OPIPZA contains aripiprazole, an atypical antipsychotic drug. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. Aripiprazole has a pKa of 6.2. It is freely soluble in dichloromethane, sparingly soluble in toluene, and insoluble in methanol and water. The empirical formula is C23H27Cl2N3O2 with a molecular weight of 448.38. The chemical structure is. OPIPZA is for oral administration and is available in 2 mg, 5 mg, and 10 mg strengths. Inactive ingredients include hydroxypropyl cellulose, sodium lauryl sulfate, and sucralose. Imprinting ink contains glycerin, FD&C Blue No.1, polysorbate 20, and propylene glycol."
},
{
"NDCCode": "15370-402-30",
"PackageDescription": "30 POUCH in 1 CARTON (15370-402-30) / 1 FILM, SOLUBLE in 1 POUCH (15370-402-01) ",
"NDC11Code": "15370-0402-30",
"ProductNDC": "15370-402",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Opipza",
"NonProprietaryName": "Aripiprazole",
"DosageFormName": "FILM, SOLUBLE",
"RouteName": "ORAL",
"StartMarketingDate": "20241101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216655",
"LabelerName": "Carwin Pharmaceutical Associates, LLC",
"SubstanceName": "ARIPIPRAZOLE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241101",
"SamplePackage": "N",
"IndicationAndUsage": "OPIPZA is indicated for the: 1 treatment of schizophrenia in patients ages 13 years and older, 2 adjunctive treatment of major depressive disorder (MDD) in adults, 3 treatment of irritability associated with autistic disorder in pediatric patients 6 years and older, 4 treatment of Tourette's disorder in pediatric patients 6 years and older.",
"Description": "OPIPZA contains aripiprazole, an atypical antipsychotic drug. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. Aripiprazole has a pKa of 6.2. It is freely soluble in dichloromethane, sparingly soluble in toluene, and insoluble in methanol and water. The empirical formula is C23H27Cl2N3O2 with a molecular weight of 448.38. The chemical structure is. OPIPZA is for oral administration and is available in 2 mg, 5 mg, and 10 mg strengths. Inactive ingredients include hydroxypropyl cellulose, sodium lauryl sulfate, and sucralose. Imprinting ink contains glycerin, FD&C Blue No.1, polysorbate 20, and propylene glycol."
},
{
"NDCCode": "16590-403-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (16590-403-30)",
"NDC11Code": "16590-0403-30",
"ProductNDC": "16590-403",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20031201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021210",
"LabelerName": "STAT Rx USA LLC",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": ".05",
"StrengthUnit": "mg/1",
"Pharm_Classes": "l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Levothyroxine sodium is used for the following indications. Hypothyroidism - As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter. Pituitary TSH Suppression - In the treatment or prevention of various types of euthyroid goiters (see WARNINGS and PRECAUTIONS), including thyroid nodules (see WARNINGS and PRECAUTIONS), subacute or chronic Iymphocytic thyroiditis (Hashimoto's thyroiditis), multinodular goiter (see WARNINGS and PRECAUTIONS), and, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.",
"Description": "Levothyroxine Sodium Tablets, USP contain synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4N NaO4 H2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown."
},
{
"NDCCode": "21695-403-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (21695-403-30)",
"NDC11Code": "21695-0403-30",
"ProductNDC": "21695-403",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19991220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074984",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "Diltiazem hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-benzothiazepin-4(5 H)one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem hydrochloride is formulated as a once-a-day extended release capsule containing either 120 mg, 180 mg, 240 mg, or 300 mg diltiazem hydrochloride. Each diltiazem extended-release capsule, for oral administration, contains the following inactive ingredients. 120 mg â ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, black iron oxide, gelatin, hydroxypropyl cellulose, pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate. 180 mg â ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, D&C yellow #10, FD&C blue #1, FD&C green #3, gelatin, hydroxypropyl cellulose, pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate. 240 mg â ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, D&C yellow #10, FD&C green #3, gelatin, hydroxypropyl cellulose, pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate. 300 mgâ ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, black iron oxide, D&C yellow #10, FD&C green #3, gelatin, hydroxypropyl cellulose, pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate. This drug product conforms to USP Drug release test #11."
