{
"NDC": [
{
"NDCCode": "55301-504-44",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (55301-504-44) / 1 GUM, CHEWING in 1 BLISTER PACK",
"NDC11Code": "55301-0504-44",
"ProductNDC": "55301-504",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine Polacrilex",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "GUM, CHEWING",
"RouteName": "BUCCAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079038",
"LabelerName": "AAFES/Your Military Exchanges",
"SubstanceName": "NICOTINE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2026-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140101",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "56062-504-44",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (56062-504-44) / 10 GUM, CHEWING in 1 BLISTER PACK",
"NDC11Code": "56062-0504-44",
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine Polacrilex",
"ProprietaryNameSuffix": "Coated Fruit",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "GUM, CHEWING",
"RouteName": "BUCCAL",
"StartMarketingDate": "20140101",
"EndMarketingDate": "20270101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079038",
"LabelerName": "Publix Supermarkets, Inc.",
"SubstanceName": "NICOTINE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140101",
"EndMarketingDatePackage": "20270101",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "65753-504-36",
"PackageDescription": "1 KIT in 1 KIT (65753-504-36) * 44.4 mL in 1 APPLICATOR * 1.1 mL in 1 POUCH * 1 mL in 1 POUCH * 3.5 mL in 1 POUCH * 7 g in 1 POUCH * 44 mL in 1 PACKET (65753-100-37) ",
"NDC11Code": "65753-0504-36",
"ProductNDC": "65753-504",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Coretex Professional Outdoor Skin Protection Wallet",
"NonProprietaryName": "Coretex Professional Outdoor Skin Protection Wallet",
"DosageFormName": "KIT",
"StartMarketingDate": "20191127",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "CoreTex Products Inc",
"Status": "Deprecated",
"LastUpdate": "2024-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20191127",
"SamplePackage": "N"
},
{
"NDCCode": "55301-004-44",
"PackageDescription": "532 mL in 1 BOTTLE, PLASTIC (55301-004-44) ",
"NDC11Code": "55301-0004-44",
"ProductNDC": "55301-004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Kids Flouride Rinse",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "RINSE",
"RouteName": "ORAL",
"StartMarketingDate": "20110209",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Your Military Exchanges",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110209",
"SamplePackage": "N",
"IndicationAndUsage": "aids in the prevention of dental cavities."
},
{
"NDCCode": "55301-213-44",
"PackageDescription": "532 mL in 1 BOTTLE, PLASTIC (55301-213-44) ",
"NDC11Code": "55301-0213-44",
"ProductNDC": "55301-213",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anticavity Fluoride Rinse",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "MOUTHWASH",
"RouteName": "ORAL",
"StartMarketingDate": "20041224",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Your Military Exchanges",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20041224",
"SamplePackage": "N",
"IndicationAndUsage": "aids in the prevention of dental cavities."
},
{
"NDCCode": "55301-428-44",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (55301-428-44) / 1 GUM, CHEWING in 1 BLISTER PACK",
"NDC11Code": "55301-0428-44",
"ProductNDC": "55301-428",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine Polacrilex",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "GUM, CHEWING",
"RouteName": "BUCCAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078699",
"LabelerName": "AAFES/Your Military Exchanges",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2025-05-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140101",
"SamplePackage": "N",
"IndicationAndUsage": " reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "55301-429-44",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (55301-429-44) / 1 GUM, CHEWING in 1 BLISTER PACK",
"NDC11Code": "55301-0429-44",
"ProductNDC": "55301-429",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine Polacrilex",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "GUM, CHEWING",
"RouteName": "BUCCAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078697",
"LabelerName": "AAFES/Your Military Exchanges",
"SubstanceName": "NICOTINE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2025-05-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140101",
"SamplePackage": "N",
"IndicationAndUsage": " reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "55301-453-44",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (55301-453-44) > 18 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "55301-0453-44",
"ProductNDC": "55301-453",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Suphedrine Pe Congestion",
"ProprietaryNameSuffix": "Non-drowsy",
"NonProprietaryName": "Phenylephrine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050114",
"EndMarketingDate": "20230625",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "ARMY AND AIR FORCE EXCHANGE SERVICE",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050114",
"EndMarketingDatePackage": "20230625",
"SamplePackage": "N"
},
{
"NDCCode": "55301-503-44",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (55301-503-44) / 1 GUM, CHEWING in 1 BLISTER PACK",
"NDC11Code": "55301-0503-44",
"ProductNDC": "55301-503",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine Polacrilex",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "GUM, CHEWING",
"RouteName": "BUCCAL",
"StartMarketingDate": "20140101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079044",
"LabelerName": "AAFES/Your Military Exchanges",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2026-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140101",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "55301-608-44",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (55301-608-44) > 9 TABLET, CHEWABLE in 1 BLISTER PACK",
"NDC11Code": "55301-0608-44",
"ProductNDC": "55301-608",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gas Relief",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Simethicone",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20130701",
"EndMarketingDate": "20230114",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part332",
"LabelerName": "ARMY AND AIR FORCE EXCHANGE SERVICE",
"SubstanceName": "DIMETHICONE",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130701",
"EndMarketingDatePackage": "20230114",
"SamplePackage": "N"
},
{
"NDCCode": "55301-680-44",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (55301-680-44) / 9 TABLET, CHEWABLE in 1 BLISTER PACK",
"NDC11Code": "55301-0680-44",
"ProductNDC": "55301-680",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gas Relief",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Simethicone",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20210423",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M002",
"LabelerName": "ARMY AND AIR FORCE EXCHANGE SERVICE",
"SubstanceName": "DIMETHICONE",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210423",
"SamplePackage": "N",
"IndicationAndUsage": "for the relief of pressure, bloating, and fullness commonly referred to as gas."
},
{
"NDCCode": "55301-753-44",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (55301-753-44) / 18 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "55301-0753-44",
"ProductNDC": "55301-753",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Suphedrine Pe Sinus Congestion",
"ProprietaryNameSuffix": "Non-drowsy",
"NonProprietaryName": "Phenylephrine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210115",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "ARMY AND AIR FORCE EXCHANGE SERVICE",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210115",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves sinus congestion and pressure. temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies."
},
{
"NDCCode": "0472-1790-30",
"PackageDescription": "1 TUBE in 1 CARTON (0472-1790-30) / 30 g in 1 TUBE",
"NDC11Code": "00472-1790-30",
"ProductNDC": "0472-1790",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Phosphate And Tretinoin",
"NonProprietaryName": "Clindamycin Phosphate And Tretinoin",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160705",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202564",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "CLINDAMYCIN PHOSPHATE; TRETINOIN",
"StrengthNumber": "12; .25",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2024-03-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160705",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin phosphate and tretinoin gel 1.2% / 0.025% is indicated for the topical treatment of acne vulgaris in patients 12 years or older.",
"Description": "Clindamycin phosphate and tretinoin gel 1.2% / 0.025%, is an antibiotic and retinoid combination gel product with two active ingredients. Clindamycin phosphate, USP is a water-soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate, USP is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4- propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate, USP is represented below. Clindamycin phosphate, USP. Molecular Formula: C18H34ClN2O8PS Molecular Weight: 504.97. The chemical name for tretinoin, USP is 3,7-Dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8- nonatetraenoic acid (all-trans form). The structural formula for tretinoin, USP is represented below. Tretinoin, USP. Molecular Formula: C20H28O2 Molecular Weight: 300.44. Clindamycin phosphate and tretinoin gel 1.2% / 0.025% contains the following inactive ingredients: anhydrous citric acid, butylated hydroxytoluene, edetate disodium, hydroxyethyl cellulose, glycerin, methylparaben, polysorbate 80, propylparaben, purified water, tromethamine and xanthan gum."
