{
"NDC": [
{
"NDCCode": "42571-134-29",
"PackageDescription": "60 BLISTER PACK in 1 CARTON (42571-134-29) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "42571-0134-29",
"ProductNDC": "42571-134",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium/misoprostol",
"ProprietaryNameSuffix": "Diclofenac-sodium-misoprostol",
"NonProprietaryName": "Diclofenac Sodium/misoprostol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204355",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "DICLOFENAC SODIUM; MISOPROSTOL",
"StrengthNumber": "75; 200",
"StrengthUnit": "mg/1; ug/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]",
"Status": "Active",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210901",
"SamplePackage": "N",
"IndicationAndUsage": "Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions ( 5.3)] .",
"Description": "Diclofenac sodium and misoprostol delayed-release tablets, USP is a combination product containing diclofenac sodium, an NSAID with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin-1 (PGE1) analog. Diclofenac sodium and misoprostol delayed-release tablets are white to off-white, round, biconvex, and approximately 11 mm in diameter. Each tablet consists of an enteric-coated core containing 50 mg (diclofenac sodium and misoprostol delayed-release tablets 50 mg/200 mcg) or 75 mg (diclofenac sodium and misoprostol delayed-release tablets 75 mg/200 mcg) of diclofenac sodium (equivalent to 46.39 mg or 69.58 mg of diclofenac, respectively) surrounded by an outer mantle containing 200 mcg misoprostol. Diclofenac sodium, USP is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium, USP is freely soluble in methanol, soluble in ethanol, and practically insoluble in chloroform and in dilute acid. Diclofenac sodium, USP is sparingly soluble in water. Its chemical formula and name are. C 14H 10Cl 2NO 2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt. Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are. C 22H 38O 5[M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate. Inactive ingredients in diclofenac sodium and misoprostol delayed-release tablets include: colloidal silicon dioxide; corn starch; crospovidone; hydrogenated castor oil; hypromellose; lactose monohydrate; magnesium stearate; methacrylic acid copolymer; microcrystalline cellulose; povidone; sodium hydroxide; talc; triethyl citrate. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "42571-134-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (42571-134-30) ",
"NDC11Code": "42571-0134-30",
"ProductNDC": "42571-134",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium/misoprostol",
"ProprietaryNameSuffix": "Diclofenac-sodium-misoprostol",
"NonProprietaryName": "Diclofenac Sodium/misoprostol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204355",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "DICLOFENAC SODIUM; MISOPROSTOL",
"StrengthNumber": "75; 200",
"StrengthUnit": "mg/1; ug/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]",
"Status": "Active",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210901",
"SamplePackage": "N",
"IndicationAndUsage": "Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions ( 5.3)] .",
"Description": "Diclofenac sodium and misoprostol delayed-release tablets, USP is a combination product containing diclofenac sodium, an NSAID with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin-1 (PGE1) analog. Diclofenac sodium and misoprostol delayed-release tablets are white to off-white, round, biconvex, and approximately 11 mm in diameter. Each tablet consists of an enteric-coated core containing 50 mg (diclofenac sodium and misoprostol delayed-release tablets 50 mg/200 mcg) or 75 mg (diclofenac sodium and misoprostol delayed-release tablets 75 mg/200 mcg) of diclofenac sodium (equivalent to 46.39 mg or 69.58 mg of diclofenac, respectively) surrounded by an outer mantle containing 200 mcg misoprostol. Diclofenac sodium, USP is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium, USP is freely soluble in methanol, soluble in ethanol, and practically insoluble in chloroform and in dilute acid. Diclofenac sodium, USP is sparingly soluble in water. Its chemical formula and name are. C 14H 10Cl 2NO 2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt. Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are. C 22H 38O 5[M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate. Inactive ingredients in diclofenac sodium and misoprostol delayed-release tablets include: colloidal silicon dioxide; corn starch; crospovidone; hydrogenated castor oil; hypromellose; lactose monohydrate; magnesium stearate; methacrylic acid copolymer; microcrystalline cellulose; povidone; sodium hydroxide; talc; triethyl citrate. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "42571-134-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (42571-134-60) ",
"NDC11Code": "42571-0134-60",
"ProductNDC": "42571-134",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium/misoprostol",
"ProprietaryNameSuffix": "Diclofenac-sodium-misoprostol",
"NonProprietaryName": "Diclofenac Sodium/misoprostol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204355",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "DICLOFENAC SODIUM; MISOPROSTOL",
"StrengthNumber": "75; 200",
"StrengthUnit": "mg/1; ug/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]",
"Status": "Active",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210901",
"SamplePackage": "N",
"IndicationAndUsage": "Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions ( 5.3)] .",
"Description": "Diclofenac sodium and misoprostol delayed-release tablets, USP is a combination product containing diclofenac sodium, an NSAID with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin-1 (PGE1) analog. Diclofenac sodium and misoprostol delayed-release tablets are white to off-white, round, biconvex, and approximately 11 mm in diameter. Each tablet consists of an enteric-coated core containing 50 mg (diclofenac sodium and misoprostol delayed-release tablets 50 mg/200 mcg) or 75 mg (diclofenac sodium and misoprostol delayed-release tablets 75 mg/200 mcg) of diclofenac sodium (equivalent to 46.39 mg or 69.58 mg of diclofenac, respectively) surrounded by an outer mantle containing 200 mcg misoprostol. Diclofenac sodium, USP is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium, USP is freely soluble in methanol, soluble in ethanol, and practically insoluble in chloroform and in dilute acid. Diclofenac sodium, USP is sparingly soluble in water. Its chemical formula and name are. C 14H 10Cl 2NO 2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt. Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are. C 22H 38O 5[M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate. Inactive ingredients in diclofenac sodium and misoprostol delayed-release tablets include: colloidal silicon dioxide; corn starch; crospovidone; hydrogenated castor oil; hypromellose; lactose monohydrate; magnesium stearate; methacrylic acid copolymer; microcrystalline cellulose; povidone; sodium hydroxide; talc; triethyl citrate. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "42571-134-90",
"PackageDescription": "90 TABLET in 1 BOTTLE (42571-134-90) ",
"NDC11Code": "42571-0134-90",
"ProductNDC": "42571-134",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium/misoprostol",
"ProprietaryNameSuffix": "Diclofenac-sodium-misoprostol",
"NonProprietaryName": "Diclofenac Sodium/misoprostol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204355",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "DICLOFENAC SODIUM; MISOPROSTOL",
"StrengthNumber": "75; 200",
"StrengthUnit": "mg/1; ug/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]",
"Status": "Active",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210901",
"SamplePackage": "N",
"IndicationAndUsage": "Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions ( 5.3)] .",
"Description": "Diclofenac sodium and misoprostol delayed-release tablets, USP is a combination product containing diclofenac sodium, an NSAID with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin-1 (PGE1) analog. Diclofenac sodium and misoprostol delayed-release tablets are white to off-white, round, biconvex, and approximately 11 mm in diameter. Each tablet consists of an enteric-coated core containing 50 mg (diclofenac sodium and misoprostol delayed-release tablets 50 mg/200 mcg) or 75 mg (diclofenac sodium and misoprostol delayed-release tablets 75 mg/200 mcg) of diclofenac sodium (equivalent to 46.39 mg or 69.58 mg of diclofenac, respectively) surrounded by an outer mantle containing 200 mcg misoprostol. Diclofenac sodium, USP is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium, USP is freely soluble in methanol, soluble in ethanol, and practically insoluble in chloroform and in dilute acid. Diclofenac sodium, USP is sparingly soluble in water. Its chemical formula and name are. C 14H 10Cl 2NO 2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt. Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are. C 22H 38O 5[M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate. Inactive ingredients in diclofenac sodium and misoprostol delayed-release tablets include: colloidal silicon dioxide; corn starch; crospovidone; hydrogenated castor oil; hypromellose; lactose monohydrate; magnesium stearate; methacrylic acid copolymer; microcrystalline cellulose; povidone; sodium hydroxide; talc; triethyl citrate. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "42571-131-29",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (42571-131-29) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "42571-0131-29",
"ProductNDC": "42571-131",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nevirapine",
"NonProprietaryName": "Nevirapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120522",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203080",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "NEVIRAPINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120522",
"SamplePackage": "N",
"IndicationAndUsage": "Nevirapine tablet is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 15 days and older [see Clinical Studies (14.1, 14.2)] . Limitations of Use. Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine tablet is not recommended to be initiated, unless the benefit outweighs the risk, in: 1 adult females with CD4 +cell counts greater than 250 cells/mm 3or , 2 adult males with CD4 +cell counts greater than 400 cells/mm 3[see Warnings and Precautions (5.1)] . .",
"Description": "Nevirapine tablets USP, 200 mg is the brand name for nevirapine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) with activity against Human Immunodeficiency Virus Type 1 (HIV-1). Nevirapine USP is structurally a member of the dipyridodiazepinone chemical class of compounds. The chemical name of nevirapine is 11-cyclopropyl-5, 11-dihydro-4-methyl-6H-dipyrido [3,2-b:2',3'-e][1,4] diazepin-6-one. Nevirapine USP is a white to off-white crystalline powder with the molecular weight of 266.30 and the molecular formula C 15H 14N 4O. Nevirapine has the following structural formula:. Nevirapine tablets USP, 200 mg is for oral administration. Each tablet contains 200 mg of nevirapine anhydrous and the inactive ingredients microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, magnesium stearate, povidone, and Sodium starch glycolate."
