{
"NDC": [
{
"NDCCode": "0378-4201-24",
"PackageDescription": "240 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-4201-24)",
"NDC11Code": "00378-4201-24",
"ProductNDC": "0378-4201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mycophenolic Acid",
"NonProprietaryName": "Mycophenilic Acid",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091248",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "MYCOPHENOLIC ACID",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimetabolite Immunosuppressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-03-06"
},
{
"NDCCode": "0378-4201-78",
"PackageDescription": "120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-4201-78) ",
"NDC11Code": "00378-4201-78",
"ProductNDC": "0378-4201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mycophenolic Acid",
"NonProprietaryName": "Mycophenolic Acid",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140108",
"EndMarketingDate": "20231130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091248",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "MYCOPHENOLIC ACID",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimetabolite Immunosuppressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140108",
"EndMarketingDatePackage": "20231130",
"SamplePackage": "N"
},
{
"NDCCode": "0078-0378-45",
"PackageDescription": "24 POUCH in 1 CARTON (0078-0378-45) > 3.5 d in 1 POUCH",
"NDC11Code": "00078-0378-45",
"ProductNDC": "0078-0378",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Combipatch",
"NonProprietaryName": "Estradiol And Norethindrone Acetate",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20000101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020870",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "ESTRADIOL; NORETHINDRONE ACETATE",
"StrengthNumber": ".05; .25",
"StrengthUnit": "mg/d; mg/d",
"Pharm_Classes": "Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-09-19"
},
{
"NDCCode": "0378-4202-24",
"PackageDescription": "240 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-4202-24)",
"NDC11Code": "00378-4202-24",
"ProductNDC": "0378-4202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mycophenolic Acid",
"NonProprietaryName": "Mycophenilic Acid",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091248",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "MYCOPHENOLIC ACID",
"StrengthNumber": "360",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimetabolite Immunosuppressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2015-03-06"
},
{
"NDCCode": "0378-6470-44",
"PackageDescription": "24 POUCH in 1 CARTON (0378-6470-44) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH",
"NDC11Code": "00378-6470-44",
"ProductNDC": "0378-6470",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Scopolamine",
"NonProprietaryName": "Scopolamine",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20190619",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203753",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "SCOPOLAMINE",
"StrengthNumber": "1",
"StrengthUnit": "mg/3d",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190619",
"SamplePackage": "N",
"IndicationAndUsage": "Scopolamine transdermal system is indicated in adults for the prevention of: 1 nausea and vomiting associated with motion sickness., 2 post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.",
"Description": "Scopolamine transdermal system is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.5 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The scopolamine transdermal system is a circular, 1.8 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing layer of peach-colored polyethylene/polyester film printed with brown ink; (2) a solid matrix drug reservoir layer of silicone adhesive, scopolamine and povidone; (3) a microporous polypropylene membrane; and (4) an adhesive formulation of silicone adhesive, povidone and scopolamine. A protective, oversized release liner of fluoropolymer-coated polyester, which covers the adhesive formulation layer, is removed before the system is used. The brown ink contains acrylic polymers, carbon black, iron oxides (red and yellow), polydimethylsiloxane, polyethylene wax, polytetrafluoroethylene, polyvinylpyrrolidone, sodium dioctyl sulfosuccinate and triethanolamine. Scopolamine transdermal systems are packaged with an additional piece of protective film covering the system within each pouch. This piece of protective film is removed and discarded at the time of use. Cross section of the system."
},
{
"NDCCode": "0378-9070-93",
"PackageDescription": "30 POUCH in 1 CARTON (0378-9070-93) / 1 PATCH in 1 POUCH (0378-9070-16) / 24 h in 1 PATCH",
"NDC11Code": "00378-9070-93",
"ProductNDC": "0378-9070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivastigmine",
"NonProprietaryName": "Rivastigmine",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20180620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205622",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "RIVASTIGMINE",
"StrengthNumber": "4.6",
"StrengthUnit": "mg/24h",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-10-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180620",
"SamplePackage": "N",
"IndicationAndUsage": "Rivastigmine transdermal system is an acetylcholinesterase inhibitor indicated for treatment of: : 1 Mild, moderate, and severe dementia of the Alzheimer’s type (AD). (1.1), 2 Mild-to-moderate dementia associated with Parkinson’s disease (PD). (1.2) .",
"Description": "Rivastigmine transdermal system contains rivastigmine, a reversible cholinesterase inhibitor known chemically as (S)-3-[1-(Dimethylamino) ethyl]phenyl ethyl(methyl)carbamate. It has a molecular formula of C14H22N2O2 as the base and a molecular weight of 250.34 g/mol (as the base). Rivastigmine, USP is a viscous, clear, and colorless to yellow to very slightly brown liquid that is sparingly soluble in water and very soluble in ethanol, acetonitrile, n-octanol and ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 4.27. Rivastigmine transdermal system is for transdermal administration. The transdermal system is a 4-layer laminate containing the backing layer, drug matrix, adhesive matrix and slit protective release liner (see Figure 1). The release liner is removed and discarded prior to use. Excipients within the formulation include acrylic adhesive, dimethicone, poly(butylmethacrylate, methylmethacrylate), silicone adhesive, and flexible polymer backing film printed with brown ink. The brown ink contains acrylic polymers, carbon black, iron oxides (yellow and red), polyethylene wax, polytetrafluoroethylene, polyvinylpyrrolidone, and sodium dioctyl sulfosuccinate. Rivastigmine transdermal systems are packaged with an additional piece of protective film below the system within each pouch. This piece of protective film is removed and discarded at the time of use."
