{
"NDC": [
{
"NDCCode": "0187-1950-12",
"PackageDescription": "340 g in 1 JAR (0187-1950-12)",
"NDC11Code": "00187-1950-12",
"ProductNDC": "0187-1950",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cerave",
"ProprietaryNameSuffix": "Healing",
"NonProprietaryName": "Petrolatum",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151102",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Valeant Pharmaceuticals North America LLC",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "46.5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "0187-1950-03",
"PackageDescription": "85 g in 1 TUBE (0187-1950-03)",
"NDC11Code": "00187-1950-03",
"ProductNDC": "0187-1950",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cerave",
"ProprietaryNameSuffix": "Healing",
"NonProprietaryName": "Petrolatum",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151102",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Valeant Pharmaceuticals North America LLC",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "46.5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "0187-1950-05",
"PackageDescription": "144 g in 1 TUBE (0187-1950-05)",
"NDC11Code": "00187-1950-05",
"ProductNDC": "0187-1950",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cerave",
"ProprietaryNameSuffix": "Healing",
"NonProprietaryName": "Petrolatum",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151102",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Valeant Pharmaceuticals North America LLC",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "46.5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "0187-1950-35",
"PackageDescription": "10 g in 1 TUBE (0187-1950-35)",
"NDC11Code": "00187-1950-35",
"ProductNDC": "0187-1950",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cerave",
"ProprietaryNameSuffix": "Healing",
"NonProprietaryName": "Petrolatum",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151102",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Valeant Pharmaceuticals North America LLC",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "46.5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "0187-1950-40",
"PackageDescription": "2 TUBE in 1 CARTON (0187-1950-40) > 10 g in 1 TUBE",
"NDC11Code": "00187-1950-40",
"ProductNDC": "0187-1950",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cerave",
"ProprietaryNameSuffix": "Healing",
"NonProprietaryName": "Petrolatum",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151102",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Valeant Pharmaceuticals North America LLC",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "46.5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "0187-1950-99",
"PackageDescription": "15 JAR in 1 TRAY (0187-1950-99) > 2.5 g in 1 JAR",
"NDC11Code": "00187-1950-99",
"ProductNDC": "0187-1950",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cerave",
"ProprietaryNameSuffix": "Healing",
"NonProprietaryName": "Petrolatum",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151102",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Valeant Pharmaceuticals North America LLC",
"SubstanceName": "PETROLATUM",
"StrengthNumber": "46.5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "0187-1975-12",
"PackageDescription": "340 g in 1 JAR (0187-1975-12)",
"NDC11Code": "00187-1975-12",
"ProductNDC": "0187-1975",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cerave Itch Relief Moisturizing",
"ProprietaryNameSuffix": "Cream",
"NonProprietaryName": "Pramoxine Hydrochloride",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "VALEANT PHARMACEUTICALS NORTH AMERICA LLC",
"SubstanceName": "PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0187-5268-03",
"PackageDescription": "12 BOTTLE in 1 TRAY (0187-5268-03) > 5 CAPSULE, LIQUID FILLED in 1 BOTTLE",
"NDC11Code": "00187-5268-03",
"ProductNDC": "0187-5268",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nephrocaps",
"NonProprietaryName": "Ascorbic Acid, Folic Acid, Niacin, Thiamine, Riboflavin, Pyridoxine, Cyanocobalamin, Pantothenic Acid, Biotin",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20120618",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Valeant Pharmaceuticals North America LLC",
"SubstanceName": "ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; FOLIC ACID; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; RIBOFLAVIN; THIAMINE",
"StrengthNumber": "100; 150; 6; 1; 20; 5; 10; 1.7; 1.5",
"StrengthUnit": "mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-02-27"
},
{
"NDCCode": "0187-5269-03",
"PackageDescription": "12 BOTTLE in 1 TRAY (0187-5269-03) > 5 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE",
"NDC11Code": "00187-5269-03",
"ProductNDC": "0187-5269",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nephrocaps-qt",
"NonProprietaryName": "Cholecalciferol, Ascorbic Acid, Folic Acid, Thiamin, Riboflavin, Niacin, Pantothenic Acid, Pyridoxine Hcl, Biotin, Cyanocobalamin",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20120608",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Valeant Pharmaceuticals North America LLC",
"SubstanceName": "ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE",
"StrengthNumber": "100; 150; 1750; 6; 1; 20; 5; 10; 1.7; 1.5",
"StrengthUnit": "mg/1; ug/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-02-27"
},
{
"NDCCode": "68428-187-12",
"PackageDescription": "600 PELLET in 1 BOTTLE, GLASS (68428-187-12) ",
"NDC11Code": "68428-0187-12",
"ProductNDC": "68428-187",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aletris Farinosa",
"NonProprietaryName": "Aletris Farinosa Root",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100212",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "ALETRIS FARINOSA ROOT",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2022-04-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100212",
"SamplePackage": "N"
},
{
"NDCCode": "69761-187-12",
"PackageDescription": "12 PELLET in 1 PACKAGE (69761-187-12) ",
"NDC11Code": "69761-0187-12",
"ProductNDC": "69761-187",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Testosterone",
"NonProprietaryName": "Testosterone",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150901",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Qualgen LLC",
"SubstanceName": "TESTOSTERONE",
"StrengthNumber": "87.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2021-10-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20150901",
"SamplePackage": "N"
},
{
"NDCCode": "72865-187-12",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (72865-187-12) ",
"NDC11Code": "72865-0187-12",
"ProductNDC": "72865-187",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210415",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090515",
"LabelerName": "XLCare Pharmaceuticals Inc.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2024-09-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210415",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3).",
"Description": "Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (1040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insoluble in n-hexane. (Solubility limits are expressed as mg/mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, talc and additional agents listed below. 250 mg tablets: opadry II blue (FD&C blue #2/indigo carmine aluminum lake, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 500 mg tablets: opadry II yellow (iron oxide yellow, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 750 mg tablets: opadry II orange (FD&C yellow # 6/sunset yellow FCF aluminum lake, iron oxide red, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 1000 mg tablets: opadry II white (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). USP Dissolution test is 4."
},
{
"NDCCode": "0220-1950-41",
"PackageDescription": "9 [hp_C] in 1 TUBE (0220-1950-41) ",
"NDC11Code": "00220-1950-41",
"ProductNDC": "0220-1950",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eupatorium Perfoliatum",
"NonProprietaryName": "Eupatorium Perfoliatum Flowering Top",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "19830303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Boiron",
"SubstanceName": "EUPATORIUM PERFOLIATUM FLOWERING TOP",
"StrengthNumber": "9",
"StrengthUnit": "[hp_C]/9[hp_C]",
"Status": "Active",
"LastUpdate": "2023-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19830303",
"SamplePackage": "N",
"IndicationAndUsage": "Stiffness And Bone Pain Associated With Flu Symptoms*."