},
{
"NDCCode": "42571-133-29",
"PackageDescription": "60 BLISTER PACK in 1 CARTON (42571-133-29) / 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "42571-0133-29",
"ProductNDC": "42571-133",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium/misoprostol",
"ProprietaryNameSuffix": "Diclofenac-sodium-misoprostol",
"NonProprietaryName": "Diclofenac Sodium/misoprostol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204355",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "DICLOFENAC SODIUM; MISOPROSTOL",
"StrengthNumber": "50; 200",
"StrengthUnit": "mg/1; ug/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]",
"Status": "Active",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210901",
"SamplePackage": "N",
"IndicationAndUsage": "Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions ( 5.3)] .",
"Description": "Diclofenac sodium and misoprostol delayed-release tablets, USP is a combination product containing diclofenac sodium, an NSAID with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin-1 (PGE1) analog. Diclofenac sodium and misoprostol delayed-release tablets are white to off-white, round, biconvex, and approximately 11 mm in diameter. Each tablet consists of an enteric-coated core containing 50 mg (diclofenac sodium and misoprostol delayed-release tablets 50 mg/200 mcg) or 75 mg (diclofenac sodium and misoprostol delayed-release tablets 75 mg/200 mcg) of diclofenac sodium (equivalent to 46.39 mg or 69.58 mg of diclofenac, respectively) surrounded by an outer mantle containing 200 mcg misoprostol. Diclofenac sodium, USP is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium, USP is freely soluble in methanol, soluble in ethanol, and practically insoluble in chloroform and in dilute acid. Diclofenac sodium, USP is sparingly soluble in water. Its chemical formula and name are. C 14H 10Cl 2NO 2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt. Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are. C 22H 38O 5[M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate. Inactive ingredients in diclofenac sodium and misoprostol delayed-release tablets include: colloidal silicon dioxide; corn starch; crospovidone; hydrogenated castor oil; hypromellose; lactose monohydrate; magnesium stearate; methacrylic acid copolymer; microcrystalline cellulose; povidone; sodium hydroxide; talc; triethyl citrate. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "42571-144-29",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (42571-144-29) / 10 CAPSULE in 1 BLISTER PACK (42571-144-32) ",
"NDC11Code": "42571-0144-29",
"ProductNDC": "42571-144",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20180601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204776",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180601",
"SamplePackage": "N",
"IndicationAndUsage": "Celecoxib is indicated.",
"Description": "Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib USP is a white or almost white crystalline powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib USP is hydrophobic (log P is 3.5) and is soluble in ethanol and in methylene chloride, practically insoluble in water. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate. The empty hard gelatin capsule shell contains gelatin and titanium dioxide. The capsules are printed with ink containing black iron oxide, potassium hydroxide, propylene glycol and shellac."
},
{
"NDCCode": "42571-166-29",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (42571-166-29) > 10 TABLET, FILM COATED in 1 BLISTER PACK (42571-166-32) ",
"NDC11Code": "42571-0166-29",
"ProductNDC": "42571-166",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lamivudine, Nevirapine, And Zidovudine",
"NonProprietaryName": "Lamivudine, Nevirapine, And Zidovudine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180903",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205626",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE",
"StrengthNumber": "150; 200; 300",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [EXT],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180903",
"SamplePackage": "N"
},
{
"NDCCode": "42571-508-29",
"PackageDescription": "60 POUCH in 1 CARTON (42571-508-29) / 9 g in 1 POUCH (42571-508-04) ",
"NDC11Code": "42571-0508-29",
"ProductNDC": "42571-508",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cholestyramine",
"NonProprietaryName": "Cholestyramine",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20260401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219318",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "CHOLESTYRAMINE",
"StrengthNumber": "4",
"StrengthUnit": "g/9g",
"Pharm_Classes": "Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260401",
"SamplePackage": "N",
"IndicationAndUsage": "1) Cholestyramine for oral suspension is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. Cholestyramine for oral suspension may be useful to lower LDL cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy specific for the type of hyperlipoproteinemia determined prior to initiation of drug therapy. Excess body weight may be an important factor and caloric restriction for weight normalization should be addressed prior to drug therapy in the overweight. Prior to initiating therapy with cholestyramine resin, secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism), should be excluded, and a lipid profile performed to assess Total cholesterol, HDL-C, and triglycerides (TG). For individuals with TG less than 400 mg/dL (<4.5 mmol/L), LDL-C can be estimated using the following equation:-. LDL-C = Total cholesterol - [(TG/5) + HDL-C]. For TG levels > 400 mg/dL, this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated Total-C. In such cases cholestyramine resin may not be indicated. Serum cholesterol and triglyceride levels should be determined periodically based on NCEP guidelines to confirm initial and adequate long-term response. A favorable trend in cholesterol reduction should occur during the first month of cholestyramine resin therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of cholestyramine resin or adding other lipid-lowering agents in combination with cholestyramine resin should be considered. Since the goal of treatment is to lower LDL-C, the NCEP 4recommends that LDL-C levels be used to initiate and assess treatment response. If LDL-C levels are not available then Total-C alone may be used to monitor long-term therapy. A lipoprotein analysis (including LDL-C determination) should be carried out once a year. The NCEP treatment guidelines are summarized below. *Coronary heart disease or peripheral vascular disease (including symptomatic carotid artery disease). **Other risk factors for coronary heart disease (CHD) include: age (males: ≥ 45 years; females: ≥ 55 years or premature menopause without estrogen replacement therapy); family history of premature CHD; current cigarette smoking; hypertension; confirmed HDL-C <35 mg/dL (<0.91 mmol/L); and diabetes mellitus. Subtract one risk factor if HDL-C is ≥ 60 mg/dL (≥ 1.6 mmol/L). Cholestyramine resin monotherapy has been demonstrated to retard the rate of progression 2,3and increase the rate of regression 3of coronary atherosclerosis. 2) Cholestyramine for oral suspension is indicated for the relief of pruritus associated with partial biliary obstruction. Cholestyramine resin has been shown to have a variable effect on serum cholesterol in these patients. Patients with primary biliary cirrhosis may exhibit an elevated cholesterol as part of their disease.",
"Description": "Cholestyramine for oral suspension USP, the chloride salt of a basic anion exchange resin, a cholesterol lowering agent, is intended for oral administration. Cholestyramine resin, USP is quite hydrophilic, but insoluble in water. The cholestyramine resin in cholestyramine for oral suspension, USP is not absorbed from the digestive tract. Four grams of anhydrous cholestyramine resin, USP is contained in 9 grams of cholestyramine for oral suspension, USP. It is represented by the following structural formula. Representation of structure of main polymeric groups. Cholestyramine for oral suspension, USP contains the following inactive ingredients: anhydrous citric acid, D&C yellow No. 10, FD&C yellow No. 6, natural and artificial orange flavor, fructose, propylene glycol alginate, sorbitol, sucrose and xanthan gum."
},
{
"NDCCode": "50563-134-01",
"PackageDescription": "29 mL in 1 BOTTLE (50563-134-01)",
"NDC11Code": "50563-0134-01",
"ProductNDC": "50563-134",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rue21 Cotton Candy Antibacterial Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130709",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "ENCHANTE ACCESSORIES INC.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "63",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Uses. To decrease bacteria on the skin."
},
{
"NDCCode": "54860-134-01",
"PackageDescription": "29 mL in 1 BOTTLE, PLASTIC (54860-134-01) ",
"NDC11Code": "54860-0134-01",
"ProductNDC": "54860-134",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Berry Kissed Hand Sanitizer",
"ProprietaryNameSuffix": "01",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191105",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Shenzhen Lantern Cosmetic Co Ltd",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "65",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20191105",
"SamplePackage": "N"
},
{
"NDCCode": "70692-134-29",
"PackageDescription": "3 TABLET in 1 BLISTER PACK (70692-134-29) ",
"NDC11Code": "70692-0134-29",
"ProductNDC": "70692-134",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fexofenadine Hydrochloride",
"NonProprietaryName": "Fexofenadine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211075",
"LabelerName": "Strive Pharmaceuticals Inc",
"SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20190722",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
},
{
"NDCCode": "72888-134-29",
"PackageDescription": "10 TABLET, ORALLY DISINTEGRATING in 1 CARTON (72888-134-29) ",
"NDC11Code": "72888-0134-29",
"ProductNDC": "72888-134",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonazepam",
"NonProprietaryName": "Clonazepam",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20260521",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216988",
"LabelerName": "Advagen Pharma Ltd",
"SubstanceName": "CLONAZEPAM",
"StrengthNumber": ".25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-05-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260521",
"SamplePackage": "N",
"IndicationAndUsage": "Seizure Disorders. Clonazepam orally disintegrating tablet is useful alone or as an adjunct in the treatment of the Lennox- Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam orally disintegrating tablets may be useful. In some studies, up to 30% of patients have shown a loss of anticonvulsant activity, often within 3 months of administration. In some cases, dosage adjustment may reestablish efficacy. Panic Disorder. Clonazepam orally disintegrating tablet is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-V. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of clonazepam orally disintegrating tablets was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-lIlR category of panic disorder (see CLINICAL PHARMACOLOGY:Clinical Trials). Panic disorder (DSM-V) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The effectiveness of clonazepam orally disintegrating tablets in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use clonazepam orally disintegrating tablets for extended periods should periodically reevaluate the long- term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).",
"Description": "Clonazepam, USP a benzodiazepine, is available as an orally disintegrating tablet containing 0.125 mg, 0.25 mg, 0.5 mg, 1 mg or 2 mg clonazepam, USP. Each orally disintegrating tablet also contains aspartame, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, sorbitol, sodium lauryl sulfate, and talc. Chemically, clonazepam is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula."
},
{
"NDCCode": "75660-134-44",
"PackageDescription": "118.29 mL in 1 BOTTLE, PLASTIC (75660-134-44) ",
"NDC11Code": "75660-0134-44",
"ProductNDC": "75660-134",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clean All Gel Hand Sanitizer Fresh Linen",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201014",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Solvents and Petroleum Inc",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "65",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20201014",
"SamplePackage": "N",
"IndicationAndUsage": "to reduce bacteria on hands. For use when soap and water are not available."
},
{
"NDCCode": "76891-134-11",
"PackageDescription": "29 mL in 1 BOTTLE (76891-134-11) ",
"NDC11Code": "76891-0134-11",
"ProductNDC": "76891-134",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"ProprietaryNameSuffix": "All Variants",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221111",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "SCENT THEORY PRODUCTS LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20221111",
"SamplePackage": "N",
"IndicationAndUsage": "FOR HANDWASHING TO DECREASE BACTERIA ON THE SKIN."