},
{
"NDCCode": "0378-9071-93",
"PackageDescription": "30 POUCH in 1 CARTON (0378-9071-93) / 1 PATCH in 1 POUCH (0378-9071-16) / 24 h in 1 PATCH",
"NDC11Code": "00378-9071-93",
"ProductNDC": "0378-9071",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivastigmine",
"NonProprietaryName": "Rivastigmine",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20180620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205622",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "RIVASTIGMINE",
"StrengthNumber": "9.5",
"StrengthUnit": "mg/24h",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-10-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180620",
"SamplePackage": "N",
"IndicationAndUsage": "Rivastigmine transdermal system is an acetylcholinesterase inhibitor indicated for treatment of: : 1 Mild, moderate, and severe dementia of the Alzheimer’s type (AD). (1.1), 2 Mild-to-moderate dementia associated with Parkinson’s disease (PD). (1.2) .",
"Description": "Rivastigmine transdermal system contains rivastigmine, a reversible cholinesterase inhibitor known chemically as (S)-3-[1-(Dimethylamino) ethyl]phenyl ethyl(methyl)carbamate. It has a molecular formula of C14H22N2O2 as the base and a molecular weight of 250.34 g/mol (as the base). Rivastigmine, USP is a viscous, clear, and colorless to yellow to very slightly brown liquid that is sparingly soluble in water and very soluble in ethanol, acetonitrile, n-octanol and ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 4.27. Rivastigmine transdermal system is for transdermal administration. The transdermal system is a 4-layer laminate containing the backing layer, drug matrix, adhesive matrix and slit protective release liner (see Figure 1). The release liner is removed and discarded prior to use. Excipients within the formulation include acrylic adhesive, dimethicone, poly(butylmethacrylate, methylmethacrylate), silicone adhesive, and flexible polymer backing film printed with brown ink. The brown ink contains acrylic polymers, carbon black, iron oxides (yellow and red), polyethylene wax, polytetrafluoroethylene, polyvinylpyrrolidone, and sodium dioctyl sulfosuccinate. Rivastigmine transdermal systems are packaged with an additional piece of protective film below the system within each pouch. This piece of protective film is removed and discarded at the time of use."
},
{
"NDCCode": "0378-9072-93",
"PackageDescription": "30 POUCH in 1 CARTON (0378-9072-93) / 1 PATCH in 1 POUCH (0378-9072-16) / 24 h in 1 PATCH",
"NDC11Code": "00378-9072-93",
"ProductNDC": "0378-9072",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rivastigmine",
"NonProprietaryName": "Rivastigmine",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20180620",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205622",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "RIVASTIGMINE",
"StrengthNumber": "13.3",
"StrengthUnit": "mg/24h",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-10-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180620",
"SamplePackage": "N",
"IndicationAndUsage": "Rivastigmine transdermal system is an acetylcholinesterase inhibitor indicated for treatment of: : 1 Mild, moderate, and severe dementia of the Alzheimer’s type (AD). (1.1), 2 Mild-to-moderate dementia associated with Parkinson’s disease (PD). (1.2) .",
"Description": "Rivastigmine transdermal system contains rivastigmine, a reversible cholinesterase inhibitor known chemically as (S)-3-[1-(Dimethylamino) ethyl]phenyl ethyl(methyl)carbamate. It has a molecular formula of C14H22N2O2 as the base and a molecular weight of 250.34 g/mol (as the base). Rivastigmine, USP is a viscous, clear, and colorless to yellow to very slightly brown liquid that is sparingly soluble in water and very soluble in ethanol, acetonitrile, n-octanol and ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 4.27. Rivastigmine transdermal system is for transdermal administration. The transdermal system is a 4-layer laminate containing the backing layer, drug matrix, adhesive matrix and slit protective release liner (see Figure 1). The release liner is removed and discarded prior to use. Excipients within the formulation include acrylic adhesive, dimethicone, poly(butylmethacrylate, methylmethacrylate), silicone adhesive, and flexible polymer backing film printed with brown ink. The brown ink contains acrylic polymers, carbon black, iron oxides (yellow and red), polyethylene wax, polytetrafluoroethylene, polyvinylpyrrolidone, and sodium dioctyl sulfosuccinate. Rivastigmine transdermal systems are packaged with an additional piece of protective film below the system within each pouch. This piece of protective film is removed and discarded at the time of use."
},
{
"NDCCode": "36800-378-24",
"PackageDescription": "24 PATCH in 1 BOX (36800-378-24) ",
"NDC11Code": "36800-0378-24",
"ProductNDC": "36800-378",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Salicylic Acid",
"NonProprietaryName": "Medicated Plantar Wart Remover",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171206",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M028",
"LabelerName": "Topco Associates LLC",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "40",
"StrengthUnit": "mg/241",
"Status": "Active",
"LastUpdate": "2026-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171206",
"SamplePackage": "N",
"IndicationAndUsage": "for the removal of plantar warts on the bottom of the foot. The plantar wart is recognized by its location only on the bottom of the foot, its tenderness, and the interruption of the footprint pattern."
},
{
"NDCCode": "70000-0378-1",
"PackageDescription": "24 BLISTER PACK in 1 CARTON (70000-0378-1) > 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "70000-0378-01",
"ProductNDC": "70000-0378",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leader Acid Control",
"NonProprietaryName": "Ranitidine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180829",
"EndMarketingDate": "20210228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091429",
"LabelerName": "Cardinal Health",
"SubstanceName": "RANITIDINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-03-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180829",
"EndMarketingDatePackage": "20210228",
"SamplePackage": "N"
},
{
"NDCCode": "0378-0005-85",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (0378-0005-85) / 7 TABLET, FOR SUSPENSION in 1 BLISTER PACK",
"NDC11Code": "00378-0005-85",
"ProductNDC": "0378-0005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Everolimus",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20211001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210130",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211001",
"SamplePackage": "N",
"IndicationAndUsage": "Everolimus tablets for oral suspension are a kinase inhibitor indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5). Everolimus tablets for oral suspension are a kinase inhibitor indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures. (1.6).",
"Description": "Everolimus tablets for oral suspension are a kinase inhibitor. The chemical name of everolimus is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-Hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclohentriacontine-1,5,11,28,29(4H,6H,31H)-pentone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is:. Everolimus tablets for oral suspension contain 2 mg, 3 mg, or 5 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, croscarmellose sodium, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose and silicon dioxide."
},
{
"NDCCode": "0378-0006-85",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (0378-0006-85) / 7 TABLET, FOR SUSPENSION in 1 BLISTER PACK",
"NDC11Code": "00378-0006-85",
"ProductNDC": "0378-0006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Everolimus",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20211001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210130",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211001",
"SamplePackage": "N",
"IndicationAndUsage": "Everolimus tablets for oral suspension are a kinase inhibitor indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5). Everolimus tablets for oral suspension are a kinase inhibitor indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures. (1.6).",
"Description": "Everolimus tablets for oral suspension are a kinase inhibitor. The chemical name of everolimus is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-Hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclohentriacontine-1,5,11,28,29(4H,6H,31H)-pentone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is:. Everolimus tablets for oral suspension contain 2 mg, 3 mg, or 5 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, croscarmellose sodium, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose and silicon dioxide."