},
{
"NDCCode": "0472-1790-60",
"PackageDescription": "1 TUBE in 1 CARTON (0472-1790-60) / 60 g in 1 TUBE",
"NDC11Code": "00472-1790-60",
"ProductNDC": "0472-1790",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Phosphate And Tretinoin",
"NonProprietaryName": "Clindamycin Phosphate And Tretinoin",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160705",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202564",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "CLINDAMYCIN PHOSPHATE; TRETINOIN",
"StrengthNumber": "12; .25",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2024-03-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160705",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin phosphate and tretinoin gel 1.2% / 0.025% is indicated for the topical treatment of acne vulgaris in patients 12 years or older.",
"Description": "Clindamycin phosphate and tretinoin gel 1.2% / 0.025%, is an antibiotic and retinoid combination gel product with two active ingredients. Clindamycin phosphate, USP is a water-soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate, USP is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4- propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate, USP is represented below. Clindamycin phosphate, USP. Molecular Formula: C18H34ClN2O8PS Molecular Weight: 504.97. The chemical name for tretinoin, USP is 3,7-Dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8- nonatetraenoic acid (all-trans form). The structural formula for tretinoin, USP is represented below. Tretinoin, USP. Molecular Formula: C20H28O2 Molecular Weight: 300.44. Clindamycin phosphate and tretinoin gel 1.2% / 0.025% contains the following inactive ingredients: anhydrous citric acid, butylated hydroxytoluene, edetate disodium, hydroxyethyl cellulose, glycerin, methylparaben, polysorbate 80, propylparaben, purified water, tromethamine and xanthan gum."
},
{
"NDCCode": "0641-2569-44",
"PackageDescription": "5 VIAL in 1 CARTON (0641-2569-44) / 10 mL in 1 VIAL (0641-2569-41) ",
"NDC11Code": "00641-2569-44",
"ProductNDC": "0641-2569",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dipyridamole",
"NonProprietaryName": "Dipyridamole",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19961018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074521",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "DIPYRIDAMOLE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19961018",
"SamplePackage": "N",
"IndicationAndUsage": "Dipyridamole Injection is indicated as an alternative to exercise in thallium myocardial perfusion imaging for the evaluation of coronary artery disease in patients who cannot exercise adequately. In a study of about 1100 patients who underwent coronary arteriography and Dipyridamole Injection assisted thallium imaging, the results of both tests were interpreted blindly and the sensitivity and specificity of the dipyridamole thallium study in predicting the angiographic outcome were calculated. The sensitivity of the dipyridamole test (true positive dipyridamole divided by the total number of patients with positive angiography) was about 85%. The specificity (true negative divided by the number of patients with negative angiograms) was about 50%. In a subset of patients who had exercise thallium imaging as well as dipyridamole thallium imaging, sensitivity and specificity of the two tests were almost identical.",
"Description": "Dipyridamole is a coronary vasodilator described as 2,2',2'',2'''-[(4,8 Dipiperidinopyrimido[ 5,4-d]pyrimidine-2,6-diyl)dinitrilo]-tetraethanol. The structural formula is. C24H40N8O4 MW 504.63. Dipyridamole Injection, USP is a sterile, odorless, pale yellow liquid which can be diluted in sodium chloride injection or dextrose injection for intravenous administration. Each mL contains 5 mg dipyridamole, USP, 50 mg polyethylene glycol 600 and 2 mg tartaric acid in Water for Injection, USP. pH 2.2-3.2; hydrochloric acid added for pH adjustment."
},
{
"NDCCode": "0781-7287-50",
"PackageDescription": "1 KIT in 1 CARTON (0781-7287-50) * 10 g in 1 BOTTLE (0781-6536-21) * 40 g in 1 BOTTLE, PUMP (0781-7286-44) ",
"NDC11Code": "00781-7287-50",
"ProductNDC": "0781-7287",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin And Benzoyl Peroxide",
"NonProprietaryName": "Clindamycin And Benzoyl Peroxide",
"DosageFormName": "KIT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170815",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204087",
"LabelerName": "Sandoz Inc.",
"Status": "Deprecated",
"LastUpdate": "2024-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170815",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris.",
"Description": "For Dermatological Use Only - Not for Ophthalmic Use. *Reconstitute Before Dispensing*. Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (C18H34ClN2O8PS). The structural formula for clindamycin is represented below. clindamycin phosphate. Clindamycin phosphate has molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7, 8-trideoxy-6-(1-methyl-trans- 4-propyl-L-2-pyrrolidinecarboxamido) -1-thio-L- threo-alpha-D- galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin and benzoyl peroxide gel, 1%/5%also contains benzoyl peroxide, for topical use. Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula. Benzoyl Peroxide. Benzoyl peroxide has a molecular weight of 242.23. Each gram of clindamycin and benzoyl peroxide gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbopol 980, d-limonene, docusate sodium solution, phosphoric acid, propylene glycol, purified water and sodium hydroxide."
},
{
"NDCCode": "16110-071-30",
"PackageDescription": "1 TUBE in 1 CARTON (16110-071-30) > 30 g in 1 TUBE",
"NDC11Code": "16110-0071-30",
"ProductNDC": "16110-071",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Veltin",
"NonProprietaryName": "Clindamycin Phosphate And Tretinoin",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100729",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050803",
"LabelerName": "Almirall, LLC",
"SubstanceName": "CLINDAMYCIN PHOSPHATE; TRETINOIN",
"StrengthNumber": "10; .25",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100729",
"SamplePackage": "N",
"IndicationAndUsage": "VELTIN (clindamycin phosphate and tretinoin) Gel, 1.2%/0.025% is indicated for the topical treatment of acne vulgaris in patients 12 years and older.",
"Description": "VELTIN (clindamycin phosphate and tretinoin) Gel, 1.2%/0.025%, is a fixed combination of 2 solubilized active ingredients in an aqueous-based gel. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Molecular Formula: C18H34ClN2O8PS. Molecular Weight: 504.97. The chemical name for tretinoin is all-trans 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is a member of the retinoid family of compounds. The structural formula for tretinoin is represented below. Molecular Formula: C20H28O2. Molecular Weight: 300.44. VELTIN Gel contains the following inactive ingredients: anhydrous citric acid, butylated hydroxytoluene, carbomer homopolymer (type C), edetate disodium, laureth 4, methylparaben, propylene glycol, purified water, and tromethamine."
},
{
"NDCCode": "16110-071-60",
"PackageDescription": "1 TUBE in 1 CARTON (16110-071-60) > 60 g in 1 TUBE",
"NDC11Code": "16110-0071-60",
"ProductNDC": "16110-071",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Veltin",
"NonProprietaryName": "Clindamycin Phosphate And Tretinoin",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100729",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050803",
"LabelerName": "Almirall, LLC",
"SubstanceName": "CLINDAMYCIN PHOSPHATE; TRETINOIN",
"StrengthNumber": "10; .25",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Retinoid [EPC], Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100729",
"SamplePackage": "N",
"IndicationAndUsage": "VELTIN (clindamycin phosphate and tretinoin) Gel, 1.2%/0.025% is indicated for the topical treatment of acne vulgaris in patients 12 years and older.",
"Description": "VELTIN (clindamycin phosphate and tretinoin) Gel, 1.2%/0.025%, is a fixed combination of 2 solubilized active ingredients in an aqueous-based gel. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Molecular Formula: C18H34ClN2O8PS. Molecular Weight: 504.97. The chemical name for tretinoin is all-trans 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is a member of the retinoid family of compounds. The structural formula for tretinoin is represented below. Molecular Formula: C20H28O2. Molecular Weight: 300.44. VELTIN Gel contains the following inactive ingredients: anhydrous citric acid, butylated hydroxytoluene, carbomer homopolymer (type C), edetate disodium, laureth 4, methylparaben, propylene glycol, purified water, and tromethamine."