},
{
"NDCCode": "24236-403-02",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (24236-403-02)",
"NDC11Code": "24236-0403-02",
"ProductNDC": "24236-403",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propranolol Hydrochloride",
"NonProprietaryName": "Propranolol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070622",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071972",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "PROPRANOLOL HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-10-20",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "35356-403-30",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (35356-403-30)",
"NDC11Code": "35356-0403-30",
"ProductNDC": "35356-403",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Opana",
"ProprietaryNameSuffix": "Er",
"NonProprietaryName": "Oxymorphone Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120214",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA201655",
"LabelerName": "Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC",
"SubstanceName": "OXYMORPHONE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2016-12-22"
},
{
"NDCCode": "35573-403-31",
"PackageDescription": "1 TUBE in 1 CARTON (35573-403-31) > 30 g in 1 TUBE",
"NDC11Code": "35573-0403-31",
"ProductNDC": "35573-403",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190509",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205591",
"LabelerName": "Burel Pharmaceuticals, LLC",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20190509",
"SamplePackage": "N"
},
{
"NDCCode": "37000-403-01",
"PackageDescription": "1 KIT in 1 PACKAGE (37000-403-01) * 354 mL in 1 BOTTLE, PLASTIC (37000-032-03) * 1 BOTTLE, PLASTIC in 1 CARTON (37000-691-30) > 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC",
"NDC11Code": "37000-0403-01",
"ProductNDC": "37000-403",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pepto-bismol",
"NonProprietaryName": "Bismuth Subsalicylate",
"DosageFormName": "KIT",
"StartMarketingDate": "20120305",
"EndMarketingDate": "20211201",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part335",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"Status": "Deprecated",
"LastUpdate": "2021-12-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20120305",
"EndMarketingDatePackage": "20211201",
"SamplePackage": "N"
},
{
"NDCCode": "43063-403-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-403-30) ",
"NDC11Code": "43063-0403-30",
"ProductNDC": "43063-403",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benazepril Hydrochloride",
"NonProprietaryName": "Benazepril Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100906",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076118",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "BENAZEPRIL HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20100930",
"SamplePackage": "N"
},
{
"NDCCode": "46708-403-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (46708-403-30) ",
"NDC11Code": "46708-0403-30",
"ProductNDC": "46708-403",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nadolol",
"NonProprietaryName": "Nadolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230608",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211763",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "NADOLOL",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-06-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230608",
"SamplePackage": "N",
"IndicationAndUsage": "Angina Pectoris. Nadolol tablets are indicated for the long-term management of patients with angina pectoris. Hypertension. Nadolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with nadolol tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Programâs Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Nadolol tablets may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.",
"Description": "Nadolol, USP is a synthetic nonselective beta-adrenergic receptor blocking agent designated chemically as 1-(tert-butylamino)-3-[(5,6,7,8-tetrahydro-cis-6,7-dihydroxy-1- naphthyl)oxy]-2-propanol. Structural formula. C17H27NO4 MW 309.40. Nadolol, USP is a white to off-white powder. It is freely soluble in alcohol and in methanol, soluble in water at pH 2, slightly soluble in chloroform, in methylene chloride, in isopropyl alcohol, and in water (between pH 7 and pH 10); insoluble in acetone, in benzene, in ether, in hexane, and in trichloroethane. Each tablet for oral administration contains 20 mg, 40 mg, or 80 mg of nadolol, USP and the following inactive ingredients: povidone K-30, corn starch, microcrystalline cellulose, citric acid monohydrate, FD&C Blue No. 2 Aluminum Lake, and magnesium stearate."
},
{
"NDCCode": "49643-403-30",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49643-403-30) ",
"NDC11Code": "49643-0403-30",
"ProductNDC": "49643-403",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "California Scrub Oak Pollen",
"NonProprietaryName": "Quercus Dumosa",
"DosageFormName": "INJECTION",
"RouteName": "CUTANEOUS; INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740312",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102211",
"LabelerName": "Allermed Laboratories, Inc.",
"SubstanceName": "QUERCUS DUMOSA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19740312",
"SamplePackage": "N",
"IndicationAndUsage": "Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.",
"Description": "Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength."
},
{
"NDCCode": "49852-403-01",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BLISTER PACK (49852-403-01) > 30 mL in 1 BOTTLE, PLASTIC (49852-403-30) ",
"NDC11Code": "49852-0403-01",
"ProductNDC": "49852-403",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kindred Goods",
"ProprietaryNameSuffix": "Hand Sanitizer Sea Salt Fig",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180921",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Tri-Coastal Design Company Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "68",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20180921",
"SamplePackage": "N",
"IndicationAndUsage": "For decreasing bacteria on the skin."
},
{
"NDCCode": "49873-403-01",
"PackageDescription": "2 BOTTLE in 1 CARTON (49873-403-01) / 30 mL in 1 BOTTLE",
"NDC11Code": "49873-0403-01",
"ProductNDC": "49873-403",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Inon Ace",
"NonProprietaryName": "Magnesium Aluminosilicate, Magnesium Hydroxide",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20000520",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "Sato Pharmaceutical Co., Ltd.",
"SubstanceName": "SILODRATE; MAGNESIUM HYDROXIDE",
"StrengthNumber": "900; 250",
"StrengthUnit": "mg/30mL; mg/30mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2023-12-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20000520",
"SamplePackage": "N",
"IndicationAndUsage": "Uses relieves these symptoms: â heartburn â sour stomach â acid indigestion."