},
{
"NDCCode": "42571-258-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (42571-258-01) ",
"NDC11Code": "42571-0258-01",
"ProductNDC": "42571-258",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mefenamic Acid",
"NonProprietaryName": "Mefenamic Acid",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20101119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090562",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "MEFENAMIC ACID",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101119",
"SamplePackage": "N",
"IndicationAndUsage": "Mefenamic acid capsules are a nonsteroidal anti-inflammatory drug indicated for: 1 For management of mild to moderate pain in patient 14 years of age and older, when therapy will not exceed one week (7 days). ( 1.1) , 2 For treatment of primary dysmenorrhea. ( 1.2) .",
"Description": "Mefenamic acid capsules, USP contains active moiety mefenamic acid, USP which is a member of the fenamate group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name of mefenamic acid, USP is N-2,3-xylylanthranilic acid. The molecular weight is 241.29 g/mol. Its molecular formula is C 15H 15N0 2and the structural formula of mefenamic acid is:. Mefenamic acid, USP is a white to greyish-white, odorless, microcrystalline powder with a melting point of 230° to 231°C and water solubility of 0.004% at pH 7.1. Mefenamic acid capsule, USP is for oral administration. Each capsule contains 250 mg of mefenamic acid, USP and lactose monohydrate. The capsule shell contains D&C yellow No. 10; FD&C blue No. 1; FD&C red No. 3; FD&C yellow No. 6; gelatin, sodium lauryl sulfate, titanium dioxide, black iron oxide, propylene glycol & shellac."
},
{
"NDCCode": "42571-258-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (42571-258-30) ",
"NDC11Code": "42571-0258-30",
"ProductNDC": "42571-258",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mefenamic Acid",
"NonProprietaryName": "Mefenamic Acid",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20101119",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090562",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "MEFENAMIC ACID",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101119",
"SamplePackage": "N",
"IndicationAndUsage": "Mefenamic acid capsules are a nonsteroidal anti-inflammatory drug indicated for: 1 For management of mild to moderate pain in patient 14 years of age and older, when therapy will not exceed one week (7 days). ( 1.1) , 2 For treatment of primary dysmenorrhea. ( 1.2) .",
"Description": "Mefenamic acid capsules, USP contains active moiety mefenamic acid, USP which is a member of the fenamate group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name of mefenamic acid, USP is N-2,3-xylylanthranilic acid. The molecular weight is 241.29 g/mol. Its molecular formula is C 15H 15N0 2and the structural formula of mefenamic acid is:. Mefenamic acid, USP is a white to greyish-white, odorless, microcrystalline powder with a melting point of 230° to 231°C and water solubility of 0.004% at pH 7.1. Mefenamic acid capsule, USP is for oral administration. Each capsule contains 250 mg of mefenamic acid, USP and lactose monohydrate. The capsule shell contains D&C yellow No. 10; FD&C blue No. 1; FD&C red No. 3; FD&C yellow No. 6; gelatin, sodium lauryl sulfate, titanium dioxide, black iron oxide, propylene glycol & shellac."
},
{
"NDCCode": "42571-370-99",
"PackageDescription": "10 VIAL in 1 CARTON (42571-370-99) / 5 mL in 1 VIAL (42571-370-92) ",
"NDC11Code": "42571-0370-99",
"ProductNDC": "42571-370",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brivaracetam",
"NonProprietaryName": "Brivaracetam",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214880",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "BRIVARACETAM",
"StrengthNumber": "50",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Epoxide Hydrolase Inhibitors [MoA]",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260301",
"SamplePackage": "N",
"IndicationAndUsage": "Brivaracetam injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.",
"Description": "The chemical name of brivaracetam is (2S)-2-[(4R)-2-oxo-4-propyltetrahydro-1 H-pyrrol-1-yl] butanamide. Its molecular formula is C 11H 20N 2O 2and its molecular weight is 212.29. The chemical structure is:. Brivaracetam is a white to off-white crystalline powder. It is very soluble in water, buffer (pH 1.2, 4.5, and 7.4), ethanol, methanol, and glacial acetic acid. It is freely soluble in acetonitrile and acetone and soluble in toluene. It is very slightly soluble in n-hexane. Injection. Brivaracetam injection is a clear, colorless liquid provided as a sterile, preservative-free solution. Brivaracetam injection contains 10 mg brivaracetam per mL for intravenous administration. One vial contains 50 mg of brivaracetam drug substance. It contains the following inactive ingredients: sodium acetate trihydrate (2.7 mg/mL), glacial acetic acid (for pH adjustment to 5.5), sodium chloride (9 mg/mL), and water for injection."
},
{
"NDCCode": "11523-7061-2",
"PackageDescription": "237 mL in 1 BOTTLE, PLASTIC (11523-7061-2)",
"NDC11Code": "11523-7061-02",
"ProductNDC": "11523-7061",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Coppertone Oil Free",
"ProprietaryNameSuffix": "Spf 30",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "19990521",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "MSD Consumer Care, Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "20.7; 134.55; 51.75; 20.7; 41.4",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-03-29",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "23155-216-31",
"PackageDescription": "5 mL in 1 VIAL, GLASS (23155-216-31) ",
"NDC11Code": "23155-0216-31",
"ProductNDC": "23155-216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cidofovir Dihydrate",
"NonProprietaryName": "Cidofovir Dihydrate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20120806",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202501",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "CIDOFOVIR",
"StrengthNumber": "375",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog [EXT]",
"Status": "Active",
"LastUpdate": "2023-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120806",
"SamplePackage": "N",
"IndicationAndUsage": "Cidofovir injection is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). THE SAFETY AND EFFICACY OF CIDOFOVIR INJECTION HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER CMV INFECTIONS (SUCH AS PNEUMONITIS OR GASTROENTERITIS), CONGENITAL OR NEONATAL CMV DISEASE, OR CMV DISEASE IN NON-HIV-INFECTED INDIVIDUALS. DESCRIPTION OF CLINICAL TRIALS. Three phase II/III controlled trials of cidofovir injection have been conducted in HIV-infected patients with CMV retinitis. Delayed Versus Immediate Therapy (Study 105). In stage 1 of this open-label trial, conducted by the Studies of the Ocular Complications of AIDS (SOCA) Clinical Research Group, 29 previously untreated patients with peripheral CMV retinitis were randomized to either immediate treatment with cidofovir injection (5 mg/kg once a week for 2 weeks, then 3 mg/kg every other week) or to have cidofovir injection delayed until progression of CMV retinitis13. In stage 2 of this trial, an additional 35 previously untreated patients with peripheral CMV retinitis were randomized to either immediate treatment with cidofovir injection (5 mg/kg once a week for 2 weeks, then 5 mg/kg every other week), immediate treatment with cidofovir injection (5 mg/kg once a week for 2 weeks, then 3 mg/kg every other week), or to have cidofovir injection delayed until progression of CMV retinitis. Of the 64 patients in this study, 12 were randomized to 5 mg/kg maintenance therapy, 26 to 3 mg/kg maintenance therapy, and 26 to delayed therapy. Of the 12 patients enrolled in the 5 mg/kg maintenance group, 5 patients progressed, 5 patients discontinued therapy and 2 patients had no progression at study completion. Based on masked readings of retinal photographs, the median [95% confidence interval (CI)] time to retinitis progression was not reached (25, not reached) for the 5 mg/kg maintenance group. Median (95% CI) time to the alternative endpoint of retinitis progression or study drug discontinuation was 44 days (24, 207) for the 5 mg/kg maintenance group. Patients receiving 5 mg/kg maintenance had delayed time to retinitis progression compared to patients receiving 3 mg/kg maintenance or deferred therapy. Delayed Versus Immediate Therapy (Study 106). In an open-label trial, 48 previously untreated patients with peripheral CMV retinitis were randomized to either immediate treatment with cidofovir injection (5 mg/kg once a week for 2 weeks, then 5 mg/kg every other week), or to have cidofovir injection delayed until progression of CMV retinitis14. Patient baseline characteristics and disposition are shown in Table 3. Of 25 and 23 patients in the immediate and delayed groups respectively, 23 and 21 were evaluable for retinitis progression as determined by retinal photography. Based on masked readings of retinal photographs, the median [95% confidence interval (CI)] times to retinitis progression were 120 days (40, 134) and 22 days (10, 27) for the immediate and delayed therapy groups, respectively. This difference was statistically significant. However, because of the limited number of patients remaining on treatment over time (3 of 25 patients received cidofovir injection for 120 days or longer), the median time to progression for the immediate therapy group was difficult to precisely estimate. Median (95% CI) times to the alternative endpoint of retinitis progression or study drug discontinuation (including adverse events, withdrawn consent, and systemic CMV disease) were 52 days (37, 85) and 22 days (13, 27) for the immediate and delayed therapy groups, respectively. This difference was statistically significant. Time to progression estimates from this study may not be directly comparable to estimates reported for other therapies. Dose-response study of cidofovir injection (Study 107). In an open-label trial, 100 patients with relapsing CMV retinitis were randomized to receive 5 mg/kg once a week for 2 weeks and then either 5 mg/kg (n = 49) or 3 mg/kg (n = 51) every other week. Enrolled patients had been diagnosed with CMV retinitis an average of 390 days prior to randomization and had received a median of 3.8 prior courses of systemic CMV therapy. Eighty four of the 100 patients were considered evaluable for progression by serial retinal photographs (43 randomized to 5 mg/kg and 41 randomized to 3 mg/kg). Twenty-six and 21 patients discontinued therapy due to either an adverse event, intercurrent illness, excluded medication, or withdrawn consent in the 5 mg/kg and 3 mg/kg groups, respectively. Thirty-eight of the 100 randomized patients had progressed according to masked assessment of serial retinal photographs (13 randomized to 5 mg/kg and 25 randomized to 3 mg/kg). Using retinal photographs, the median (95% CI) times to retinitis progression for the 5 mg/kg and 3 mg/kg groups were 115 days (70, not reached) and 49 days (35, 52), respectively. This difference was statistically significant. Similar to Study 106, the median time to retinitis progression for the 5 mg/kg group was difficult to precisely estimate due to the limited number of patients remaining on treatment over time (4 of the 49 patients in the 5 mg/kg group were treated for 115 days or longer). Median (95% CI) times to the alternative endpoint of retinitis progression or study drug discontinuation were 49 days (38, 63) and 35 days (27, 39) for the 5 mg/kg and 3 mg/kg groups, respectively. This difference was statistically significant.",
