{
"NDC": [
{
"NDCCode": "49884-882-99",
"PackageDescription": "1 BLISTER PACK in 1 PACKAGE, COMBINATION (49884-882-99) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "49884-0882-99",
"ProductNDC": "49884-882",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "KIT",
"StartMarketingDate": "20151127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204158",
"LabelerName": "Par Health USA, LLC",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151216",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine orally disintegrating tablets are indicated for. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).",
"Description": "Lamotrigine, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine, USP is slightly soluble in 0.1 N hydrochloric acid, in acetone, in methanol and in water. The structural formula is. Lamotrigine orally disintegrating tablets are supplied for oral administration. The tablets contain 25 mg (white), 50 mg (white), 100 mg (peach), 200 mg (white) of lamotrigine, USP and the following inactive ingredients. For lamotrigine orally disintegrating tablets 25 mg, 50 mg and 200 mg: Colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, starch (maize), microcrystalline cellulose, pregelatinized starch, peppermint flavor, sodium stearyl fumarate and sucralose. For lamotrigine orally disintegrating tablets 100 mg: Colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, starch (maize), microcrystalline cellulose, pregelatinized starch, peppermint flavor, sodium stearyl fumarate, sucralose and idacol red oxide of iron. Lamotrigine orally disintegrating tablets are formulated using in-house technologies designed to mask the bitter taste of lamotrigine and achieve a rapid dissolution profile."
},
{
"NDCCode": "49884-882-84",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 CARTON (49884-882-84)",
"NDC11Code": "49884-0882-84",
"ProductNDC": "49884-882",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20130602",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204158",
"LabelerName": "Par Pharmaceutical Companies, Inc.",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "50",
"StrengthUnit": "1/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-01-08"
},
{
"NDCCode": "49884-880-99",
"PackageDescription": "1 BLISTER PACK in 1 PACKAGE, COMBINATION (49884-880-99) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "49884-0880-99",
"ProductNDC": "49884-880",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "KIT",
"StartMarketingDate": "20151127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204158",
"LabelerName": "Par Health USA, LLC",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151216",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine orally disintegrating tablets are indicated for. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).",
"Description": "Lamotrigine, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine, USP is slightly soluble in 0.1 N hydrochloric acid, in acetone, in methanol and in water. The structural formula is. Lamotrigine orally disintegrating tablets are supplied for oral administration. The tablets contain 25 mg (white), 50 mg (white), 100 mg (peach), 200 mg (white) of lamotrigine, USP and the following inactive ingredients. For lamotrigine orally disintegrating tablets 25 mg, 50 mg and 200 mg: Colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, starch (maize), microcrystalline cellulose, pregelatinized starch, peppermint flavor, sodium stearyl fumarate and sucralose. For lamotrigine orally disintegrating tablets 100 mg: Colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, starch (maize), microcrystalline cellulose, pregelatinized starch, peppermint flavor, sodium stearyl fumarate, sucralose and idacol red oxide of iron. Lamotrigine orally disintegrating tablets are formulated using in-house technologies designed to mask the bitter taste of lamotrigine and achieve a rapid dissolution profile."
},
{
"NDCCode": "49884-881-99",
"PackageDescription": "1 BLISTER PACK in 1 PACKAGE, COMBINATION (49884-881-99) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "49884-0881-99",
"ProductNDC": "49884-881",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamotrigine",
"NonProprietaryName": "Lamotrigine",
"DosageFormName": "KIT",
"StartMarketingDate": "20151127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204158",
"LabelerName": "Par Health USA, LLC",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151216",
"SamplePackage": "N",
"IndicationAndUsage": "Lamotrigine orally disintegrating tablets are indicated for. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).",
"Description": "Lamotrigine, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine, USP is slightly soluble in 0.1 N hydrochloric acid, in acetone, in methanol and in water. The structural formula is. Lamotrigine orally disintegrating tablets are supplied for oral administration. The tablets contain 25 mg (white), 50 mg (white), 100 mg (peach), 200 mg (white) of lamotrigine, USP and the following inactive ingredients. For lamotrigine orally disintegrating tablets 25 mg, 50 mg and 200 mg: Colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, starch (maize), microcrystalline cellulose, pregelatinized starch, peppermint flavor, sodium stearyl fumarate and sucralose. For lamotrigine orally disintegrating tablets 100 mg: Colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, starch (maize), microcrystalline cellulose, pregelatinized starch, peppermint flavor, sodium stearyl fumarate, sucralose and idacol red oxide of iron. Lamotrigine orally disintegrating tablets are formulated using in-house technologies designed to mask the bitter taste of lamotrigine and achieve a rapid dissolution profile."
},
{
"NDCCode": "49884-944-99",
"PackageDescription": "1 KIT in 1 BOX (49884-944-99) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "49884-0944-99",
"ProductNDC": "49884-944",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Varenicline",
"NonProprietaryName": "Varenicline Tartrate",
"DosageFormName": "KIT",
"StartMarketingDate": "20210921",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201785",
"LabelerName": "Par Health USA, LLC",
"Status": "Active",
"LastUpdate": "2026-05-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210921",
"SamplePackage": "N",
"IndicationAndUsage": "Varenicline tablets are indicated for use as an aid to smoking cessation treatment.",
"Description": "Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt of maltodextrin premix (1:1:10), is a powder which is a off-white to pinkish brown color with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate with maltodextrin (1:1:10). It is soluble in water, practically insoluble in acetone and methylene dichloride. Varenicline tartrate has a molecular weight of 361.35 Daltons and maltodextrin, and a molecular formula of C13H13N3 C4H6O6 and maltodextrin. The chemical structure is. Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg circular, biconvex, white to off-white film-coated tablets, debossed with “P” on one side and “155” on other side and a 1 mg circular, biconvex, light blue film-coated tablets, debossed with “P” on one side and “156” on other side. Each 0.5 mg varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: croscarmellose sodium, maltodextrin, microcrystalline cellulose, stearic acid. The tablets are film-coated with a coating material containing hydroxypropyl cellulose, hypromellose, talc, and titanium dioxide. In addition to these, the 1 mg tablet film coating includes FD&C blue #2/indigo carmine aluminum lake and iron oxide yellow."
},
{
"NDCCode": "0869-0295-20",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (0869-0295-20) ",
"NDC11Code": "00869-0295-20",
"ProductNDC": "0869-0295",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Itch Relief",
"NonProprietaryName": "Diphenhydramine Hcl, Zinc Acetate",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100714",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Vi-Jon, LLC",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE",
"StrengthNumber": "18; 882",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20100714",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of pain and itching associated with ■ insect bites ■ minor skin irritations ■ sunburn■ minor burns ■ minor cuts ■ scrapes ■ rashes due to poison: ■ ivy ■ oak ■ sumac. dries the oozing and weeping of poison: ■ ivy ■ oak ■ sumac."