},
{
"NDCCode": "51346-403-02",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (51346-403-02) > 30 mL in 1 BOTTLE, PUMP (51346-403-01)",
"NDC11Code": "51346-0403-02",
"ProductNDC": "51346-403",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Provence Air Skin Fit Foundation Pink Beige C01",
"NonProprietaryName": "Titanium Dioxide, Octinoxate, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "NATURE REPUBLIC CO., LTD.",
"SubstanceName": "TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE",
"StrengthNumber": "3.24; .9; .57",
"StrengthUnit": "g/30mL; g/30mL; g/30mL",
"Status": "Deprecated",
"LastUpdate": "2020-08-19",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "51655-403-52",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (51655-403-52) ",
"NDC11Code": "51655-0403-52",
"ProductNDC": "51655-403",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Digoxin",
"NonProprietaryName": "Digoxin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230413",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215307",
"LabelerName": "Northwind Health Company, LLC",
"SubstanceName": "DIGOXIN",
"StrengthNumber": ".125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cardiac Glycoside [EPC], Cardiac Glycosides [CS]",
"Status": "Active",
"LastUpdate": "2026-01-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230413",
"SamplePackage": "N",
"IndicationAndUsage": "Digoxin is a cardiac glycoside indicated for: : 1 Treatment of mild to moderate heart failure in adults. (1.1), 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2), 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).",
"Description": "Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term âdigitalisâ is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence âglycosidesâ). Digoxin is described chemically as (3β,5β,12β)-3-[( O-2,6-dideoxy-β- D-ribo-hexopyranosyl-(1â4)- O- 2,6-dideoxy-β- D-ribo-hexopyranosyl-(1â4)-2,6-dideoxy-β- D- ribo-hexopyranosyl)oxy]-12,14- dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is:. Digoxin exists as white or almost white powder or colorless crystals. The drug is practically insoluble in water; soluble in mixture of methanol & methylene chloride and slightly soluble in ethyl alcohol. Digoxin is supplied as 62.5 mcg (unscored), 125 mcg (scored), and 250 mcg (scored) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, lactose anhydrous, magnesium stearate. Additionally, the 62.5 mcg tablets contain FD&C Yellow No. 6 and 125 mcg tablets contain yellow iron oxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "52125-403-02",
"PackageDescription": "30 TABLET in 1 VIAL (52125-403-02)",
"NDC11Code": "52125-0403-02",
"ProductNDC": "52125-403",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Finasteride",
"NonProprietaryName": "Finasteride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076437",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "FINASTERIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-01-13"
},
{
"NDCCode": "52685-403-30",
"PackageDescription": "1 TRAY in 1 CARTON (52685-403-30) > 9.8 g in 1 TRAY",
"NDC11Code": "52685-0403-30",
"ProductNDC": "52685-403",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Shiseido Sheer Matifying Compact (refill)",
"ProprietaryNameSuffix": "O60",
"NonProprietaryName": "Octinoxate And Titanium Dioxide",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120301",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SHISEIDO CO., LTD.",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "382; 588",
"StrengthUnit": "mg/9.8g; mg/9.8g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20120301",
"SamplePackage": "N"
},
{
"NDCCode": "53041-403-30",
"PackageDescription": "368 g in 1 CANISTER (53041-403-30)",
"NDC11Code": "53041-0403-30",
"ProductNDC": "53041-403",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Smooth Texture Orange Flavor",
"NonProprietaryName": "Psyllium Husk",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20030101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Guardian",
"SubstanceName": "PSYLLIUM HUSK",
"StrengthNumber": "3.4",
"StrengthUnit": "g/12g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "55111-403-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (55111-403-30)",
"NDC11Code": "55111-0403-30",
"ProductNDC": "55111-403",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zonisamide",
"NonProprietaryName": "Zonisamide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20051222",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077645",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "ZONISAMIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Anti-epileptic Agent [EPC],Sulfonamides [CS],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-04-11",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55289-403-92",
"PackageDescription": "1 KIT in 1 CARTON (55289-403-92) * 30 TABLET in 1 BOTTLE, PLASTIC (55289-567-30) * 60 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "55289-0403-92",
"ProductNDC": "55289-403",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Comfort Pac With Cyclobenzaprine",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20130715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078218",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
}
]
}
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<NDCList>
<NDC>
<NDCCode>15370-403-30</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (15370-403-30) / 1 FILM, SOLUBLE in 1 POUCH (15370-403-01) </PackageDescription>
<NDC11Code>15370-0403-30</NDC11Code>
<ProductNDC>15370-403</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Opipza</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>FILM, SOLUBLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216655</ApplicationNumber>
<LabelerName>Carwin Pharmaceutical Associates, LLC</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OPIPZA is indicated for the: 1 treatment of schizophrenia in patients ages 13 years and older, 2 adjunctive treatment of major depressive disorder (MDD) in adults, 3 treatment of irritability associated with autistic disorder in pediatric patients 6 years and older, 4 treatment of Tourette's disorder in pediatric patients 6 years and older.</IndicationAndUsage>
<Description>OPIPZA contains aripiprazole, an atypical antipsychotic drug. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. Aripiprazole has a pKa of 6.2. It is freely soluble in dichloromethane, sparingly soluble in toluene, and insoluble in methanol and water. The empirical formula is C23H27Cl2N3O2 with a molecular weight of 448.38. The chemical structure is. OPIPZA is for oral administration and is available in 2 mg, 5 mg, and 10 mg strengths. Inactive ingredients include hydroxypropyl cellulose, sodium lauryl sulfate, and sucralose. Imprinting ink contains glycerin, FD&C Blue No.1, polysorbate 20, and propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>15370-103-30</NDCCode>
<PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE (15370-103-30) </PackageDescription>
<NDC11Code>15370-0103-30</NDC11Code>
<ProductNDC>15370-103</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quflora Pediatric</ProprietaryName>
<NonProprietaryName>Vitamin A Acetate, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Dl-, Thiamine Hydrochloride, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Levomefolic Acid, Folic Acid, Cyanocobalamin, Magnesium Oxide, Cupric Sulfate, And Sodium Fluoride</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140106</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>CarWin Pharmaceutical Associates, LLC</LabelerName>
<SubstanceName>VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL, DL-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLIC ACID; FOLIC ACID; CYANOCOBALAMIN; MAGNESIUM OXIDE; CUPRIC SULFATE; SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1200; 60; 400; 15; 1.2; 1.3; 5; 1.5; 108; 100; 4; 15; 1; .25</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calculi Dissolution Agent [EPC], Folate Analog [EPC], Folic Acid [CS], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quflora Pediatric Chewable Tablets with 0.5 mg Fluoride is a prescription dietary fluoride supplement providing twelve essential vitamins and minerals.</IndicationAndUsage>
<Description>Quflora Pediatric Chewable Tablets with 0.5 mg Fluoride is a yellow round tablet imprinted "104".</Description>
</NDC>
<NDC>
<NDCCode>15370-104-30</NDCCode>
<PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE (15370-104-30) </PackageDescription>
<NDC11Code>15370-0104-30</NDC11Code>
<ProductNDC>15370-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quflora Pediatric</ProprietaryName>
<NonProprietaryName>Vitamin A Acetate, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Dl-, Thiamine Hydrochloride, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Levomefolic Acid, Folic Acid, Cyanocobalamin, Magnesium Oxide, Cupric Sulfate, And Sodium Fluoride</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140106</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>CarWin Pharmaceutical Associates, LLC</LabelerName>
<SubstanceName>VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL, DL-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLIC ACID; FOLIC ACID; CYANOCOBALAMIN; MAGNESIUM OXIDE; CUPRIC SULFATE; SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1200; 60; 400; 15; 1.2; 1.3; 5; 1.5; 108; 100; 4; 15; 1; .5</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calculi Dissolution Agent [EPC], Folate Analog [EPC], Folic Acid [CS], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quflora Pediatric Chewable Tablets with 0.5 mg Fluoride is a prescription dietary fluoride supplement providing twelve essential vitamins and minerals.</IndicationAndUsage>
<Description>Quflora Pediatric Chewable Tablets with 0.5 mg Fluoride is a yellow round tablet imprinted "104".</Description>
</NDC>
<NDC>
<NDCCode>15370-105-30</NDCCode>
<PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE (15370-105-30) </PackageDescription>
<NDC11Code>15370-0105-30</NDC11Code>
<ProductNDC>15370-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quflora Pediatric</ProprietaryName>
<NonProprietaryName>Vitamin A Acetate, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Dl-, Thiamine Hydrochloride, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Levomefolic Acid, Folic Acid, Cyanocobalamin, Magnesium Oxide, Cupric Sulfate, And Sodium Fluoride</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140106</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>CarWin Pharmaceutical Associates, LLC</LabelerName>
<SubstanceName>VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL, DL-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLIC ACID; FOLIC ACID; CYANOCOBALAMIN; MAGNESIUM OXIDE; CUPRIC SULFATE; SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1200; 60; 400; 15; 1.2; 1.3; 5; 1.5; 108; 100; 4; 15; 1; 1</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calculi Dissolution Agent [EPC], Folate Analog [EPC], Folic Acid [CS], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quflora Pediatric Chewable Tablets with 0.5 mg Fluoride is a prescription dietary fluoride supplement providing twelve essential vitamins and minerals.</IndicationAndUsage>
<Description>Quflora Pediatric Chewable Tablets with 0.5 mg Fluoride is a yellow round tablet imprinted "104".</Description>
</NDC>
<NDC>
<NDCCode>15370-170-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (15370-170-30) </PackageDescription>
<NDC11Code>15370-0170-30</NDC11Code>
<ProductNDC>15370-170</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Relafen Ds</ProprietaryName>
<NonProprietaryName>Nabumetone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190920</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203166</ApplicationNumber>
<LabelerName>Carwin Pharmaceutical Associates, LLC</LabelerName>
<SubstanceName>NABUMETONE</SubstanceName>
<StrengthNumber>1000</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>2024-01-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190920</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of nabumetone tablets and other treatment options before deciding to use nabumetone tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS]. Nabumetone tablets are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.</IndicationAndUsage>
<Description>Nabumetone is a naphthylalkanone designated chemically as 4-(6-methoxy-2-naphthalenyl)-2-butanone. It has the following structure. Nabumetone is a white to off-white crystalline substance. It is nonacidic and practically insoluble in water, but soluble in alcohol and most organic solvents. It has an n-octanol:phosphate buffer partition coefficient of 2,400 at pH 7.4. Each tablet, for oral administration, contains either 500 mg, 750 mg, or 1000 mg of nabumetone. In addition, each tablet contains the following inactive ingredients: povidone, croscarmellose, magnesium stearate, sodium lauryl sulfate, and colloidal silicon dioxide. The coating contains hydroxypropyl cellulose and hypromellose.</Description>
</NDC>
<NDC>
<NDCCode>15370-185-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (15370-185-30) </PackageDescription>
<NDC11Code>15370-0185-30</NDC11Code>
<ProductNDC>15370-185</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Potassium</ProprietaryName>
<NonProprietaryName>Diclofenac Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076561</ApplicationNumber>
<LabelerName>Carwin Pharmaceutical Associates, LLC</LabelerName>