},
{
"NDCCode": "0378-0007-85",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (0378-0007-85) / 7 TABLET, FOR SUSPENSION in 1 BLISTER PACK",
"NDC11Code": "00378-0007-85",
"ProductNDC": "0378-0007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Everolimus",
"NonProprietaryName": "Everolimus",
"DosageFormName": "TABLET, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20211001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210130",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "EVEROLIMUS",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211001",
"SamplePackage": "N",
"IndicationAndUsage": "Everolimus tablets for oral suspension are a kinase inhibitor indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5). Everolimus tablets for oral suspension are a kinase inhibitor indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures. (1.6).",
"Description": "Everolimus tablets for oral suspension are a kinase inhibitor. The chemical name of everolimus is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-Hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclohentriacontine-1,5,11,28,29(4H,6H,31H)-pentone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is:. Everolimus tablets for oral suspension contain 2 mg, 3 mg, or 5 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, croscarmellose sodium, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose and silicon dioxide."
},
{
"NDCCode": "0378-0088-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0088-01) ",
"NDC11Code": "00378-0088-01",
"ProductNDC": "0378-0088",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
"NonProprietaryName": "Carbidopa And Levodopa",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20000426",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075091",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "CARBIDOPA; LEVODOPA",
"StrengthNumber": "25; 100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20000426",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa and levodopa extended-release tablets are indicated in the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.",
"Description": "Carbidopa and levodopa extended-release tablets, USP are an extended-release combination of carbidopa and levodopa for the treatment of Parkinson’s disease and syndrome. Carbidopa, USP, an inhibitor of aromatic amino acid decarboxylation, is a white to creamy white powder, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-Hydrazino-3,4-dihydroxy-α-methylhydrocinnamic acid monohydrate. Its empirical formula is C10H14N2O4H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.23. Levodopa, USP, an aromatic amino acid, is a white to off-white crystalline powder, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (-)-3-(3,4-Dihydroxyphenyl)-L-alanine. Its empirical formula is C9H11NO4, and its structural formula is. Each extended-release tablet, for oral administration, contains either 25 mg of carbidopa and 100 mg of levodopa, or 50 mg of carbidopa and 200 mg of levodopa. In addition, each tablet contains the following inactive ingredients: FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl cellulose, hypromellose, and magnesium stearate. The 25 mg/100 mg tablets are purple, oval, unscored tablets debossed with MYLAN on one side of the tablet and 88 on the other side of the tablet. The 50 mg/200 mg tablets are purple, oval, scored tablets debossed with MYLAN on one side of the tablet and 9 to the left of the score and 4 to the right of the score on the other side of the tablet. Carbidopa and levodopa extended-release tablets are designed in a drug delivery system that controls the release of carbidopa and levodopa as the tablets slowly erode. The 25 mg/100 mg carbidopa and levodopa extended-release tablet is available to facilitate titration and as an alternative to the half-tablet of 50 mg/200 mg carbidopa and levodopa extended-release. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "0378-0094-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0094-01) ",
"NDC11Code": "00378-0094-01",
"ProductNDC": "0378-0094",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
"NonProprietaryName": "Carbidopa And Levodopa",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19991006",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075091",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "CARBIDOPA; LEVODOPA",
"StrengthNumber": "50; 200",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19991006",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa and levodopa extended-release tablets are indicated in the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.",
"Description": "Carbidopa and levodopa extended-release tablets, USP are an extended-release combination of carbidopa and levodopa for the treatment of Parkinson’s disease and syndrome. Carbidopa, USP, an inhibitor of aromatic amino acid decarboxylation, is a white to creamy white powder, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-Hydrazino-3,4-dihydroxy-α-methylhydrocinnamic acid monohydrate. Its empirical formula is C10H14N2O4H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.23. Levodopa, USP, an aromatic amino acid, is a white to off-white crystalline powder, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (-)-3-(3,4-Dihydroxyphenyl)-L-alanine. Its empirical formula is C9H11NO4, and its structural formula is. Each extended-release tablet, for oral administration, contains either 25 mg of carbidopa and 100 mg of levodopa, or 50 mg of carbidopa and 200 mg of levodopa. In addition, each tablet contains the following inactive ingredients: FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl cellulose, hypromellose, and magnesium stearate. The 25 mg/100 mg tablets are purple, oval, unscored tablets debossed with MYLAN on one side of the tablet and 88 on the other side of the tablet. The 50 mg/200 mg tablets are purple, oval, scored tablets debossed with MYLAN on one side of the tablet and 9 to the left of the score and 4 to the right of the score on the other side of the tablet. Carbidopa and levodopa extended-release tablets are designed in a drug delivery system that controls the release of carbidopa and levodopa as the tablets slowly erode. The 25 mg/100 mg carbidopa and levodopa extended-release tablet is available to facilitate titration and as an alternative to the half-tablet of 50 mg/200 mg carbidopa and levodopa extended-release. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "0378-0374-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0374-05) ",
"NDC11Code": "00378-0374-05",
"ProductNDC": "0378-0374",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
"NonProprietaryName": "Ondansetron",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076930",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "24",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20070625",
"SamplePackage": "N",
"IndicationAndUsage": "Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 . , 2 initial and repeat courses of moderately emetogenic cancer chemotherapy. , 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. .",
"Description": "The active ingredient in ondansetron tablets, USP is ondansetron hydrochloride, USP as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is 4H-Carbazol-4-one,1,2,3,9-tetrahydro-9-methyl-3-(2-methyl-1H-imidazol-1-yl)methyl-,monohydrochloride,(±)-,dihydrate. It has the following structural formula. The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9. Ondansetron hydrochloride dihydrate is a white to off-white powder that is soluble in water and normal saline. Each 4 mg ondansetron tablet for oral administration contains ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablet for oral administration contains ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron. Each tablet also contains the inactive ingredients anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch (corn), sodium lauryl sulfate, titanium dioxide and triacetin. In addition, the 8 mg tablet contains FD&C Yellow No. 6 Aluminum Lake. Meets USP Dissolution Test 4."