"Description": "The chemical name of cidofovir USP is 1-[(S)-3-hydroxy-2-(phosphonomethoxy)propyl]cytosine dihydrate (HPMPC), with the molecular formula of C8H14N3O6P2H2O and a molecular weight of 315.22 (279.19 for anhydrous). The chemical structure is. Cidofovir USP is a white crystalline powder with an aqueous solubility of ≥ 170 mg/mL at pH 6 to 8 and a log P (octanol/aqueous buffer, pH 7.1) value of -3.3. Cidofovir Injection, USP is a sterile, hypertonic aqueous solution for intravenous infusion only. The solution is clear and colorless. It is supplied in clear glass vials, each containing 375 mg of anhydrous cidofovir USP in 5 mL aqueous solution at a concentration of 75 mg/mL. The formulation is pH-adjusted to 7.4 (range 7.1 to 7.7) with sodium hydroxide and/or hydrochloric acid and contains no preservatives. The appropriate volume of Cidofovir Injection must be removed from the single-dose vial and diluted prior to administration (see DOSAGE AND ADMINISTRATION). MICROBIOLOGY. Mechanism of Action. Cidofovir suppresses cytomegalovirus (CMV) replication by selective inhibition of viral DNA synthesis. Biochemical data support selective inhibition of CMV DNA polymerase by cidofovir diphosphate, the active intracellular metabolite of cidofovir. Cidofovir diphosphate inhibits herpesvirus polymerases at concentrations that are 8- to 600-fold lower than those needed to inhibit human cellular DNA polymerases alpha, beta, and gamma1, 2, 3. Incorporation of cidofovir into the growing viral DNA chain results in reductions in the rate of viral DNA synthesis. In Vitro Susceptibility. Cidofovir is active in vitro against a variety of laboratory and clinical isolates of CMV and other herpesviruses (Table 1). Controlled clinical studies of efficacy have been limited to patients with AIDS and CMV retinitis. Table 1. Cidofovir Inhibition of Virus Multiplication in Cell Culture. Resistance. CMV isolates with reduced susceptibility to cidofovir have been selected in vitro in the presence of high concentrations of cidofovir4. IC50 values for selected resistant isolates ranged from 7 to 15 μM. There are insufficient data at this time to assess the frequency or the clinical significance of the development of resistant isolates following cidofovir injection administration to patients. The possibility of viral resistance should be considered for patients who show a poor clinical response or experience recurrent retinitis progression during therapy. Cross Resistance. Cidofovir-resistant isolates selected in vitro following exposure to increasing concentrations of cidofovir were assessed for susceptibility to ganciclovir and foscarnet4. All were cross resistant to ganciclovir, but remained susceptible to foscarnet. Ganciclovir or ganciclovir/foscarnet-resistant isolates that are cross resistant to cidofovir have been obtained from drug naive patients and from patients following ganciclovir or ganciclovir/ foscarnet therapy. To date, the majority of ganciclovir-resistant isolates are UL97 gene product (phosphokinase) mutants and remain susceptible to cidofovir5. Reduced susceptibility to cidofovir, however, has been reported for DNA polymerase mutants of CMV which are resistant to ganciclovir6–9. To date, all clinical isolates which exhibit high level resistance to ganciclovir, due to mutations in both the DNA polymerase and UL97 genes, have been shown to be cross resistant to cidofovir. Cidofovir is active against some, but not all, CMV isolates which are resistant to foscarnet10–12. The incidence of foscarnet-resistant isolates that are resistant to cidofovir is not known. A few triple-drug resistant isolates have been described. Genotypic analysis of two of these triple-resistant isolates revealed several point mutations in the CMV DNA polymerase gene. The clinical significance of the development of these cross-resistant isolates is not known."
},
{
"NDCCode": "37000-134-17",
"PackageDescription": "170 g in 1 CAN (37000-134-17) ",
"NDC11Code": "37000-0134-17",
"ProductNDC": "37000-134",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Secret Antiperspirant",
"ProprietaryNameSuffix": "Powder Fresh",
"NonProprietaryName": "Aluminum Chlorohydrate",
"DosageFormName": "AEROSOL, SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20070401",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M019",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "ALUMINUM CHLOROHYDRATE",
"StrengthNumber": ".24",
"StrengthUnit": "g/g",
"Status": "Active",
"LastUpdate": "2026-05-29",
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"IndicationAndUsage": "reduces underarm wetness."
},
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"PackageDescription": "296 mL in 1 BOTTLE, GLASS (49614-134-42) ",
"NDC11Code": "49614-0134-42",
"ProductNDC": "49614-134",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Magnesium Citrate",
"NonProprietaryName": "Magnesium Citrate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19890621",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Medicine Shoppe International",
"SubstanceName": "MAGNESIUM CITRATE",
"StrengthNumber": "1.745",
"StrengthUnit": "g/29.6mL",
"Status": "Deprecated",
"LastUpdate": "2021-03-27",
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"NDCCode": "51316-134-13",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (51316-134-13) / 9 TABLET, CHEWABLE in 1 BLISTER PACK",
"NDC11Code": "51316-0134-13",
"ProductNDC": "51316-134",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Extra Strength Gas Relief Cherry Creme",
"NonProprietaryName": "Simethicone",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20250106",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M002",
"LabelerName": "CVS",
"SubstanceName": "DIMETHICONE",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Active",
"LastUpdate": "2025-01-29",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20250121",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: : 1 Pressure, 2 bloating, 3 Symptoms referred to as gas."
},
{
"NDCCode": "58103-134-10",
"PackageDescription": "100 kg in 1 DRUM (58103-134-10) ",
"NDC11Code": "58103-0134-10",
"ProductNDC": "58103-134",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20200129",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "SPI Pharma Inc",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "58",
"StrengthUnit": "kg/100kg",
"Status": "Unfinished",
"LastUpdate": "2025-01-15",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "29-JAN-20"
},
{
"NDCCode": "67457-134-50",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (67457-134-50) > 50 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "67457-0134-50",
"ProductNDC": "67457-134",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Magnesium Chloride",
"NonProprietaryName": "Magnesium Chloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20130314",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "MAGNESIUM CHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2021-10-29",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20130314",
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"IndicationAndUsage": "As an electrolyte replenisher in magnesium deficiencies.",
"Description": "Magnesium Chloride Injection is a sterile solution of Magnesium Chloride Hexahydrate in Water for Injection q.s. Each mL contains Magnesium Chloride Hexahydrate 200 mg, Sodium Chloride 9 mg, Benzyl Alcohol 1% as a preservative, Water for Injection, q.s. pH adjusted with Hydrochloric Acid and/or Sodium Hydroxide. Total osmolarity equivalent to 2.951 mOsm/mL. Contains 1.97 mEq of Mg++ and Cl- per mL. The structural formula is MgCl26H2O."
},
{
"NDCCode": "69367-134-06",
"PackageDescription": "500 TABLET in 1 BOTTLE (69367-134-06) ",
"NDC11Code": "69367-0134-06",
"ProductNDC": "69367-134",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160411",
"EndMarketingDate": "20260201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205101",
"LabelerName": "Westminster Pharmaceuticals, LLC",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
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"EndMarketingDatePackage": "20260201",
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"IndicationAndUsage": "Gabapentin is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in gabapentin capsules and tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 4.72±0.10 and a pKa2 of 10.27±0.29. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient is -1.083±0.235 at 25°C temperature. Each gabapentin capsule contains 100 mg, 300 mg or 400 mg of gabapentin, USP and the following inactive ingredients: pregelatinized starch (maize), and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate (SLS) and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide, FD&C Red 40, D&C Yellow 10, and sodium lauryl sulfate (SLS). The 400mg capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate (SLS), D&C Yellow 10, and FD&C Red 40. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide. Each gabapentin tablet contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: poloxamer 407, mannitol, magnesium stearate, hydroxypropyl cellulose, talc, copovidone, crospovidone, colloidal silicon dioxide and coating agent contains hypromellose, titanium dioxide, polyethylene glycol and talc."
},
{
"NDCCode": "71093-134-04",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (71093-134-04) ",
"NDC11Code": "71093-0134-04",
"ProductNDC": "71093-134",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203769",
"LabelerName": "ACI Healthcare USA, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2020-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180115",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin Hydrochloride Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.",
"Description": "Metformin Hydrochloride Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene hydrochloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin Hydrochloride Tablets contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients pregelatinized starch (maize), povidone, crospovidone, magnesium stearate. In addition, the coating for the tablets contains Hypromellose, polyethylene glycol, titanium dioxide and flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol and silicon dioxide."
},
{
"NDCCode": "71093-134-05",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (71093-134-05) ",
"NDC11Code": "71093-0134-05",
"ProductNDC": "71093-134",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203769",
"LabelerName": "ACI Healthcare USA, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2020-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180115",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin Hydrochloride Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.",
"Description": "Metformin Hydrochloride Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene hydrochloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin Hydrochloride Tablets contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients pregelatinized starch (maize), povidone, crospovidone, magnesium stearate. In addition, the coating for the tablets contains Hypromellose, polyethylene glycol, titanium dioxide and flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol and silicon dioxide."