},
{
"NDCCode": "21922-050-05",
"PackageDescription": "1 TUBE in 1 CARTON (21922-050-05) / 30 g in 1 TUBE",
"NDC11Code": "21922-0050-05",
"ProductNDC": "21922-050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Phosphate And Tretinoin Gel 1.2%/0.025%",
"NonProprietaryName": "Clindamycin Phosphate And Tretinoin Gel 1.2%/0.025%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230904",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216943",
"LabelerName": "Encube Ethicals, Inc.",
"SubstanceName": "CLINDAMYCIN PHOSPHATE; TRETINOIN",
"StrengthNumber": "10; .25",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2025-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230904",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin phosphate and tretinoin gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older.",
"Description": "Clindamycin phosphate and tretinoin gel 1.2%/0.025%, is a fixed combination of 2 solubilized active ingredients in an aqueous-based gel. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Molecular Formula: C18H34ClN2O8PS Molecular Weight: 504.97. The chemical name for tretinoin is all-trans 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is a member of the retinoid family of compounds. The structural formula for tretinoin is represented below. Molecular Formula: C20H28O2 Molecular Weight: 300.44. Clindamycin phosphate and tretinoin gel contains the following inactive ingredients: anhydrous citric acid, butylated hydroxytoluene, carbomer homopolymer (type C), edetate disodium, laureth 4, methylparaben, propylene glycol, purified water, and tromethamine."
},
{
"NDCCode": "21922-050-07",
"PackageDescription": "1 TUBE in 1 CARTON (21922-050-07) / 60 g in 1 TUBE",
"NDC11Code": "21922-0050-07",
"ProductNDC": "21922-050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Phosphate And Tretinoin Gel 1.2%/0.025%",
"NonProprietaryName": "Clindamycin Phosphate And Tretinoin Gel 1.2%/0.025%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230904",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216943",
"LabelerName": "Encube Ethicals, Inc.",
"SubstanceName": "CLINDAMYCIN PHOSPHATE; TRETINOIN",
"StrengthNumber": "10; .25",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]",
"Status": "Active",
"LastUpdate": "2025-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230904",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin phosphate and tretinoin gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older.",
"Description": "Clindamycin phosphate and tretinoin gel 1.2%/0.025%, is a fixed combination of 2 solubilized active ingredients in an aqueous-based gel. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Molecular Formula: C18H34ClN2O8PS Molecular Weight: 504.97. The chemical name for tretinoin is all-trans 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is a member of the retinoid family of compounds. The structural formula for tretinoin is represented below. Molecular Formula: C20H28O2 Molecular Weight: 300.44. Clindamycin phosphate and tretinoin gel contains the following inactive ingredients: anhydrous citric acid, butylated hydroxytoluene, carbomer homopolymer (type C), edetate disodium, laureth 4, methylparaben, propylene glycol, purified water, and tromethamine."
},
{
"NDCCode": "21922-068-44",
"PackageDescription": "1 KIT in 1 CARTON (21922-068-44) * 20 g in 1 JAR (21922-067-62) * 40 g in 1 JAR (21922-067-41) * 28 g in 1 BOTTLE, PUMP (21922-067-39) * 40 g in 1 BOTTLE, PUMP (21922-067-42) * 10 g in 1 BOTTLE (21922-066-12) * 7 g in 1 BOTTLE (21922-066-37) * 5 g in 1 BOTTLE (21922-066-36) ",
"NDC11Code": "21922-0068-44",
"ProductNDC": "21922-068",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin And Benzoyl Peroxide",
"NonProprietaryName": "Clindamycin And Benzoyl Peroxide",
"DosageFormName": "KIT",
"StartMarketingDate": "20251007",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204087",
"LabelerName": "Encube Ethicals, Inc.",
"Status": "Active",
"LastUpdate": "2025-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251007",
"SamplePackage": "N",
"IndicationAndUsage": "Clindamycin and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris.",
"Description": "Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (C18H34ClN2O8PS). The structural formula for clindamycin is represented below. Clindamycin phosphate has molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7, 8-trideoxy-6-(1-methyl-trans- 4-propyl-L-2-pyrrolidinecarboxamido) -1-thio-L- threo-alpha-D- galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin and benzoyl peroxide gel, 1%/5%also contains benzoyl peroxide, for topical use.Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula. Benzoyl peroxide has a molecular weight of 242.23. Each gram of clindamycin and benzoyl peroxide gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbopol 980, d-limonene, docusate sodium solution, phosphoric acid, propylene glycol, purified water and sodium hydroxide."
},
{
"NDCCode": "65757-651-40",
"PackageDescription": "1 BOTTLE in 1 CARTON (65757-651-40) / 7 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "65757-0651-40",
"ProductNDC": "65757-651",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lybalvi",
"NonProprietaryName": "Olanzapine And Samidorphan L-malate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210920",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213378",
"LabelerName": "Alkermes, Inc.",
"SubstanceName": "OLANZAPINE; SAMIDORPHAN L-MALATE",
"StrengthNumber": "5; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC], Opioid Antagonist [EPC], Opioid Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210920",
"SamplePackage": "N",
"IndicationAndUsage": "LYBALVI is indicated for the treatment of: : 1 Schizophrenia in adults , 2 Bipolar I disorder in adultsAcute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate Maintenance monotherapy treatment .",
"Description": "LYBALVI is a combination of olanzapine, an atypical antipsychotic, and samidorphan (as samidorphan L-malate), an opioid antagonist. Olanzapine is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine. The molecular formula of olanzapine is: C17H20N4S and the molecular weight is 312.44 g/mol. It is a yellow crystalline powder and has pKa values of 7.80 and 5.44. The chemical structure is:. Samidorphan L-malate is morphinan-3-carboxamide, 17-(cyclopropylmethyl)-4, 14-dihydroxy-6-oxo-, (2S)-2-hydroxybutanedioate. The molecular formula of samidorphan L-malate is C21H26N2O4 C4H6O5 and the molecular weight is 504.54 g/mol. It is a white to off-white crystalline powder and has pKa values of 8.3 (amine) and 10.1 (phenol). The chemical structure is:. LYBALVI is intended for oral administration and is available as film-coated, bilayer tablets in the following strengths: 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg, and 20 mg/10 mg of olanzapine and samidorphan (equivalent to 13.6 mg of samidorphan L-malate). Inactive ingredients include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The film coating ingredients include hypromellose, titanium dioxide, triacetin, and color additives [iron oxide yellow (5 mg/10 mg); iron oxide yellow and iron oxide red (10 mg/10 mg); FD&C Blue No. 2/ indigo carmine aluminum lake (15 mg/10 mg); iron oxide red (20 mg/10 mg)]."
},
{
"NDCCode": "65757-651-41",
"PackageDescription": "1 BOTTLE in 1 CARTON (65757-651-41) / 7 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "65757-0651-41",
"ProductNDC": "65757-651",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lybalvi",
"NonProprietaryName": "Olanzapine And Samidorphan L-malate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210920",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213378",
"LabelerName": "Alkermes, Inc.",
"SubstanceName": "OLANZAPINE; SAMIDORPHAN L-MALATE",
"StrengthNumber": "5; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC], Opioid Antagonist [EPC], Opioid Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210920",
"SamplePackage": "Y",
"IndicationAndUsage": "LYBALVI is indicated for the treatment of: : 1 Schizophrenia in adults , 2 Bipolar I disorder in adultsAcute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate Maintenance monotherapy treatment .",
"Description": "LYBALVI is a combination of olanzapine, an atypical antipsychotic, and samidorphan (as samidorphan L-malate), an opioid antagonist. Olanzapine is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine. The molecular formula of olanzapine is: C17H20N4S and the molecular weight is 312.44 g/mol. It is a yellow crystalline powder and has pKa values of 7.80 and 5.44. The chemical structure is:. Samidorphan L-malate is morphinan-3-carboxamide, 17-(cyclopropylmethyl)-4, 14-dihydroxy-6-oxo-, (2S)-2-hydroxybutanedioate. The molecular formula of samidorphan L-malate is C21H26N2O4 C4H6O5 and the molecular weight is 504.54 g/mol. It is a white to off-white crystalline powder and has pKa values of 8.3 (amine) and 10.1 (phenol). The chemical structure is:. LYBALVI is intended for oral administration and is available as film-coated, bilayer tablets in the following strengths: 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg, and 20 mg/10 mg of olanzapine and samidorphan (equivalent to 13.6 mg of samidorphan L-malate). Inactive ingredients include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The film coating ingredients include hypromellose, titanium dioxide, triacetin, and color additives [iron oxide yellow (5 mg/10 mg); iron oxide yellow and iron oxide red (10 mg/10 mg); FD&C Blue No. 2/ indigo carmine aluminum lake (15 mg/10 mg); iron oxide red (20 mg/10 mg)]."