},
{
"NDCCode": "0378-0374-32",
"PackageDescription": "1 TABLET, FILM COATED in 1 BLISTER PACK (0378-0374-32) ",
"NDC11Code": "00378-0374-32",
"ProductNDC": "0378-0374",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
"NonProprietaryName": "Ondansetron",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076930",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "24",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20070625",
"SamplePackage": "N",
"IndicationAndUsage": "Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 . , 2 initial and repeat courses of moderately emetogenic cancer chemotherapy. , 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. .",
"Description": "The active ingredient in ondansetron tablets, USP is ondansetron hydrochloride, USP as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is 4H-Carbazol-4-one,1,2,3,9-tetrahydro-9-methyl-3-(2-methyl-1H-imidazol-1-yl)methyl-,monohydrochloride,(±)-,dihydrate. It has the following structural formula. The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9. Ondansetron hydrochloride dihydrate is a white to off-white powder that is soluble in water and normal saline. Each 4 mg ondansetron tablet for oral administration contains ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablet for oral administration contains ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron. Each tablet also contains the inactive ingredients anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch (corn), sodium lauryl sulfate, titanium dioxide and triacetin. In addition, the 8 mg tablet contains FD&C Yellow No. 6 Aluminum Lake. Meets USP Dissolution Test 4."
},
{
"NDCCode": "0378-0374-93",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0374-93) ",
"NDC11Code": "00378-0374-93",
"ProductNDC": "0378-0374",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
"NonProprietaryName": "Ondansetron",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076930",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "24",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20070625",
"SamplePackage": "N",
"IndicationAndUsage": "Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 . , 2 initial and repeat courses of moderately emetogenic cancer chemotherapy. , 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. .",
"Description": "The active ingredient in ondansetron tablets, USP is ondansetron hydrochloride, USP as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is 4H-Carbazol-4-one,1,2,3,9-tetrahydro-9-methyl-3-(2-methyl-1H-imidazol-1-yl)methyl-,monohydrochloride,(±)-,dihydrate. It has the following structural formula. The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9. Ondansetron hydrochloride dihydrate is a white to off-white powder that is soluble in water and normal saline. Each 4 mg ondansetron tablet for oral administration contains ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablet for oral administration contains ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron. Each tablet also contains the inactive ingredients anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch (corn), sodium lauryl sulfate, titanium dioxide and triacetin. In addition, the 8 mg tablet contains FD&C Yellow No. 6 Aluminum Lake. Meets USP Dissolution Test 4."
},
{
"NDCCode": "0378-0472-01",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0472-01) ",
"NDC11Code": "00378-0472-01",
"ProductNDC": "0378-0472",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077567",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090129",
"SamplePackage": "N"
},
{
"NDCCode": "0378-0472-05",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0472-05) ",
"NDC11Code": "00378-0472-05",
"ProductNDC": "0378-0472",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077567",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090129",
"SamplePackage": "N"
},
{
"NDCCode": "0378-0473-01",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0473-01) ",
"NDC11Code": "00378-0473-01",
"ProductNDC": "0378-0473",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077567",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090202",
"SamplePackage": "N"
},
{
"NDCCode": "0378-0473-05",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0473-05) ",
"NDC11Code": "00378-0473-05",
"ProductNDC": "0378-0473",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Divalproex Sodium",
"NonProprietaryName": "Divalproex Sodium",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077567",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "DIVALPROEX SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20090202",
"SamplePackage": "N"
},
{
"NDCCode": "0378-0552-77",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (0378-0552-77)",
"NDC11Code": "00378-0552-77",
"ProductNDC": "0378-0552",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pravastatin Sodium",
"NonProprietaryName": "Pravastatin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079187",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "PRAVASTATIN SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-01-24",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0378-0553-77",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (0378-0553-77)",
"NDC11Code": "00378-0553-77",
"ProductNDC": "0378-0553",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pravastatin Sodium",
"NonProprietaryName": "Pravastatin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079187",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "PRAVASTATIN SODIUM",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-01-24",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0378-0554-77",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (0378-0554-77)",
"NDC11Code": "00378-0554-77",
"ProductNDC": "0378-0554",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pravastatin Sodium",
"NonProprietaryName": "Pravastatin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079187",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "PRAVASTATIN SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-01-24",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0378-0557-77",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (0378-0557-77)",
"NDC11Code": "00378-0557-77",
"ProductNDC": "0378-0557",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pravastatin Sodium",
"NonProprietaryName": "Pravastatin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079187",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "PRAVASTATIN SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-01-24",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0378-1089-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0378-1089-01)",
"NDC11Code": "00378-1089-01",
"ProductNDC": "0378-1089",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Meloxicam",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20060719",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077923",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-01-24",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0378-1145-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0378-1145-01) ",
"NDC11Code": "00378-1145-01",
"ProductNDC": "0378-1145",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076008",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2026-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130731",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets have been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 1.Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 2.Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 3.Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 4.Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge,” irritability, impatience.",
"Description": "Buspirone hydrochloride tablets, USP are an antianxiety agent that are not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The molecular formula C21H31N5O2HCl is represented by the following structural formula. Buspirone hydrochloride tablets are supplied as tablets for oral administration containing 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg, and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg and 30 mg tablets are provided in a multi-scored tablet design. These tablets are scored so they can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet). Buspirone hydrochloride tablets contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and sodium starch glycolate (potato)."