},
{
"NDCCode": "10927-101-06",
"PackageDescription": "1950 L in 1 CYLINDER (10927-101-06)",
"NDC11Code": "10927-0101-06",
"ProductNDC": "10927-101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrogen",
"NonProprietaryName": "Nitrogen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19381020",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "PURITY CYLINDER GASES INC",
"SubstanceName": "NITROGEN",
"StrengthNumber": "99",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2017-12-20",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "43742-1950-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43742-1950-1) ",
"NDC11Code": "43742-1950-01",
"ProductNDC": "43742-1950",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Enviro I",
"NonProprietaryName": "Potassium Gluconate, Glandula Suprarenalis Suis, Hepar Suis, Coffea Tosta, Thea Sinensis, Carbo Vegetabilis, Ferrum Iodatum, Ferrum Metallicum, Gelsemium Sempervirens, Iodium, Iridium Metallicum, Lycopodium Clavatum, Pulsatilla (pratensis), Selenium Metallicum, Zincum Metallicum, Peanut, Black Walnut, English Walnut, Amygdala Amara, Cashew, Coconut, Pecan, Brazil Nut, Tomato, Solanum Tuberosum, Piper Nigrum, Eggplant, Rape Seed Oil, Linum Usitatissimum, Sesame, Seed, Cheese (stilton), Lac Vaccinum, Beef,",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20210226",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Deseret Biologicals, Inc.",
"SubstanceName": "POTASSIUM GLUCONATE; SUS SCROFA ADRENAL GLAND; PORK LIVER; COFFEA ARABICA SEED, ROASTED; GREEN TEA LEAF; ACTIVATED CHARCOAL; FERROUS IODIDE; IRON; GELSEMIUM SEMPERVIRENS ROOT; IODINE; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; PULSATILLA PRATENSIS WHOLE; SELENIUM; ZINC; PEANUT; BLACK WALNUT; ENGLISH WALNUT; BITTER ALMOND; CASHEW; COCONUT; PECAN; BRAZIL NUT; TOMATO; SOLANUM TUBEROSUM WHOLE; GREEN PEPPERCORN; EGGPLANT; CANOLA OIL; FLAX SEED; SESAME SEED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGED; COW MILK; BEEF; LAMB; PORK; CHICKEN; EGG; KIDNEY BEAN; ONION; APPLE; WHEAT; BANANA; FRAGARIA VESCA FRUIT; ORANGE; ATLANTIC COD; NORTHERN BLUEFIN TUNA; ATLANTIC SALMON; EDIBLE ROCK CRAB; PACIFIC OYSTER; COMMON SHRIMP; CORTISONE ACETATE; HISTAMINE DIHYDROCHLORIDE; HYALURONIDASE; INTERFERON .GAMMA. PORCINE RECOMBINANT; SEROTONIN HYDROCHLORIDE; COCOA",
"StrengthNumber": "6; 8; 8; 10; 10; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 10",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Egg Proteins, Dietary [CS], Endoglycosidase [EPC], Fish Proteins, Dietary [EXT], Fish Proteins, Dietary [EXT], Fruit Proteins [EXT], Fruit Proteins [EXT], Fruit Proteins [EXT], Fruit Proteins [EXT], Glycoside Hydrolases [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Meat Proteins [EXT], Meat Proteins [EXT], Meat Proteins [EXT], Milk Proteins [CS], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2024-04-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210226",
"SamplePackage": "N",
"IndicationAndUsage": " For the temporary relief of symptoms including. sensitivity to food swelling of lips stomach cramps. vomiting occasional diarrhea skin rash. These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "0187-0003-01",
"PackageDescription": "473 mL in 1 BOTTLE (0187-0003-01)",
"NDC11Code": "00187-0003-01",
"ProductNDC": "0187-0003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Capital And Codeine",
"NonProprietaryName": "Acetaminophen And Codeine Phosphate",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20040503",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086024",
"LabelerName": "Valeant Pharmaceuticals International",
"SubstanceName": "ACETAMINOPHEN; CODEINE PHOSPHATE",
"StrengthNumber": "120; 12",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "0187-0006-10",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (0187-0006-10) / 20 g in 1 BOTTLE, PUMP",
"NDC11Code": "00187-0006-10",
"ProductNDC": "0187-0006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cabtreo",
"NonProprietaryName": "Clindamycin Phosphate/benzoyl Peroxide/adapalene",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20231020",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216632",
"LabelerName": "Bausch Health US LLC",
"SubstanceName": "CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE; ADAPALENE",
"StrengthNumber": "12; 31; 1.5",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2025-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231020",
"SamplePackage": "N",
"IndicationAndUsage": "CABTREO is indicated for the topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older.",
"Description": "CABTREO (clindamycin phosphate, adapalene, and benzoyl peroxide) topical gel is a white to off-white, opaque gel. Each gram of CABTREO contains 12 mg (1.2%) clindamycin phosphate, equivalent to 10 mg (1%) clindamycin and 1.5 mg (0.15%) adapalene, and 31 mg (3.1%) benzoyl peroxide. Clindamycin phosphate is a water-soluble ester of the semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. Benzoyl peroxide is an oxidizing agent. The chemical name for clindamycin phosphate is Methyl-7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Clindamycin phosphate. Molecular Formula: C 18H 34ClN 2O 8PS Molecular Weight: 504.97. The chemical name for adapalene is 6-[3-(1-Adamantyl)-4-methoxyphenyl]-2-naphthoic acid. The structural formula for adapalene is represented below. Adapalene. Molecular Formula: C 28H 28O 3. Molecular Weight: 412.52. The chemical name for benzoyl peroxide is dibenzoyl peroxide. The structural formula for benzoyl peroxide is represented below. Benzoyl peroxide. Molecular Formula: C 14H 10O 4 Molecular Weight: 242.23. CABTREO contains the following inactive ingredients: carbomer homopolymer type C (carbomer 980), potassium hydroxide, propylene glycol, and purified water."
},
{
"NDCCode": "0187-0006-25",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (0187-0006-25) / 50 g in 1 BOTTLE, PUMP",
"NDC11Code": "00187-0006-25",
"ProductNDC": "0187-0006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cabtreo",
"NonProprietaryName": "Clindamycin Phosphate/benzoyl Peroxide/adapalene",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20231020",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216632",
"LabelerName": "Bausch Health US LLC",
"SubstanceName": "CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE; ADAPALENE",
"StrengthNumber": "12; 31; 1.5",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2025-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231020",
"SamplePackage": "N",
"IndicationAndUsage": "CABTREO is indicated for the topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older.",
"Description": "CABTREO (clindamycin phosphate, adapalene, and benzoyl peroxide) topical gel is a white to off-white, opaque gel. Each gram of CABTREO contains 12 mg (1.2%) clindamycin phosphate, equivalent to 10 mg (1%) clindamycin and 1.5 mg (0.15%) adapalene, and 31 mg (3.1%) benzoyl peroxide. Clindamycin phosphate is a water-soluble ester of the semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. Benzoyl peroxide is an oxidizing agent. The chemical name for clindamycin phosphate is Methyl-7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Clindamycin phosphate. Molecular Formula: C 18H 34ClN 2O 8PS Molecular Weight: 504.97. The chemical name for adapalene is 6-[3-(1-Adamantyl)-4-methoxyphenyl]-2-naphthoic acid. The structural formula for adapalene is represented below. Adapalene. Molecular Formula: C 28H 28O 3. Molecular Weight: 412.52. The chemical name for benzoyl peroxide is dibenzoyl peroxide. The structural formula for benzoyl peroxide is represented below. Benzoyl peroxide. Molecular Formula: C 14H 10O 4 Molecular Weight: 242.23. CABTREO contains the following inactive ingredients: carbomer homopolymer type C (carbomer 980), potassium hydroxide, propylene glycol, and purified water."