},
{
"NDCCode": "72570-134-09",
"PackageDescription": "1 TUBE in 1 CARTON (72570-134-09) > 256 g in 1 TUBE",
"NDC11Code": "72570-0134-09",
"ProductNDC": "72570-134",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Diaperene Adult",
"NonProprietaryName": "Menthol, Zinc Oxide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210701",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part346",
"LabelerName": "Delsam Pharma Llc",
"SubstanceName": "MENTHOL, UNSPECIFIED FORM; ZINC OXIDE",
"StrengthNumber": "4.4; 206",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2021-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210906",
"SamplePackage": "N"
},
{
"NDCCode": "72570-134-16",
"PackageDescription": "454 g in 1 CONTAINER (72570-134-16) ",
"NDC11Code": "72570-0134-16",
"ProductNDC": "72570-134",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Diaperene Adult",
"NonProprietaryName": "Menthol, Zinc Oxide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210701",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part346",
"LabelerName": "Delsam Pharma Llc",
"SubstanceName": "MENTHOL, UNSPECIFIED FORM; ZINC OXIDE",
"StrengthNumber": "4.4; 206",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2021-09-29",
"PackageNdcExcludeFlag": "N",
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<NDCList>
<NDC>
<NDCCode>42571-134-29</NDCCode>
<PackageDescription>60 BLISTER PACK in 1 CARTON (42571-134-29) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>42571-0134-29</NDC11Code>
<ProductNDC>42571-134</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium/misoprostol</ProprietaryName>
<ProprietaryNameSuffix>Diclofenac-sodium-misoprostol</ProprietaryNameSuffix>
<NonProprietaryName>Diclofenac Sodium/misoprostol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204355</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>DICLOFENAC SODIUM; MISOPROSTOL</SubstanceName>
<StrengthNumber>75; 200</StrengthNumber>
<StrengthUnit>mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-30</LastUpdate>
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<IndicationAndUsage>Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions ( 5.3)] .</IndicationAndUsage>
<Description>Diclofenac sodium and misoprostol delayed-release tablets, USP is a combination product containing diclofenac sodium, an NSAID with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin-1 (PGE1) analog. Diclofenac sodium and misoprostol delayed-release tablets are white to off-white, round, biconvex, and approximately 11 mm in diameter. Each tablet consists of an enteric-coated core containing 50 mg (diclofenac sodium and misoprostol delayed-release tablets 50 mg/200 mcg) or 75 mg (diclofenac sodium and misoprostol delayed-release tablets 75 mg/200 mcg) of diclofenac sodium (equivalent to 46.39 mg or 69.58 mg of diclofenac, respectively) surrounded by an outer mantle containing 200 mcg misoprostol. Diclofenac sodium, USP is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium, USP is freely soluble in methanol, soluble in ethanol, and practically insoluble in chloroform and in dilute acid. Diclofenac sodium, USP is sparingly soluble in water. Its chemical formula and name are. C 14H 10Cl 2NO 2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt. Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are. C 22H 38O 5[M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate. Inactive ingredients in diclofenac sodium and misoprostol delayed-release tablets include: colloidal silicon dioxide; corn starch; crospovidone; hydrogenated castor oil; hypromellose; lactose monohydrate; magnesium stearate; methacrylic acid copolymer; microcrystalline cellulose; povidone; sodium hydroxide; talc; triethyl citrate. FDA approved dissolution test specifications differ from USP.</Description>
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<NDCCode>42571-134-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (42571-134-30) </PackageDescription>
<NDC11Code>42571-0134-30</NDC11Code>
<ProductNDC>42571-134</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium/misoprostol</ProprietaryName>
<ProprietaryNameSuffix>Diclofenac-sodium-misoprostol</ProprietaryNameSuffix>
<NonProprietaryName>Diclofenac Sodium/misoprostol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204355</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>DICLOFENAC SODIUM; MISOPROSTOL</SubstanceName>
<StrengthNumber>75; 200</StrengthNumber>
<StrengthUnit>mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions ( 5.3)] .</IndicationAndUsage>
<Description>Diclofenac sodium and misoprostol delayed-release tablets, USP is a combination product containing diclofenac sodium, an NSAID with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin-1 (PGE1) analog. Diclofenac sodium and misoprostol delayed-release tablets are white to off-white, round, biconvex, and approximately 11 mm in diameter. Each tablet consists of an enteric-coated core containing 50 mg (diclofenac sodium and misoprostol delayed-release tablets 50 mg/200 mcg) or 75 mg (diclofenac sodium and misoprostol delayed-release tablets 75 mg/200 mcg) of diclofenac sodium (equivalent to 46.39 mg or 69.58 mg of diclofenac, respectively) surrounded by an outer mantle containing 200 mcg misoprostol. Diclofenac sodium, USP is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium, USP is freely soluble in methanol, soluble in ethanol, and practically insoluble in chloroform and in dilute acid. Diclofenac sodium, USP is sparingly soluble in water. Its chemical formula and name are. C 14H 10Cl 2NO 2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt. Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are. C 22H 38O 5[M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate. Inactive ingredients in diclofenac sodium and misoprostol delayed-release tablets include: colloidal silicon dioxide; corn starch; crospovidone; hydrogenated castor oil; hypromellose; lactose monohydrate; magnesium stearate; methacrylic acid copolymer; microcrystalline cellulose; povidone; sodium hydroxide; talc; triethyl citrate. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>42571-134-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (42571-134-60) </PackageDescription>
<NDC11Code>42571-0134-60</NDC11Code>
<ProductNDC>42571-134</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium/misoprostol</ProprietaryName>
<ProprietaryNameSuffix>Diclofenac-sodium-misoprostol</ProprietaryNameSuffix>
<NonProprietaryName>Diclofenac Sodium/misoprostol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204355</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>DICLOFENAC SODIUM; MISOPROSTOL</SubstanceName>
<StrengthNumber>75; 200</StrengthNumber>
<StrengthUnit>mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions ( 5.3)] .</IndicationAndUsage>
<Description>Diclofenac sodium and misoprostol delayed-release tablets, USP is a combination product containing diclofenac sodium, an NSAID with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin-1 (PGE1) analog. Diclofenac sodium and misoprostol delayed-release tablets are white to off-white, round, biconvex, and approximately 11 mm in diameter. Each tablet consists of an enteric-coated core containing 50 mg (diclofenac sodium and misoprostol delayed-release tablets 50 mg/200 mcg) or 75 mg (diclofenac sodium and misoprostol delayed-release tablets 75 mg/200 mcg) of diclofenac sodium (equivalent to 46.39 mg or 69.58 mg of diclofenac, respectively) surrounded by an outer mantle containing 200 mcg misoprostol. Diclofenac sodium, USP is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium, USP is freely soluble in methanol, soluble in ethanol, and practically insoluble in chloroform and in dilute acid. Diclofenac sodium, USP is sparingly soluble in water. Its chemical formula and name are. C 14H 10Cl 2NO 2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt. Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are. C 22H 38O 5[M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate. Inactive ingredients in diclofenac sodium and misoprostol delayed-release tablets include: colloidal silicon dioxide; corn starch; crospovidone; hydrogenated castor oil; hypromellose; lactose monohydrate; magnesium stearate; methacrylic acid copolymer; microcrystalline cellulose; povidone; sodium hydroxide; talc; triethyl citrate. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>42571-134-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (42571-134-90) </PackageDescription>
<NDC11Code>42571-0134-90</NDC11Code>
<ProductNDC>42571-134</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium/misoprostol</ProprietaryName>
<ProprietaryNameSuffix>Diclofenac-sodium-misoprostol</ProprietaryNameSuffix>
<NonProprietaryName>Diclofenac Sodium/misoprostol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204355</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>DICLOFENAC SODIUM; MISOPROSTOL</SubstanceName>
<StrengthNumber>75; 200</StrengthNumber>
<StrengthUnit>mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions ( 5.3)] .</IndicationAndUsage>
<Description>Diclofenac sodium and misoprostol delayed-release tablets, USP is a combination product containing diclofenac sodium, an NSAID with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin-1 (PGE1) analog. Diclofenac sodium and misoprostol delayed-release tablets are white to off-white, round, biconvex, and approximately 11 mm in diameter. Each tablet consists of an enteric-coated core containing 50 mg (diclofenac sodium and misoprostol delayed-release tablets 50 mg/200 mcg) or 75 mg (diclofenac sodium and misoprostol delayed-release tablets 75 mg/200 mcg) of diclofenac sodium (equivalent to 46.39 mg or 69.58 mg of diclofenac, respectively) surrounded by an outer mantle containing 200 mcg misoprostol. Diclofenac sodium, USP is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium, USP is freely soluble in methanol, soluble in ethanol, and practically insoluble in chloroform and in dilute acid. Diclofenac sodium, USP is sparingly soluble in water. Its chemical formula and name are. C 14H 10Cl 2NO 2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt. Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are. C 22H 38O 5[M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate. Inactive ingredients in diclofenac sodium and misoprostol delayed-release tablets include: colloidal silicon dioxide; corn starch; crospovidone; hydrogenated castor oil; hypromellose; lactose monohydrate; magnesium stearate; methacrylic acid copolymer; microcrystalline cellulose; povidone; sodium hydroxide; talc; triethyl citrate. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>42571-131-29</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (42571-131-29) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>42571-0131-29</NDC11Code>
<ProductNDC>42571-131</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nevirapine</ProprietaryName>
<NonProprietaryName>Nevirapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120522</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203080</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>NEVIRAPINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nevirapine tablet is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 15 days and older [see Clinical Studies (14.1, 14.2)] . Limitations of Use. Based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine tablet is not recommended to be initiated, unless the benefit outweighs the risk, in: 1 adult females with CD4 +cell counts greater than 250 cells/mm 3or , 2 adult males with CD4 +cell counts greater than 400 cells/mm 3[see Warnings and Precautions (5.1)] . .</IndicationAndUsage>
<Description>Nevirapine tablets USP, 200 mg is the brand name for nevirapine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) with activity against Human Immunodeficiency Virus Type 1 (HIV-1). Nevirapine USP is structurally a member of the dipyridodiazepinone chemical class of compounds. The chemical name of nevirapine is 11-cyclopropyl-5, 11-dihydro-4-methyl-6H-dipyrido [3,2-b:2',3'-e][1,4] diazepin-6-one. Nevirapine USP is a white to off-white crystalline powder with the molecular weight of 266.30 and the molecular formula C 15H 14N 4O. Nevirapine has the following structural formula:. Nevirapine tablets USP, 200 mg is for oral administration. Each tablet contains 200 mg of nevirapine anhydrous and the inactive ingredients microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, magnesium stearate, povidone, and Sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>42571-133-29</NDCCode>
<PackageDescription>60 BLISTER PACK in 1 CARTON (42571-133-29) / 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>42571-0133-29</NDC11Code>