},
{
"NDCCode": "0378-1418-77",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1418-77)",
"NDC11Code": "00378-1418-77",
"ProductNDC": "0378-1418",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
"NonProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20121005",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091652",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "50; 12.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-01-24",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0378-1418-93",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1418-93)",
"NDC11Code": "00378-1418-93",
"ProductNDC": "0378-1418",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
"NonProprietaryName": "Losartan Potassium And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20121005",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091652",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "50; 12.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-01-24",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>0378-4201-24</NDCCode>
<PackageDescription>240 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-4201-24)</PackageDescription>
<NDC11Code>00378-4201-24</NDC11Code>
<ProductNDC>0378-4201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mycophenolic Acid</ProprietaryName>
<NonProprietaryName>Mycophenilic Acid</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140108</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091248</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>MYCOPHENOLIC ACID</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimetabolite Immunosuppressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-03-06</LastUpdate>
</NDC>
<NDC>
<NDCCode>0378-4201-78</NDCCode>
<PackageDescription>120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-4201-78) </PackageDescription>
<NDC11Code>00378-4201-78</NDC11Code>
<ProductNDC>0378-4201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mycophenolic Acid</ProprietaryName>
<NonProprietaryName>Mycophenolic Acid</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140108</StartMarketingDate>
<EndMarketingDate>20231130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091248</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>MYCOPHENOLIC ACID</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimetabolite Immunosuppressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140108</StartMarketingDatePackage>
<EndMarketingDatePackage>20231130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0078-0378-45</NDCCode>
<PackageDescription>24 POUCH in 1 CARTON (0078-0378-45) > 3.5 d in 1 POUCH</PackageDescription>
<NDC11Code>00078-0378-45</NDC11Code>
<ProductNDC>0078-0378</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Combipatch</ProprietaryName>
<NonProprietaryName>Estradiol And Norethindrone Acetate</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20000101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020870</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>ESTRADIOL; NORETHINDRONE ACETATE</SubstanceName>
<StrengthNumber>.05; .25</StrengthNumber>
<StrengthUnit>mg/d; mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-09-19</LastUpdate>
</NDC>
<NDC>
<NDCCode>0378-4202-24</NDCCode>
<PackageDescription>240 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-4202-24)</PackageDescription>
<NDC11Code>00378-4202-24</NDC11Code>
<ProductNDC>0378-4202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mycophenolic Acid</ProprietaryName>
<NonProprietaryName>Mycophenilic Acid</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140108</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091248</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>MYCOPHENOLIC ACID</SubstanceName>
<StrengthNumber>360</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimetabolite Immunosuppressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-03-06</LastUpdate>
</NDC>
<NDC>
<NDCCode>0378-6470-44</NDCCode>
<PackageDescription>24 POUCH in 1 CARTON (0378-6470-44) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH</PackageDescription>
<NDC11Code>00378-6470-44</NDC11Code>
<ProductNDC>0378-6470</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Scopolamine</ProprietaryName>
<NonProprietaryName>Scopolamine</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20190619</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203753</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>SCOPOLAMINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/3d</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190619</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Scopolamine transdermal system is indicated in adults for the prevention of: 1 nausea and vomiting associated with motion sickness., 2 post-operative nausea and vomiting (PONV) associated with recovery from anesthesia and/or opiate analgesia and surgery.</IndicationAndUsage>
<Description>Scopolamine transdermal system is designed for continuous release of scopolamine following application to an area of intact skin on the head, behind the ear. Each system contains 1.5 mg of scopolamine base. Scopolamine is (9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl) 3-hydroxy-2-phenylpropanoate. The empirical formula is C17H21NO4 and its structural formula is. Scopolamine has a molecular weight of 303.35 and a pKa of 7.55-7.81. The scopolamine transdermal system is a circular, 1.8 cm2 film with four layers. Proceeding from the visible surface towards the surface attached to the skin, these layers are: (1) a backing layer of peach-colored polyethylene/polyester film printed with brown ink; (2) a solid matrix drug reservoir layer of silicone adhesive, scopolamine and povidone; (3) a microporous polypropylene membrane; and (4) an adhesive formulation of silicone adhesive, povidone and scopolamine. A protective, oversized release liner of fluoropolymer-coated polyester, which covers the adhesive formulation layer, is removed before the system is used. The brown ink contains acrylic polymers, carbon black, iron oxides (red and yellow), polydimethylsiloxane, polyethylene wax, polytetrafluoroethylene, polyvinylpyrrolidone, sodium dioctyl sulfosuccinate and triethanolamine. Scopolamine transdermal systems are packaged with an additional piece of protective film covering the system within each pouch. This piece of protective film is removed and discarded at the time of use. Cross section of the system.</Description>
</NDC>
<NDC>
<NDCCode>0378-9070-93</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (0378-9070-93) / 1 PATCH in 1 POUCH (0378-9070-16) / 24 h in 1 PATCH</PackageDescription>
<NDC11Code>00378-9070-93</NDC11Code>
<ProductNDC>0378-9070</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivastigmine</ProprietaryName>
<NonProprietaryName>Rivastigmine</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20180620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205622</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>RIVASTIGMINE</SubstanceName>
<StrengthNumber>4.6</StrengthNumber>
<StrengthUnit>mg/24h</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rivastigmine transdermal system is an acetylcholinesterase inhibitor indicated for treatment of: : 1 Mild, moderate, and severe dementia of the Alzheimer’s type (AD). (1.1), 2 Mild-to-moderate dementia associated with Parkinson’s disease (PD). (1.2) .</IndicationAndUsage>
<Description>Rivastigmine transdermal system contains rivastigmine, a reversible cholinesterase inhibitor known chemically as (S)-3-[1-(Dimethylamino) ethyl]phenyl ethyl(methyl)carbamate. It has a molecular formula of C14H22N2O2 as the base and a molecular weight of 250.34 g/mol (as the base). Rivastigmine, USP is a viscous, clear, and colorless to yellow to very slightly brown liquid that is sparingly soluble in water and very soluble in ethanol, acetonitrile, n-octanol and ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 4.27. Rivastigmine transdermal system is for transdermal administration. The transdermal system is a 4-layer laminate containing the backing layer, drug matrix, adhesive matrix and slit protective release liner (see Figure 1). The release liner is removed and discarded prior to use. Excipients within the formulation include acrylic adhesive, dimethicone, poly(butylmethacrylate, methylmethacrylate), silicone adhesive, and flexible polymer backing film printed with brown ink. The brown ink contains acrylic polymers, carbon black, iron oxides (yellow and red), polyethylene wax, polytetrafluoroethylene, polyvinylpyrrolidone, and sodium dioctyl sulfosuccinate. Rivastigmine transdermal systems are packaged with an additional piece of protective film below the system within each pouch. This piece of protective film is removed and discarded at the time of use.</Description>
</NDC>
<NDC>
