{
"NDC": [
{
"NDCCode": "0781-6185-56",
"PackageDescription": "1 BOTTLE in 1 CARTON (0781-6185-56) / 2.5 mL in 1 BOTTLE",
"NDC11Code": "00781-6185-56",
"ProductNDC": "0781-6185",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Travoprost Ophthalmic Solution",
"NonProprietaryName": "Travoprost",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20191218",
"EndMarketingDate": "20260131",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021994",
"LabelerName": "Sandoz Inc",
"SubstanceName": "TRAVOPROST",
"StrengthNumber": ".04",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Prostaglandin Analog [EPC], Prostaglandins [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20191218",
"EndMarketingDatePackage": "20260131",
"SamplePackage": "N"
},
{
"NDCCode": "0781-6185-75",
"PackageDescription": "1 BOTTLE in 1 CARTON (0781-6185-75) / 5 mL in 1 BOTTLE",
"NDC11Code": "00781-6185-75",
"ProductNDC": "0781-6185",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Travoprost Ophthalmic Solution",
"NonProprietaryName": "Travoprost",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20191218",
"EndMarketingDate": "20260131",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021994",
"LabelerName": "Sandoz Inc",
"SubstanceName": "TRAVOPROST",
"StrengthNumber": ".04",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Prostaglandin Analog [EPC], Prostaglandins [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20191218",
"EndMarketingDatePackage": "20260131",
"SamplePackage": "N"
},
{
"NDCCode": "0781-2043-16",
"PackageDescription": "56 CAPSULE in 1 BOTTLE (0781-2043-16)",
"NDC11Code": "00781-2043-16",
"ProductNDC": "0781-2043",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ribavirin",
"NonProprietaryName": "Ribavirin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20040406",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076192",
"LabelerName": "Sandoz Inc",
"SubstanceName": "RIBAVIRIN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-06-15",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "0781-3485-95",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3485-95) / 2.5 mL in 1 VIAL, SINGLE-DOSE (0781-3485-56) ",
"NDC11Code": "00781-3485-95",
"ProductNDC": "0781-3485",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Iron Sucrose",
"NonProprietaryName": "Iron Sucrose",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250922",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212340",
"LabelerName": "Sandoz Inc",
"SubstanceName": "IRON SUCROSE",
"StrengthNumber": "50",
"StrengthUnit": "mg/2.5mL",
"Pharm_Classes": "Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250922",
"SamplePackage": "N",
"IndicationAndUsage": "Iron sucrose injection is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).",
"Description": "Iron sucrose injection, USP, an iron replacement product, is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. Iron sucrose injection has a molecular weight of approximately 34,000 to 60,000 daltons and a proposed structural formula:. [Na2Fe5O8(OH) ·3(H2O)]n ·m(C12H22O11) where: n is the degree of iron polymerization and m is the number of sucrose molecules associated with the iron (III)-hydroxide. Each mL contains 20 mg elemental iron as iron sucrose in water for injection. Iron sucrose injection is available in 10 mL single-dose vials (200 mg elemental iron per 10 mL), 5 mL single-dose vials (100 mg elemental iron per 5 mL), and 2.5 mL single-dose vials (50 mg elemental iron per 2.5 mL). The drug product contains approximately 30% sucrose w/v (300 mg/mL) and sodium chloride for tonicity. Sodium hydroxide may be added to adjust pH to 10.5 to 11.1. The product contains no preservatives. The osmolarity of the injection is 1,250 mOsmol/L."