<ProductNDC>42571-133</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium/misoprostol</ProprietaryName>
<ProprietaryNameSuffix>Diclofenac-sodium-misoprostol</ProprietaryNameSuffix>
<NonProprietaryName>Diclofenac Sodium/misoprostol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204355</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>DICLOFENAC SODIUM; MISOPROSTOL</SubstanceName>
<StrengthNumber>50; 200</StrengthNumber>
<StrengthUnit>mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions ( 5.3)] .</IndicationAndUsage>
<Description>Diclofenac sodium and misoprostol delayed-release tablets, USP is a combination product containing diclofenac sodium, an NSAID with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin-1 (PGE1) analog. Diclofenac sodium and misoprostol delayed-release tablets are white to off-white, round, biconvex, and approximately 11 mm in diameter. Each tablet consists of an enteric-coated core containing 50 mg (diclofenac sodium and misoprostol delayed-release tablets 50 mg/200 mcg) or 75 mg (diclofenac sodium and misoprostol delayed-release tablets 75 mg/200 mcg) of diclofenac sodium (equivalent to 46.39 mg or 69.58 mg of diclofenac, respectively) surrounded by an outer mantle containing 200 mcg misoprostol. Diclofenac sodium, USP is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium, USP is freely soluble in methanol, soluble in ethanol, and practically insoluble in chloroform and in dilute acid. Diclofenac sodium, USP is sparingly soluble in water. Its chemical formula and name are. C 14H 10Cl 2NO 2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt. Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are. C 22H 38O 5[M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate. Inactive ingredients in diclofenac sodium and misoprostol delayed-release tablets include: colloidal silicon dioxide; corn starch; crospovidone; hydrogenated castor oil; hypromellose; lactose monohydrate; magnesium stearate; methacrylic acid copolymer; microcrystalline cellulose; povidone; sodium hydroxide; talc; triethyl citrate. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>42571-144-29</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (42571-144-29) / 10 CAPSULE in 1 BLISTER PACK (42571-144-32) </PackageDescription>
<NDC11Code>42571-0144-29</NDC11Code>
<ProductNDC>42571-144</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204776</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib is indicated.</IndicationAndUsage>
<Description>Celecoxib capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib for oral administration. The chemical name is 4-[5-(4-methylphenyl)- 3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C 17H 14F 3N 3O 2S, and it has the following chemical structure:. Celecoxib USP is a white or almost white crystalline powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib USP is hydrophobic (log P is 3.5) and is soluble in ethanol and in methylene chloride, practically insoluble in water. The inactive ingredients in celecoxib capsules include: croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate. The empty hard gelatin capsule shell contains gelatin and titanium dioxide. The capsules are printed with ink containing black iron oxide, potassium hydroxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>42571-166-29</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (42571-166-29) > 10 TABLET, FILM COATED in 1 BLISTER PACK (42571-166-32) </PackageDescription>
<NDC11Code>42571-0166-29</NDC11Code>
<ProductNDC>42571-166</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamivudine, Nevirapine, And Zidovudine</ProprietaryName>
<NonProprietaryName>Lamivudine, Nevirapine, And Zidovudine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180903</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205626</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE</SubstanceName>
<StrengthNumber>150; 200; 300</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Non-Nucleoside Analog [EXT],Non-Nucleoside Reverse Transcriptase Inhibitors [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180903</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42571-508-29</NDCCode>
<PackageDescription>60 POUCH in 1 CARTON (42571-508-29) / 9 g in 1 POUCH (42571-508-04) </PackageDescription>
<NDC11Code>42571-0508-29</NDC11Code>
<ProductNDC>42571-508</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cholestyramine</ProprietaryName>
<NonProprietaryName>Cholestyramine</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219318</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>CHOLESTYRAMINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>g/9g</StrengthUnit>
<Pharm_Classes>Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1) Cholestyramine for oral suspension is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. Cholestyramine for oral suspension may be useful to lower LDL cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy specific for the type of hyperlipoproteinemia determined prior to initiation of drug therapy. Excess body weight may be an important factor and caloric restriction for weight normalization should be addressed prior to drug therapy in the overweight. Prior to initiating therapy with cholestyramine resin, secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism), should be excluded, and a lipid profile performed to assess Total cholesterol, HDL-C, and triglycerides (TG). For individuals with TG less than 400 mg/dL (<4.5 mmol/L), LDL-C can be estimated using the following equation:-. LDL-C = Total cholesterol - [(TG/5) + HDL-C]. For TG levels > 400 mg/dL, this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated Total-C. In such cases cholestyramine resin may not be indicated. Serum cholesterol and triglyceride levels should be determined periodically based on NCEP guidelines to confirm initial and adequate long-term response. A favorable trend in cholesterol reduction should occur during the first month of cholestyramine resin therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of cholestyramine resin or adding other lipid-lowering agents in combination with cholestyramine resin should be considered. Since the goal of treatment is to lower LDL-C, the NCEP 4recommends that LDL-C levels be used to initiate and assess treatment response. If LDL-C levels are not available then Total-C alone may be used to monitor long-term therapy. A lipoprotein analysis (including LDL-C determination) should be carried out once a year. The NCEP treatment guidelines are summarized below. *Coronary heart disease or peripheral vascular disease (including symptomatic carotid artery disease). **Other risk factors for coronary heart disease (CHD) include: age (males: ≥ 45 years; females: ≥ 55 years or premature menopause without estrogen replacement therapy); family history of premature CHD; current cigarette smoking; hypertension; confirmed HDL-C <35 mg/dL (<0.91 mmol/L); and diabetes mellitus. Subtract one risk factor if HDL-C is ≥ 60 mg/dL (≥ 1.6 mmol/L). Cholestyramine resin monotherapy has been demonstrated to retard the rate of progression 2,3and increase the rate of regression 3of coronary atherosclerosis. 2) Cholestyramine for oral suspension is indicated for the relief of pruritus associated with partial biliary obstruction. Cholestyramine resin has been shown to have a variable effect on serum cholesterol in these patients. Patients with primary biliary cirrhosis may exhibit an elevated cholesterol as part of their disease.</IndicationAndUsage>
<Description>Cholestyramine for oral suspension USP, the chloride salt of a basic anion exchange resin, a cholesterol lowering agent, is intended for oral administration. Cholestyramine resin, USP is quite hydrophilic, but insoluble in water. The cholestyramine resin in cholestyramine for oral suspension, USP is not absorbed from the digestive tract. Four grams of anhydrous cholestyramine resin, USP is contained in 9 grams of cholestyramine for oral suspension, USP. It is represented by the following structural formula. Representation of structure of main polymeric groups. Cholestyramine for oral suspension, USP contains the following inactive ingredients: anhydrous citric acid, D&C yellow No. 10, FD&C yellow No. 6, natural and artificial orange flavor, fructose, propylene glycol alginate, sorbitol, sucrose and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>50563-134-01</NDCCode>
<PackageDescription>29 mL in 1 BOTTLE (50563-134-01)</PackageDescription>
<NDC11Code>50563-0134-01</NDC11Code>
<ProductNDC>50563-134</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rue21 Cotton Candy Antibacterial Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130709</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>ENCHANTE ACCESSORIES INC.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>63</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses. To decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54860-134-01</NDCCode>
<PackageDescription>29 mL in 1 BOTTLE, PLASTIC (54860-134-01) </PackageDescription>
<NDC11Code>54860-0134-01</NDC11Code>
<ProductNDC>54860-134</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Berry Kissed Hand Sanitizer</ProprietaryName>
<ProprietaryNameSuffix>01</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191105</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Shenzhen Lantern Cosmetic Co Ltd</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>65</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70692-134-29</NDCCode>
<PackageDescription>3 TABLET in 1 BLISTER PACK (70692-134-29) </PackageDescription>
<NDC11Code>70692-0134-29</NDC11Code>
<ProductNDC>70692-134</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fexofenadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Fexofenadine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211075</ApplicationNumber>
<LabelerName>Strive Pharmaceuticals Inc</LabelerName>
<SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190722</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72888-134-29</NDCCode>
<PackageDescription>10 TABLET, ORALLY DISINTEGRATING in 1 CARTON (72888-134-29) </PackageDescription>
<NDC11Code>72888-0134-29</NDC11Code>
<ProductNDC>72888-134</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonazepam</ProprietaryName>
<NonProprietaryName>Clonazepam</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260521</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216988</ApplicationNumber>
<LabelerName>Advagen Pharma Ltd</LabelerName>
<SubstanceName>CLONAZEPAM</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260521</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Seizure Disorders. Clonazepam orally disintegrating tablet is useful alone or as an adjunct in the treatment of the Lennox- Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam orally disintegrating tablets may be useful. In some studies, up to 30% of patients have shown a loss of anticonvulsant activity, often within 3 months of administration. In some cases, dosage adjustment may reestablish efficacy. Panic Disorder. Clonazepam orally disintegrating tablet is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-V. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of clonazepam orally disintegrating tablets was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-lIlR category of panic disorder (see CLINICAL PHARMACOLOGY:Clinical Trials). Panic disorder (DSM-V) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The effectiveness of clonazepam orally disintegrating tablets in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use clonazepam orally disintegrating tablets for extended periods should periodically reevaluate the long- term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Clonazepam, USP a benzodiazepine, is available as an orally disintegrating tablet containing 0.125 mg, 0.25 mg, 0.5 mg, 1 mg or 2 mg clonazepam, USP. Each orally disintegrating tablet also contains aspartame, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, sorbitol, sodium lauryl sulfate, and talc. Chemically, clonazepam is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>75660-134-44</NDCCode>
<PackageDescription>118.29 mL in 1 BOTTLE, PLASTIC (75660-134-44) </PackageDescription>
<NDC11Code>75660-0134-44</NDC11Code>
<ProductNDC>75660-134</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Clean All Gel Hand Sanitizer Fresh Linen</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201014</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Solvents and Petroleum Inc</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>65</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201014</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to reduce bacteria on hands. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76891-134-11</NDCCode>