},
{
"NDCCode": "0187-0006-35",
"PackageDescription": "3.5 g in 1 TUBE (0187-0006-35) ",
"NDC11Code": "00187-0006-35",
"ProductNDC": "0187-0006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cabtreo",
"NonProprietaryName": "Clindamycin Phosphate/benzoyl Peroxide/adapalene",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20231020",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216632",
"LabelerName": "Bausch Health US LLC",
"SubstanceName": "CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE; ADAPALENE",
"StrengthNumber": "12; 31; 1.5",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2025-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231020",
"SamplePackage": "Y",
"IndicationAndUsage": "CABTREO is indicated for the topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older.",
"Description": "CABTREO (clindamycin phosphate, adapalene, and benzoyl peroxide) topical gel is a white to off-white, opaque gel. Each gram of CABTREO contains 12 mg (1.2%) clindamycin phosphate, equivalent to 10 mg (1%) clindamycin and 1.5 mg (0.15%) adapalene, and 31 mg (3.1%) benzoyl peroxide. Clindamycin phosphate is a water-soluble ester of the semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. Benzoyl peroxide is an oxidizing agent. The chemical name for clindamycin phosphate is Methyl-7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Clindamycin phosphate. Molecular Formula: C 18H 34ClN 2O 8PS Molecular Weight: 504.97. The chemical name for adapalene is 6-[3-(1-Adamantyl)-4-methoxyphenyl]-2-naphthoic acid. The structural formula for adapalene is represented below. Adapalene. Molecular Formula: C 28H 28O 3. Molecular Weight: 412.52. The chemical name for benzoyl peroxide is dibenzoyl peroxide. The structural formula for benzoyl peroxide is represented below. Benzoyl peroxide. Molecular Formula: C 14H 10O 4 Molecular Weight: 242.23. CABTREO contains the following inactive ingredients: carbomer homopolymer type C (carbomer 980), potassium hydroxide, propylene glycol, and purified water."
},
{
"NDCCode": "0187-0245-01",
"PackageDescription": "1 VIAL in 1 KIT (0187-0245-01) / 1 mL in 1 VIAL",
"NDC11Code": "00187-0245-01",
"ProductNDC": "0187-0245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Migranal",
"NonProprietaryName": "Dihydroergotamine Mesylate",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "19971208",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020148",
"LabelerName": "Bausch Health US, LLC",
"SubstanceName": "DIHYDROERGOTAMINE MESYLATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Ergotamine Derivative [EPC], Ergotamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19971208",
"SamplePackage": "Y",
"IndicationAndUsage": "MIGRANAL (dihydroergotamine mesylate) Nasal Spray is indicated for the acute treatment of migraine headaches with or without aura. MIGRANAL (dihydroergotamine mesylate) Nasal Spray is not intended for the prophylactic therapy of migraine or for the management of hemiplegic or basilar migraine.",
"Description": "MIGRANAL is ergotamine hydrogenated in the 9,10 position as the mesylate salt. MIGRANAL is known chemically as ergotaman-3’, 6’, 18-trione, 9,10-dihydro-12’-hydroxy-2’-methyl-5’- (phenylmethyl)-, (5’α)-, monomethane-sulfonate. Its molecular weight is 679.78 and its empirical formula is C 33H 37N 5O 5CH 4O 3S. The chemical structure is. MIGRANAL (dihydroergotamine mesylate) Nasal Spray is provided for intranasal administration as a clear, colorless to light yellow aqueous solution in an amber glass vial containing: 1 dihydroergotamine mesylate ………4 mg, 2 caffeine, anhydrous .……..10 mg, 3 dextrose, anhydrous ……...50 mg, 4 carbon dioxide ………….qs, 5 purified water .. ……..qs 1 mL."
},
{
"NDCCode": "0187-0245-03",
"PackageDescription": "8 VIAL in 1 KIT (0187-0245-03) > 1 mL in 1 VIAL",
"NDC11Code": "00187-0245-03",
"ProductNDC": "0187-0245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Migranal",
"NonProprietaryName": "Dihydroergotamine Mesylate",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "19971208",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020148",
"LabelerName": "Bausch Health US, LLC",
"SubstanceName": "DIHYDROERGOTAMINE MESYLATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Ergotamine Derivative [EPC], Ergotamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-03-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19971208",
"SamplePackage": "N",
"IndicationAndUsage": "MIGRANAL (dihydroergotamine mesylate) Nasal Spray is indicated for the acute treatment of migraine headaches with or without aura. MIGRANAL (dihydroergotamine mesylate) Nasal Spray is not intended for the prophylactic therapy of migraine or for the management of hemiplegic or basilar migraine.",
"Description": "MIGRANAL is ergotamine hydrogenated in the 9,10 position as the mesylate salt. MIGRANAL is known chemically as ergotaman-3’, 6’, 18-trione, 9,10-dihydro-12’-hydroxy-2’-methyl-5’- (phenylmethyl)-, (5’α)-, monomethane-sulfonate. Its molecular weight is 679.78 and its empirical formula is C33H37N5O5CH4O3S. The chemical structure is. MIGRANAL (dihydroergotamine mesylate) Nasal Spray is provided for intranasal administration as a clear, colorless to light yellow aqueous solution in an amber glass vial containing: 1 dihydroergotamine mesylate ………4 mg, 2 caffeine, anhydrous ……..10 mg, 3 dextrose, anhydrous ……..50 mg, 4 carbon dioxide ………….qs, 5 purified water.. ……..qs 1 mL."
},
{
"NDCCode": "0187-0245-04",
"PackageDescription": "1 VIAL in 1 KIT (0187-0245-04) / 1 mL in 1 VIAL",
"NDC11Code": "00187-0245-04",
"ProductNDC": "0187-0245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Migranal",
"NonProprietaryName": "Dihydroergotamine Mesylate",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "19971208",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020148",
"LabelerName": "Bausch Health US, LLC",
"SubstanceName": "DIHYDROERGOTAMINE MESYLATE",
"StrengthNumber": "4",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Ergotamine Derivative [EPC], Ergotamines [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19971208",
"SamplePackage": "N",
"IndicationAndUsage": "MIGRANAL (dihydroergotamine mesylate) Nasal Spray is indicated for the acute treatment of migraine headaches with or without aura. MIGRANAL (dihydroergotamine mesylate) Nasal Spray is not intended for the prophylactic therapy of migraine or for the management of hemiplegic or basilar migraine.",
"Description": "MIGRANAL is ergotamine hydrogenated in the 9,10 position as the mesylate salt. MIGRANAL is known chemically as ergotaman-3’, 6’, 18-trione, 9,10-dihydro-12’-hydroxy-2’-methyl-5’- (phenylmethyl)-, (5’α)-, monomethane-sulfonate. Its molecular weight is 679.78 and its empirical formula is C 33H 37N 5O 5CH 4O 3S. The chemical structure is. MIGRANAL (dihydroergotamine mesylate) Nasal Spray is provided for intranasal administration as a clear, colorless to light yellow aqueous solution in an amber glass vial containing: 1 dihydroergotamine mesylate ………4 mg, 2 caffeine, anhydrous .……..10 mg, 3 dextrose, anhydrous ……...50 mg, 4 carbon dioxide ………….qs, 5 purified water .. ……..qs 1 mL."