<SubstanceName>DICLOFENAC POTASSIUM</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac potassium tablets, and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac potassium tablets is indicated: 1 For treatment of primary dysmenorrhea, 2 For relief of mild to moderate pain, 3 For relief of the signs and symptoms of osteoarthritis, 4 For relief of the signs and symptoms of rheumatoid arthritis.</IndicationAndUsage>
<Description>Diclofenac potassium tablets are a benzeneacetic acid derivative. Diclofenac potassium tablets are available as tablets of 25 mg (yellow) for oral administration. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monopotassium salt. The molecular weight is 334.25. Its molecular formula is C14H10Cl2NKO2, and it has the following structural formula. Each 25mg diclofenac potassium tablets intended for oral administration, contains 25 mg diclofenac potassium for oral administration. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hydroxyethyl cellulose, iron oxide red, magnesium stearate, methanol, polyethylene glycol, povidone, sodium bicarbonate, titanium dioxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>15370-250-30</NDCCode>
<PackageDescription>30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (15370-250-30) </PackageDescription>
<NDC11Code>15370-0250-30</NDC11Code>
<ProductNDC>15370-250</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tristart Dha</ProprietaryName>
<NonProprietaryName>Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, D-, Thiamine Hydrochloride, Riboflavin, Niacin, Pyridoxine Hydrochloride, Levomefolate Magnesium, Folic Acid, Cyanocobalamin, Iron Pentacarbonyl, Potassium Iodide, Magnesium Oxide, Doconexent, And Icosapent</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150601</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>CarWin Pharmaceutical Associates, LLC</LabelerName>
<SubstanceName>ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, D-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN; NIACIN; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLATE MAGNESIUM; FOLIC ACID; CYANOCOBALAMIN; IRON PENTACARBONYL; POTASSIUM IODIDE; MAGNESIUM OXIDE; DOCONEXENT; ICOSAPENT</SubstanceName>
<StrengthNumber>55; 1000; 15; 1.3; 1.8; 5; 35; 600; 400; 14; 31; 200; 30; 200; 15</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calculi Dissolution Agent [EPC], Folate Analog [EPC], Folic Acid [CS], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Nicotinic Acid [EPC], Nicotinic Acids [CS], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TriStart DHA is an orally administered multivitamin/multimineral fatty acid dietary supplement indicated to improve the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. TriStart DHA can also be beneficial in improving the nutritional status of women prior to conception.This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent disease.</IndicationAndUsage>
<Description>OTHER INGREDIENTS: Gelatin (bovine), Glycerin, Purified Water, Yellow Bees Wax, Caramel Powder, Soy Lecithin, Natural Orange Flavor, Ethyl Vanillin. Contains: Soy and Fish. TriStart DHA Softgel capsules are dye free, lactose, gluten and sugar free. They do not contain any artificial flavors or sweeteners. TriStart DHA contains bovine gelatin.</Description>
</NDC>
<NDC>
<NDCCode>15370-265-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (15370-265-30)</PackageDescription>
<NDC11Code>15370-0265-30</NDC11Code>
<ProductNDC>15370-265</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nufera</ProprietaryName>
<NonProprietaryName>Ascorbic Acid, Cholecalciferol, Pyridoxine Hydrochloride, Levomefolate Magnesium, Folic Acid, Cyanocobalamin, And Iron Pentacarbonyl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151216</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>CarWin Pharmaceutical Associates, LLC</LabelerName>
<SubstanceName>ASCORBIC ACID; CHOLECALCIFEROL; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLATE MAGNESIUM; FOLIC ACID; CYANOCOBALAMIN; IRON PENTACARBONYL</SubstanceName>
<StrengthNumber>170; 1000; 15; 600; 400; 16; 125</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; mg/1; ug/1; ug/1; ug/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>15370-305-30</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (15370-305-30) / .79 g in 1 POUCH (15370-305-01) </PackageDescription>
<NDC11Code>15370-0305-30</NDC11Code>
<ProductNDC>15370-305</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pokonza</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230919</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208019</ApplicationNumber>
<LabelerName>Carwin Pharmaceutical Associates, LLC</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>.75</StrengthNumber>
<StrengthUnit>g/.79g</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>2024-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240318</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>POKONZA (Potassium Chloride for Oral Solution, USP) 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 is a white crystalline or colorless solid. It is soluble in water and slightly soluble in alcohol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55. Each pouch of POKONZA (Potassium Chloride for Oral Solution, USP) is a light pink to orange powder containing: 1 10 mEq: contains 0.75 g of potassium chloride, USP, which is equivalent to potassium 10 mEq and chloride 10 mEq and the following inactive ingredients: citric acid anhydrous, colloidal silicon dioxide, FD&C Yellow #6, natural and artificial orange flavor, and sucralose.</Description>
</NDC>
<NDC>
<NDCCode>15370-306-30</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (15370-306-30) / 1.185 g in 1 POUCH</PackageDescription>
<NDC11Code>15370-0306-30</NDC11Code>
<ProductNDC>15370-306</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pokonza</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251209</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208019</ApplicationNumber>
<LabelerName>Carwin Pharmaceutical Associates, LLC</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.125</StrengthNumber>
<StrengthUnit>g/1.185g</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>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>POKONZA® (Potasium Chloride for Oral Solution, USP) 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 is a white crystalline or colorless solid. It is soluble in water and slightly soluble in alcohol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55. Each pouch of POKONZA® (Potassium Chloride for Oral Solution, USP) is a light pink to orange powder containing: 1 10 mEq: contains 0.75 g of potassium chloride, USP, which is equivalent to potassium 10 mEq and chloride 10 mEq and the following inactive ingredients: citric acid anhydrous, colloidal silicon dioxide, FD&C Yellow #6, natural and artificial orange flavor, and sucralose., 2 15 mEq: contains 1.185 g of potassium chloride, USP, which is equivalent to potassium 15 mEq and chloride 15 mEq and the following inactive ingredients: citric acid anhydrous, colloidal silicon dioxide, FD&C Yellow #6, natural and artificial orange flavor, and sucralose.</Description>