<NDCCode>0378-9071-93</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (0378-9071-93) / 1 PATCH in 1 POUCH (0378-9071-16) / 24 h in 1 PATCH</PackageDescription>
<NDC11Code>00378-9071-93</NDC11Code>
<ProductNDC>0378-9071</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivastigmine</ProprietaryName>
<NonProprietaryName>Rivastigmine</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20180620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205622</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>RIVASTIGMINE</SubstanceName>
<StrengthNumber>9.5</StrengthNumber>
<StrengthUnit>mg/24h</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rivastigmine transdermal system is an acetylcholinesterase inhibitor indicated for treatment of: : 1 Mild, moderate, and severe dementia of the Alzheimer’s type (AD). (1.1), 2 Mild-to-moderate dementia associated with Parkinson’s disease (PD). (1.2) .</IndicationAndUsage>
<Description>Rivastigmine transdermal system contains rivastigmine, a reversible cholinesterase inhibitor known chemically as (S)-3-[1-(Dimethylamino) ethyl]phenyl ethyl(methyl)carbamate. It has a molecular formula of C14H22N2O2 as the base and a molecular weight of 250.34 g/mol (as the base). Rivastigmine, USP is a viscous, clear, and colorless to yellow to very slightly brown liquid that is sparingly soluble in water and very soluble in ethanol, acetonitrile, n-octanol and ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 4.27. Rivastigmine transdermal system is for transdermal administration. The transdermal system is a 4-layer laminate containing the backing layer, drug matrix, adhesive matrix and slit protective release liner (see Figure 1). The release liner is removed and discarded prior to use. Excipients within the formulation include acrylic adhesive, dimethicone, poly(butylmethacrylate, methylmethacrylate), silicone adhesive, and flexible polymer backing film printed with brown ink. The brown ink contains acrylic polymers, carbon black, iron oxides (yellow and red), polyethylene wax, polytetrafluoroethylene, polyvinylpyrrolidone, and sodium dioctyl sulfosuccinate. Rivastigmine transdermal systems are packaged with an additional piece of protective film below the system within each pouch. This piece of protective film is removed and discarded at the time of use.</Description>
</NDC>
<NDC>
<NDCCode>0378-9072-93</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (0378-9072-93) / 1 PATCH in 1 POUCH (0378-9072-16) / 24 h in 1 PATCH</PackageDescription>
<NDC11Code>00378-9072-93</NDC11Code>
<ProductNDC>0378-9072</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rivastigmine</ProprietaryName>
<NonProprietaryName>Rivastigmine</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20180620</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205622</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>RIVASTIGMINE</SubstanceName>
<StrengthNumber>13.3</StrengthNumber>
<StrengthUnit>mg/24h</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rivastigmine transdermal system is an acetylcholinesterase inhibitor indicated for treatment of: : 1 Mild, moderate, and severe dementia of the Alzheimer’s type (AD). (1.1), 2 Mild-to-moderate dementia associated with Parkinson’s disease (PD). (1.2) .</IndicationAndUsage>
<Description>Rivastigmine transdermal system contains rivastigmine, a reversible cholinesterase inhibitor known chemically as (S)-3-[1-(Dimethylamino) ethyl]phenyl ethyl(methyl)carbamate. It has a molecular formula of C14H22N2O2 as the base and a molecular weight of 250.34 g/mol (as the base). Rivastigmine, USP is a viscous, clear, and colorless to yellow to very slightly brown liquid that is sparingly soluble in water and very soluble in ethanol, acetonitrile, n-octanol and ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 4.27. Rivastigmine transdermal system is for transdermal administration. The transdermal system is a 4-layer laminate containing the backing layer, drug matrix, adhesive matrix and slit protective release liner (see Figure 1). The release liner is removed and discarded prior to use. Excipients within the formulation include acrylic adhesive, dimethicone, poly(butylmethacrylate, methylmethacrylate), silicone adhesive, and flexible polymer backing film printed with brown ink. The brown ink contains acrylic polymers, carbon black, iron oxides (yellow and red), polyethylene wax, polytetrafluoroethylene, polyvinylpyrrolidone, and sodium dioctyl sulfosuccinate. Rivastigmine transdermal systems are packaged with an additional piece of protective film below the system within each pouch. This piece of protective film is removed and discarded at the time of use.</Description>
</NDC>
<NDC>
<NDCCode>36800-378-24</NDCCode>
<PackageDescription>24 PATCH in 1 BOX (36800-378-24) </PackageDescription>
<NDC11Code>36800-0378-24</NDC11Code>
<ProductNDC>36800-378</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Salicylic Acid</ProprietaryName>
<NonProprietaryName>Medicated Plantar Wart Remover</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171206</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M028</ApplicationNumber>
<LabelerName>Topco Associates LLC</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/241</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the removal of plantar warts on the bottom of the foot. The plantar wart is recognized by its location only on the bottom of the foot, its tenderness, and the interruption of the footprint pattern.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70000-0378-1</NDCCode>
<PackageDescription>24 BLISTER PACK in 1 CARTON (70000-0378-1) > 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70000-0378-01</NDC11Code>
<ProductNDC>70000-0378</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leader Acid Control</ProprietaryName>
<NonProprietaryName>Ranitidine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180829</StartMarketingDate>
<EndMarketingDate>20210228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091429</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>RANITIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-03-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180829</StartMarketingDatePackage>
<EndMarketingDatePackage>20210228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0378-0005-85</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (0378-0005-85) / 7 TABLET, FOR SUSPENSION in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00378-0005-85</NDC11Code>
<ProductNDC>0378-0005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Everolimus</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210130</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Everolimus tablets for oral suspension are a kinase inhibitor indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5). Everolimus tablets for oral suspension are a kinase inhibitor indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures. (1.6).</IndicationAndUsage>
<Description>Everolimus tablets for oral suspension are a kinase inhibitor. The chemical name of everolimus is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-Hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclohentriacontine-1,5,11,28,29(4H,6H,31H)-pentone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is:. Everolimus tablets for oral suspension contain 2 mg, 3 mg, or 5 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, croscarmellose sodium, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose and silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0378-0006-85</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (0378-0006-85) / 7 TABLET, FOR SUSPENSION in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00378-0006-85</NDC11Code>
<ProductNDC>0378-0006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Everolimus</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210130</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Everolimus tablets for oral suspension are a kinase inhibitor indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5). Everolimus tablets for oral suspension are a kinase inhibitor indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures. (1.6).</IndicationAndUsage>
<Description>Everolimus tablets for oral suspension are a kinase inhibitor. The chemical name of everolimus is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-Hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclohentriacontine-1,5,11,28,29(4H,6H,31H)-pentone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is:. Everolimus tablets for oral suspension contain 2 mg, 3 mg, or 5 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, croscarmellose sodium, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose and silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0378-0007-85</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (0378-0007-85) / 7 TABLET, FOR SUSPENSION in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00378-0007-85</NDC11Code>