},
{
"NDCCode": "65757-651-42",
"PackageDescription": "1 BOTTLE in 1 CARTON (65757-651-42) / 30 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "65757-0651-42",
"ProductNDC": "65757-651",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lybalvi",
"NonProprietaryName": "Olanzapine And Samidorphan L-malate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210920",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213378",
"LabelerName": "Alkermes, Inc.",
"SubstanceName": "OLANZAPINE; SAMIDORPHAN L-MALATE",
"StrengthNumber": "5; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC], Opioid Antagonist [EPC], Opioid Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210920",
"SamplePackage": "N",
"IndicationAndUsage": "LYBALVI is indicated for the treatment of: : 1 Schizophrenia in adults , 2 Bipolar I disorder in adultsAcute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate Maintenance monotherapy treatment .",
"Description": "LYBALVI is a combination of olanzapine, an atypical antipsychotic, and samidorphan (as samidorphan L-malate), an opioid antagonist. Olanzapine is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine. The molecular formula of olanzapine is: C17H20N4S and the molecular weight is 312.44 g/mol. It is a yellow crystalline powder and has pKa values of 7.80 and 5.44. The chemical structure is:. Samidorphan L-malate is morphinan-3-carboxamide, 17-(cyclopropylmethyl)-4, 14-dihydroxy-6-oxo-, (2S)-2-hydroxybutanedioate. The molecular formula of samidorphan L-malate is C21H26N2O4 C4H6O5 and the molecular weight is 504.54 g/mol. It is a white to off-white crystalline powder and has pKa values of 8.3 (amine) and 10.1 (phenol). The chemical structure is:. LYBALVI is intended for oral administration and is available as film-coated, bilayer tablets in the following strengths: 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg, and 20 mg/10 mg of olanzapine and samidorphan (equivalent to 13.6 mg of samidorphan L-malate). Inactive ingredients include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The film coating ingredients include hypromellose, titanium dioxide, triacetin, and color additives [iron oxide yellow (5 mg/10 mg); iron oxide yellow and iron oxide red (10 mg/10 mg); FD&C Blue No. 2/ indigo carmine aluminum lake (15 mg/10 mg); iron oxide red (20 mg/10 mg)]."
},
{
"NDCCode": "65757-651-44",
"PackageDescription": "1 BOTTLE in 1 CARTON (65757-651-44) / 90 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "65757-0651-44",
"ProductNDC": "65757-651",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lybalvi",
"NonProprietaryName": "Olanzapine And Samidorphan L-malate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210920",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213378",
"LabelerName": "Alkermes, Inc.",
"SubstanceName": "OLANZAPINE; SAMIDORPHAN L-MALATE",
"StrengthNumber": "5; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC], Opioid Antagonist [EPC], Opioid Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210920",
"SamplePackage": "N",
"IndicationAndUsage": "LYBALVI is indicated for the treatment of: : 1 Schizophrenia in adults , 2 Bipolar I disorder in adultsAcute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate Maintenance monotherapy treatment .",
"Description": "LYBALVI is a combination of olanzapine, an atypical antipsychotic, and samidorphan (as samidorphan L-malate), an opioid antagonist. Olanzapine is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine. The molecular formula of olanzapine is: C17H20N4S and the molecular weight is 312.44 g/mol. It is a yellow crystalline powder and has pKa values of 7.80 and 5.44. The chemical structure is:. Samidorphan L-malate is morphinan-3-carboxamide, 17-(cyclopropylmethyl)-4, 14-dihydroxy-6-oxo-, (2S)-2-hydroxybutanedioate. The molecular formula of samidorphan L-malate is C21H26N2O4 C4H6O5 and the molecular weight is 504.54 g/mol. It is a white to off-white crystalline powder and has pKa values of 8.3 (amine) and 10.1 (phenol). The chemical structure is:. LYBALVI is intended for oral administration and is available as film-coated, bilayer tablets in the following strengths: 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg, and 20 mg/10 mg of olanzapine and samidorphan (equivalent to 13.6 mg of samidorphan L-malate). Inactive ingredients include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The film coating ingredients include hypromellose, titanium dioxide, triacetin, and color additives [iron oxide yellow (5 mg/10 mg); iron oxide yellow and iron oxide red (10 mg/10 mg); FD&C Blue No. 2/ indigo carmine aluminum lake (15 mg/10 mg); iron oxide red (20 mg/10 mg)]."
},
{
"NDCCode": "65757-652-40",
"PackageDescription": "1 BOTTLE in 1 CARTON (65757-652-40) / 7 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "65757-0652-40",
"ProductNDC": "65757-652",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lybalvi",
"NonProprietaryName": "Olanzapine And Samidorphan L-malate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210920",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213378",
"LabelerName": "Alkermes, Inc.",
"SubstanceName": "OLANZAPINE; SAMIDORPHAN L-MALATE",
"StrengthNumber": "10; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC], Opioid Antagonist [EPC], Opioid Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210920",
"SamplePackage": "N",
"IndicationAndUsage": "LYBALVI is indicated for the treatment of: : 1 Schizophrenia in adults , 2 Bipolar I disorder in adultsAcute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate Maintenance monotherapy treatment .",
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<Status>Active</Status>
<LastUpdate>2026-01-19</LastUpdate>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
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<PackageDescription>2 BLISTER PACK in 1 CARTON (55301-608-44) > 9 TABLET, CHEWABLE in 1 BLISTER PACK</PackageDescription>
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<ProductNDC>55301-608</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gas Relief</ProprietaryName>
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<DosageFormName>TABLET, CHEWABLE</DosageFormName>
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<StartMarketingDate>20130701</StartMarketingDate>
<EndMarketingDate>20230114</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part332</ApplicationNumber>
<LabelerName>ARMY AND AIR FORCE EXCHANGE SERVICE</LabelerName>
<SubstanceName>DIMETHICONE</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130701</StartMarketingDatePackage>
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<NDC>
<NDCCode>55301-680-44</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (55301-680-44) / 9 TABLET, CHEWABLE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55301-0680-44</NDC11Code>
<ProductNDC>55301-680</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gas Relief</ProprietaryName>
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<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210423</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M002</ApplicationNumber>
<LabelerName>ARMY AND AIR FORCE EXCHANGE SERVICE</LabelerName>
<SubstanceName>DIMETHICONE</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210423</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the relief of pressure, bloating, and fullness commonly referred to as gas.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55301-753-44</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (55301-753-44) / 18 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55301-0753-44</NDC11Code>
<ProductNDC>55301-753</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Suphedrine Pe Sinus Congestion</ProprietaryName>
<ProprietaryNameSuffix>Non-drowsy</ProprietaryNameSuffix>
<NonProprietaryName>Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210115</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>ARMY AND AIR FORCE EXCHANGE SERVICE</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves sinus congestion and pressure. temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0472-1790-30</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0472-1790-30) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>00472-1790-30</NDC11Code>
<ProductNDC>0472-1790</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Phosphate And Tretinoin</ProprietaryName>
<NonProprietaryName>Clindamycin Phosphate And Tretinoin</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160705</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202564</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE; TRETINOIN</SubstanceName>
<StrengthNumber>12; .25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160705</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin phosphate and tretinoin gel 1.2% / 0.025% is indicated for the topical treatment of acne vulgaris in patients 12 years or older.</IndicationAndUsage>