</NDC>
<NDC>
<NDCCode>15370-401-30</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (15370-401-30) / 1 FILM, SOLUBLE in 1 POUCH (15370-401-01) </PackageDescription>
<NDC11Code>15370-0401-30</NDC11Code>
<ProductNDC>15370-401</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Opipza</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>FILM, SOLUBLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216655</ApplicationNumber>
<LabelerName>Carwin Pharmaceutical Associates, LLC</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OPIPZA is indicated for the: 1 treatment of schizophrenia in patients ages 13 years and older, 2 adjunctive treatment of major depressive disorder (MDD) in adults, 3 treatment of irritability associated with autistic disorder in pediatric patients 6 years and older, 4 treatment of Tourette's disorder in pediatric patients 6 years and older.</IndicationAndUsage>
<Description>OPIPZA contains aripiprazole, an atypical antipsychotic drug. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. Aripiprazole has a pKa of 6.2. It is freely soluble in dichloromethane, sparingly soluble in toluene, and insoluble in methanol and water. The empirical formula is C23H27Cl2N3O2 with a molecular weight of 448.38. The chemical structure is. OPIPZA is for oral administration and is available in 2 mg, 5 mg, and 10 mg strengths. Inactive ingredients include hydroxypropyl cellulose, sodium lauryl sulfate, and sucralose. Imprinting ink contains glycerin, FD&C Blue No.1, polysorbate 20, and propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>15370-402-30</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (15370-402-30) / 1 FILM, SOLUBLE in 1 POUCH (15370-402-01) </PackageDescription>
<NDC11Code>15370-0402-30</NDC11Code>
<ProductNDC>15370-402</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Opipza</ProprietaryName>
<NonProprietaryName>Aripiprazole</NonProprietaryName>
<DosageFormName>FILM, SOLUBLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216655</ApplicationNumber>
<LabelerName>Carwin Pharmaceutical Associates, LLC</LabelerName>
<SubstanceName>ARIPIPRAZOLE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OPIPZA is indicated for the: 1 treatment of schizophrenia in patients ages 13 years and older, 2 adjunctive treatment of major depressive disorder (MDD) in adults, 3 treatment of irritability associated with autistic disorder in pediatric patients 6 years and older, 4 treatment of Tourette's disorder in pediatric patients 6 years and older.</IndicationAndUsage>
<Description>OPIPZA contains aripiprazole, an atypical antipsychotic drug. Aripiprazole is 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril. Aripiprazole has a pKa of 6.2. It is freely soluble in dichloromethane, sparingly soluble in toluene, and insoluble in methanol and water. The empirical formula is C23H27Cl2N3O2 with a molecular weight of 448.38. The chemical structure is. OPIPZA is for oral administration and is available in 2 mg, 5 mg, and 10 mg strengths. Inactive ingredients include hydroxypropyl cellulose, sodium lauryl sulfate, and sucralose. Imprinting ink contains glycerin, FD&C Blue No.1, polysorbate 20, and propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>16590-403-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (16590-403-30)</PackageDescription>
<NDC11Code>16590-0403-30</NDC11Code>
<ProductNDC>16590-403</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20031201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021210</ApplicationNumber>
<LabelerName>STAT Rx USA LLC</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>l-Thyroxine [EPC],Thyroxine [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Levothyroxine sodium is used for the following indications. Hypothyroidism - As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter. Pituitary TSH Suppression - In the treatment or prevention of various types of euthyroid goiters (see WARNINGS and PRECAUTIONS), including thyroid nodules (see WARNINGS and PRECAUTIONS), subacute or chronic Iymphocytic thyroiditis (Hashimoto's thyroiditis), multinodular goiter (see WARNINGS and PRECAUTIONS), and, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.</IndicationAndUsage>
<Description>Levothyroxine Sodium Tablets, USP contain synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt [levothyroxine (T4) sodium]. Synthetic T4 is identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4N NaO4 H2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown.</Description>
</NDC>
<NDC>
<NDCCode>21695-403-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (21695-403-30)</PackageDescription>
<NDC11Code>21695-0403-30</NDC11Code>
<ProductNDC>21695-403</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19991220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074984</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-benzothiazepin-4(5 H)one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride,(+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform. It has a molecular weight of 450.98. Diltiazem hydrochloride is formulated as a once-a-day extended release capsule containing either 120 mg, 180 mg, 240 mg, or 300 mg diltiazem hydrochloride. Each diltiazem extended-release capsule, for oral administration, contains the following inactive ingredients. 120 mg â ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, black iron oxide, gelatin, hydroxypropyl cellulose, pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate. 180 mg â ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, D&C yellow #10, FD&C blue #1, FD&C green #3, gelatin, hydroxypropyl cellulose, pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate. 240 mg â ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, D&C yellow #10, FD&C green #3, gelatin, hydroxypropyl cellulose, pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate. 300 mgâ ammonio methacrylate copolymer NF, type A, ammonio methacrylate copolymer NF, type B, ammonium hydroxide, black iron oxide, D&C yellow #10, FD&C green #3, gelatin, hydroxypropyl cellulose, pharmaceutical glaze, propylene glycol, silicon dioxide, simethicone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate. This drug product conforms to USP Drug release test #11.</Description>
</NDC>
<NDC>
<NDCCode>24236-403-02</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (24236-403-02)</PackageDescription>
<NDC11Code>24236-0403-02</NDC11Code>