},
{
"NDCCode": "10875-5000-3",
"PackageDescription": "882.24 kg in 1 CONTAINER (10875-5000-3) ",
"NDC11Code": "10875-5000-03",
"ProductNDC": "10875-5000",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Mineral",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20140626",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Calumet Karns City Refining LLC",
"SubstanceName": "MINERAL OIL",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "26-JUN-14"
},
{
"NDCCode": "11673-882-10",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (11673-882-10) > 30 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "11673-0882-10",
"ProductNDC": "11673-882",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up Infants Gas Relief",
"NonProprietaryName": "Simethicone",
"DosageFormName": "EMULSION",
"RouteName": "ORAL",
"StartMarketingDate": "20090721",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part332",
"LabelerName": "Target Corporation",
"SubstanceName": "DIMETHICONE",
"StrengthNumber": "20",
"StrengthUnit": "mg/.3mL",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20090721",
"SamplePackage": "N",
"IndicationAndUsage": "relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods."
},
{
"NDCCode": "13411-882-05",
"PackageDescription": "5 PACKET in 1 BOX (13411-882-05) / 12 g in 1 PACKET",
"NDC11Code": "13411-0882-05",
"ProductNDC": "13411-882",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Jba Collagen-electrolyte Mocktail",
"NonProprietaryName": "Vitamin C,thiamin,riboflavin,niacin,vitamin B6,folate,biotin,pantothenic Acid,magnesium,zinc,sodium,potassium,bovine Collagen Peptides",
"DosageFormName": "POWDER",
"RouteName": "ORAL",
"StartMarketingDate": "20240306",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals",
"SubstanceName": "ASCORBIC ACID; BIOTIN; FOLIC ACID; MAGNESIUM; NIACIN; PANTOTHENIC ACID; POTASSIUM; PYRIDOXINE; RIBOFLAVIN; SODIUM; THIAMINE; ZINC",
"StrengthNumber": "100; 80; 200; 50; 18; 6; 190; 2.5; 1.6; 250; 1.2; 10",
"StrengthUnit": "mg/12g; ug/12g; ug/12g; mg/12g; mg/12g; mg/12g; mg/12g; mg/12g; mg/12g; mg/12g; mg/12g; mg/12g",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240313",
"SamplePackage": "N"
},
{
"NDCCode": "13411-882-15",
"PackageDescription": "15 PACKET in 1 BOX (13411-882-15) / 12 g in 1 PACKET",
"NDC11Code": "13411-0882-15",
"ProductNDC": "13411-882",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Jba Collagen-electrolyte Mocktail",
"NonProprietaryName": "Vitamin C,thiamin,riboflavin,niacin,vitamin B6,folate,biotin,pantothenic Acid,magnesium,zinc,sodium,potassium,bovine Collagen Peptides",
"DosageFormName": "POWDER",
"RouteName": "ORAL",
"StartMarketingDate": "20240306",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals",
"SubstanceName": "ASCORBIC ACID; BIOTIN; FOLIC ACID; MAGNESIUM; NIACIN; PANTOTHENIC ACID; POTASSIUM; PYRIDOXINE; RIBOFLAVIN; SODIUM; THIAMINE; ZINC",
"StrengthNumber": "100; 80; 200; 50; 18; 6; 190; 2.5; 1.6; 250; 1.2; 10",
"StrengthUnit": "mg/12g; ug/12g; ug/12g; mg/12g; mg/12g; mg/12g; mg/12g; mg/12g; mg/12g; mg/12g; mg/12g; mg/12g",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240313",
"SamplePackage": "N"
},
{
"NDCCode": "13411-882-30",
"PackageDescription": "30 PACKET in 1 BOX (13411-882-30) / 12 g in 1 PACKET",
"NDC11Code": "13411-0882-30",
"ProductNDC": "13411-882",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Jba Collagen-electrolyte Mocktail",
"NonProprietaryName": "Vitamin C,thiamin,riboflavin,niacin,vitamin B6,folate,biotin,pantothenic Acid,magnesium,zinc,sodium,potassium,bovine Collagen Peptides",
"DosageFormName": "POWDER",
"RouteName": "ORAL",
"StartMarketingDate": "20240306",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals",
"SubstanceName": "ASCORBIC ACID; BIOTIN; FOLIC ACID; MAGNESIUM; NIACIN; PANTOTHENIC ACID; POTASSIUM; PYRIDOXINE; RIBOFLAVIN; SODIUM; THIAMINE; ZINC",
"StrengthNumber": "100; 80; 200; 50; 18; 6; 190; 2.5; 1.6; 250; 1.2; 10",
"StrengthUnit": "mg/12g; ug/12g; ug/12g; mg/12g; mg/12g; mg/12g; mg/12g; mg/12g; mg/12g; mg/12g; mg/12g; mg/12g",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-03-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240313",
"SamplePackage": "N"
},
{
"NDCCode": "13537-882-24",
"PackageDescription": "1 TUBE in 1 BOX (13537-882-24) > 4 g in 1 TUBE (13537-882-23)",
"NDC11Code": "13537-0882-24",
"ProductNDC": "13537-882",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Effet Parfait Rouge Amplifier",
"ProprietaryNameSuffix": "Amplifying Spf 15 (rouge Provocation) - Red",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140911",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": ".072",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "14141-882-01",
"PackageDescription": "30 g in 1 TUBE (14141-882-01) ",
"NDC11Code": "14141-0882-01",
"ProductNDC": "14141-882",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Studio Look Base De Alta Cobertura Para El Rostro Con Fps 20 Espresso 450-c",
"NonProprietaryName": "Octinoxate, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200401",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "BEL STAR S A",
"SubstanceName": "OCTINOXATE; ZINC OXIDE",
"StrengthNumber": "4; 2.4",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2023-12-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200401",
"SamplePackage": "N"
},
{
"NDCCode": "14783-882-24",
"PackageDescription": "1 TUBE in 1 BOX (14783-882-24) > 4 g in 1 TUBE (14783-882-23)",
"NDC11Code": "14783-0882-24",
"ProductNDC": "14783-882",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Effet Parfait Rouge Amplifier",
"ProprietaryNameSuffix": "Amplifying Spf 15 (rouge Provocation) - Red",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140911",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": ".072",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "16571-882-05",
"PackageDescription": "1 CONTAINER in 1 CARTON (16571-882-05) / 5 mL in 1 CONTAINER",
"NDC11Code": "16571-0882-05",
"ProductNDC": "16571-882",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Olopatadine Hydrochloride",
"NonProprietaryName": "Olopatadine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20250501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204392",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "OLOPATADINE HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250501",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander."