<PackageDescription>29 mL in 1 BOTTLE (76891-134-11) </PackageDescription>
<NDC11Code>76891-0134-11</NDC11Code>
<ProductNDC>76891-134</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<ProprietaryNameSuffix>All Variants</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221111</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>SCENT THEORY PRODUCTS LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FOR HANDWASHING TO DECREASE BACTERIA ON THE SKIN.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42571-258-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (42571-258-01) </PackageDescription>
<NDC11Code>42571-0258-01</NDC11Code>
<ProductNDC>42571-258</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mefenamic Acid</ProprietaryName>
<NonProprietaryName>Mefenamic Acid</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090562</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>MEFENAMIC ACID</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mefenamic acid capsules are a nonsteroidal anti-inflammatory drug indicated for: 1 For management of mild to moderate pain in patient 14 years of age and older, when therapy will not exceed one week (7 days). ( 1.1) , 2 For treatment of primary dysmenorrhea. ( 1.2) .</IndicationAndUsage>
<Description>Mefenamic acid capsules, USP contains active moiety mefenamic acid, USP which is a member of the fenamate group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name of mefenamic acid, USP is N-2,3-xylylanthranilic acid. The molecular weight is 241.29 g/mol. Its molecular formula is C 15H 15N0 2and the structural formula of mefenamic acid is:. Mefenamic acid, USP is a white to greyish-white, odorless, microcrystalline powder with a melting point of 230° to 231°C and water solubility of 0.004% at pH 7.1. Mefenamic acid capsule, USP is for oral administration. Each capsule contains 250 mg of mefenamic acid, USP and lactose monohydrate. The capsule shell contains D&C yellow No. 10; FD&C blue No. 1; FD&C red No. 3; FD&C yellow No. 6; gelatin, sodium lauryl sulfate, titanium dioxide, black iron oxide, propylene glycol & shellac.</Description>
</NDC>
<NDC>
<NDCCode>42571-258-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (42571-258-30) </PackageDescription>
<NDC11Code>42571-0258-30</NDC11Code>
<ProductNDC>42571-258</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mefenamic Acid</ProprietaryName>
<NonProprietaryName>Mefenamic Acid</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101119</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090562</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>MEFENAMIC ACID</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mefenamic acid capsules are a nonsteroidal anti-inflammatory drug indicated for: 1 For management of mild to moderate pain in patient 14 years of age and older, when therapy will not exceed one week (7 days). ( 1.1) , 2 For treatment of primary dysmenorrhea. ( 1.2) .</IndicationAndUsage>
<Description>Mefenamic acid capsules, USP contains active moiety mefenamic acid, USP which is a member of the fenamate group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name of mefenamic acid, USP is N-2,3-xylylanthranilic acid. The molecular weight is 241.29 g/mol. Its molecular formula is C 15H 15N0 2and the structural formula of mefenamic acid is:. Mefenamic acid, USP is a white to greyish-white, odorless, microcrystalline powder with a melting point of 230° to 231°C and water solubility of 0.004% at pH 7.1. Mefenamic acid capsule, USP is for oral administration. Each capsule contains 250 mg of mefenamic acid, USP and lactose monohydrate. The capsule shell contains D&C yellow No. 10; FD&C blue No. 1; FD&C red No. 3; FD&C yellow No. 6; gelatin, sodium lauryl sulfate, titanium dioxide, black iron oxide, propylene glycol & shellac.</Description>
</NDC>
<NDC>
<NDCCode>42571-370-99</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (42571-370-99) / 5 mL in 1 VIAL (42571-370-92) </PackageDescription>
<NDC11Code>42571-0370-99</NDC11Code>
<ProductNDC>42571-370</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Brivaracetam</ProprietaryName>
<NonProprietaryName>Brivaracetam</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214880</ApplicationNumber>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>BRIVARACETAM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Epoxide Hydrolase Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Brivaracetam injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.</IndicationAndUsage>
<Description>The chemical name of brivaracetam is (2S)-2-[(4R)-2-oxo-4-propyltetrahydro-1 H-pyrrol-1-yl] butanamide. Its molecular formula is C 11H 20N 2O 2and its molecular weight is 212.29. The chemical structure is:. Brivaracetam is a white to off-white crystalline powder. It is very soluble in water, buffer (pH 1.2, 4.5, and 7.4), ethanol, methanol, and glacial acetic acid. It is freely soluble in acetonitrile and acetone and soluble in toluene. It is very slightly soluble in n-hexane. Injection. Brivaracetam injection is a clear, colorless liquid provided as a sterile, preservative-free solution. Brivaracetam injection contains 10 mg brivaracetam per mL for intravenous administration. One vial contains 50 mg of brivaracetam drug substance. It contains the following inactive ingredients: sodium acetate trihydrate (2.7 mg/mL), glacial acetic acid (for pH adjustment to 5.5), sodium chloride (9 mg/mL), and water for injection.</Description>
</NDC>
<NDC>
<NDCCode>11523-7061-2</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE, PLASTIC (11523-7061-2)</PackageDescription>
<NDC11Code>11523-7061-02</NDC11Code>
<ProductNDC>11523-7061</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Coppertone Oil Free</ProprietaryName>
<ProprietaryNameSuffix>Spf 30</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19990521</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>MSD Consumer Care, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>20.7; 134.55; 51.75; 20.7; 41.4</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-03-29</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>23155-216-31</NDCCode>
<PackageDescription>5 mL in 1 VIAL, GLASS (23155-216-31) </PackageDescription>
<NDC11Code>23155-0216-31</NDC11Code>
<ProductNDC>23155-216</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cidofovir Dihydrate</ProprietaryName>
<NonProprietaryName>Cidofovir Dihydrate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20120806</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202501</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CIDOFOVIR</SubstanceName>
<StrengthNumber>375</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], DNA Polymerase Inhibitors [MoA], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120806</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cidofovir injection is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). THE SAFETY AND EFFICACY OF CIDOFOVIR INJECTION HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER CMV INFECTIONS (SUCH AS PNEUMONITIS OR GASTROENTERITIS), CONGENITAL OR NEONATAL CMV DISEASE, OR CMV DISEASE IN NON-HIV-INFECTED INDIVIDUALS. DESCRIPTION OF CLINICAL TRIALS. Three phase II/III controlled trials of cidofovir injection have been conducted in HIV-infected patients with CMV retinitis. Delayed Versus Immediate Therapy (Study 105). In stage 1 of this open-label trial, conducted by the Studies of the Ocular Complications of AIDS (SOCA) Clinical Research Group, 29 previously untreated patients with peripheral CMV retinitis were randomized to either immediate treatment with cidofovir injection (5 mg/kg once a week for 2 weeks, then 3 mg/kg every other week) or to have cidofovir injection delayed until progression of CMV retinitis13. In stage 2 of this trial, an additional 35 previously untreated patients with peripheral CMV retinitis were randomized to either immediate treatment with cidofovir injection (5 mg/kg once a week for 2 weeks, then 5 mg/kg every other week), immediate treatment with cidofovir injection (5 mg/kg once a week for 2 weeks, then 3 mg/kg every other week), or to have cidofovir injection delayed until progression of CMV retinitis. Of the 64 patients in this study, 12 were randomized to 5 mg/kg maintenance therapy, 26 to 3 mg/kg maintenance therapy, and 26 to delayed therapy. Of the 12 patients enrolled in the 5 mg/kg maintenance group, 5 patients progressed, 5 patients discontinued therapy and 2 patients had no progression at study completion. Based on masked readings of retinal photographs, the median [95% confidence interval (CI)] time to retinitis progression was not reached (25, not reached) for the 5 mg/kg maintenance group. Median (95% CI) time to the alternative endpoint of retinitis progression or study drug discontinuation was 44 days (24, 207) for the 5 mg/kg maintenance group. Patients receiving 5 mg/kg maintenance had delayed time to retinitis progression compared to patients receiving 3 mg/kg maintenance or deferred therapy. Delayed Versus Immediate Therapy (Study 106). In an open-label trial, 48 previously untreated patients with peripheral CMV retinitis were randomized to either immediate treatment with cidofovir injection (5 mg/kg once a week for 2 weeks, then 5 mg/kg every other week), or to have cidofovir injection delayed until progression of CMV retinitis14. Patient baseline characteristics and disposition are shown in Table 3. Of 25 and 23 patients in the immediate and delayed groups respectively, 23 and 21 were evaluable for retinitis progression as determined by retinal photography. Based on masked readings of retinal photographs, the median [95% confidence interval (CI)] times to retinitis progression were 120 days (40, 134) and 22 days (10, 27) for the immediate and delayed therapy groups, respectively. This difference was statistically significant. However, because of the limited number of patients remaining on treatment over time (3 of 25 patients received cidofovir injection for 120 days or longer), the median time to progression for the immediate therapy group was difficult to precisely estimate. Median (95% CI) times to the alternative endpoint of retinitis progression or study drug discontinuation (including adverse events, withdrawn consent, and systemic CMV disease) were 52 days (37, 85) and 22 days (13, 27) for the immediate and delayed therapy groups, respectively. This difference was statistically significant. Time to progression estimates from this study may not be directly comparable to estimates reported for other therapies. Dose-response study of cidofovir injection (Study 107). In an open-label trial, 100 patients with relapsing CMV retinitis were randomized to receive 5 mg/kg once a week for 2 weeks and then either 5 mg/kg (n = 49) or 3 mg/kg (n = 51) every other week. Enrolled patients had been diagnosed with CMV retinitis an average of 390 days prior to randomization and had received a median of 3.8 prior courses of systemic CMV therapy. Eighty four of the 100 patients were considered evaluable for progression by serial retinal photographs (43 randomized to 5 mg/kg and 41 randomized to 3 mg/kg). Twenty-six and 21 patients discontinued therapy due to either an adverse event, intercurrent illness, excluded medication, or withdrawn consent in the 5 mg/kg and 3 mg/kg groups, respectively. Thirty-eight of the 100 randomized patients had progressed according to masked assessment of serial retinal photographs (13 randomized to 5 mg/kg and 25 randomized to 3 mg/kg). Using retinal photographs, the median (95% CI) times to retinitis progression for the 5 mg/kg and 3 mg/kg groups were 115 days (70, not reached) and 49 days (35, 52), respectively. This difference was statistically significant. Similar to Study 106, the median time to retinitis progression for the 5 mg/kg group was difficult to precisely estimate due to the limited number of patients remaining on treatment over time (4 of the 49 patients in the 5 mg/kg group were treated for 115 days or longer). Median (95% CI) times to the alternative endpoint of retinitis progression or study drug discontinuation were 49 days (38, 63) and 35 days (27, 39) for the 5 mg/kg and 3 mg/kg groups, respectively. This difference was statistically significant.</IndicationAndUsage>