<Description>Clindamycin phosphate and tretinoin gel 1.2% / 0.025%, is an antibiotic and retinoid combination gel product with two active ingredients. Clindamycin phosphate, USP is a water-soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate, USP is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4- propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate, USP is represented below. Clindamycin phosphate, USP. Molecular Formula: C18H34ClN2O8PS Molecular Weight: 504.97. The chemical name for tretinoin, USP is 3,7-Dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8- nonatetraenoic acid (all-trans form). The structural formula for tretinoin, USP is represented below. Tretinoin, USP. Molecular Formula: C20H28O2 Molecular Weight: 300.44. Clindamycin phosphate and tretinoin gel 1.2% / 0.025% contains the following inactive ingredients: anhydrous citric acid, butylated hydroxytoluene, edetate disodium, hydroxyethyl cellulose, glycerin, methylparaben, polysorbate 80, propylparaben, purified water, tromethamine and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>0472-1790-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0472-1790-60) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>00472-1790-60</NDC11Code>
<ProductNDC>0472-1790</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Phosphate And Tretinoin</ProprietaryName>
<NonProprietaryName>Clindamycin Phosphate And Tretinoin</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160705</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202564</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE; TRETINOIN</SubstanceName>
<StrengthNumber>12; .25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160705</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin phosphate and tretinoin gel 1.2% / 0.025% is indicated for the topical treatment of acne vulgaris in patients 12 years or older.</IndicationAndUsage>
<Description>Clindamycin phosphate and tretinoin gel 1.2% / 0.025%, is an antibiotic and retinoid combination gel product with two active ingredients. Clindamycin phosphate, USP is a water-soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate, USP is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4- propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate, USP is represented below. Clindamycin phosphate, USP. Molecular Formula: C18H34ClN2O8PS Molecular Weight: 504.97. The chemical name for tretinoin, USP is 3,7-Dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8- nonatetraenoic acid (all-trans form). The structural formula for tretinoin, USP is represented below. Tretinoin, USP. Molecular Formula: C20H28O2 Molecular Weight: 300.44. Clindamycin phosphate and tretinoin gel 1.2% / 0.025% contains the following inactive ingredients: anhydrous citric acid, butylated hydroxytoluene, edetate disodium, hydroxyethyl cellulose, glycerin, methylparaben, polysorbate 80, propylparaben, purified water, tromethamine and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>0641-2569-44</NDCCode>
<PackageDescription>5 VIAL in 1 CARTON (0641-2569-44) / 10 mL in 1 VIAL (0641-2569-41) </PackageDescription>
<NDC11Code>00641-2569-44</NDC11Code>
<ProductNDC>0641-2569</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dipyridamole</ProprietaryName>
<NonProprietaryName>Dipyridamole</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19961018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074521</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>DIPYRIDAMOLE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19961018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dipyridamole Injection is indicated as an alternative to exercise in thallium myocardial perfusion imaging for the evaluation of coronary artery disease in patients who cannot exercise adequately. In a study of about 1100 patients who underwent coronary arteriography and Dipyridamole Injection assisted thallium imaging, the results of both tests were interpreted blindly and the sensitivity and specificity of the dipyridamole thallium study in predicting the angiographic outcome were calculated. The sensitivity of the dipyridamole test (true positive dipyridamole divided by the total number of patients with positive angiography) was about 85%. The specificity (true negative divided by the number of patients with negative angiograms) was about 50%. In a subset of patients who had exercise thallium imaging as well as dipyridamole thallium imaging, sensitivity and specificity of the two tests were almost identical.</IndicationAndUsage>
<Description>Dipyridamole is a coronary vasodilator described as 2,2',2'',2'''-[(4,8 Dipiperidinopyrimido[ 5,4-d]pyrimidine-2,6-diyl)dinitrilo]-tetraethanol. The structural formula is. C24H40N8O4 MW 504.63. Dipyridamole Injection, USP is a sterile, odorless, pale yellow liquid which can be diluted in sodium chloride injection or dextrose injection for intravenous administration. Each mL contains 5 mg dipyridamole, USP, 50 mg polyethylene glycol 600 and 2 mg tartaric acid in Water for Injection, USP. pH 2.2-3.2; hydrochloric acid added for pH adjustment.</Description>
</NDC>
<NDC>
<NDCCode>0781-7287-50</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0781-7287-50) * 10 g in 1 BOTTLE (0781-6536-21) * 40 g in 1 BOTTLE, PUMP (0781-7286-44) </PackageDescription>
<NDC11Code>00781-7287-50</NDC11Code>
<ProductNDC>0781-7287</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin And Benzoyl Peroxide</ProprietaryName>
<NonProprietaryName>Clindamycin And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170815</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204087</ApplicationNumber>
<LabelerName>Sandoz Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris.</IndicationAndUsage>
<Description>For Dermatological Use Only - Not for Ophthalmic Use. *Reconstitute Before Dispensing*. Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (C18H34ClN2O8PS). The structural formula for clindamycin is represented below. clindamycin phosphate. Clindamycin phosphate has molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7, 8-trideoxy-6-(1-methyl-trans- 4-propyl-L-2-pyrrolidinecarboxamido) -1-thio-L- threo-alpha-D- galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin and benzoyl peroxide gel, 1%/5%also contains benzoyl peroxide, for topical use. Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula. Benzoyl Peroxide. Benzoyl peroxide has a molecular weight of 242.23. Each gram of clindamycin and benzoyl peroxide gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbopol 980, d-limonene, docusate sodium solution, phosphoric acid, propylene glycol, purified water and sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>16110-071-30</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (16110-071-30) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>16110-0071-30</NDC11Code>
<ProductNDC>16110-071</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Veltin</ProprietaryName>
<NonProprietaryName>Clindamycin Phosphate And Tretinoin</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100729</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050803</ApplicationNumber>
<LabelerName>Almirall, LLC</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE; TRETINOIN</SubstanceName>
<StrengthNumber>10; .25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VELTIN (clindamycin phosphate and tretinoin) Gel, 1.2%/0.025% is indicated for the topical treatment of acne vulgaris in patients 12 years and older.</IndicationAndUsage>
<Description>VELTIN (clindamycin phosphate and tretinoin) Gel, 1.2%/0.025%, is a fixed combination of 2 solubilized active ingredients in an aqueous-based gel. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Molecular Formula: C18H34ClN2O8PS. Molecular Weight: 504.97. The chemical name for tretinoin is all-trans 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is a member of the retinoid family of compounds. The structural formula for tretinoin is represented below. Molecular Formula: C20H28O2. Molecular Weight: 300.44. VELTIN Gel contains the following inactive ingredients: anhydrous citric acid, butylated hydroxytoluene, carbomer homopolymer (type C), edetate disodium, laureth 4, methylparaben, propylene glycol, purified water, and tromethamine.</Description>
</NDC>
<NDC>
<NDCCode>16110-071-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (16110-071-60) > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>16110-0071-60</NDC11Code>
<ProductNDC>16110-071</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Veltin</ProprietaryName>
<NonProprietaryName>Clindamycin Phosphate And Tretinoin</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100729</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050803</ApplicationNumber>
<LabelerName>Almirall, LLC</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE; TRETINOIN</SubstanceName>
<StrengthNumber>10; .25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VELTIN (clindamycin phosphate and tretinoin) Gel, 1.2%/0.025% is indicated for the topical treatment of acne vulgaris in patients 12 years and older.</IndicationAndUsage>