},
{
"NDCCode": "21130-882-10",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (21130-882-10) > 30 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "21130-0882-10",
"ProductNDC": "21130-882",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Infants Gas Relief",
"NonProprietaryName": "Simethicone",
"DosageFormName": "EMULSION",
"RouteName": "ORAL",
"StartMarketingDate": "20020822",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part332",
"LabelerName": "Safeway",
"SubstanceName": "DIMETHICONE",
"StrengthNumber": "20",
"StrengthUnit": "mg/.3mL",
"Status": "Deprecated",
"LastUpdate": "2017-12-13",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "23155-882-31",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (23155-882-31) / 5 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "23155-0882-31",
"ProductNDC": "23155-882",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paclitaxel",
"ProprietaryNameSuffix": "Paclitaxel",
"NonProprietaryName": "Paclitaxel",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207326",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "PACLITAXEL",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230831",
"SamplePackage": "N",
"IndicationAndUsage": "Paclitaxel Injection, USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, paclitaxel is indicated in combination with cisplatin. Paclitaxel is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptornegative tumors. (See CLINICAL STUDIES: Breast Carcinoma.)Paclitaxel Injection, USP is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.Paclitaxel, in combination with cisplatin, is indicated for the first-line treatment of nonsmall cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Paclitaxel is indicated for the second-line treatment of AIDS-related Kaposi’s sarcoma.",
"Description": "Paclitaxel Injection, USP is a clear colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel, 527 mg of Polyoxyl 35 Castor Oil, NF, 49.7% (v/v) Dehydrated Alcohol, USP and 2 mg Citric Acid, USP. Paclitaxel is a natural product with antitumor activity. Paclitaxel is obtained via an extraction process from Taxus X media ‘Hicksii’. The chemical name for paclitaxel is (2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-1,2a,3,4,4a,6,9,10,11, 12,12a,12b-Dodecahydro-4,6,9,11,12,-12b-hexahydroxy-4a,8, 13,13-tetramethyl-7,11-methano-5H-cyclodeca [3,4] benz [1,2-b] oxet-5-one 6,12b-diacetate, 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine.Paclitaxel has the following structural formula. Paclitaxel is a white to off-white crystalline powder with the empirical formula C47H51NO14 and molecular weight of 853.9. It is highly lipophilic, insoluble in water, and melts at around 216 to 217°C."
},
{
"NDCCode": "24236-882-60",
"PackageDescription": "60 CAPSULE in 1 CANISTER (24236-882-60)",
"NDC11Code": "24236-0882-60",
"ProductNDC": "24236-882",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Strattera",
"NonProprietaryName": "Atomoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130509",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021411",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "ATOMOXETINE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "24689-882-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (24689-882-01) ",
"NDC11Code": "24689-0882-01",
"ProductNDC": "24689-882",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Terazosin Hydrochloride",
"NonProprietaryName": "Terazosin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074823",
"LabelerName": "Apnar Pharma LP",
"SubstanceName": "TERAZOSIN HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200630",
"SamplePackage": "N",
"IndicationAndUsage": "Terazosin capsules, USP are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules, USP. The long-term effects of terazosin capsules, USP on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules, USP are also indicated for the treatment of hypertension. Terazosin capsules, USP can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.",
"Description": "Terazosin hydrochloride, an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name, molecular formula and structural formula: (RS)-Piperazine, 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetrahydro-2-furanyl)carbonyl]-, monohydrochloride, C 19H 26ClN 5O 4. It has the following structural formula:. Terazosin hydrochloride is a white, crystalline substance, freely soluble in water and isotonic saline and has a molecular weight of 423.93. Terazosin capsules, USP, for oral administration, are supplied in four dosage strengths containing terazosin hydrochloride, USP equivalent to 1 mg, 2 mg, 5 mg, or 10 mg of terazosin. Inactive ingredients: Crospovidone, lactose (monohydrate), magnesium stearate, and microcrystalline cellulose. The capsule shells and imprinting inks contain: D & C Yellow #10 Aluminum Lake, FD & C Blue #1 Aluminum Lake, FD & C Blue #2 Aluminum Lake, FD & C Red #40 Aluminum Lake, gelatin, propylene glycol, shellac, synthetic black iron oxide, and titanium dioxide. The 5 mg also contains: D & C Red #28."
},
{
"NDCCode": "24689-882-03",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (24689-882-03) ",
"NDC11Code": "24689-0882-03",
"ProductNDC": "24689-882",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Terazosin Hydrochloride",
"NonProprietaryName": "Terazosin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074823",
"LabelerName": "Apnar Pharma LP",
"SubstanceName": "TERAZOSIN HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250215",
"SamplePackage": "N",
"IndicationAndUsage": "Terazosin capsules, USP are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules, USP. The long-term effects of terazosin capsules, USP on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules, USP are also indicated for the treatment of hypertension. Terazosin capsules, USP can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.",
"Description": "Terazosin hydrochloride, an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name, molecular formula and structural formula: (RS)-Piperazine, 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetrahydro-2-furanyl)carbonyl]-, monohydrochloride, C 19H 26ClN 5O 4. It has the following structural formula:. Terazosin hydrochloride is a white, crystalline substance, freely soluble in water and isotonic saline and has a molecular weight of 423.93. Terazosin capsules, USP, for oral administration, are supplied in four dosage strengths containing terazosin hydrochloride, USP equivalent to 1 mg, 2 mg, 5 mg, or 10 mg of terazosin. Inactive ingredients: Crospovidone, lactose (monohydrate), magnesium stearate, and microcrystalline cellulose. The capsule shells and imprinting inks contain: D & C Yellow #10 Aluminum Lake, FD & C Blue #1 Aluminum Lake, FD & C Blue #2 Aluminum Lake, FD & C Red #40 Aluminum Lake, gelatin, propylene glycol, shellac, synthetic black iron oxide, and titanium dioxide. The 5 mg also contains: D & C Red #28."