},
{
"NDCCode": "0781-5177-16",
"PackageDescription": "56 TABLET, FILM COATED in 1 BOTTLE (0781-5177-16)",
"NDC11Code": "00781-5177-16",
"ProductNDC": "0781-5177",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ribavirin",
"NonProprietaryName": "Ribavirin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061003",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077743",
"LabelerName": "Sandoz Inc",
"SubstanceName": "RIBAVIRIN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-04-30",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "0781-7171-56",
"PackageDescription": "56 AMPULE in 1 CARTON (0781-7171-56) > 5 mL in 1 AMPULE (0781-7171-75) ",
"NDC11Code": "00781-7171-56",
"ProductNDC": "0781-7171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tobramycin",
"NonProprietaryName": "Tobramycin",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20140709",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA050753",
"LabelerName": "Sandoz Inc",
"SubstanceName": "TOBRAMYCIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-07-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20140709",
"SamplePackage": "N"
},
{
"NDCCode": "71335-0781-6",
"PackageDescription": "56 TABLET in 1 BOTTLE (71335-0781-6) ",
"NDC11Code": "71335-0781-06",
"ProductNDC": "71335-0781",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nabumetone",
"NonProprietaryName": "Nabumentone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020225",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075280",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "NABUMETONE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-10-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20061228",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of nabumetone tablets, USP and other treatment options before deciding to use nabumetone tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Nabumetone tablets, USP are indicated: 1 For relief of the signs and symptoms of rheumatoid arthritis. , 2 For relief of the signs and symptoms of osteoarthritis.",
"Description": "Nabumetone is a naphthylalkanone designated chemically as 4-(6-methoxy-2-naphthalenyl)-2-butanone. It has the following structure. nabumetone. Nabumetone is a white to off-white crystalline substance with a molecular weight of 228.3. It is nonacidic and practically insoluble in water, but soluble in alcohol and most organic solvents. It has an n-octanol:phosphate buffer partition coefficient of 2400 at pH 7.4."
},
{
"NDCCode": "0781-5780-31",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0781-5780-31) ",
"NDC11Code": "00781-5780-31",
"ProductNDC": "0781-5780",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201047",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-09-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20120901",
"SamplePackage": "N",
"IndicationAndUsage": "Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease.",
"Description": "Ropinirole extended-release tablets contain ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the molecular formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream colored crystalline powder with a melting range of 241° to 245°C and a solubility of 134 mg/mL in water. Ropinirole extended-release tablets are formulated as a single layer matrix tablets coated with functional polymer. Each biconvex, capsule-shaped tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg of ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethyl cellulose sodium, colloidal silicon dioxide, diethyl phthalate, ethyl cellulose, hydrogenated castor oil, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, maltodextrin, polyethylene glycol, talc, titanium dioxide and ferric oxide. The film coating contains: iron oxide red (for the 2 mg, 4 mg, and 8 mg strengths), iron oxide black (for the 4 mg and 8 mg strengths), iron oxide yellow (for the 4 mg, 8 mg, and 12 mg strengths), polysorbate 80 (for the 6 mg strength), and FD&C Blue No. 2 aluminum lake (for the 12 mg strength)."
},
{
"NDCCode": "0781-5780-92",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0781-5780-92) ",
"NDC11Code": "00781-5780-92",
"ProductNDC": "0781-5780",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201047",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-09-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20120901",
"SamplePackage": "N",
"IndicationAndUsage": "Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease.",
"Description": "Ropinirole extended-release tablets contain ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the molecular formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream colored crystalline powder with a melting range of 241° to 245°C and a solubility of 134 mg/mL in water. Ropinirole extended-release tablets are formulated as a single layer matrix tablets coated with functional polymer. Each biconvex, capsule-shaped tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg of ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethyl cellulose sodium, colloidal silicon dioxide, diethyl phthalate, ethyl cellulose, hydrogenated castor oil, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, maltodextrin, polyethylene glycol, talc, titanium dioxide and ferric oxide. The film coating contains: iron oxide red (for the 2 mg, 4 mg, and 8 mg strengths), iron oxide black (for the 4 mg and 8 mg strengths), iron oxide yellow (for the 4 mg, 8 mg, and 12 mg strengths), polysorbate 80 (for the 6 mg strength), and FD&C Blue No. 2 aluminum lake (for the 12 mg strength)."
},
{
"NDCCode": "0781-5782-31",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0781-5782-31) ",
"NDC11Code": "00781-5782-31",
"ProductNDC": "0781-5782",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201047",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-09-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20120901",
"SamplePackage": "N",
"IndicationAndUsage": "Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease.",
"Description": "Ropinirole extended-release tablets contain ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the molecular formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream colored crystalline powder with a melting range of 241° to 245°C and a solubility of 134 mg/mL in water. Ropinirole extended-release tablets are formulated as a single layer matrix tablets coated with functional polymer. Each biconvex, capsule-shaped tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg of ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethyl cellulose sodium, colloidal silicon dioxide, diethyl phthalate, ethyl cellulose, hydrogenated castor oil, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, maltodextrin, polyethylene glycol, talc, titanium dioxide and ferric oxide. The film coating contains: iron oxide red (for the 2 mg, 4 mg, and 8 mg strengths), iron oxide black (for the 4 mg and 8 mg strengths), iron oxide yellow (for the 4 mg, 8 mg, and 12 mg strengths), polysorbate 80 (for the 6 mg strength), and FD&C Blue No. 2 aluminum lake (for the 12 mg strength)."