<ProductNDC>24236-403</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propranolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Propranolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070622</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071972</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>PROPRANOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-10-20</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>35356-403-30</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (35356-403-30)</PackageDescription>
<NDC11Code>35356-0403-30</NDC11Code>
<ProductNDC>35356-403</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Opana</ProprietaryName>
<ProprietaryNameSuffix>Er</ProprietaryNameSuffix>
<NonProprietaryName>Oxymorphone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120214</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA201655</ApplicationNumber>
<LabelerName>Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC</LabelerName>
<SubstanceName>OXYMORPHONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2016-12-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>35573-403-31</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (35573-403-31) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>35573-0403-31</NDC11Code>
<ProductNDC>35573-403</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190509</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205591</ApplicationNumber>
<LabelerName>Burel Pharmaceuticals, LLC</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190509</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37000-403-01</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (37000-403-01) * 354 mL in 1 BOTTLE, PLASTIC (37000-032-03) * 1 BOTTLE, PLASTIC in 1 CARTON (37000-691-30) > 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>37000-0403-01</NDC11Code>
<ProductNDC>37000-403</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pepto-bismol</ProprietaryName>
<NonProprietaryName>Bismuth Subsalicylate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20120305</StartMarketingDate>
<EndMarketingDate>20211201</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part335</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2021-12-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20120305</StartMarketingDatePackage>
<EndMarketingDatePackage>20211201</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43063-403-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-403-30) </PackageDescription>
<NDC11Code>43063-0403-30</NDC11Code>
<ProductNDC>43063-403</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benazepril Hydrochloride</ProprietaryName>
<NonProprietaryName>Benazepril Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100906</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076118</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BENAZEPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>46708-403-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (46708-403-30) </PackageDescription>
<NDC11Code>46708-0403-30</NDC11Code>
<ProductNDC>46708-403</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nadolol</ProprietaryName>
<NonProprietaryName>Nadolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230608</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211763</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>NADOLOL</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-06-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230608</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Angina Pectoris. Nadolol tablets are indicated for the long-term management of patients with angina pectoris. Hypertension. Nadolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with nadolol tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Programâs Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Nadolol tablets may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.</IndicationAndUsage>
<Description>Nadolol, USP is a synthetic nonselective beta-adrenergic receptor blocking agent designated chemically as 1-(tert-butylamino)-3-[(5,6,7,8-tetrahydro-cis-6,7-dihydroxy-1- naphthyl)oxy]-2-propanol. Structural formula. C17H27NO4 MW 309.40. Nadolol, USP is a white to off-white powder. It is freely soluble in alcohol and in methanol, soluble in water at pH 2, slightly soluble in chloroform, in methylene chloride, in isopropyl alcohol, and in water (between pH 7 and pH 10); insoluble in acetone, in benzene, in ether, in hexane, and in trichloroethane. Each tablet for oral administration contains 20 mg, 40 mg, or 80 mg of nadolol, USP and the following inactive ingredients: povidone K-30, corn starch, microcrystalline cellulose, citric acid monohydrate, FD&C Blue No. 2 Aluminum Lake, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>49643-403-30</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (49643-403-30) </PackageDescription>
<NDC11Code>49643-0403-30</NDC11Code>
<ProductNDC>49643-403</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>California Scrub Oak Pollen</ProprietaryName>
<NonProprietaryName>Quercus Dumosa</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>CUTANEOUS; INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740312</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102211</ApplicationNumber>
<LabelerName>Allermed Laboratories, Inc.</LabelerName>
<SubstanceName>QUERCUS DUMOSA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19740312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Allergenic extract may be used as a diagnostic skin test reagent in persons suspected of being sensitive to the allergenic source material from which the extract is made. Skin tests should be used in conjunction with a thorough allergic history to establish the relevance of a given allergen in the etiology of allergic disease. (4,5,6) Immunotherapy with allergenic extract is indicated in persons suffering from allergic rhinitis, bronchitis, conjunctivitis, urticaria and asthma. The therapeutic efficacy of allergenic extract has been proven in ragweed, grass, and mountain cedar pollinosis, cat-induced asthma and hypersensitivity to hymenoptera venoms. (7-12). Immunotherapy may be used along with or exclusive of antihistamines and other medications used to control allergic symptoms.</IndicationAndUsage>
<Description>Allergenic extract contains the aqueous extractables from allergenic source material in extracting solution containing 0.25% sodium chloride, 0.125% sodium bicarbonate, and 50% glycerol. 0.4% phenol is added as a preservative. The weight by volume value shown on the label is a measurement of extract concentration, rather than extract potency. Extracts for which U.S. standards exist are labeled in allergy units, in addition to w/v strength.</Description>
</NDC>
<NDC>
<NDCCode>49852-403-01</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BLISTER PACK (49852-403-01) > 30 mL in 1 BOTTLE, PLASTIC (49852-403-30) </PackageDescription>