<Description>VELTIN (clindamycin phosphate and tretinoin) Gel, 1.2%/0.025%, is a fixed combination of 2 solubilized active ingredients in an aqueous-based gel. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Molecular Formula: C18H34ClN2O8PS. Molecular Weight: 504.97. The chemical name for tretinoin is all-trans 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is a member of the retinoid family of compounds. The structural formula for tretinoin is represented below. Molecular Formula: C20H28O2. Molecular Weight: 300.44. VELTIN Gel contains the following inactive ingredients: anhydrous citric acid, butylated hydroxytoluene, carbomer homopolymer (type C), edetate disodium, laureth 4, methylparaben, propylene glycol, purified water, and tromethamine.</Description>
</NDC>
<NDC>
<NDCCode>21922-050-05</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (21922-050-05) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>21922-0050-05</NDC11Code>
<ProductNDC>21922-050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Phosphate And Tretinoin Gel 1.2%/0.025%</ProprietaryName>
<NonProprietaryName>Clindamycin Phosphate And Tretinoin Gel 1.2%/0.025%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230904</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216943</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE; TRETINOIN</SubstanceName>
<StrengthNumber>10; .25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin phosphate and tretinoin gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older.</IndicationAndUsage>
<Description>Clindamycin phosphate and tretinoin gel 1.2%/0.025%, is a fixed combination of 2 solubilized active ingredients in an aqueous-based gel. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Molecular Formula: C18H34ClN2O8PS Molecular Weight: 504.97. The chemical name for tretinoin is all-trans 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is a member of the retinoid family of compounds. The structural formula for tretinoin is represented below. Molecular Formula: C20H28O2 Molecular Weight: 300.44. Clindamycin phosphate and tretinoin gel contains the following inactive ingredients: anhydrous citric acid, butylated hydroxytoluene, carbomer homopolymer (type C), edetate disodium, laureth 4, methylparaben, propylene glycol, purified water, and tromethamine.</Description>
</NDC>
<NDC>
<NDCCode>21922-050-07</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (21922-050-07) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>21922-0050-07</NDC11Code>
<ProductNDC>21922-050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Phosphate And Tretinoin Gel 1.2%/0.025%</ProprietaryName>
<NonProprietaryName>Clindamycin Phosphate And Tretinoin Gel 1.2%/0.025%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230904</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216943</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<SubstanceName>CLINDAMYCIN PHOSPHATE; TRETINOIN</SubstanceName>
<StrengthNumber>10; .25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin phosphate and tretinoin gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older.</IndicationAndUsage>
<Description>Clindamycin phosphate and tretinoin gel 1.2%/0.025%, is a fixed combination of 2 solubilized active ingredients in an aqueous-based gel. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate is represented below. Molecular Formula: C18H34ClN2O8PS Molecular Weight: 504.97. The chemical name for tretinoin is all-trans 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is a member of the retinoid family of compounds. The structural formula for tretinoin is represented below. Molecular Formula: C20H28O2 Molecular Weight: 300.44. Clindamycin phosphate and tretinoin gel contains the following inactive ingredients: anhydrous citric acid, butylated hydroxytoluene, carbomer homopolymer (type C), edetate disodium, laureth 4, methylparaben, propylene glycol, purified water, and tromethamine.</Description>
</NDC>
<NDC>
<NDCCode>21922-068-44</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (21922-068-44) * 20 g in 1 JAR (21922-067-62) * 40 g in 1 JAR (21922-067-41) * 28 g in 1 BOTTLE, PUMP (21922-067-39) * 40 g in 1 BOTTLE, PUMP (21922-067-42) * 10 g in 1 BOTTLE (21922-066-12) * 7 g in 1 BOTTLE (21922-066-37) * 5 g in 1 BOTTLE (21922-066-36) </PackageDescription>
<NDC11Code>21922-0068-44</NDC11Code>
<ProductNDC>21922-068</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin And Benzoyl Peroxide</ProprietaryName>
<NonProprietaryName>Clindamycin And Benzoyl Peroxide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20251007</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204087</ApplicationNumber>
<LabelerName>Encube Ethicals, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251007</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clindamycin and Benzoyl Peroxide Gel, 1%/5% is indicated for the topical treatment of acne vulgaris.</IndicationAndUsage>
<Description>Clindamycin and Benzoyl Peroxide Gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-phosphate). Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. Chemically, clindamycin phosphate is (C18H34ClN2O8PS). The structural formula for clindamycin is represented below. Clindamycin phosphate has molecular weight of 504.97 and its chemical name is Methyl 7-chloro-6,7, 8-trideoxy-6-(1-methyl-trans- 4-propyl-L-2-pyrrolidinecarboxamido) -1-thio-L- threo-alpha-D- galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin and benzoyl peroxide gel, 1%/5%also contains benzoyl peroxide, for topical use.Chemically, benzoyl peroxide is (C14H10O4). It has the following structural formula. Benzoyl peroxide has a molecular weight of 242.23. Each gram of clindamycin and benzoyl peroxide gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbopol 980, d-limonene, docusate sodium solution, phosphoric acid, propylene glycol, purified water and sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>65757-651-40</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (65757-651-40) / 7 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>65757-0651-40</NDC11Code>
<ProductNDC>65757-651</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lybalvi</ProprietaryName>
<NonProprietaryName>Olanzapine And Samidorphan L-malate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210920</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213378</ApplicationNumber>
<LabelerName>Alkermes, Inc.</LabelerName>
<SubstanceName>OLANZAPINE; SAMIDORPHAN L-MALATE</SubstanceName>
<StrengthNumber>5; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC], Opioid Antagonist [EPC], Opioid Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210920</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LYBALVI is indicated for the treatment of: : 1 Schizophrenia in adults , 2 Bipolar I disorder in adultsAcute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate Maintenance monotherapy treatment .</IndicationAndUsage>
<Description>LYBALVI is a combination of olanzapine, an atypical antipsychotic, and samidorphan (as samidorphan L-malate), an opioid antagonist. Olanzapine is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine. The molecular formula of olanzapine is: C17H20N4S and the molecular weight is 312.44 g/mol. It is a yellow crystalline powder and has pKa values of 7.80 and 5.44. The chemical structure is:. Samidorphan L-malate is morphinan-3-carboxamide, 17-(cyclopropylmethyl)-4, 14-dihydroxy-6-oxo-, (2S)-2-hydroxybutanedioate. The molecular formula of samidorphan L-malate is C21H26N2O4 C4H6O5 and the molecular weight is 504.54 g/mol. It is a white to off-white crystalline powder and has pKa values of 8.3 (amine) and 10.1 (phenol). The chemical structure is:. LYBALVI is intended for oral administration and is available as film-coated, bilayer tablets in the following strengths: 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg, and 20 mg/10 mg of olanzapine and samidorphan (equivalent to 13.6 mg of samidorphan L-malate). Inactive ingredients include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The film coating ingredients include hypromellose, titanium dioxide, triacetin, and color additives [iron oxide yellow (5 mg/10 mg); iron oxide yellow and iron oxide red (10 mg/10 mg); FD&C Blue No. 2/ indigo carmine aluminum lake (15 mg/10 mg); iron oxide red (20 mg/10 mg)].</Description>
</NDC>
<NDC>
<NDCCode>65757-651-41</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (65757-651-41) / 7 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>65757-0651-41</NDC11Code>
<ProductNDC>65757-651</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lybalvi</ProprietaryName>
<NonProprietaryName>Olanzapine And Samidorphan L-malate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210920</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213378</ApplicationNumber>
<LabelerName>Alkermes, Inc.</LabelerName>
<SubstanceName>OLANZAPINE; SAMIDORPHAN L-MALATE</SubstanceName>
<StrengthNumber>5; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC], Opioid Antagonist [EPC], Opioid Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210920</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>LYBALVI is indicated for the treatment of: : 1 Schizophrenia in adults , 2 Bipolar I disorder in adultsAcute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate Maintenance monotherapy treatment .</IndicationAndUsage>