},
{
"NDCCode": "24689-882-10",
"PackageDescription": "1000 CAPSULE in 1 BOTTLE (24689-882-10) ",
"NDC11Code": "24689-0882-10",
"ProductNDC": "24689-882",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Terazosin Hydrochloride",
"NonProprietaryName": "Terazosin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074823",
"LabelerName": "Apnar Pharma LP",
"SubstanceName": "TERAZOSIN HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-06-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200630",
"SamplePackage": "N",
"IndicationAndUsage": "Terazosin capsules, USP are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules, USP. The long-term effects of terazosin capsules, USP on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules, USP are also indicated for the treatment of hypertension. Terazosin capsules, USP can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.",
"Description": "Terazosin hydrochloride, an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name, molecular formula and structural formula: (RS)-Piperazine, 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetrahydro-2-furanyl)carbonyl]-, monohydrochloride, C 19H 26ClN 5O 4. It has the following structural formula:. Terazosin hydrochloride is a white, crystalline substance, freely soluble in water and isotonic saline and has a molecular weight of 423.93. Terazosin capsules, USP, for oral administration, are supplied in four dosage strengths containing terazosin hydrochloride, USP equivalent to 1 mg, 2 mg, 5 mg, or 10 mg of terazosin. Inactive ingredients: Crospovidone, lactose (monohydrate), magnesium stearate, and microcrystalline cellulose. The capsule shells and imprinting inks contain: D & C Yellow #10 Aluminum Lake, FD & C Blue #1 Aluminum Lake, FD & C Blue #2 Aluminum Lake, FD & C Red #40 Aluminum Lake, gelatin, propylene glycol, shellac, synthetic black iron oxide, and titanium dioxide. The 5 mg also contains: D & C Red #28."
},
{
"NDCCode": "30142-882-10",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (30142-882-10) > 30 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "30142-0882-10",
"ProductNDC": "30142-882",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gas Relief",
"ProprietaryNameSuffix": "Infants",
"NonProprietaryName": "Simethicone",
"DosageFormName": "EMULSION",
"RouteName": "ORAL",
"StartMarketingDate": "19990304",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part332",
"LabelerName": "Kroger Company",
"SubstanceName": "DIMETHICONE",
"StrengthNumber": "20",
"StrengthUnit": "mg/.3mL",
"Status": "Deprecated",
"LastUpdate": "2020-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19990304",
"SamplePackage": "N"
},
{
"NDCCode": "31722-882-01",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (31722-882-01) ",
"NDC11Code": "31722-0882-01",
"ProductNDC": "31722-882",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin",
"NonProprietaryName": "Rosuvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20161029",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207616",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240209",
"SamplePackage": "N",
"IndicationAndUsage": "Rosuvastatin tablets are indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.",
"Description": "Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is (3R, 5S, 6E) -7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid calcium salt with the following structural formula:. The molecular formula for rosuvastatin calcium is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium USP is a white or almost white hygroscopic powder that is sparingly soluble in methanol, slightly soluble in water, practically insoluble in anhydrous ethanol. Rosuvastatin tablets USP for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: crospovidone, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, talc, titanium dioxide and triacetin. Additionally 5 mg tablets contain FD&C yellow #5/tartrazine aluminum lake and 10 mg, 20 mg and 40 mg tablets contain FD&C yellow #6/sunset yellow FCF aluminum lake. USP Dissolution test is pending."
},
{
"NDCCode": "31722-882-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (31722-882-05) ",
"NDC11Code": "31722-0882-05",
"ProductNDC": "31722-882",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin",
"NonProprietaryName": "Rosuvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20161029",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207616",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240209",
"SamplePackage": "N",
"IndicationAndUsage": "Rosuvastatin tablets are indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.",
"Description": "Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is (3R, 5S, 6E) -7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid calcium salt with the following structural formula:. The molecular formula for rosuvastatin calcium is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium USP is a white or almost white hygroscopic powder that is sparingly soluble in methanol, slightly soluble in water, practically insoluble in anhydrous ethanol. Rosuvastatin tablets USP for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: crospovidone, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, talc, titanium dioxide and triacetin. Additionally 5 mg tablets contain FD&C yellow #5/tartrazine aluminum lake and 10 mg, 20 mg and 40 mg tablets contain FD&C yellow #6/sunset yellow FCF aluminum lake. USP Dissolution test is pending."
},
{
"NDCCode": "31722-882-10",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (31722-882-10) ",
"NDC11Code": "31722-0882-10",
"ProductNDC": "31722-882",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin",
"NonProprietaryName": "Rosuvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20161029",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207616",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240209",
"SamplePackage": "N",
"IndicationAndUsage": "Rosuvastatin tablets are indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.",
"Description": "Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is (3R, 5S, 6E) -7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid calcium salt with the following structural formula:. The molecular formula for rosuvastatin calcium is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium USP is a white or almost white hygroscopic powder that is sparingly soluble in methanol, slightly soluble in water, practically insoluble in anhydrous ethanol. Rosuvastatin tablets USP for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: crospovidone, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, talc, titanium dioxide and triacetin. Additionally 5 mg tablets contain FD&C yellow #5/tartrazine aluminum lake and 10 mg, 20 mg and 40 mg tablets contain FD&C yellow #6/sunset yellow FCF aluminum lake. USP Dissolution test is pending."
},
{
"NDCCode": "31722-882-31",
"PackageDescription": "100 TABLET, FILM COATED in 1 CARTON (31722-882-31) ",
"NDC11Code": "31722-0882-31",
"ProductNDC": "31722-882",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin",
"NonProprietaryName": "Rosuvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20161029",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207616",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161029",
"SamplePackage": "N",
"IndicationAndUsage": "Rosuvastatin tablets are indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.",
"Description": "Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is (3R, 5S, 6E) -7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid calcium salt with the following structural formula:. The molecular formula for rosuvastatin calcium is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium USP is a white or almost white hygroscopic powder that is sparingly soluble in methanol, slightly soluble in water, practically insoluble in anhydrous ethanol. Rosuvastatin tablets USP for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: crospovidone, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, talc, titanium dioxide and triacetin. Additionally 5 mg tablets contain FD&C yellow #5/tartrazine aluminum lake and 10 mg, 20 mg and 40 mg tablets contain FD&C yellow #6/sunset yellow FCF aluminum lake. USP Dissolution test is pending."
},
{
"NDCCode": "31722-882-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (31722-882-90) ",
"NDC11Code": "31722-0882-90",
"ProductNDC": "31722-882",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin",
"NonProprietaryName": "Rosuvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20161029",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207616",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20161029",
"SamplePackage": "N",
"IndicationAndUsage": "Rosuvastatin tablets are indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.",
"Description": "Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is (3R, 5S, 6E) -7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid calcium salt with the following structural formula:. The molecular formula for rosuvastatin calcium is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium USP is a white or almost white hygroscopic powder that is sparingly soluble in methanol, slightly soluble in water, practically insoluble in anhydrous ethanol. Rosuvastatin tablets USP for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: crospovidone, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, talc, titanium dioxide and triacetin. Additionally 5 mg tablets contain FD&C yellow #5/tartrazine aluminum lake and 10 mg, 20 mg and 40 mg tablets contain FD&C yellow #6/sunset yellow FCF aluminum lake. USP Dissolution test is pending."