},
{
"NDCCode": "0781-5782-92",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0781-5782-92) ",
"NDC11Code": "00781-5782-92",
"ProductNDC": "0781-5782",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201047",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-09-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20120901",
"SamplePackage": "N",
"IndicationAndUsage": "Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease.",
"Description": "Ropinirole extended-release tablets contain ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the molecular formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream colored crystalline powder with a melting range of 241° to 245°C and a solubility of 134 mg/mL in water. Ropinirole extended-release tablets are formulated as a single layer matrix tablets coated with functional polymer. Each biconvex, capsule-shaped tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg of ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethyl cellulose sodium, colloidal silicon dioxide, diethyl phthalate, ethyl cellulose, hydrogenated castor oil, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, maltodextrin, polyethylene glycol, talc, titanium dioxide and ferric oxide. The film coating contains: iron oxide red (for the 2 mg, 4 mg, and 8 mg strengths), iron oxide black (for the 4 mg and 8 mg strengths), iron oxide yellow (for the 4 mg, 8 mg, and 12 mg strengths), polysorbate 80 (for the 6 mg strength), and FD&C Blue No. 2 aluminum lake (for the 12 mg strength)."
},
{
"NDCCode": "0781-5784-31",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0781-5784-31) ",
"NDC11Code": "00781-5784-31",
"ProductNDC": "0781-5784",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201047",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-09-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20120901",
"SamplePackage": "N",
"IndicationAndUsage": "Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease.",
"Description": "Ropinirole extended-release tablets contain ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the molecular formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream colored crystalline powder with a melting range of 241° to 245°C and a solubility of 134 mg/mL in water. Ropinirole extended-release tablets are formulated as a single layer matrix tablets coated with functional polymer. Each biconvex, capsule-shaped tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg of ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethyl cellulose sodium, colloidal silicon dioxide, diethyl phthalate, ethyl cellulose, hydrogenated castor oil, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, maltodextrin, polyethylene glycol, talc, titanium dioxide and ferric oxide. The film coating contains: iron oxide red (for the 2 mg, 4 mg, and 8 mg strengths), iron oxide black (for the 4 mg and 8 mg strengths), iron oxide yellow (for the 4 mg, 8 mg, and 12 mg strengths), polysorbate 80 (for the 6 mg strength), and FD&C Blue No. 2 aluminum lake (for the 12 mg strength)."
},
{
"NDCCode": "0781-5786-31",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0781-5786-31) ",
"NDC11Code": "00781-5786-31",
"ProductNDC": "0781-5786",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201047",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-09-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20120901",
"SamplePackage": "N",
"IndicationAndUsage": "Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease.",
"Description": "Ropinirole extended-release tablets contain ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the molecular formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream colored crystalline powder with a melting range of 241° to 245°C and a solubility of 134 mg/mL in water. Ropinirole extended-release tablets are formulated as a single layer matrix tablets coated with functional polymer. Each biconvex, capsule-shaped tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg of ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethyl cellulose sodium, colloidal silicon dioxide, diethyl phthalate, ethyl cellulose, hydrogenated castor oil, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, maltodextrin, polyethylene glycol, talc, titanium dioxide and ferric oxide. The film coating contains: iron oxide red (for the 2 mg, 4 mg, and 8 mg strengths), iron oxide black (for the 4 mg and 8 mg strengths), iron oxide yellow (for the 4 mg, 8 mg, and 12 mg strengths), polysorbate 80 (for the 6 mg strength), and FD&C Blue No. 2 aluminum lake (for the 12 mg strength)."