<Description>LYBALVI is a combination of olanzapine, an atypical antipsychotic, and samidorphan (as samidorphan L-malate), an opioid antagonist. Olanzapine is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine. The molecular formula of olanzapine is: C17H20N4S and the molecular weight is 312.44 g/mol. It is a yellow crystalline powder and has pKa values of 7.80 and 5.44. The chemical structure is:. Samidorphan L-malate is morphinan-3-carboxamide, 17-(cyclopropylmethyl)-4, 14-dihydroxy-6-oxo-, (2S)-2-hydroxybutanedioate. The molecular formula of samidorphan L-malate is C21H26N2O4 C4H6O5 and the molecular weight is 504.54 g/mol. It is a white to off-white crystalline powder and has pKa values of 8.3 (amine) and 10.1 (phenol). The chemical structure is:. LYBALVI is intended for oral administration and is available as film-coated, bilayer tablets in the following strengths: 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg, and 20 mg/10 mg of olanzapine and samidorphan (equivalent to 13.6 mg of samidorphan L-malate). Inactive ingredients include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The film coating ingredients include hypromellose, titanium dioxide, triacetin, and color additives [iron oxide yellow (5 mg/10 mg); iron oxide yellow and iron oxide red (10 mg/10 mg); FD&C Blue No. 2/ indigo carmine aluminum lake (15 mg/10 mg); iron oxide red (20 mg/10 mg)].</Description>
</NDC>
<NDC>
<NDCCode>65757-651-42</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (65757-651-42) / 30 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>65757-0651-42</NDC11Code>
<ProductNDC>65757-651</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lybalvi</ProprietaryName>
<NonProprietaryName>Olanzapine And Samidorphan L-malate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210920</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213378</ApplicationNumber>
<LabelerName>Alkermes, Inc.</LabelerName>
<SubstanceName>OLANZAPINE; SAMIDORPHAN L-MALATE</SubstanceName>
<StrengthNumber>5; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC], Opioid Antagonist [EPC], Opioid Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210920</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LYBALVI is indicated for the treatment of: : 1 Schizophrenia in adults , 2 Bipolar I disorder in adultsAcute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate Maintenance monotherapy treatment .</IndicationAndUsage>
<Description>LYBALVI is a combination of olanzapine, an atypical antipsychotic, and samidorphan (as samidorphan L-malate), an opioid antagonist. Olanzapine is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine. The molecular formula of olanzapine is: C17H20N4S and the molecular weight is 312.44 g/mol. It is a yellow crystalline powder and has pKa values of 7.80 and 5.44. The chemical structure is:. Samidorphan L-malate is morphinan-3-carboxamide, 17-(cyclopropylmethyl)-4, 14-dihydroxy-6-oxo-, (2S)-2-hydroxybutanedioate. The molecular formula of samidorphan L-malate is C21H26N2O4 C4H6O5 and the molecular weight is 504.54 g/mol. It is a white to off-white crystalline powder and has pKa values of 8.3 (amine) and 10.1 (phenol). The chemical structure is:. LYBALVI is intended for oral administration and is available as film-coated, bilayer tablets in the following strengths: 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg, and 20 mg/10 mg of olanzapine and samidorphan (equivalent to 13.6 mg of samidorphan L-malate). Inactive ingredients include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The film coating ingredients include hypromellose, titanium dioxide, triacetin, and color additives [iron oxide yellow (5 mg/10 mg); iron oxide yellow and iron oxide red (10 mg/10 mg); FD&C Blue No. 2/ indigo carmine aluminum lake (15 mg/10 mg); iron oxide red (20 mg/10 mg)].</Description>
</NDC>
<NDC>
<NDCCode>65757-651-44</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (65757-651-44) / 90 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>65757-0651-44</NDC11Code>
<ProductNDC>65757-651</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lybalvi</ProprietaryName>
<NonProprietaryName>Olanzapine And Samidorphan L-malate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210920</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213378</ApplicationNumber>
<LabelerName>Alkermes, Inc.</LabelerName>
<SubstanceName>OLANZAPINE; SAMIDORPHAN L-MALATE</SubstanceName>
<StrengthNumber>5; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC], Opioid Antagonist [EPC], Opioid Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210920</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LYBALVI is indicated for the treatment of: : 1 Schizophrenia in adults , 2 Bipolar I disorder in adultsAcute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate Maintenance monotherapy treatment .</IndicationAndUsage>
<Description>LYBALVI is a combination of olanzapine, an atypical antipsychotic, and samidorphan (as samidorphan L-malate), an opioid antagonist. Olanzapine is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine. The molecular formula of olanzapine is: C17H20N4S and the molecular weight is 312.44 g/mol. It is a yellow crystalline powder and has pKa values of 7.80 and 5.44. The chemical structure is:. Samidorphan L-malate is morphinan-3-carboxamide, 17-(cyclopropylmethyl)-4, 14-dihydroxy-6-oxo-, (2S)-2-hydroxybutanedioate. The molecular formula of samidorphan L-malate is C21H26N2O4 C4H6O5 and the molecular weight is 504.54 g/mol. It is a white to off-white crystalline powder and has pKa values of 8.3 (amine) and 10.1 (phenol). The chemical structure is:. LYBALVI is intended for oral administration and is available as film-coated, bilayer tablets in the following strengths: 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg, and 20 mg/10 mg of olanzapine and samidorphan (equivalent to 13.6 mg of samidorphan L-malate). Inactive ingredients include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The film coating ingredients include hypromellose, titanium dioxide, triacetin, and color additives [iron oxide yellow (5 mg/10 mg); iron oxide yellow and iron oxide red (10 mg/10 mg); FD&C Blue No. 2/ indigo carmine aluminum lake (15 mg/10 mg); iron oxide red (20 mg/10 mg)].</Description>
</NDC>
<NDC>
<NDCCode>65757-652-40</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (65757-652-40) / 7 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>65757-0652-40</NDC11Code>
<ProductNDC>65757-652</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lybalvi</ProprietaryName>
<NonProprietaryName>Olanzapine And Samidorphan L-malate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210920</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213378</ApplicationNumber>
<LabelerName>Alkermes, Inc.</LabelerName>
<SubstanceName>OLANZAPINE; SAMIDORPHAN L-MALATE</SubstanceName>
<StrengthNumber>10; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC], Opioid Antagonist [EPC], Opioid Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210920</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LYBALVI is indicated for the treatment of: : 1 Schizophrenia in adults , 2 Bipolar I disorder in adultsAcute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate Maintenance monotherapy treatment .</IndicationAndUsage>
<Description>LYBALVI is a combination of olanzapine, an atypical antipsychotic, and samidorphan (as samidorphan L-malate), an opioid antagonist. Olanzapine is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine. The molecular formula of olanzapine is: C17H20N4S and the molecular weight is 312.44 g/mol. It is a yellow crystalline powder and has pKa values of 7.80 and 5.44. The chemical structure is:. Samidorphan L-malate is morphinan-3-carboxamide, 17-(cyclopropylmethyl)-4, 14-dihydroxy-6-oxo-, (2S)-2-hydroxybutanedioate. The molecular formula of samidorphan L-malate is C21H26N2O4 C4H6O5 and the molecular weight is 504.54 g/mol. It is a white to off-white crystalline powder and has pKa values of 8.3 (amine) and 10.1 (phenol). The chemical structure is:. LYBALVI is intended for oral administration and is available as film-coated, bilayer tablets in the following strengths: 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg, and 20 mg/10 mg of olanzapine and samidorphan (equivalent to 13.6 mg of samidorphan L-malate). Inactive ingredients include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The film coating ingredients include hypromellose, titanium dioxide, triacetin, and color additives [iron oxide yellow (5 mg/10 mg); iron oxide yellow and iron oxide red (10 mg/10 mg); FD&C Blue No. 2/ indigo carmine aluminum lake (15 mg/10 mg); iron oxide red (20 mg/10 mg)].</Description>
</NDC>
<NDC>
<NDCCode>65757-652-41</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (65757-652-41) / 7 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>65757-0652-41</NDC11Code>
<ProductNDC>65757-652</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lybalvi</ProprietaryName>