},
{
"NDCCode": "0187-0402-31",
"PackageDescription": "29.57 mL in 1 BOTTLE, GLASS (0187-0402-31)",
"NDC11Code": "00187-0402-31",
"ProductNDC": "0187-0402",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxsoralen",
"NonProprietaryName": "Methoxsalen",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "19541203",
"EndMarketingDate": "20160630",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA009048",
"LabelerName": "Valeant Pharmaceuticals North America LLC",
"SubstanceName": "METHOXSALEN",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Photoabsorption [MoA],Photoactivated Radical Generator [EPC],Photosensitizing Activity [PE],Psoralen [EPC],Psoralens [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0187-0500-02",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0187-0500-02)",
"NDC11Code": "00187-0500-02",
"ProductNDC": "0187-0500",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Motofen",
"NonProprietaryName": "Difenoxin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19620714",
"EndMarketingDate": "20141130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017744",
"LabelerName": "Valeant Pharmaceuticals North America LLC",
"SubstanceName": "ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE",
"StrengthNumber": ".025; 1",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2014-12-05"
},
{
"NDCCode": "0187-0650-42",
"PackageDescription": "50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0187-0650-42) ",
"NDC11Code": "00187-0650-42",
"ProductNDC": "0187-0650",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxsoralen-ultra",
"NonProprietaryName": "Methoxsalen",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "19861030",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019600",
"LabelerName": "Bausch Health US, LLC",
"SubstanceName": "METHOXSALEN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Psoralen [EPC],Psoralens [CS],Photoabsorption [MoA],Photoactivated Radical Generator [EPC],Photosensitizing Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19861030",
"SamplePackage": "N"
},
{
"NDCCode": "0187-0653-01",
"PackageDescription": "1 TUBE in 1 CARTON (0187-0653-01) / 100 g in 1 TUBE",
"NDC11Code": "00187-0653-01",
"ProductNDC": "0187-0653",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duobrii",
"NonProprietaryName": "Halobetasol Propionate And Tazarotene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190425",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209354",
"LabelerName": "Bausch Health US, LLC",
"SubstanceName": "HALOBETASOL PROPIONATE; TAZAROTENE",
"StrengthNumber": ".1; .45",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2023-04-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190425",
"SamplePackage": "N",
"IndicationAndUsage": "DUOBRII® (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045% is indicated for the topical treatment of plaque psoriasis in adults.",
"Description": "DUOBRII Lotion is a combination product with halobetasol propionate and tazarotene as the active ingredients in a white to off-white lotion formulation intended for topical use. Halobetasol propionate is a synthetic corticosteroid. The chemical name for halobetasol propionate is [(6S,9R,16S,17R)-17-(2-chloroacetyl)-6,9-difluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] propanoate. The structural formula for halobetasol propionate is represented below. Molecular Formula: C25H31ClF2O5 Molecular Weight: 484.96. Tazarotene is a member of the acetylenic class of retinoids. The chemical name for tazarotene is 6-[(3,4-Dihydro-4,4-dimethyl-2H-1-benzothiopyran-6-yl)ethynyl]-3-pyridinecarboxylic acid ethyl ester. The structural formula for tazarotene is represented below. Molecular Formula: C21H21NO2S Molecular Weight: 351.46. Each gram of DUOBRII Lotion contains 0.1 mg (0.01%) halobetasol propionate and 0.45 mg (0.045%) tazarotene in a white to off-white lotion base consisting of carbomer copolymer type B, carbomer homopolymer type A, diethyl sebacate, edetate disodium dihydrate, light mineral oil, methylparaben, propylparaben, purified water, sodium hydroxide, sorbitan monooleate and sorbitol solution, 70%."
},
{
"NDCCode": "0187-0653-03",
"PackageDescription": "6 TUBE in 1 CARTON (0187-0653-03) / 3 g in 1 TUBE",
"NDC11Code": "00187-0653-03",
"ProductNDC": "0187-0653",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duobrii",
"NonProprietaryName": "Halobetasol Propionate And Tazarotene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190425",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA209354",
"LabelerName": "Bausch Health US, LLC",
"SubstanceName": "HALOBETASOL PROPIONATE; TAZAROTENE",
"StrengthNumber": ".1; .45",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2023-04-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190425",
"SamplePackage": "Y",
"IndicationAndUsage": "DUOBRII® (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045% is indicated for the topical treatment of plaque psoriasis in adults.",
"Description": "DUOBRII Lotion is a combination product with halobetasol propionate and tazarotene as the active ingredients in a white to off-white lotion formulation intended for topical use. Halobetasol propionate is a synthetic corticosteroid. The chemical name for halobetasol propionate is [(6S,9R,16S,17R)-17-(2-chloroacetyl)-6,9-difluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] propanoate. The structural formula for halobetasol propionate is represented below. Molecular Formula: C25H31ClF2O5 Molecular Weight: 484.96. Tazarotene is a member of the acetylenic class of retinoids. The chemical name for tazarotene is 6-[(3,4-Dihydro-4,4-dimethyl-2H-1-benzothiopyran-6-yl)ethynyl]-3-pyridinecarboxylic acid ethyl ester. The structural formula for tazarotene is represented below. Molecular Formula: C21H21NO2S Molecular Weight: 351.46. Each gram of DUOBRII Lotion contains 0.1 mg (0.01%) halobetasol propionate and 0.45 mg (0.045%) tazarotene in a white to off-white lotion base consisting of carbomer copolymer type B, carbomer homopolymer type A, diethyl sebacate, edetate disodium dihydrate, light mineral oil, methylparaben, propylparaben, purified water, sodium hydroxide, sorbitan monooleate and sorbitol solution, 70%."
},
{
"NDCCode": "0187-0795-30",
"PackageDescription": "30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-0795-30) ",
"NDC11Code": "00187-0795-30",
"ProductNDC": "0187-0795",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cardizem Cd",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20010411",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020062",
"LabelerName": "Bausch Health US LLC",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20010411",
"SamplePackage": "N",
"IndicationAndUsage": "CARDIZEM CD is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. CARDIZEM CD is indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "CARDIZEM® CD (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-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. CARDIZEM CD is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem). Capsules also contain: black iron oxide (300 mg), FD&C Blue #1, gelatin, hypromellose, magnesium stearate, microcrystalline cellulose, ethyl acrylate and methyl methacrylate copolymer, polysorbate, povidone, simethicone emulsion, sucrose stearate, talc, and titanium dioxide. For oral administration."
},
{
"NDCCode": "0187-0795-42",
"PackageDescription": "90 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-0795-42) ",
"NDC11Code": "00187-0795-42",
"ProductNDC": "0187-0795",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cardizem Cd",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20010411",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020062",
"LabelerName": "Bausch Health US LLC",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "120",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20010411",
"SamplePackage": "N",
"IndicationAndUsage": "CARDIZEM CD is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. CARDIZEM CD is indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "CARDIZEM® CD (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-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. CARDIZEM CD is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem). Capsules also contain: black iron oxide (300 mg), FD&C Blue #1, gelatin, hypromellose, magnesium stearate, microcrystalline cellulose, ethyl acrylate and methyl methacrylate copolymer, polysorbate, povidone, simethicone emulsion, sucrose stearate, talc, and titanium dioxide. For oral administration."