},
{
"NDCCode": "0781-5786-92",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0781-5786-92) ",
"NDC11Code": "00781-5786-92",
"ProductNDC": "0781-5786",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201047",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-09-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20120901",
"SamplePackage": "N",
"IndicationAndUsage": "Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease.",
"Description": "Ropinirole extended-release tablets contain ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the molecular formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream colored crystalline powder with a melting range of 241° to 245°C and a solubility of 134 mg/mL in water. Ropinirole extended-release tablets are formulated as a single layer matrix tablets coated with functional polymer. Each biconvex, capsule-shaped tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg of ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethyl cellulose sodium, colloidal silicon dioxide, diethyl phthalate, ethyl cellulose, hydrogenated castor oil, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, maltodextrin, polyethylene glycol, talc, titanium dioxide and ferric oxide. The film coating contains: iron oxide red (for the 2 mg, 4 mg, and 8 mg strengths), iron oxide black (for the 4 mg and 8 mg strengths), iron oxide yellow (for the 4 mg, 8 mg, and 12 mg strengths), polysorbate 80 (for the 6 mg strength), and FD&C Blue No. 2 aluminum lake (for the 12 mg strength)."
},
{
"NDCCode": "0781-5788-31",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0781-5788-31) ",
"NDC11Code": "00781-5788-31",
"ProductNDC": "0781-5788",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201047",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "12",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-09-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20120901",
"SamplePackage": "N",
"IndicationAndUsage": "Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease.",
"Description": "Ropinirole extended-release tablets contain ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the molecular formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream colored crystalline powder with a melting range of 241° to 245°C and a solubility of 134 mg/mL in water. Ropinirole extended-release tablets are formulated as a single layer matrix tablets coated with functional polymer. Each biconvex, capsule-shaped tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg of ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethyl cellulose sodium, colloidal silicon dioxide, diethyl phthalate, ethyl cellulose, hydrogenated castor oil, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, maltodextrin, polyethylene glycol, talc, titanium dioxide and ferric oxide. The film coating contains: iron oxide red (for the 2 mg, 4 mg, and 8 mg strengths), iron oxide black (for the 4 mg and 8 mg strengths), iron oxide yellow (for the 4 mg, 8 mg, and 12 mg strengths), polysorbate 80 (for the 6 mg strength), and FD&C Blue No. 2 aluminum lake (for the 12 mg strength)."
},
{
"NDCCode": "0781-6000-78",
"PackageDescription": "1 BOTTLE in 1 CARTON (0781-6000-78) / 5 mL in 1 BOTTLE",
"NDC11Code": "00781-6000-78",
"ProductNDC": "0781-6000",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Difluprednate Ophthalmic",
"NonProprietaryName": "Difluprednate Ophthalmic",
"DosageFormName": "EMULSION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20130515",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA022212",
"LabelerName": "Sandoz Inc",
"SubstanceName": "DIFLUPREDNATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210915",
"SamplePackage": "N",
"IndicationAndUsage": "Difluprednate ophthalmic emulsion is a corticosteroid indicated for: 1 The treatment of inflammation and pain associated with ocular surgery. (1.1), 2 The treatment of endogenous anterior uveitis. (1.2).",
"Description": "Difluprednate ophthalmic emulsion, 0.05% is a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. The chemical name is 6α,9difluoro-11β,17,21-trihydroxypregna-1,4- diene-3,20-dione 21-acetate 17-butyrate (CAS number 23674-86-4). Difluprednate is represented by the following structural formula. Difluprednate has a molecular weight of 508.56 g/mol, and the empirical formula is C27H34F2O7. Each mL of difluprednate ophthalmic emulsion contains:. Active: difluprednate 0.5 mg (0.05%);. Inactives: boric acid, castor oil, edetate disodium, glycerin, polysorbate 80, sodium acetate, sodium hydroxide (to adjust the pH to 5.2 to 5.8), water for injection. Preservative: sorbic acid 0.1%. The emulsion is essentially isotonic with a tonicity of 304 to 411 mOsm/kg."