<NonProprietaryName>Olanzapine And Samidorphan L-malate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210920</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213378</ApplicationNumber>
<LabelerName>Alkermes, Inc.</LabelerName>
<SubstanceName>OLANZAPINE; SAMIDORPHAN L-MALATE</SubstanceName>
<StrengthNumber>10; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC], Opioid Antagonist [EPC], Opioid Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210920</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>LYBALVI is indicated for the treatment of: : 1 Schizophrenia in adults , 2 Bipolar I disorder in adultsAcute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate Maintenance monotherapy treatment .</IndicationAndUsage>
<Description>LYBALVI is a combination of olanzapine, an atypical antipsychotic, and samidorphan (as samidorphan L-malate), an opioid antagonist. Olanzapine is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine. The molecular formula of olanzapine is: C17H20N4S and the molecular weight is 312.44 g/mol. It is a yellow crystalline powder and has pKa values of 7.80 and 5.44. The chemical structure is:. Samidorphan L-malate is morphinan-3-carboxamide, 17-(cyclopropylmethyl)-4, 14-dihydroxy-6-oxo-, (2S)-2-hydroxybutanedioate. The molecular formula of samidorphan L-malate is C21H26N2O4 C4H6O5 and the molecular weight is 504.54 g/mol. It is a white to off-white crystalline powder and has pKa values of 8.3 (amine) and 10.1 (phenol). The chemical structure is:. LYBALVI is intended for oral administration and is available as film-coated, bilayer tablets in the following strengths: 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg, and 20 mg/10 mg of olanzapine and samidorphan (equivalent to 13.6 mg of samidorphan L-malate). Inactive ingredients include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The film coating ingredients include hypromellose, titanium dioxide, triacetin, and color additives [iron oxide yellow (5 mg/10 mg); iron oxide yellow and iron oxide red (10 mg/10 mg); FD&C Blue No. 2/ indigo carmine aluminum lake (15 mg/10 mg); iron oxide red (20 mg/10 mg)].</Description>
</NDC>
<NDC>
<NDCCode>65757-652-42</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (65757-652-42) / 30 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>65757-0652-42</NDC11Code>
<ProductNDC>65757-652</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lybalvi</ProprietaryName>
<NonProprietaryName>Olanzapine And Samidorphan L-malate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210920</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213378</ApplicationNumber>
<LabelerName>Alkermes, Inc.</LabelerName>
<SubstanceName>OLANZAPINE; SAMIDORPHAN L-MALATE</SubstanceName>
<StrengthNumber>10; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC], Opioid Antagonist [EPC], Opioid Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<IndicationAndUsage>LYBALVI is indicated for the treatment of: : 1 Schizophrenia in adults , 2 Bipolar I disorder in adultsAcute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate Maintenance monotherapy treatment .</IndicationAndUsage>
<Description>LYBALVI is a combination of olanzapine, an atypical antipsychotic, and samidorphan (as samidorphan L-malate), an opioid antagonist. Olanzapine is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine. The molecular formula of olanzapine is: C17H20N4S and the molecular weight is 312.44 g/mol. It is a yellow crystalline powder and has pKa values of 7.80 and 5.44. The chemical structure is:. Samidorphan L-malate is morphinan-3-carboxamide, 17-(cyclopropylmethyl)-4, 14-dihydroxy-6-oxo-, (2S)-2-hydroxybutanedioate. The molecular formula of samidorphan L-malate is C21H26N2O4 C4H6O5 and the molecular weight is 504.54 g/mol. It is a white to off-white crystalline powder and has pKa values of 8.3 (amine) and 10.1 (phenol). The chemical structure is:. LYBALVI is intended for oral administration and is available as film-coated, bilayer tablets in the following strengths: 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg, and 20 mg/10 mg of olanzapine and samidorphan (equivalent to 13.6 mg of samidorphan L-malate). Inactive ingredients include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The film coating ingredients include hypromellose, titanium dioxide, triacetin, and color additives [iron oxide yellow (5 mg/10 mg); iron oxide yellow and iron oxide red (10 mg/10 mg); FD&C Blue No. 2/ indigo carmine aluminum lake (15 mg/10 mg); iron oxide red (20 mg/10 mg)].</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lybalvi</ProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20210920</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213378</ApplicationNumber>
<LabelerName>Alkermes, Inc.</LabelerName>
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<Pharm_Classes>Atypical Antipsychotic [EPC], Opioid Antagonist [EPC], Opioid Antagonists [MoA]</Pharm_Classes>
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<LastUpdate>2025-12-16</LastUpdate>
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<IndicationAndUsage>LYBALVI is indicated for the treatment of: : 1 Schizophrenia in adults , 2 Bipolar I disorder in adultsAcute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate Maintenance monotherapy treatment .</IndicationAndUsage>
<Description>LYBALVI is a combination of olanzapine, an atypical antipsychotic, and samidorphan (as samidorphan L-malate), an opioid antagonist. Olanzapine is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine. The molecular formula of olanzapine is: C17H20N4S and the molecular weight is 312.44 g/mol. It is a yellow crystalline powder and has pKa values of 7.80 and 5.44. The chemical structure is:. Samidorphan L-malate is morphinan-3-carboxamide, 17-(cyclopropylmethyl)-4, 14-dihydroxy-6-oxo-, (2S)-2-hydroxybutanedioate. The molecular formula of samidorphan L-malate is C21H26N2O4 C4H6O5 and the molecular weight is 504.54 g/mol. It is a white to off-white crystalline powder and has pKa values of 8.3 (amine) and 10.1 (phenol). The chemical structure is:. LYBALVI is intended for oral administration and is available as film-coated, bilayer tablets in the following strengths: 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg, and 20 mg/10 mg of olanzapine and samidorphan (equivalent to 13.6 mg of samidorphan L-malate). Inactive ingredients include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The film coating ingredients include hypromellose, titanium dioxide, triacetin, and color additives [iron oxide yellow (5 mg/10 mg); iron oxide yellow and iron oxide red (10 mg/10 mg); FD&C Blue No. 2/ indigo carmine aluminum lake (15 mg/10 mg); iron oxide red (20 mg/10 mg)].</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lybalvi</ProprietaryName>
<NonProprietaryName>Olanzapine And Samidorphan L-malate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210920</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213378</ApplicationNumber>
<LabelerName>Alkermes, Inc.</LabelerName>
<SubstanceName>OLANZAPINE; SAMIDORPHAN L-MALATE</SubstanceName>
<StrengthNumber>15; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC], Opioid Antagonist [EPC], Opioid Antagonists [MoA]</Pharm_Classes>
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<LastUpdate>2025-12-16</LastUpdate>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LYBALVI is indicated for the treatment of: : 1 Schizophrenia in adults , 2 Bipolar I disorder in adultsAcute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate Maintenance monotherapy treatment .</IndicationAndUsage>
<Description>LYBALVI is a combination of olanzapine, an atypical antipsychotic, and samidorphan (as samidorphan L-malate), an opioid antagonist. Olanzapine is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine. The molecular formula of olanzapine is: C17H20N4S and the molecular weight is 312.44 g/mol. It is a yellow crystalline powder and has pKa values of 7.80 and 5.44. The chemical structure is:. Samidorphan L-malate is morphinan-3-carboxamide, 17-(cyclopropylmethyl)-4, 14-dihydroxy-6-oxo-, (2S)-2-hydroxybutanedioate. The molecular formula of samidorphan L-malate is C21H26N2O4 C4H6O5 and the molecular weight is 504.54 g/mol. It is a white to off-white crystalline powder and has pKa values of 8.3 (amine) and 10.1 (phenol). The chemical structure is:. LYBALVI is intended for oral administration and is available as film-coated, bilayer tablets in the following strengths: 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg, and 20 mg/10 mg of olanzapine and samidorphan (equivalent to 13.6 mg of samidorphan L-malate). Inactive ingredients include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The film coating ingredients include hypromellose, titanium dioxide, triacetin, and color additives [iron oxide yellow (5 mg/10 mg); iron oxide yellow and iron oxide red (10 mg/10 mg); FD&C Blue No. 2/ indigo carmine aluminum lake (15 mg/10 mg); iron oxide red (20 mg/10 mg)].</Description>
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