},
{
"NDCCode": "0187-0796-30",
"PackageDescription": "30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-0796-30) ",
"NDC11Code": "00187-0796-30",
"ProductNDC": "0187-0796",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cardizem Cd",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20010411",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020062",
"LabelerName": "Bausch Health US LLC",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20010411",
"SamplePackage": "N",
"IndicationAndUsage": "CARDIZEM CD is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. CARDIZEM CD is indicated for the management of chronic stable angina and angina due to coronary artery spasm.",
"Description": "CARDIZEM® CD (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-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. CARDIZEM CD is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem). Capsules also contain: black iron oxide (300 mg), FD&C Blue #1, gelatin, hypromellose, magnesium stearate, microcrystalline cellulose, ethyl acrylate and methyl methacrylate copolymer, polysorbate, povidone, simethicone emulsion, sucrose stearate, talc, and titanium dioxide. For oral administration."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>0187-1950-12</NDCCode>
<PackageDescription>340 g in 1 JAR (0187-1950-12)</PackageDescription>
<NDC11Code>00187-1950-12</NDC11Code>
<ProductNDC>0187-1950</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cerave</ProprietaryName>
<ProprietaryNameSuffix>Healing</ProprietaryNameSuffix>
<NonProprietaryName>Petrolatum</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151102</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Valeant Pharmaceuticals North America LLC</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>46.5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0187-1950-03</NDCCode>
<PackageDescription>85 g in 1 TUBE (0187-1950-03)</PackageDescription>
<NDC11Code>00187-1950-03</NDC11Code>
<ProductNDC>0187-1950</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cerave</ProprietaryName>
<ProprietaryNameSuffix>Healing</ProprietaryNameSuffix>
<NonProprietaryName>Petrolatum</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151102</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Valeant Pharmaceuticals North America LLC</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>46.5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0187-1950-05</NDCCode>
<PackageDescription>144 g in 1 TUBE (0187-1950-05)</PackageDescription>
<NDC11Code>00187-1950-05</NDC11Code>
<ProductNDC>0187-1950</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cerave</ProprietaryName>
<ProprietaryNameSuffix>Healing</ProprietaryNameSuffix>
<NonProprietaryName>Petrolatum</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151102</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Valeant Pharmaceuticals North America LLC</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>46.5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0187-1950-35</NDCCode>
<PackageDescription>10 g in 1 TUBE (0187-1950-35)</PackageDescription>
<NDC11Code>00187-1950-35</NDC11Code>
<ProductNDC>0187-1950</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cerave</ProprietaryName>
<ProprietaryNameSuffix>Healing</ProprietaryNameSuffix>
<NonProprietaryName>Petrolatum</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151102</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Valeant Pharmaceuticals North America LLC</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>46.5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0187-1950-40</NDCCode>
<PackageDescription>2 TUBE in 1 CARTON (0187-1950-40) > 10 g in 1 TUBE</PackageDescription>
<NDC11Code>00187-1950-40</NDC11Code>
<ProductNDC>0187-1950</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cerave</ProprietaryName>
<ProprietaryNameSuffix>Healing</ProprietaryNameSuffix>
<NonProprietaryName>Petrolatum</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151102</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Valeant Pharmaceuticals North America LLC</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>46.5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0187-1950-99</NDCCode>
<PackageDescription>15 JAR in 1 TRAY (0187-1950-99) > 2.5 g in 1 JAR</PackageDescription>
<NDC11Code>00187-1950-99</NDC11Code>
<ProductNDC>0187-1950</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cerave</ProprietaryName>
<ProprietaryNameSuffix>Healing</ProprietaryNameSuffix>
<NonProprietaryName>Petrolatum</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151102</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Valeant Pharmaceuticals North America LLC</LabelerName>
<SubstanceName>PETROLATUM</SubstanceName>
<StrengthNumber>46.5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0187-1975-12</NDCCode>
<PackageDescription>340 g in 1 JAR (0187-1975-12)</PackageDescription>
<NDC11Code>00187-1975-12</NDC11Code>
<ProductNDC>0187-1975</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cerave Itch Relief Moisturizing</ProprietaryName>
<ProprietaryNameSuffix>Cream</ProprietaryNameSuffix>
<NonProprietaryName>Pramoxine Hydrochloride</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>VALEANT PHARMACEUTICALS NORTH AMERICA LLC</LabelerName>
<SubstanceName>PRAMOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0187-5268-03</NDCCode>
<PackageDescription>12 BOTTLE in 1 TRAY (0187-5268-03) > 5 CAPSULE, LIQUID FILLED in 1 BOTTLE</PackageDescription>
<NDC11Code>00187-5268-03</NDC11Code>
<ProductNDC>0187-5268</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nephrocaps</ProprietaryName>
<NonProprietaryName>Ascorbic Acid, Folic Acid, Niacin, Thiamine, Riboflavin, Pyridoxine, Cyanocobalamin, Pantothenic Acid, Biotin</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120618</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Valeant Pharmaceuticals North America LLC</LabelerName>
<SubstanceName>ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; FOLIC ACID; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; RIBOFLAVIN; THIAMINE</SubstanceName>
<StrengthNumber>100; 150; 6; 1; 20; 5; 10; 1.7; 1.5</StrengthNumber>
<StrengthUnit>mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-02-27</LastUpdate>
</NDC>
<NDC>
<NDCCode>0187-5269-03</NDCCode>
<PackageDescription>12 BOTTLE in 1 TRAY (0187-5269-03) > 5 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE</PackageDescription>
<NDC11Code>00187-5269-03</NDC11Code>
<ProductNDC>0187-5269</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nephrocaps-qt</ProprietaryName>
<NonProprietaryName>Cholecalciferol, Ascorbic Acid, Folic Acid, Thiamin, Riboflavin, Niacin, Pantothenic Acid, Pyridoxine Hcl, Biotin, Cyanocobalamin</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120608</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Valeant Pharmaceuticals North America LLC</LabelerName>
<SubstanceName>ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; NIACIN; PANTOTHENIC ACID; PYRIDOXINE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100; 150; 1750; 6; 1; 20; 5; 10; 1.7; 1.5</StrengthNumber>
<StrengthUnit>mg/1; ug/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-02-27</LastUpdate>
</NDC>
<NDC>
<NDCCode>68428-187-12</NDCCode>
<PackageDescription>600 PELLET in 1 BOTTLE, GLASS (68428-187-12) </PackageDescription>
<NDC11Code>68428-0187-12</NDC11Code>
<ProductNDC>68428-187</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aletris Farinosa</ProprietaryName>
<NonProprietaryName>Aletris Farinosa Root</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100212</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>ALETRIS FARINOSA ROOT</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-04-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69761-187-12</NDCCode>
<PackageDescription>12 PELLET in 1 PACKAGE (69761-187-12) </PackageDescription>
<NDC11Code>69761-0187-12</NDC11Code>
<ProductNDC>69761-187</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Testosterone</ProprietaryName>
<NonProprietaryName>Testosterone</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Qualgen LLC</LabelerName>
<SubstanceName>TESTOSTERONE</SubstanceName>
<StrengthNumber>87.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-10-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72865-187-12</NDCCode>
<PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (72865-187-12) </PackageDescription>
<NDC11Code>72865-0187-12</NDC11Code>
<ProductNDC>72865-187</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210415</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090515</ApplicationNumber>
<LabelerName>XLCare Pharmaceuticals Inc.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3).</IndicationAndUsage>