},
{
"NDCCode": "35000-882-56",
"PackageDescription": "515 mL in 1 BOTTLE (35000-882-56) ",
"NDC11Code": "35000-0882-56",
"ProductNDC": "35000-882",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Colgate Zero Fresh Breath",
"NonProprietaryName": "Cetylpyridinium Chloride",
"DosageFormName": "MOUTHWASH",
"RouteName": "DENTAL",
"StartMarketingDate": "20191212",
"EndMarketingDate": "20221231",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part356",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "CETYLPYRIDINIUM CHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/20mL",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20191212",
"EndMarketingDatePackage": "20221231",
"SamplePackage": "N"
},
{
"NDCCode": "35356-882-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (35356-882-30)",
"NDC11Code": "35356-0882-30",
"ProductNDC": "35356-882",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20011211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076045",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2017-01-02"
},
{
"NDCCode": "35356-882-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (35356-882-60)",
"NDC11Code": "35356-0882-60",
"ProductNDC": "35356-882",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lorazepam",
"NonProprietaryName": "Lorazepam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20011211",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076045",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "LORAZEPAM",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2017-01-02"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>49884-882-99</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 PACKAGE, COMBINATION (49884-882-99) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>49884-0882-99</NDC11Code>
<ProductNDC>49884-882</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20151127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204158</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine orally disintegrating tablets are indicated for. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).</IndicationAndUsage>
<Description>Lamotrigine, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine, USP is slightly soluble in 0.1 N hydrochloric acid, in acetone, in methanol and in water. The structural formula is. Lamotrigine orally disintegrating tablets are supplied for oral administration. The tablets contain 25 mg (white), 50 mg (white), 100 mg (peach), 200 mg (white) of lamotrigine, USP and the following inactive ingredients. For lamotrigine orally disintegrating tablets 25 mg, 50 mg and 200 mg: Colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, starch (maize), microcrystalline cellulose, pregelatinized starch, peppermint flavor, sodium stearyl fumarate and sucralose. For lamotrigine orally disintegrating tablets 100 mg: Colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, starch (maize), microcrystalline cellulose, pregelatinized starch, peppermint flavor, sodium stearyl fumarate, sucralose and idacol red oxide of iron. Lamotrigine orally disintegrating tablets are formulated using in-house technologies designed to mask the bitter taste of lamotrigine and achieve a rapid dissolution profile.</Description>
</NDC>
<NDC>
<NDCCode>49884-882-84</NDCCode>
<PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 CARTON (49884-882-84)</PackageDescription>
<NDC11Code>49884-0882-84</NDC11Code>
<ProductNDC>49884-882</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130602</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204158</ApplicationNumber>
<LabelerName>Par Pharmaceutical Companies, Inc.</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>1/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-01-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>49884-880-99</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 PACKAGE, COMBINATION (49884-880-99) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>49884-0880-99</NDC11Code>
<ProductNDC>49884-880</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20151127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204158</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine orally disintegrating tablets are indicated for. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).</IndicationAndUsage>
<Description>Lamotrigine, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine, USP is slightly soluble in 0.1 N hydrochloric acid, in acetone, in methanol and in water. The structural formula is. Lamotrigine orally disintegrating tablets are supplied for oral administration. The tablets contain 25 mg (white), 50 mg (white), 100 mg (peach), 200 mg (white) of lamotrigine, USP and the following inactive ingredients. For lamotrigine orally disintegrating tablets 25 mg, 50 mg and 200 mg: Colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, starch (maize), microcrystalline cellulose, pregelatinized starch, peppermint flavor, sodium stearyl fumarate and sucralose. For lamotrigine orally disintegrating tablets 100 mg: Colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, starch (maize), microcrystalline cellulose, pregelatinized starch, peppermint flavor, sodium stearyl fumarate, sucralose and idacol red oxide of iron. Lamotrigine orally disintegrating tablets are formulated using in-house technologies designed to mask the bitter taste of lamotrigine and achieve a rapid dissolution profile.</Description>
</NDC>
<NDC>
<NDCCode>49884-881-99</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 PACKAGE, COMBINATION (49884-881-99) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>49884-0881-99</NDC11Code>
<ProductNDC>49884-881</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20151127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204158</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lamotrigine orally disintegrating tablets are indicated for. Epilepsy—adjunctive therapy in patients aged 2 years and older: 1 partial-onset seizures., 2 primary generalized tonic-clonic (PGTC) seizures., 3 generalized seizures of Lennox-Gastaut syndrome. (1.1).</IndicationAndUsage>
<Description>Lamotrigine, USP an AED of the phenyltriazine class, is chemically unrelated to existing AEDs. Lamotrigine’s chemical name is 3,5-diamino-6-(2,3-dichlorophenyl)-as-triazine, its molecular formula is C9H7N5Cl2, and its molecular weight is 256.09. Lamotrigine, USP is a white to pale cream-colored powder and has a pKa of 5.7. Lamotrigine, USP is slightly soluble in 0.1 N hydrochloric acid, in acetone, in methanol and in water. The structural formula is. Lamotrigine orally disintegrating tablets are supplied for oral administration. The tablets contain 25 mg (white), 50 mg (white), 100 mg (peach), 200 mg (white) of lamotrigine, USP and the following inactive ingredients. For lamotrigine orally disintegrating tablets 25 mg, 50 mg and 200 mg: Colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, starch (maize), microcrystalline cellulose, pregelatinized starch, peppermint flavor, sodium stearyl fumarate and sucralose. For lamotrigine orally disintegrating tablets 100 mg: Colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, starch (maize), microcrystalline cellulose, pregelatinized starch, peppermint flavor, sodium stearyl fumarate, sucralose and idacol red oxide of iron. Lamotrigine orally disintegrating tablets are formulated using in-house technologies designed to mask the bitter taste of lamotrigine and achieve a rapid dissolution profile.</Description>
</NDC>
<NDC>
<NDCCode>49884-944-99</NDCCode>
<PackageDescription>1 KIT in 1 BOX (49884-944-99) * 11 TABLET, FILM COATED in 1 BLISTER PACK * 42 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>49884-0944-99</NDC11Code>
<ProductNDC>49884-944</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Varenicline</ProprietaryName>
<NonProprietaryName>Varenicline Tartrate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20210921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201785</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Varenicline tablets are indicated for use as an aid to smoking cessation treatment.</IndicationAndUsage>