<Description>The chemical name of cidofovir USP is 1-[(S)-3-hydroxy-2-(phosphonomethoxy)propyl]cytosine dihydrate (HPMPC), with the molecular formula of C8H14N3O6P2H2O and a molecular weight of 315.22 (279.19 for anhydrous). The chemical structure is. Cidofovir USP is a white crystalline powder with an aqueous solubility of ≥ 170 mg/mL at pH 6 to 8 and a log P (octanol/aqueous buffer, pH 7.1) value of -3.3. Cidofovir Injection, USP is a sterile, hypertonic aqueous solution for intravenous infusion only. The solution is clear and colorless. It is supplied in clear glass vials, each containing 375 mg of anhydrous cidofovir USP in 5 mL aqueous solution at a concentration of 75 mg/mL. The formulation is pH-adjusted to 7.4 (range 7.1 to 7.7) with sodium hydroxide and/or hydrochloric acid and contains no preservatives. The appropriate volume of Cidofovir Injection must be removed from the single-dose vial and diluted prior to administration (see DOSAGE AND ADMINISTRATION). MICROBIOLOGY. Mechanism of Action. Cidofovir suppresses cytomegalovirus (CMV) replication by selective inhibition of viral DNA synthesis. Biochemical data support selective inhibition of CMV DNA polymerase by cidofovir diphosphate, the active intracellular metabolite of cidofovir. Cidofovir diphosphate inhibits herpesvirus polymerases at concentrations that are 8- to 600-fold lower than those needed to inhibit human cellular DNA polymerases alpha, beta, and gamma1, 2, 3. Incorporation of cidofovir into the growing viral DNA chain results in reductions in the rate of viral DNA synthesis. In Vitro Susceptibility. Cidofovir is active in vitro against a variety of laboratory and clinical isolates of CMV and other herpesviruses (Table 1). Controlled clinical studies of efficacy have been limited to patients with AIDS and CMV retinitis. Table 1. Cidofovir Inhibition of Virus Multiplication in Cell Culture. Resistance. CMV isolates with reduced susceptibility to cidofovir have been selected in vitro in the presence of high concentrations of cidofovir4. IC50 values for selected resistant isolates ranged from 7 to 15 μM. There are insufficient data at this time to assess the frequency or the clinical significance of the development of resistant isolates following cidofovir injection administration to patients. The possibility of viral resistance should be considered for patients who show a poor clinical response or experience recurrent retinitis progression during therapy. Cross Resistance. Cidofovir-resistant isolates selected in vitro following exposure to increasing concentrations of cidofovir were assessed for susceptibility to ganciclovir and foscarnet4. All were cross resistant to ganciclovir, but remained susceptible to foscarnet. Ganciclovir or ganciclovir/foscarnet-resistant isolates that are cross resistant to cidofovir have been obtained from drug naive patients and from patients following ganciclovir or ganciclovir/ foscarnet therapy. To date, the majority of ganciclovir-resistant isolates are UL97 gene product (phosphokinase) mutants and remain susceptible to cidofovir5. Reduced susceptibility to cidofovir, however, has been reported for DNA polymerase mutants of CMV which are resistant to ganciclovir6–9. To date, all clinical isolates which exhibit high level resistance to ganciclovir, due to mutations in both the DNA polymerase and UL97 genes, have been shown to be cross resistant to cidofovir. Cidofovir is active against some, but not all, CMV isolates which are resistant to foscarnet10–12. The incidence of foscarnet-resistant isolates that are resistant to cidofovir is not known. A few triple-drug resistant isolates have been described. Genotypic analysis of two of these triple-resistant isolates revealed several point mutations in the CMV DNA polymerase gene. The clinical significance of the development of these cross-resistant isolates is not known.</Description>
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<NDCCode>37000-134-17</NDCCode>
<PackageDescription>170 g in 1 CAN (37000-134-17) </PackageDescription>
<NDC11Code>37000-0134-17</NDC11Code>
<ProductNDC>37000-134</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Secret Antiperspirant</ProprietaryName>
<ProprietaryNameSuffix>Powder Fresh</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName>
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<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20070401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M019</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>ALUMINUM CHLOROHYDRATE</SubstanceName>
<StrengthNumber>.24</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces underarm wetness.</IndicationAndUsage>
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<NDC>
<NDCCode>49614-134-42</NDCCode>
<PackageDescription>296 mL in 1 BOTTLE, GLASS (49614-134-42) </PackageDescription>
<NDC11Code>49614-0134-42</NDC11Code>
<ProductNDC>49614-134</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Magnesium Citrate</ProprietaryName>
<NonProprietaryName>Magnesium Citrate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19890621</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Medicine Shoppe International</LabelerName>
<SubstanceName>MAGNESIUM CITRATE</SubstanceName>
<StrengthNumber>1.745</StrengthNumber>
<StrengthUnit>g/29.6mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19890621</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDCCode>51316-134-13</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (51316-134-13) / 9 TABLET, CHEWABLE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>51316-0134-13</NDC11Code>
<ProductNDC>51316-134</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Extra Strength Gas Relief Cherry Creme</ProprietaryName>
<NonProprietaryName>Simethicone</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250106</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M002</ApplicationNumber>
<LabelerName>CVS</LabelerName>
<SubstanceName>DIMETHICONE</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: : 1 Pressure, 2 bloating, 3 Symptoms referred to as gas.</IndicationAndUsage>
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<NDC>
<NDCCode>58103-134-10</NDCCode>
<PackageDescription>100 kg in 1 DRUM (58103-134-10) </PackageDescription>
<NDC11Code>58103-0134-10</NDC11Code>
<ProductNDC>58103-134</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20200129</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>SPI Pharma Inc</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>58</StrengthNumber>
<StrengthUnit>kg/100kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-01-15</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>29-JAN-20</StartMarketingDatePackage>
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<NDC>
<NDCCode>67457-134-50</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (67457-134-50) > 50 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>67457-0134-50</NDC11Code>
<ProductNDC>67457-134</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Magnesium Chloride</ProprietaryName>
<NonProprietaryName>Magnesium Chloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20130314</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>MAGNESIUM CHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-10-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>As an electrolyte replenisher in magnesium deficiencies.</IndicationAndUsage>
<Description>Magnesium Chloride Injection is a sterile solution of Magnesium Chloride Hexahydrate in Water for Injection q.s. Each mL contains Magnesium Chloride Hexahydrate 200 mg, Sodium Chloride 9 mg, Benzyl Alcohol 1% as a preservative, Water for Injection, q.s. pH adjusted with Hydrochloric Acid and/or Sodium Hydroxide. Total osmolarity equivalent to 2.951 mOsm/mL. Contains 1.97 mEq of Mg++ and Cl- per mL. The structural formula is MgCl26H2O.</Description>
</NDC>
<NDC>
<NDCCode>69367-134-06</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (69367-134-06) </PackageDescription>
<NDC11Code>69367-0134-06</NDC11Code>
<ProductNDC>69367-134</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160411</StartMarketingDate>
<EndMarketingDate>20260201</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205101</ApplicationNumber>
<LabelerName>Westminster Pharmaceuticals, LLC</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160411</StartMarketingDatePackage>
<EndMarketingDatePackage>20260201</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin is indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in gabapentin capsules and tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl) cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 4.72±0.10 and a pKa2 of 10.27±0.29. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient is -1.083±0.235 at 25°C temperature. Each gabapentin capsule contains 100 mg, 300 mg or 400 mg of gabapentin, USP and the following inactive ingredients: pregelatinized starch (maize), and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate (SLS) and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide, FD&C Red 40, D&C Yellow 10, and sodium lauryl sulfate (SLS). The 400mg capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate (SLS), D&C Yellow 10, and FD&C Red 40. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide. Each gabapentin tablet contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: poloxamer 407, mannitol, magnesium stearate, hydroxypropyl cellulose, talc, copovidone, crospovidone, colloidal silicon dioxide and coating agent contains hypromellose, titanium dioxide, polyethylene glycol and talc.</Description>
</NDC>
<NDC>
<NDCCode>71093-134-04</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (71093-134-04) </PackageDescription>
<NDC11Code>71093-0134-04</NDC11Code>
<ProductNDC>71093-134</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203769</ApplicationNumber>
<LabelerName>ACI Healthcare USA, Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin Hydrochloride Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin Hydrochloride Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene hydrochloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin Hydrochloride Tablets contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients pregelatinized starch (maize), povidone, crospovidone, magnesium stearate. In addition, the coating for the tablets contains Hypromellose, polyethylene glycol, titanium dioxide and flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol and silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71093-134-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (71093-134-05) </PackageDescription>
<NDC11Code>71093-0134-05</NDC11Code>
<ProductNDC>71093-134</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203769</ApplicationNumber>
<LabelerName>ACI Healthcare USA, Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin Hydrochloride Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin Hydrochloride Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water, slightly soluble in alcohol, practically insoluble in acetone and in methylene hydrochloride. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin Hydrochloride Tablets contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients pregelatinized starch (maize), povidone, crospovidone, magnesium stearate. In addition, the coating for the tablets contains Hypromellose, polyethylene glycol, titanium dioxide and flavoring agent contains dextrose, ethyl alcohol, gum arabic, propylene glycol and silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>72570-134-09</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (72570-134-09) > 256 g in 1 TUBE</PackageDescription>
<NDC11Code>72570-0134-09</NDC11Code>
<ProductNDC>72570-134</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Diaperene Adult</ProprietaryName>
<NonProprietaryName>Menthol, Zinc Oxide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part346</ApplicationNumber>
<LabelerName>Delsam Pharma Llc</LabelerName>
<SubstanceName>MENTHOL, UNSPECIFIED FORM; ZINC OXIDE</SubstanceName>
<StrengthNumber>4.4; 206</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210906</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>72570-134-16</NDCCode>
<PackageDescription>454 g in 1 CONTAINER (72570-134-16) </PackageDescription>
<NDC11Code>72570-0134-16</NDC11Code>
<ProductNDC>72570-134</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Diaperene Adult</ProprietaryName>
<NonProprietaryName>Menthol, Zinc Oxide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part346</ApplicationNumber>
<LabelerName>Delsam Pharma Llc</LabelerName>
<SubstanceName>MENTHOL, UNSPECIFIED FORM; ZINC OXIDE</SubstanceName>
<StrengthNumber>4.4; 206</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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