<Description>Levetiracetam is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (1040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insoluble in n-hexane. (Solubility limits are expressed as mg/mL solvent.). Levetiracetam tablets, USP contain the labeled amount of levetiracetam USP. Inactive ingredients: corn starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, povidone, talc and additional agents listed below. 250 mg tablets: opadry II blue (FD&C blue #2/indigo carmine aluminum lake, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 500 mg tablets: opadry II yellow (iron oxide yellow, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 750 mg tablets: opadry II orange (FD&C yellow # 6/sunset yellow FCF aluminum lake, iron oxide red, polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). 1000 mg tablets: opadry II white (polyvinyl alcohol, polyethylene glycol 3350, titanium dioxide, talc). USP Dissolution test is 4.</Description>
</NDC>
<NDC>
<NDCCode>0220-1950-41</NDCCode>
<PackageDescription>9 [hp_C] in 1 TUBE (0220-1950-41) </PackageDescription>
<NDC11Code>00220-1950-41</NDC11Code>
<ProductNDC>0220-1950</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Eupatorium Perfoliatum</ProprietaryName>
<NonProprietaryName>Eupatorium Perfoliatum Flowering Top</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19830303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Boiron</LabelerName>
<SubstanceName>EUPATORIUM PERFOLIATUM FLOWERING TOP</SubstanceName>
<StrengthNumber>9</StrengthNumber>
<StrengthUnit>[hp_C]/9[hp_C]</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19830303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Stiffness And Bone Pain Associated With Flu Symptoms*.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10927-101-06</NDCCode>
<PackageDescription>1950 L in 1 CYLINDER (10927-101-06)</PackageDescription>
<NDC11Code>10927-0101-06</NDC11Code>
<ProductNDC>10927-101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrogen</ProprietaryName>
<NonProprietaryName>Nitrogen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19381020</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>PURITY CYLINDER GASES INC</LabelerName>
<SubstanceName>NITROGEN</SubstanceName>
<StrengthNumber>99</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-20</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>43742-1950-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (43742-1950-1) </PackageDescription>
<NDC11Code>43742-1950-01</NDC11Code>
<ProductNDC>43742-1950</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Enviro I</ProprietaryName>
<NonProprietaryName>Potassium Gluconate, Glandula Suprarenalis Suis, Hepar Suis, Coffea Tosta, Thea Sinensis, Carbo Vegetabilis, Ferrum Iodatum, Ferrum Metallicum, Gelsemium Sempervirens, Iodium, Iridium Metallicum, Lycopodium Clavatum, Pulsatilla (pratensis), Selenium Metallicum, Zincum Metallicum, Peanut, Black Walnut, English Walnut, Amygdala Amara, Cashew, Coconut, Pecan, Brazil Nut, Tomato, Solanum Tuberosum, Piper Nigrum, Eggplant, Rape Seed Oil, Linum Usitatissimum, Sesame, Seed, Cheese (stilton), Lac Vaccinum, Beef,</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210226</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Deseret Biologicals, Inc.</LabelerName>
<SubstanceName>POTASSIUM GLUCONATE; SUS SCROFA ADRENAL GLAND; PORK LIVER; COFFEA ARABICA SEED, ROASTED; GREEN TEA LEAF; ACTIVATED CHARCOAL; FERROUS IODIDE; IRON; GELSEMIUM SEMPERVIRENS ROOT; IODINE; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; PULSATILLA PRATENSIS WHOLE; SELENIUM; ZINC; PEANUT; BLACK WALNUT; ENGLISH WALNUT; BITTER ALMOND; CASHEW; COCONUT; PECAN; BRAZIL NUT; TOMATO; SOLANUM TUBEROSUM WHOLE; GREEN PEPPERCORN; EGGPLANT; CANOLA OIL; FLAX SEED; SESAME SEED; CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGED; COW MILK; BEEF; LAMB; PORK; CHICKEN; EGG; KIDNEY BEAN; ONION; APPLE; WHEAT; BANANA; FRAGARIA VESCA FRUIT; ORANGE; ATLANTIC COD; NORTHERN BLUEFIN TUNA; ATLANTIC SALMON; EDIBLE ROCK CRAB; PACIFIC OYSTER; COMMON SHRIMP; CORTISONE ACETATE; HISTAMINE DIHYDROCHLORIDE; HYALURONIDASE; INTERFERON .GAMMA. PORCINE RECOMBINANT; SEROTONIN HYDROCHLORIDE; COCOA</SubstanceName>
<StrengthNumber>6; 8; 8; 10; 10; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 10</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Egg Proteins, Dietary [CS], Endoglycosidase [EPC], Fish Proteins, Dietary [EXT], Fish Proteins, Dietary [EXT], Fruit Proteins [EXT], Fruit Proteins [EXT], Fruit Proteins [EXT], Fruit Proteins [EXT], Glycoside Hydrolases [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Meat Proteins [EXT], Meat Proteins [EXT], Meat Proteins [EXT], Milk Proteins [CS], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> For the temporary relief of symptoms including. sensitivity to food swelling of lips stomach cramps. vomiting occasional diarrhea skin rash. These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0187-0003-01</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (0187-0003-01)</PackageDescription>
<NDC11Code>00187-0003-01</NDC11Code>
<ProductNDC>0187-0003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Capital And Codeine</ProprietaryName>
<NonProprietaryName>Acetaminophen And Codeine Phosphate</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040503</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086024</ApplicationNumber>
<LabelerName>Valeant Pharmaceuticals International</LabelerName>
<SubstanceName>ACETAMINOPHEN; CODEINE PHOSPHATE</SubstanceName>
<StrengthNumber>120; 12</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>0187-0006-10</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (0187-0006-10) / 20 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>00187-0006-10</NDC11Code>
<ProductNDC>0187-0006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cabtreo</ProprietaryName>
<NonProprietaryName>Clindamycin Phosphate/benzoyl Peroxide/adapalene</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20231020</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216632</ApplicationNumber>
<LabelerName>Bausch Health US LLC</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE; ADAPALENE</SubstanceName>
<StrengthNumber>12; 31; 1.5</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CABTREO is indicated for the topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>CABTREO (clindamycin phosphate, adapalene, and benzoyl peroxide) topical gel is a white to off-white, opaque gel. Each gram of CABTREO contains 12 mg (1.2%) clindamycin phosphate, equivalent to 10 mg (1%) clindamycin and 1.5 mg (0.15%) adapalene, and 31 mg (3.1%) benzoyl peroxide. Clindamycin phosphate is a water-soluble ester of the semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. Benzoyl peroxide is an oxidizing agent. The chemical name for clindamycin phosphate is Methyl-7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Clindamycin phosphate. Molecular Formula: C 18H 34ClN 2O 8PS Molecular Weight: 504.97. The chemical name for adapalene is 6-[3-(1-Adamantyl)-4-methoxyphenyl]-2-naphthoic acid. The structural formula for adapalene is represented below. Adapalene. Molecular Formula: C 28H 28O 3. Molecular Weight: 412.52. The chemical name for benzoyl peroxide is dibenzoyl peroxide. The structural formula for benzoyl peroxide is represented below. Benzoyl peroxide. Molecular Formula: C 14H 10O 4 Molecular Weight: 242.23. CABTREO contains the following inactive ingredients: carbomer homopolymer type C (carbomer 980), potassium hydroxide, propylene glycol, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>0187-0006-25</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (0187-0006-25) / 50 g in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>00187-0006-25</NDC11Code>
<ProductNDC>0187-0006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cabtreo</ProprietaryName>
<NonProprietaryName>Clindamycin Phosphate/benzoyl Peroxide/adapalene</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20231020</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216632</ApplicationNumber>
<LabelerName>Bausch Health US LLC</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE; ADAPALENE</SubstanceName>
<StrengthNumber>12; 31; 1.5</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231020</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CABTREO is indicated for the topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>CABTREO (clindamycin phosphate, adapalene, and benzoyl peroxide) topical gel is a white to off-white, opaque gel. Each gram of CABTREO contains 12 mg (1.2%) clindamycin phosphate, equivalent to 10 mg (1%) clindamycin and 1.5 mg (0.15%) adapalene, and 31 mg (3.1%) benzoyl peroxide. Clindamycin phosphate is a water-soluble ester of the semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. Benzoyl peroxide is an oxidizing agent. The chemical name for clindamycin phosphate is Methyl-7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Clindamycin phosphate. Molecular Formula: C 18H 34ClN 2O 8PS Molecular Weight: 504.97. The chemical name for adapalene is 6-[3-(1-Adamantyl)-4-methoxyphenyl]-2-naphthoic acid. The structural formula for adapalene is represented below. Adapalene. Molecular Formula: C 28H 28O 3. Molecular Weight: 412.52. The chemical name for benzoyl peroxide is dibenzoyl peroxide. The structural formula for benzoyl peroxide is represented below. Benzoyl peroxide. Molecular Formula: C 14H 10O 4 Molecular Weight: 242.23. CABTREO contains the following inactive ingredients: carbomer homopolymer type C (carbomer 980), potassium hydroxide, propylene glycol, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>0187-0006-35</NDCCode>