},
{
"NDCCode": "0781-7129-40",
"PackageDescription": "3 PACKET in 1 CARTON (0781-7129-40) / 8 POUCH in 1 PACKET (0781-7129-83) / 1 PATCH in 1 POUCH (0781-7129-58) / 3.5 d in 1 PATCH",
"NDC11Code": "00781-7129-40",
"ProductNDC": "0781-7129",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20141222",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020538",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".025",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20141222",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol transdermal system is indicated for.",
"Description": "Estradiol transdermal system contains estradiol in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm2 and contains 0.39, 0.585, 0.78, 1.17, or 1.56 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is. The molecular formula of estradiol is C18H2402. The molecular weight is 272.39 g/mol. Estradiol transdermal system is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film (2) an adhesive formulation containing estradiol, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive."
},
{
"NDCCode": "0781-7129-83",
"PackageDescription": "8 POUCH in 1 CARTON (0781-7129-83) / 1 PATCH in 1 POUCH (0781-7129-58) / 3.5 d in 1 PATCH",
"NDC11Code": "00781-7129-83",
"ProductNDC": "0781-7129",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20141222",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020538",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".025",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141222",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol transdermal system is indicated for.",
"Description": "Estradiol transdermal system contains estradiol in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm2 and contains 0.39, 0.585, 0.78, 1.17, or 1.56 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is. The molecular formula of estradiol is C18H2402. The molecular weight is 272.39 g/mol. Estradiol transdermal system is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film (2) an adhesive formulation containing estradiol, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive."
},
{
"NDCCode": "0781-7138-40",
"PackageDescription": "3 PACKET in 1 CARTON (0781-7138-40) / 8 POUCH in 1 PACKET (0781-7138-83) / 1 PATCH in 1 POUCH (0781-7138-58) / 3.5 d in 1 PATCH",
"NDC11Code": "00781-7138-40",
"ProductNDC": "0781-7138",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20141222",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020538",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".0375",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20141222",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol transdermal system is indicated for.",
"Description": "Estradiol transdermal system contains estradiol in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm2 and contains 0.39, 0.585, 0.78, 1.17, or 1.56 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is. The molecular formula of estradiol is C18H2402. The molecular weight is 272.39 g/mol. Estradiol transdermal system is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film (2) an adhesive formulation containing estradiol, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive."
},
{
"NDCCode": "0781-7138-83",
"PackageDescription": "8 POUCH in 1 CARTON (0781-7138-83) / 1 PATCH in 1 POUCH (0781-7138-58) / 3.5 d in 1 PATCH",
"NDC11Code": "00781-7138-83",
"ProductNDC": "0781-7138",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20141222",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020538",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".0375",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141222",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol transdermal system is indicated for.",
"Description": "Estradiol transdermal system contains estradiol in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm2 and contains 0.39, 0.585, 0.78, 1.17, or 1.56 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is. The molecular formula of estradiol is C18H2402. The molecular weight is 272.39 g/mol. Estradiol transdermal system is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film (2) an adhesive formulation containing estradiol, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive."
},
{
"NDCCode": "0781-7144-40",
"PackageDescription": "3 PACKET in 1 CARTON (0781-7144-40) / 8 POUCH in 1 PACKET (0781-7144-83) / 1 PATCH in 1 POUCH (0781-7144-58) / 3.5 d in 1 PATCH",
"NDC11Code": "00781-7144-40",
"ProductNDC": "0781-7144",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20141222",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020538",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".05",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20141222",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol transdermal system is indicated for.",
"Description": "Estradiol transdermal system contains estradiol in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm2 and contains 0.39, 0.585, 0.78, 1.17, or 1.56 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is. The molecular formula of estradiol is C18H2402. The molecular weight is 272.39 g/mol. Estradiol transdermal system is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film (2) an adhesive formulation containing estradiol, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive."
},
{
"NDCCode": "0781-7144-83",
"PackageDescription": "8 POUCH in 1 CARTON (0781-7144-83) / 1 PATCH in 1 POUCH (0781-7144-58) / 3.5 d in 1 PATCH",
"NDC11Code": "00781-7144-83",
"ProductNDC": "0781-7144",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20141222",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020538",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".05",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141222",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol transdermal system is indicated for.",
"Description": "Estradiol transdermal system contains estradiol in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm2 and contains 0.39, 0.585, 0.78, 1.17, or 1.56 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is. The molecular formula of estradiol is C18H2402. The molecular weight is 272.39 g/mol. Estradiol transdermal system is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film (2) an adhesive formulation containing estradiol, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive."