<NDC11Code>49852-0403-01</NDC11Code>
<ProductNDC>49852-403</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Kindred Goods</ProprietaryName>
<ProprietaryNameSuffix>Hand Sanitizer Sea Salt Fig</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180921</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Tri-Coastal Design Company Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>68</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For decreasing bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49873-403-01</NDCCode>
<PackageDescription>2 BOTTLE in 1 CARTON (49873-403-01) / 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>49873-0403-01</NDC11Code>
<ProductNDC>49873-403</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Inon Ace</ProprietaryName>
<NonProprietaryName>Magnesium Aluminosilicate, Magnesium Hydroxide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000520</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>Sato Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>SILODRATE; MAGNESIUM HYDROXIDE</SubstanceName>
<StrengthNumber>900; 250</StrengthNumber>
<StrengthUnit>mg/30mL; mg/30mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses relieves these symptoms: â heartburn â sour stomach â acid indigestion.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51346-403-02</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (51346-403-02) > 30 mL in 1 BOTTLE, PUMP (51346-403-01)</PackageDescription>
<NDC11Code>51346-0403-02</NDC11Code>
<ProductNDC>51346-403</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Provence Air Skin Fit Foundation Pink Beige C01</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Octinoxate, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>NATURE REPUBLIC CO., LTD.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>3.24; .9; .57</StrengthNumber>
<StrengthUnit>g/30mL; g/30mL; g/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-08-19</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>51655-403-52</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (51655-403-52) </PackageDescription>
<NDC11Code>51655-0403-52</NDC11Code>
<ProductNDC>51655-403</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Digoxin</ProprietaryName>
<NonProprietaryName>Digoxin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230413</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215307</ApplicationNumber>
<LabelerName>Northwind Health Company, LLC</LabelerName>
<SubstanceName>DIGOXIN</SubstanceName>
<StrengthNumber>.125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cardiac Glycoside [EPC], Cardiac Glycosides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230413</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Digoxin is a cardiac glycoside indicated for: : 1 Treatment of mild to moderate heart failure in adults. (1.1), 2 Increasing myocardial contractility in pediatric patients with heart failure. (1.2), 3 Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. (1.3).</IndicationAndUsage>
<Description>Digoxin is one of the cardiac (or digitalis) glycosides, a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term âdigitalisâ is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence âglycosidesâ). Digoxin is described chemically as (3β,5β,12β)-3-[( O-2,6-dideoxy-β- D-ribo-hexopyranosyl-(1â4)- O- 2,6-dideoxy-β- D-ribo-hexopyranosyl-(1â4)-2,6-dideoxy-β- D- ribo-hexopyranosyl)oxy]-12,14- dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95, and its structural formula is:. Digoxin exists as white or almost white powder or colorless crystals. The drug is practically insoluble in water; soluble in mixture of methanol & methylene chloride and slightly soluble in ethyl alcohol. Digoxin is supplied as 62.5 mcg (unscored), 125 mcg (scored), and 250 mcg (scored) tablets for oral administration. Each tablet contains the labeled amount of digoxin USP and the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, lactose anhydrous, magnesium stearate. Additionally, the 62.5 mcg tablets contain FD&C Yellow No. 6 and 125 mcg tablets contain yellow iron oxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>52125-403-02</NDCCode>
<PackageDescription>30 TABLET in 1 VIAL (52125-403-02)</PackageDescription>
<NDC11Code>52125-0403-02</NDC11Code>
<ProductNDC>52125-403</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Finasteride</ProprietaryName>
<NonProprietaryName>Finasteride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076437</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>FINASTERIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>52685-403-30</NDCCode>
<PackageDescription>1 TRAY in 1 CARTON (52685-403-30) > 9.8 g in 1 TRAY</PackageDescription>
<NDC11Code>52685-0403-30</NDC11Code>
<ProductNDC>52685-403</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Shiseido Sheer Matifying Compact (refill)</ProprietaryName>
<ProprietaryNameSuffix>O60</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SHISEIDO CO., LTD.</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>382; 588</StrengthNumber>
<StrengthUnit>mg/9.8g; mg/9.8g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>53041-403-30</NDCCode>
<PackageDescription>368 g in 1 CANISTER (53041-403-30)</PackageDescription>
<NDC11Code>53041-0403-30</NDC11Code>
<ProductNDC>53041-403</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Smooth Texture Orange Flavor</ProprietaryName>
<NonProprietaryName>Psyllium Husk</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Guardian</LabelerName>
<SubstanceName>PSYLLIUM HUSK</SubstanceName>
<StrengthNumber>3.4</StrengthNumber>
<StrengthUnit>g/12g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55111-403-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (55111-403-30)</PackageDescription>
<NDC11Code>55111-0403-30</NDC11Code>
<ProductNDC>55111-403</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zonisamide</ProprietaryName>
<NonProprietaryName>Zonisamide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077645</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>ZONISAMIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Anti-epileptic Agent [EPC],Sulfonamides [CS],Carbonic Anhydrase Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-11</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55289-403-92</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (55289-403-92) * 30 TABLET in 1 BOTTLE, PLASTIC (55289-567-30) * 60 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>55289-0403-92</NDC11Code>
<ProductNDC>55289-403</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Comfort Pac With Cyclobenzaprine</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20130715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078218</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>