<PackageDescription>3.5 g in 1 TUBE (0187-0006-35) </PackageDescription>
<NDC11Code>00187-0006-35</NDC11Code>
<ProductNDC>0187-0006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cabtreo</ProprietaryName>
<NonProprietaryName>Clindamycin Phosphate/benzoyl Peroxide/adapalene</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20231020</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216632</ApplicationNumber>
<LabelerName>Bausch Health US LLC</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE; ADAPALENE</SubstanceName>
<StrengthNumber>12; 31; 1.5</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231020</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>CABTREO is indicated for the topical treatment of acne vulgaris in adult and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>CABTREO (clindamycin phosphate, adapalene, and benzoyl peroxide) topical gel is a white to off-white, opaque gel. Each gram of CABTREO contains 12 mg (1.2%) clindamycin phosphate, equivalent to 10 mg (1%) clindamycin and 1.5 mg (0.15%) adapalene, and 31 mg (3.1%) benzoyl peroxide. Clindamycin phosphate is a water-soluble ester of the semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Adapalene, a synthetic retinoid, is a naphthoic acid derivative with retinoid-like properties. Benzoyl peroxide is an oxidizing agent. The chemical name for clindamycin phosphate is Methyl-7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Clindamycin phosphate. Molecular Formula: C 18H 34ClN 2O 8PS Molecular Weight: 504.97. The chemical name for adapalene is 6-[3-(1-Adamantyl)-4-methoxyphenyl]-2-naphthoic acid. The structural formula for adapalene is represented below. Adapalene. Molecular Formula: C 28H 28O 3. Molecular Weight: 412.52. The chemical name for benzoyl peroxide is dibenzoyl peroxide. The structural formula for benzoyl peroxide is represented below. Benzoyl peroxide. Molecular Formula: C 14H 10O 4 Molecular Weight: 242.23. CABTREO contains the following inactive ingredients: carbomer homopolymer type C (carbomer 980), potassium hydroxide, propylene glycol, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>0187-0245-01</NDCCode>
<PackageDescription>1 VIAL in 1 KIT (0187-0245-01) / 1 mL in 1 VIAL</PackageDescription>
<NDC11Code>00187-0245-01</NDC11Code>
<ProductNDC>0187-0245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Migranal</ProprietaryName>
<NonProprietaryName>Dihydroergotamine Mesylate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>19971208</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020148</ApplicationNumber>
<LabelerName>Bausch Health US, LLC</LabelerName>
<SubstanceName>DIHYDROERGOTAMINE MESYLATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Ergotamine Derivative [EPC], Ergotamines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971208</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>MIGRANAL (dihydroergotamine mesylate) Nasal Spray is indicated for the acute treatment of migraine headaches with or without aura. MIGRANAL (dihydroergotamine mesylate) Nasal Spray is not intended for the prophylactic therapy of migraine or for the management of hemiplegic or basilar migraine.</IndicationAndUsage>
<Description>MIGRANAL is ergotamine hydrogenated in the 9,10 position as the mesylate salt. MIGRANAL is known chemically as ergotaman-3’, 6’, 18-trione, 9,10-dihydro-12’-hydroxy-2’-methyl-5’- (phenylmethyl)-, (5’α)-, monomethane-sulfonate. Its molecular weight is 679.78 and its empirical formula is C 33H 37N 5O 5CH 4O 3S. The chemical structure is. MIGRANAL (dihydroergotamine mesylate) Nasal Spray is provided for intranasal administration as a clear, colorless to light yellow aqueous solution in an amber glass vial containing: 1 dihydroergotamine mesylate ………4 mg, 2 caffeine, anhydrous .……..10 mg, 3 dextrose, anhydrous ……...50 mg, 4 carbon dioxide ………….qs, 5 purified water .. ……..qs 1 mL.</Description>
</NDC>
<NDC>
<NDCCode>0187-0245-03</NDCCode>
<PackageDescription>8 VIAL in 1 KIT (0187-0245-03) > 1 mL in 1 VIAL</PackageDescription>
<NDC11Code>00187-0245-03</NDC11Code>
<ProductNDC>0187-0245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Migranal</ProprietaryName>
<NonProprietaryName>Dihydroergotamine Mesylate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>19971208</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020148</ApplicationNumber>
<LabelerName>Bausch Health US, LLC</LabelerName>
<SubstanceName>DIHYDROERGOTAMINE MESYLATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Ergotamine Derivative [EPC], Ergotamines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-03-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MIGRANAL (dihydroergotamine mesylate) Nasal Spray is indicated for the acute treatment of migraine headaches with or without aura. MIGRANAL (dihydroergotamine mesylate) Nasal Spray is not intended for the prophylactic therapy of migraine or for the management of hemiplegic or basilar migraine.</IndicationAndUsage>
<Description>MIGRANAL is ergotamine hydrogenated in the 9,10 position as the mesylate salt. MIGRANAL is known chemically as ergotaman-3’, 6’, 18-trione, 9,10-dihydro-12’-hydroxy-2’-methyl-5’- (phenylmethyl)-, (5’α)-, monomethane-sulfonate. Its molecular weight is 679.78 and its empirical formula is C33H37N5O5CH4O3S. The chemical structure is. MIGRANAL (dihydroergotamine mesylate) Nasal Spray is provided for intranasal administration as a clear, colorless to light yellow aqueous solution in an amber glass vial containing: 1 dihydroergotamine mesylate ………4 mg, 2 caffeine, anhydrous ……..10 mg, 3 dextrose, anhydrous ……..50 mg, 4 carbon dioxide ………….qs, 5 purified water.. ……..qs 1 mL.</Description>
</NDC>
<NDC>
<NDCCode>0187-0245-04</NDCCode>
<PackageDescription>1 VIAL in 1 KIT (0187-0245-04) / 1 mL in 1 VIAL</PackageDescription>
<NDC11Code>00187-0245-04</NDC11Code>
<ProductNDC>0187-0245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Migranal</ProprietaryName>
<NonProprietaryName>Dihydroergotamine Mesylate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>19971208</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020148</ApplicationNumber>
<LabelerName>Bausch Health US, LLC</LabelerName>
<SubstanceName>DIHYDROERGOTAMINE MESYLATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Ergotamine Derivative [EPC], Ergotamines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MIGRANAL (dihydroergotamine mesylate) Nasal Spray is indicated for the acute treatment of migraine headaches with or without aura. MIGRANAL (dihydroergotamine mesylate) Nasal Spray is not intended for the prophylactic therapy of migraine or for the management of hemiplegic or basilar migraine.</IndicationAndUsage>
<Description>MIGRANAL is ergotamine hydrogenated in the 9,10 position as the mesylate salt. MIGRANAL is known chemically as ergotaman-3’, 6’, 18-trione, 9,10-dihydro-12’-hydroxy-2’-methyl-5’- (phenylmethyl)-, (5’α)-, monomethane-sulfonate. Its molecular weight is 679.78 and its empirical formula is C 33H 37N 5O 5CH 4O 3S. The chemical structure is. MIGRANAL (dihydroergotamine mesylate) Nasal Spray is provided for intranasal administration as a clear, colorless to light yellow aqueous solution in an amber glass vial containing: 1 dihydroergotamine mesylate ………4 mg, 2 caffeine, anhydrous .……..10 mg, 3 dextrose, anhydrous ……...50 mg, 4 carbon dioxide ………….qs, 5 purified water .. ……..qs 1 mL.</Description>
</NDC>
<NDC>
<NDCCode>0187-0402-31</NDCCode>
<PackageDescription>29.57 mL in 1 BOTTLE, GLASS (0187-0402-31)</PackageDescription>
<NDC11Code>00187-0402-31</NDC11Code>
<ProductNDC>0187-0402</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxsoralen</ProprietaryName>
<NonProprietaryName>Methoxsalen</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19541203</StartMarketingDate>
<EndMarketingDate>20160630</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA009048</ApplicationNumber>
<LabelerName>Valeant Pharmaceuticals North America LLC</LabelerName>
<SubstanceName>METHOXSALEN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Photoabsorption [MoA],Photoactivated Radical Generator [EPC],Photosensitizing Activity [PE],Psoralen [EPC],Psoralens [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0187-0500-02</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0187-0500-02)</PackageDescription>
<NDC11Code>00187-0500-02</NDC11Code>
<ProductNDC>0187-0500</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Motofen</ProprietaryName>
<NonProprietaryName>Difenoxin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19620714</StartMarketingDate>
<EndMarketingDate>20141130</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017744</ApplicationNumber>
<LabelerName>Valeant Pharmaceuticals North America LLC</LabelerName>