},
{
"NDCCode": "0781-7156-40",
"PackageDescription": "3 PACKET in 1 CARTON (0781-7156-40) / 8 POUCH in 1 PACKET (0781-7156-83) / 1 PATCH in 1 POUCH (0781-7156-58) / 3.5 d in 1 PATCH",
"NDC11Code": "00781-7156-40",
"ProductNDC": "0781-7156",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20141222",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020538",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".075",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20141222",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol transdermal system is indicated for.",
"Description": "Estradiol transdermal system contains estradiol in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm2 and contains 0.39, 0.585, 0.78, 1.17, or 1.56 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is. The molecular formula of estradiol is C18H2402. The molecular weight is 272.39 g/mol. Estradiol transdermal system is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film (2) an adhesive formulation containing estradiol, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive."
},
{
"NDCCode": "0781-7156-83",
"PackageDescription": "8 POUCH in 1 CARTON (0781-7156-83) / 1 PATCH in 1 POUCH (0781-7156-58) / 3.5 d in 1 PATCH",
"NDC11Code": "00781-7156-83",
"ProductNDC": "0781-7156",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20141222",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020538",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".075",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141222",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol transdermal system is indicated for.",
"Description": "Estradiol transdermal system contains estradiol in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm2 and contains 0.39, 0.585, 0.78, 1.17, or 1.56 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is. The molecular formula of estradiol is C18H2402. The molecular weight is 272.39 g/mol. Estradiol transdermal system is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film (2) an adhesive formulation containing estradiol, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive."
},
{
"NDCCode": "0781-7167-40",
"PackageDescription": "3 PACKET in 1 CARTON (0781-7167-40) / 8 POUCH in 1 PACKET (0781-7167-83) / 1 PATCH in 1 POUCH (0781-7167-58) / 3.5 d in 1 PATCH",
"NDC11Code": "00781-7167-40",
"ProductNDC": "0781-7167",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20141222",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020538",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".1",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20141222",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol transdermal system is indicated for.",
"Description": "Estradiol transdermal system contains estradiol in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm2 and contains 0.39, 0.585, 0.78, 1.17, or 1.56 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is. The molecular formula of estradiol is C18H2402. The molecular weight is 272.39 g/mol. Estradiol transdermal system is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film (2) an adhesive formulation containing estradiol, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive."
},
{
"NDCCode": "0781-7167-83",
"PackageDescription": "8 POUCH in 1 CARTON (0781-7167-83) / 1 PATCH in 1 POUCH (0781-7167-58) / 3.5 d in 1 PATCH",
"NDC11Code": "00781-7167-83",
"ProductNDC": "0781-7167",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20141222",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020538",
"LabelerName": "Sandoz Inc",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".1",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141222",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol transdermal system is indicated for.",
"Description": "Estradiol transdermal system contains estradiol in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm2 and contains 0.39, 0.585, 0.78, 1.17, or 1.56 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is. The molecular formula of estradiol is C18H2402. The molecular weight is 272.39 g/mol. Estradiol transdermal system is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film (2) an adhesive formulation containing estradiol, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive."
},
{
"NDCCode": "31722-781-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (31722-781-30) / 30 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "31722-0781-30",
"ProductNDC": "31722-781",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Afatinib",
"NonProprietaryName": "Afatinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260714",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210750",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "AFATINIB DIMALEATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260714",
"SamplePackage": "N",
"IndicationAndUsage": "Afatinib tablets are a kinase inhibitor indicated for: First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test ( 1.1) Limitations of Use: Safety and efficacy of afatinib tablets were not established in patients whose tumors have resistant EGFR mutations ( 1.1) Treatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy ( 1.2).",
"Description": "Afatinib tablets contain afatinib, a tyrosine kinase inhibitor which is a 4-anilinoquinazoline. Afatinib is presented as the dimaleate salt, with the chemical name 2-butenamide, N-[4-[(3-chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-,(2E)-,(2Z)-2-butenedioate(1:2). Its structural formula is. Afatinib dimaleate is an off-white to yellow color, hygroscopic powder, slightly soluble in dimethyl sulfoxide, dimethylformamide and very slightly soluble in water, with an empirical formula of C 24H 25ClFN 5O 3.2C 4H 4O 4(1:2), and a relative molecular mass of 718.09. Afatinib tablets for oral administration are available in 40 mg, 30 mg, or 20 mg of afatinib (equivalent to 59.12 mg, 44.34 mg, or 29.56 mg afatinib dimaleate, respectively). The inactive ingredients of afatinib tablets are the following: Tablet Core: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose and Coating: hypromellose, polyethylene glycol, polysorbate 80, talc and titanium dioxide."