<Description>Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt of maltodextrin premix (1:1:10), is a powder which is a off-white to pinkish brown color with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano-6H-pyrazino[2,3- h][3]benzazepine, (2R,3R)-2,3-dihydroxybutanedioate with maltodextrin (1:1:10). It is soluble in water, practically insoluble in acetone and methylene dichloride. Varenicline tartrate has a molecular weight of 361.35 Daltons and maltodextrin, and a molecular formula of C13H13N3 C4H6O6 and maltodextrin. The chemical structure is. Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg circular, biconvex, white to off-white film-coated tablets, debossed with “P” on one side and “155” on other side and a 1 mg circular, biconvex, light blue film-coated tablets, debossed with “P” on one side and “156” on other side. Each 0.5 mg varenicline tablet contains 0.85 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablet contains 1.71 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: croscarmellose sodium, maltodextrin, microcrystalline cellulose, stearic acid. The tablets are film-coated with a coating material containing hydroxypropyl cellulose, hypromellose, talc, and titanium dioxide. In addition to these, the 1 mg tablet film coating includes FD&C blue #2/indigo carmine aluminum lake and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>0869-0295-20</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (0869-0295-20) </PackageDescription>
<NDC11Code>00869-0295-20</NDC11Code>
<ProductNDC>0869-0295</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Itch Relief</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hcl, Zinc Acetate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100714</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Vi-Jon, LLC</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE</SubstanceName>
<StrengthNumber>18; 882</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of pain and itching associated with ■ insect bites ■ minor skin irritations ■ sunburn■ minor burns ■ minor cuts ■ scrapes ■ rashes due to poison: ■ ivy ■ oak ■ sumac. dries the oozing and weeping of poison: ■ ivy ■ oak ■ sumac.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10875-5000-3</NDCCode>
<PackageDescription>882.24 kg in 1 CONTAINER (10875-5000-3) </PackageDescription>
<NDC11Code>10875-5000-03</NDC11Code>
<ProductNDC>10875-5000</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Mineral</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20140626</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Calumet Karns City Refining LLC</LabelerName>
<SubstanceName>MINERAL OIL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>26-JUN-14</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>11673-882-10</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (11673-882-10) > 30 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>11673-0882-10</NDC11Code>
<ProductNDC>11673-882</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up Infants Gas Relief</ProprietaryName>
<NonProprietaryName>Simethicone</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090721</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part332</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>DIMETHICONE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/.3mL</StrengthUnit>
<Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090721</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13411-882-05</NDCCode>
<PackageDescription>5 PACKET in 1 BOX (13411-882-05) / 12 g in 1 PACKET</PackageDescription>
<NDC11Code>13411-0882-05</NDC11Code>
<ProductNDC>13411-882</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Jba Collagen-electrolyte Mocktail</ProprietaryName>
<NonProprietaryName>Vitamin C,thiamin,riboflavin,niacin,vitamin B6,folate,biotin,pantothenic Acid,magnesium,zinc,sodium,potassium,bovine Collagen Peptides</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240306</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals</LabelerName>
<SubstanceName>ASCORBIC ACID; BIOTIN; FOLIC ACID; MAGNESIUM; NIACIN; PANTOTHENIC ACID; POTASSIUM; PYRIDOXINE; RIBOFLAVIN; SODIUM; THIAMINE; ZINC</SubstanceName>
<StrengthNumber>100; 80; 200; 50; 18; 6; 190; 2.5; 1.6; 250; 1.2; 10</StrengthNumber>
<StrengthUnit>mg/12g; ug/12g; ug/12g; mg/12g; mg/12g; mg/12g; mg/12g; mg/12g; mg/12g; mg/12g; mg/12g; mg/12g</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>13411-882-15</NDCCode>
<PackageDescription>15 PACKET in 1 BOX (13411-882-15) / 12 g in 1 PACKET</PackageDescription>
<NDC11Code>13411-0882-15</NDC11Code>
<ProductNDC>13411-882</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Jba Collagen-electrolyte Mocktail</ProprietaryName>
<NonProprietaryName>Vitamin C,thiamin,riboflavin,niacin,vitamin B6,folate,biotin,pantothenic Acid,magnesium,zinc,sodium,potassium,bovine Collagen Peptides</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240306</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals</LabelerName>
<SubstanceName>ASCORBIC ACID; BIOTIN; FOLIC ACID; MAGNESIUM; NIACIN; PANTOTHENIC ACID; POTASSIUM; PYRIDOXINE; RIBOFLAVIN; SODIUM; THIAMINE; ZINC</SubstanceName>
<StrengthNumber>100; 80; 200; 50; 18; 6; 190; 2.5; 1.6; 250; 1.2; 10</StrengthNumber>
<StrengthUnit>mg/12g; ug/12g; ug/12g; mg/12g; mg/12g; mg/12g; mg/12g; mg/12g; mg/12g; mg/12g; mg/12g; mg/12g</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>13411-882-30</NDCCode>
<PackageDescription>30 PACKET in 1 BOX (13411-882-30) / 12 g in 1 PACKET</PackageDescription>
<NDC11Code>13411-0882-30</NDC11Code>
<ProductNDC>13411-882</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Jba Collagen-electrolyte Mocktail</ProprietaryName>
<NonProprietaryName>Vitamin C,thiamin,riboflavin,niacin,vitamin B6,folate,biotin,pantothenic Acid,magnesium,zinc,sodium,potassium,bovine Collagen Peptides</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240306</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals</LabelerName>
<SubstanceName>ASCORBIC ACID; BIOTIN; FOLIC ACID; MAGNESIUM; NIACIN; PANTOTHENIC ACID; POTASSIUM; PYRIDOXINE; RIBOFLAVIN; SODIUM; THIAMINE; ZINC</SubstanceName>
<StrengthNumber>100; 80; 200; 50; 18; 6; 190; 2.5; 1.6; 250; 1.2; 10</StrengthNumber>
<StrengthUnit>mg/12g; ug/12g; ug/12g; mg/12g; mg/12g; mg/12g; mg/12g; mg/12g; mg/12g; mg/12g; mg/12g; mg/12g</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-03-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>13537-882-24</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-882-24) > 4 g in 1 TUBE (13537-882-23)</PackageDescription>
<NDC11Code>13537-0882-24</NDC11Code>
<ProductNDC>13537-882</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Effet Parfait Rouge Amplifier</ProprietaryName>
<ProprietaryNameSuffix>Amplifying Spf 15 (rouge Provocation) - Red</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140911</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE</SubstanceName>
<StrengthNumber>.072</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14141-882-01</NDCCode>
<PackageDescription>30 g in 1 TUBE (14141-882-01) </PackageDescription>
<NDC11Code>14141-0882-01</NDC11Code>
<ProductNDC>14141-882</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Studio Look Base De Alta Cobertura Para El Rostro Con Fps 20 Espresso 450-c</ProprietaryName>
<NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>BEL STAR S A</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>4; 2.4</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-12-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>14783-882-24</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (14783-882-24) > 4 g in 1 TUBE (14783-882-23)</PackageDescription>
<NDC11Code>14783-0882-24</NDC11Code>
<ProductNDC>14783-882</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Effet Parfait Rouge Amplifier</ProprietaryName>
<ProprietaryNameSuffix>Amplifying Spf 15 (rouge Provocation) - Red</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140911</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura International LTD</LabelerName>
<SubstanceName>OCTINOXATE</SubstanceName>
<StrengthNumber>.072</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16571-882-05</NDCCode>
<PackageDescription>1 CONTAINER in 1 CARTON (16571-882-05) / 5 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>16571-0882-05</NDC11Code>