<SubstanceName>ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.025; 1</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Antidiarrheal [EPC],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2014-12-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>0187-0650-42</NDCCode>
<PackageDescription>50 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0187-0650-42) </PackageDescription>
<NDC11Code>00187-0650-42</NDC11Code>
<ProductNDC>0187-0650</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxsoralen-ultra</ProprietaryName>
<NonProprietaryName>Methoxsalen</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19861030</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019600</ApplicationNumber>
<LabelerName>Bausch Health US, LLC</LabelerName>
<SubstanceName>METHOXSALEN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Psoralen [EPC],Psoralens [CS],Photoabsorption [MoA],Photoactivated Radical Generator [EPC],Photosensitizing Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19861030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0187-0653-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0187-0653-01) / 100 g in 1 TUBE</PackageDescription>
<NDC11Code>00187-0653-01</NDC11Code>
<ProductNDC>0187-0653</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duobrii</ProprietaryName>
<NonProprietaryName>Halobetasol Propionate And Tazarotene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190425</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209354</ApplicationNumber>
<LabelerName>Bausch Health US, LLC</LabelerName>
<SubstanceName>HALOBETASOL PROPIONATE; TAZAROTENE</SubstanceName>
<StrengthNumber>.1; .45</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DUOBRII® (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045% is indicated for the topical treatment of plaque psoriasis in adults.</IndicationAndUsage>
<Description>DUOBRII Lotion is a combination product with halobetasol propionate and tazarotene as the active ingredients in a white to off-white lotion formulation intended for topical use. Halobetasol propionate is a synthetic corticosteroid. The chemical name for halobetasol propionate is [(6S,9R,16S,17R)-17-(2-chloroacetyl)-6,9-difluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] propanoate. The structural formula for halobetasol propionate is represented below. Molecular Formula: C25H31ClF2O5 Molecular Weight: 484.96. Tazarotene is a member of the acetylenic class of retinoids. The chemical name for tazarotene is 6-[(3,4-Dihydro-4,4-dimethyl-2H-1-benzothiopyran-6-yl)ethynyl]-3-pyridinecarboxylic acid ethyl ester. The structural formula for tazarotene is represented below. Molecular Formula: C21H21NO2S Molecular Weight: 351.46. Each gram of DUOBRII Lotion contains 0.1 mg (0.01%) halobetasol propionate and 0.45 mg (0.045%) tazarotene in a white to off-white lotion base consisting of carbomer copolymer type B, carbomer homopolymer type A, diethyl sebacate, edetate disodium dihydrate, light mineral oil, methylparaben, propylparaben, purified water, sodium hydroxide, sorbitan monooleate and sorbitol solution, 70%.</Description>
</NDC>
<NDC>
<NDCCode>0187-0653-03</NDCCode>
<PackageDescription>6 TUBE in 1 CARTON (0187-0653-03) / 3 g in 1 TUBE</PackageDescription>
<NDC11Code>00187-0653-03</NDC11Code>
<ProductNDC>0187-0653</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duobrii</ProprietaryName>
<NonProprietaryName>Halobetasol Propionate And Tazarotene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190425</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA209354</ApplicationNumber>
<LabelerName>Bausch Health US, LLC</LabelerName>
<SubstanceName>HALOBETASOL PROPIONATE; TAZAROTENE</SubstanceName>
<StrengthNumber>.1; .45</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190425</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>DUOBRII® (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045% is indicated for the topical treatment of plaque psoriasis in adults.</IndicationAndUsage>
<Description>DUOBRII Lotion is a combination product with halobetasol propionate and tazarotene as the active ingredients in a white to off-white lotion formulation intended for topical use. Halobetasol propionate is a synthetic corticosteroid. The chemical name for halobetasol propionate is [(6S,9R,16S,17R)-17-(2-chloroacetyl)-6,9-difluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] propanoate. The structural formula for halobetasol propionate is represented below. Molecular Formula: C25H31ClF2O5 Molecular Weight: 484.96. Tazarotene is a member of the acetylenic class of retinoids. The chemical name for tazarotene is 6-[(3,4-Dihydro-4,4-dimethyl-2H-1-benzothiopyran-6-yl)ethynyl]-3-pyridinecarboxylic acid ethyl ester. The structural formula for tazarotene is represented below. Molecular Formula: C21H21NO2S Molecular Weight: 351.46. Each gram of DUOBRII Lotion contains 0.1 mg (0.01%) halobetasol propionate and 0.45 mg (0.045%) tazarotene in a white to off-white lotion base consisting of carbomer copolymer type B, carbomer homopolymer type A, diethyl sebacate, edetate disodium dihydrate, light mineral oil, methylparaben, propylparaben, purified water, sodium hydroxide, sorbitan monooleate and sorbitol solution, 70%.</Description>
</NDC>
<NDC>
<NDCCode>0187-0795-30</NDCCode>
<PackageDescription>30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-0795-30) </PackageDescription>
<NDC11Code>00187-0795-30</NDC11Code>
<ProductNDC>0187-0795</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cardizem Cd</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010411</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020062</ApplicationNumber>
<LabelerName>Bausch Health US LLC</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CARDIZEM CD is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. CARDIZEM CD is indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>CARDIZEM® CD (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-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. CARDIZEM CD is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem). Capsules also contain: black iron oxide (300 mg), FD&C Blue #1, gelatin, hypromellose, magnesium stearate, microcrystalline cellulose, ethyl acrylate and methyl methacrylate copolymer, polysorbate, povidone, simethicone emulsion, sucrose stearate, talc, and titanium dioxide. For oral administration.</Description>
</NDC>
<NDC>
<NDCCode>0187-0795-42</NDCCode>
<PackageDescription>90 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-0795-42) </PackageDescription>
<NDC11Code>00187-0795-42</NDC11Code>
<ProductNDC>0187-0795</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cardizem Cd</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010411</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020062</ApplicationNumber>
<LabelerName>Bausch Health US LLC</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>120</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CARDIZEM CD is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. CARDIZEM CD is indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>CARDIZEM® CD (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-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. CARDIZEM CD is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem). Capsules also contain: black iron oxide (300 mg), FD&C Blue #1, gelatin, hypromellose, magnesium stearate, microcrystalline cellulose, ethyl acrylate and methyl methacrylate copolymer, polysorbate, povidone, simethicone emulsion, sucrose stearate, talc, and titanium dioxide. For oral administration.</Description>
</NDC>
<NDC>
<NDCCode>0187-0796-30</NDCCode>
<PackageDescription>30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-0796-30) </PackageDescription>
<NDC11Code>00187-0796-30</NDC11Code>
<ProductNDC>0187-0796</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cardizem Cd</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010411</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020062</ApplicationNumber>
<LabelerName>Bausch Health US LLC</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CARDIZEM CD is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. CARDIZEM CD is indicated for the management of chronic stable angina and angina due to coronary artery spasm.</IndicationAndUsage>
<Description>CARDIZEM® CD (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-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. CARDIZEM CD is formulated as a once-a-day extended-release capsule containing 120 mg diltiazem hydrochloride (equivalent to 110.3 mg diltiazem), 180 mg diltiazem hydrochloride (equivalent to 165.45 mg diltiazem), 240 mg diltiazem hydrochloride (equivalent to 220.6 mg diltiazem), 300 mg diltiazem hydrochloride (equivalent to 275.75 mg diltiazem), or 360 mg diltiazem hydrochloride (equivalent to 330.9 mg diltiazem). Capsules also contain: black iron oxide (300 mg), FD&C Blue #1, gelatin, hypromellose, magnesium stearate, microcrystalline cellulose, ethyl acrylate and methyl methacrylate copolymer, polysorbate, povidone, simethicone emulsion, sucrose stearate, talc, and titanium dioxide. For oral administration.</Description>
</NDC>
</NDCList>