<ProductNDC>0378-0007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Everolimus</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210130</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Everolimus tablets for oral suspension are a kinase inhibitor indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5). Everolimus tablets for oral suspension are a kinase inhibitor indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures. (1.6).</IndicationAndUsage>
<Description>Everolimus tablets for oral suspension are a kinase inhibitor. The chemical name of everolimus is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-Hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclohentriacontine-1,5,11,28,29(4H,6H,31H)-pentone. The molecular formula is C53H83NO14 and the molecular weight is 958.2 g/mol. The structural formula is:. Everolimus tablets for oral suspension contain 2 mg, 3 mg, or 5 mg of everolimus and the following inactive ingredients: anhydrous lactose, butylated hydroxytoluene, croscarmellose sodium, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose and silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0378-0088-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0088-01) </PackageDescription>
<NDC11Code>00378-0088-01</NDC11Code>
<ProductNDC>0378-0088</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000426</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075091</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>25; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000426</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbidopa and levodopa extended-release tablets are indicated in the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.</IndicationAndUsage>
<Description>Carbidopa and levodopa extended-release tablets, USP are an extended-release combination of carbidopa and levodopa for the treatment of Parkinson’s disease and syndrome. Carbidopa, USP, an inhibitor of aromatic amino acid decarboxylation, is a white to creamy white powder, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-Hydrazino-3,4-dihydroxy-α-methylhydrocinnamic acid monohydrate. Its empirical formula is C10H14N2O4H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.23. Levodopa, USP, an aromatic amino acid, is a white to off-white crystalline powder, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (-)-3-(3,4-Dihydroxyphenyl)-L-alanine. Its empirical formula is C9H11NO4, and its structural formula is. Each extended-release tablet, for oral administration, contains either 25 mg of carbidopa and 100 mg of levodopa, or 50 mg of carbidopa and 200 mg of levodopa. In addition, each tablet contains the following inactive ingredients: FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl cellulose, hypromellose, and magnesium stearate. The 25 mg/100 mg tablets are purple, oval, unscored tablets debossed with MYLAN on one side of the tablet and 88 on the other side of the tablet. The 50 mg/200 mg tablets are purple, oval, scored tablets debossed with MYLAN on one side of the tablet and 9 to the left of the score and 4 to the right of the score on the other side of the tablet. Carbidopa and levodopa extended-release tablets are designed in a drug delivery system that controls the release of carbidopa and levodopa as the tablets slowly erode. The 25 mg/100 mg carbidopa and levodopa extended-release tablet is available to facilitate titration and as an alternative to the half-tablet of 50 mg/200 mg carbidopa and levodopa extended-release. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>0378-0094-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0094-01) </PackageDescription>
<NDC11Code>00378-0094-01</NDC11Code>
<ProductNDC>0378-0094</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19991006</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075091</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>50; 200</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19991006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbidopa and levodopa extended-release tablets are indicated in the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.</IndicationAndUsage>
<Description>Carbidopa and levodopa extended-release tablets, USP are an extended-release combination of carbidopa and levodopa for the treatment of Parkinson’s disease and syndrome. Carbidopa, USP, an inhibitor of aromatic amino acid decarboxylation, is a white to creamy white powder, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-Hydrazino-3,4-dihydroxy-α-methylhydrocinnamic acid monohydrate. Its empirical formula is C10H14N2O4H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.23. Levodopa, USP, an aromatic amino acid, is a white to off-white crystalline powder, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (-)-3-(3,4-Dihydroxyphenyl)-L-alanine. Its empirical formula is C9H11NO4, and its structural formula is. Each extended-release tablet, for oral administration, contains either 25 mg of carbidopa and 100 mg of levodopa, or 50 mg of carbidopa and 200 mg of levodopa. In addition, each tablet contains the following inactive ingredients: FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl cellulose, hypromellose, and magnesium stearate. The 25 mg/100 mg tablets are purple, oval, unscored tablets debossed with MYLAN on one side of the tablet and 88 on the other side of the tablet. The 50 mg/200 mg tablets are purple, oval, scored tablets debossed with MYLAN on one side of the tablet and 9 to the left of the score and 4 to the right of the score on the other side of the tablet. Carbidopa and levodopa extended-release tablets are designed in a drug delivery system that controls the release of carbidopa and levodopa as the tablets slowly erode. The 25 mg/100 mg carbidopa and levodopa extended-release tablet is available to facilitate titration and as an alternative to the half-tablet of 50 mg/200 mg carbidopa and levodopa extended-release. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>0378-0374-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0374-05) </PackageDescription>
<NDC11Code>00378-0374-05</NDC11Code>
<ProductNDC>0378-0374</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron</ProprietaryName>
<NonProprietaryName>Ondansetron</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076930</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>24</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 . , 2 initial and repeat courses of moderately emetogenic cancer chemotherapy. , 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. .</IndicationAndUsage>
<Description>The active ingredient in ondansetron tablets, USP is ondansetron hydrochloride, USP as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is 4H-Carbazol-4-one,1,2,3,9-tetrahydro-9-methyl-3-(2-methyl-1H-imidazol-1-yl)methyl-,monohydrochloride,(±)-,dihydrate. It has the following structural formula. The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9. Ondansetron hydrochloride dihydrate is a white to off-white powder that is soluble in water and normal saline. Each 4 mg ondansetron tablet for oral administration contains ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablet for oral administration contains ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron. Each tablet also contains the inactive ingredients anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch (corn), sodium lauryl sulfate, titanium dioxide and triacetin. In addition, the 8 mg tablet contains FD&C Yellow No. 6 Aluminum Lake. Meets USP Dissolution Test 4.</Description>
</NDC>
<NDC>
<NDCCode>0378-0374-32</NDCCode>
<PackageDescription>1 TABLET, FILM COATED in 1 BLISTER PACK (0378-0374-32) </PackageDescription>
<NDC11Code>00378-0374-32</NDC11Code>
<ProductNDC>0378-0374</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron</ProprietaryName>
<NonProprietaryName>Ondansetron</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076930</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>24</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 . , 2 initial and repeat courses of moderately emetogenic cancer chemotherapy. , 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. .</IndicationAndUsage>
<Description>The active ingredient in ondansetron tablets, USP is ondansetron hydrochloride, USP as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is 4H-Carbazol-4-one,1,2,3,9-tetrahydro-9-methyl-3-(2-methyl-1H-imidazol-1-yl)methyl-,monohydrochloride,(±)-,dihydrate. It has the following structural formula. The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9. Ondansetron hydrochloride dihydrate is a white to off-white powder that is soluble in water and normal saline. Each 4 mg ondansetron tablet for oral administration contains ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablet for oral administration contains ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron. Each tablet also contains the inactive ingredients anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch (corn), sodium lauryl sulfate, titanium dioxide and triacetin. In addition, the 8 mg tablet contains FD&C Yellow No. 6 Aluminum Lake. Meets USP Dissolution Test 4.</Description>