<ProductNDC>16571-882</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Olopatadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Olopatadine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20250501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204392</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>OLOPATADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21130-882-10</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (21130-882-10) > 30 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>21130-0882-10</NDC11Code>
<ProductNDC>21130-882</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Infants Gas Relief</ProprietaryName>
<NonProprietaryName>Simethicone</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020822</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part332</ApplicationNumber>
<LabelerName>Safeway</LabelerName>
<SubstanceName>DIMETHICONE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/.3mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-13</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>23155-882-31</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (23155-882-31) / 5 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>23155-0882-31</NDC11Code>
<ProductNDC>23155-882</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paclitaxel</ProprietaryName>
<ProprietaryNameSuffix>Paclitaxel</ProprietaryNameSuffix>
<NonProprietaryName>Paclitaxel</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207326</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PACLITAXEL</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paclitaxel Injection, USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, paclitaxel is indicated in combination with cisplatin. Paclitaxel is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptornegative tumors. (See CLINICAL STUDIES: Breast Carcinoma.)Paclitaxel Injection, USP is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.Paclitaxel, in combination with cisplatin, is indicated for the first-line treatment of nonsmall cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Paclitaxel is indicated for the second-line treatment of AIDS-related Kaposi’s sarcoma.</IndicationAndUsage>
<Description>Paclitaxel Injection, USP is a clear colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel, 527 mg of Polyoxyl 35 Castor Oil, NF, 49.7% (v/v) Dehydrated Alcohol, USP and 2 mg Citric Acid, USP. Paclitaxel is a natural product with antitumor activity. Paclitaxel is obtained via an extraction process from Taxus X media ‘Hicksii’. The chemical name for paclitaxel is (2aR,4S,4aS,6R,9S,11S,12S,12aR,12bS)-1,2a,3,4,4a,6,9,10,11, 12,12a,12b-Dodecahydro-4,6,9,11,12,-12b-hexahydroxy-4a,8, 13,13-tetramethyl-7,11-methano-5H-cyclodeca [3,4] benz [1,2-b] oxet-5-one 6,12b-diacetate, 12-benzoate, 9-ester with (2R,3S)-N-benzoyl-3-phenylisoserine.Paclitaxel has the following structural formula. Paclitaxel is a white to off-white crystalline powder with the empirical formula C47H51NO14 and molecular weight of 853.9. It is highly lipophilic, insoluble in water, and melts at around 216 to 217°C.</Description>
</NDC>
<NDC>
<NDCCode>24236-882-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 CANISTER (24236-882-60)</PackageDescription>
<NDC11Code>24236-0882-60</NDC11Code>
<ProductNDC>24236-882</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Strattera</ProprietaryName>
<NonProprietaryName>Atomoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130509</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021411</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>ATOMOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>24689-882-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (24689-882-01) </PackageDescription>
<NDC11Code>24689-0882-01</NDC11Code>
<ProductNDC>24689-882</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Terazosin Hydrochloride</ProprietaryName>
<NonProprietaryName>Terazosin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074823</ApplicationNumber>
<LabelerName>Apnar Pharma LP</LabelerName>
<SubstanceName>TERAZOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Terazosin capsules, USP are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules, USP. The long-term effects of terazosin capsules, USP on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules, USP are also indicated for the treatment of hypertension. Terazosin capsules, USP can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
<Description>Terazosin hydrochloride, an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name, molecular formula and structural formula: (RS)-Piperazine, 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetrahydro-2-furanyl)carbonyl]-, monohydrochloride, C 19H 26ClN 5O 4. It has the following structural formula:. Terazosin hydrochloride is a white, crystalline substance, freely soluble in water and isotonic saline and has a molecular weight of 423.93. Terazosin capsules, USP, for oral administration, are supplied in four dosage strengths containing terazosin hydrochloride, USP equivalent to 1 mg, 2 mg, 5 mg, or 10 mg of terazosin. Inactive ingredients: Crospovidone, lactose (monohydrate), magnesium stearate, and microcrystalline cellulose. The capsule shells and imprinting inks contain: D & C Yellow #10 Aluminum Lake, FD & C Blue #1 Aluminum Lake, FD & C Blue #2 Aluminum Lake, FD & C Red #40 Aluminum Lake, gelatin, propylene glycol, shellac, synthetic black iron oxide, and titanium dioxide. The 5 mg also contains: D & C Red #28.</Description>
</NDC>
<NDC>
<NDCCode>24689-882-03</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (24689-882-03) </PackageDescription>
<NDC11Code>24689-0882-03</NDC11Code>
<ProductNDC>24689-882</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Terazosin Hydrochloride</ProprietaryName>
<NonProprietaryName>Terazosin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074823</ApplicationNumber>
<LabelerName>Apnar Pharma LP</LabelerName>
<SubstanceName>TERAZOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Terazosin capsules, USP are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules, USP. The long-term effects of terazosin capsules, USP on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules, USP are also indicated for the treatment of hypertension. Terazosin capsules, USP can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
<Description>Terazosin hydrochloride, an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name, molecular formula and structural formula: (RS)-Piperazine, 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetrahydro-2-furanyl)carbonyl]-, monohydrochloride, C 19H 26ClN 5O 4. It has the following structural formula:. Terazosin hydrochloride is a white, crystalline substance, freely soluble in water and isotonic saline and has a molecular weight of 423.93. Terazosin capsules, USP, for oral administration, are supplied in four dosage strengths containing terazosin hydrochloride, USP equivalent to 1 mg, 2 mg, 5 mg, or 10 mg of terazosin. Inactive ingredients: Crospovidone, lactose (monohydrate), magnesium stearate, and microcrystalline cellulose. The capsule shells and imprinting inks contain: D & C Yellow #10 Aluminum Lake, FD & C Blue #1 Aluminum Lake, FD & C Blue #2 Aluminum Lake, FD & C Red #40 Aluminum Lake, gelatin, propylene glycol, shellac, synthetic black iron oxide, and titanium dioxide. The 5 mg also contains: D & C Red #28.</Description>
</NDC>
<NDC>
<NDCCode>24689-882-10</NDCCode>
<PackageDescription>1000 CAPSULE in 1 BOTTLE (24689-882-10) </PackageDescription>
<NDC11Code>24689-0882-10</NDC11Code>
<ProductNDC>24689-882</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Terazosin Hydrochloride</ProprietaryName>
<NonProprietaryName>Terazosin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074823</ApplicationNumber>
<LabelerName>Apnar Pharma LP</LabelerName>
<SubstanceName>TERAZOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Terazosin capsules, USP are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with terazosin capsules, USP. The long-term effects of terazosin capsules, USP on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules, USP are also indicated for the treatment of hypertension. Terazosin capsules, USP can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.</IndicationAndUsage>