</NDC>
<NDC>
<NDCCode>0378-0374-93</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0374-93) </PackageDescription>
<NDC11Code>00378-0374-93</NDC11Code>
<ProductNDC>0378-0374</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron</ProprietaryName>
<NonProprietaryName>Ondansetron</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076930</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>24</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: : 1 highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 . , 2 initial and repeat courses of moderately emetogenic cancer chemotherapy. , 3 radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. .</IndicationAndUsage>
<Description>The active ingredient in ondansetron tablets, USP is ondansetron hydrochloride, USP as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is 4H-Carbazol-4-one,1,2,3,9-tetrahydro-9-methyl-3-(2-methyl-1H-imidazol-1-yl)methyl-,monohydrochloride,(±)-,dihydrate. It has the following structural formula. The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9. Ondansetron hydrochloride dihydrate is a white to off-white powder that is soluble in water and normal saline. Each 4 mg ondansetron tablet for oral administration contains ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablet for oral administration contains ondansetron hydrochloride dihydrate equivalent to 8 mg of ondansetron. Each tablet also contains the inactive ingredients anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch (corn), sodium lauryl sulfate, titanium dioxide and triacetin. In addition, the 8 mg tablet contains FD&C Yellow No. 6 Aluminum Lake. Meets USP Dissolution Test 4.</Description>
</NDC>
<NDC>
<NDCCode>0378-0472-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0472-01) </PackageDescription>
<NDC11Code>00378-0472-01</NDC11Code>
<ProductNDC>0378-0472</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Divalproex Sodium</ProprietaryName>
<NonProprietaryName>Divalproex Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077567</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0378-0472-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0472-05) </PackageDescription>
<NDC11Code>00378-0472-05</NDC11Code>
<ProductNDC>0378-0472</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Divalproex Sodium</ProprietaryName>
<NonProprietaryName>Divalproex Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077567</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0378-0473-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0473-01) </PackageDescription>
<NDC11Code>00378-0473-01</NDC11Code>
<ProductNDC>0378-0473</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Divalproex Sodium</ProprietaryName>
<NonProprietaryName>Divalproex Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077567</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0378-0473-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0473-05) </PackageDescription>
<NDC11Code>00378-0473-05</NDC11Code>
<ProductNDC>0378-0473</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Divalproex Sodium</ProprietaryName>
<NonProprietaryName>Divalproex Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077567</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DIVALPROEX SODIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0378-0552-77</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (0378-0552-77)</PackageDescription>
<NDC11Code>00378-0552-77</NDC11Code>
<ProductNDC>0378-0552</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pravastatin Sodium</ProprietaryName>
<NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100527</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079187</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-24</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0378-0553-77</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (0378-0553-77)</PackageDescription>
<NDC11Code>00378-0553-77</NDC11Code>
<ProductNDC>0378-0553</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pravastatin Sodium</ProprietaryName>
<NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100527</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079187</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-24</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0378-0554-77</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (0378-0554-77)</PackageDescription>
<NDC11Code>00378-0554-77</NDC11Code>
<ProductNDC>0378-0554</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pravastatin Sodium</ProprietaryName>
<NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100527</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079187</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-24</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0378-0557-77</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (0378-0557-77)</PackageDescription>
<NDC11Code>00378-0557-77</NDC11Code>
<ProductNDC>0378-0557</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pravastatin Sodium</ProprietaryName>
<NonProprietaryName>Pravastatin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100527</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079187</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PRAVASTATIN SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-24</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0378-1089-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0378-1089-01)</PackageDescription>
<NDC11Code>00378-1089-01</NDC11Code>
<ProductNDC>0378-1089</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Meloxicam</ProprietaryName>
<NonProprietaryName>Meloxicam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060719</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077923</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>MELOXICAM</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-24</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0378-1145-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0378-1145-01) </PackageDescription>
<NDC11Code>00378-1145-01</NDC11Code>
<ProductNDC>0378-1145</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076008</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets have been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III1 as follows. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 1.Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 2.Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 3.Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 4.Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge,” irritability, impatience.</IndicationAndUsage>
<Description>Buspirone hydrochloride tablets, USP are an antianxiety agent that are not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The molecular formula C21H31N5O2HCl is represented by the following structural formula. Buspirone hydrochloride tablets are supplied as tablets for oral administration containing 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg, and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg and 30 mg tablets are provided in a multi-scored tablet design. These tablets are scored so they can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet). Buspirone hydrochloride tablets contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and sodium starch glycolate (potato).</Description>
</NDC>
<NDC>
<NDCCode>0378-1418-77</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1418-77)</PackageDescription>
<NDC11Code>00378-1418-77</NDC11Code>
<ProductNDC>0378-1418</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Losartan Potassium And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121005</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091652</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>50; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-24</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0378-1418-93</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1418-93)</PackageDescription>
<NDC11Code>00378-1418-93</NDC11Code>
<ProductNDC>0378-1418</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Losartan Potassium And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Losartan Potassium And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121005</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091652</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>50; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-24</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>