<Description>Terazosin hydrochloride, an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name, molecular formula and structural formula: (RS)-Piperazine, 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetrahydro-2-furanyl)carbonyl]-, monohydrochloride, C 19H 26ClN 5O 4. It has the following structural formula:. Terazosin hydrochloride is a white, crystalline substance, freely soluble in water and isotonic saline and has a molecular weight of 423.93. Terazosin capsules, USP, for oral administration, are supplied in four dosage strengths containing terazosin hydrochloride, USP equivalent to 1 mg, 2 mg, 5 mg, or 10 mg of terazosin. Inactive ingredients: Crospovidone, lactose (monohydrate), magnesium stearate, and microcrystalline cellulose. The capsule shells and imprinting inks contain: D & C Yellow #10 Aluminum Lake, FD & C Blue #1 Aluminum Lake, FD & C Blue #2 Aluminum Lake, FD & C Red #40 Aluminum Lake, gelatin, propylene glycol, shellac, synthetic black iron oxide, and titanium dioxide. The 5 mg also contains: D & C Red #28.</Description>
</NDC>
<NDC>
<NDCCode>30142-882-10</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (30142-882-10) > 30 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>30142-0882-10</NDC11Code>
<ProductNDC>30142-882</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gas Relief</ProprietaryName>
<ProprietaryNameSuffix>Infants</ProprietaryNameSuffix>
<NonProprietaryName>Simethicone</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990304</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part332</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>DIMETHICONE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/.3mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19990304</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>31722-882-01</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (31722-882-01) </PackageDescription>
<NDC11Code>31722-0882-01</NDC11Code>
<ProductNDC>31722-882</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvastatin</ProprietaryName>
<NonProprietaryName>Rosuvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161029</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207616</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rosuvastatin tablets are indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is (3R, 5S, 6E) -7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid calcium salt with the following structural formula:. The molecular formula for rosuvastatin calcium is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium USP is a white or almost white hygroscopic powder that is sparingly soluble in methanol, slightly soluble in water, practically insoluble in anhydrous ethanol. Rosuvastatin tablets USP for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: crospovidone, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, talc, titanium dioxide and triacetin. Additionally 5 mg tablets contain FD&C yellow #5/tartrazine aluminum lake and 10 mg, 20 mg and 40 mg tablets contain FD&C yellow #6/sunset yellow FCF aluminum lake. USP Dissolution test is pending.</Description>
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<IndicationAndUsage>Rosuvastatin tablets are indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is (3R, 5S, 6E) -7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid calcium salt with the following structural formula:. The molecular formula for rosuvastatin calcium is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium USP is a white or almost white hygroscopic powder that is sparingly soluble in methanol, slightly soluble in water, practically insoluble in anhydrous ethanol. Rosuvastatin tablets USP for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: crospovidone, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, talc, titanium dioxide and triacetin. Additionally 5 mg tablets contain FD&C yellow #5/tartrazine aluminum lake and 10 mg, 20 mg and 40 mg tablets contain FD&C yellow #6/sunset yellow FCF aluminum lake. USP Dissolution test is pending.</Description>
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<IndicationAndUsage>Rosuvastatin tablets are indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is (3R, 5S, 6E) -7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid calcium salt with the following structural formula:. The molecular formula for rosuvastatin calcium is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium USP is a white or almost white hygroscopic powder that is sparingly soluble in methanol, slightly soluble in water, practically insoluble in anhydrous ethanol. Rosuvastatin tablets USP for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: crospovidone, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, talc, titanium dioxide and triacetin. Additionally 5 mg tablets contain FD&C yellow #5/tartrazine aluminum lake and 10 mg, 20 mg and 40 mg tablets contain FD&C yellow #6/sunset yellow FCF aluminum lake. USP Dissolution test is pending.</Description>
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<StrengthUnit>mg/1</StrengthUnit>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rosuvastatin tablets are indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is (3R, 5S, 6E) -7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid calcium salt with the following structural formula:. The molecular formula for rosuvastatin calcium is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium USP is a white or almost white hygroscopic powder that is sparingly soluble in methanol, slightly soluble in water, practically insoluble in anhydrous ethanol. Rosuvastatin tablets USP for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: crospovidone, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, talc, titanium dioxide and triacetin. Additionally 5 mg tablets contain FD&C yellow #5/tartrazine aluminum lake and 10 mg, 20 mg and 40 mg tablets contain FD&C yellow #6/sunset yellow FCF aluminum lake. USP Dissolution test is pending.</Description>
</NDC>
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<StrengthUnit>mg/1</StrengthUnit>
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<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161029</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rosuvastatin tablets are indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia.</IndicationAndUsage>
<Description>Rosuvastatin is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is (3R, 5S, 6E) -7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6-heptenoic acid calcium salt with the following structural formula:. The molecular formula for rosuvastatin calcium is (C 22H 27FN 3O 6S) 2Ca and the molecular weight is 1,001.14. Rosuvastatin calcium USP is a white or almost white hygroscopic powder that is sparingly soluble in methanol, slightly soluble in water, practically insoluble in anhydrous ethanol. Rosuvastatin tablets USP for oral administration contain 5, 10, 20, or 40 mg of rosuvastatin and the following inactive ingredients: Each tablet contains: crospovidone, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red AC aluminum lake, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium bicarbonate, talc, titanium dioxide and triacetin. Additionally 5 mg tablets contain FD&C yellow #5/tartrazine aluminum lake and 10 mg, 20 mg and 40 mg tablets contain FD&C yellow #6/sunset yellow FCF aluminum lake. USP Dissolution test is pending.</Description>
</NDC>
<NDC>
<NDCCode>35000-882-56</NDCCode>
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<ProprietaryName>Colgate Zero Fresh Breath</ProprietaryName>
<NonProprietaryName>Cetylpyridinium Chloride</NonProprietaryName>
<DosageFormName>MOUTHWASH</DosageFormName>
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<EndMarketingDate>20221231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part356</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>CETYLPYRIDINIUM CHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
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<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20191212</StartMarketingDatePackage>
<EndMarketingDatePackage>20221231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<PackageDescription>30 TABLET in 1 BOTTLE (35356-882-30)</PackageDescription>
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