},
{
"NDCCode": "76420-781-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (76420-781-01) ",
"NDC11Code": "76420-0781-01",
"ProductNDC": "76420-781",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077206",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-02-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240314",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)] :.",
"Description": "Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2HCl is represented by the following structural formula: Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloridetablets USPare supplied for oral administration as scored tablets contain 28 mg, 56 mg and 112 mg sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3."
},
{
"NDCCode": "76420-781-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (76420-781-30) ",
"NDC11Code": "76420-0781-30",
"ProductNDC": "76420-781",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077206",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-02-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240314",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)] :.",
"Description": "Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2HCl is represented by the following structural formula: Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloridetablets USPare supplied for oral administration as scored tablets contain 28 mg, 56 mg and 112 mg sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3."
},
{
"NDCCode": "76420-781-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (76420-781-60) ",
"NDC11Code": "76420-0781-60",
"ProductNDC": "76420-781",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077206",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-02-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240314",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)] :.",
"Description": "Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2HCl is represented by the following structural formula: Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloridetablets USPare supplied for oral administration as scored tablets contain 28 mg, 56 mg and 112 mg sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>0781-6185-56</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0781-6185-56) / 2.5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00781-6185-56</NDC11Code>
<ProductNDC>0781-6185</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Travoprost Ophthalmic Solution</ProprietaryName>
<NonProprietaryName>Travoprost</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20191218</StartMarketingDate>
<EndMarketingDate>20260131</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021994</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>TRAVOPROST</SubstanceName>
<StrengthNumber>.04</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Prostaglandin Analog [EPC], Prostaglandins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20191218</StartMarketingDatePackage>
<EndMarketingDatePackage>20260131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0781-6185-75</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0781-6185-75) / 5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00781-6185-75</NDC11Code>
<ProductNDC>0781-6185</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Travoprost Ophthalmic Solution</ProprietaryName>
<NonProprietaryName>Travoprost</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20191218</StartMarketingDate>
<EndMarketingDate>20260131</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021994</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>TRAVOPROST</SubstanceName>
<StrengthNumber>.04</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Prostaglandin Analog [EPC], Prostaglandins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20191218</StartMarketingDatePackage>
<EndMarketingDatePackage>20260131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0781-2043-16</NDCCode>
<PackageDescription>56 CAPSULE in 1 BOTTLE (0781-2043-16)</PackageDescription>
<NDC11Code>00781-2043-16</NDC11Code>
<ProductNDC>0781-2043</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ribavirin</ProprietaryName>
<NonProprietaryName>Ribavirin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040406</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076192</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>RIBAVIRIN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-06-15</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0781-3485-95</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3485-95) / 2.5 mL in 1 VIAL, SINGLE-DOSE (0781-3485-56) </PackageDescription>
<NDC11Code>00781-3485-95</NDC11Code>
<ProductNDC>0781-3485</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Iron Sucrose</ProprietaryName>
<NonProprietaryName>Iron Sucrose</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250922</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212340</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>IRON SUCROSE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/2.5mL</StrengthUnit>
<Pharm_Classes>Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250922</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Iron sucrose injection is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).</IndicationAndUsage>
<Description>Iron sucrose injection, USP, an iron replacement product, is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use. Iron sucrose injection has a molecular weight of approximately 34,000 to 60,000 daltons and a proposed structural formula:. [Na2Fe5O8(OH) ·3(H2O)]n ·m(C12H22O11) where: n is the degree of iron polymerization and m is the number of sucrose molecules associated with the iron (III)-hydroxide. Each mL contains 20 mg elemental iron as iron sucrose in water for injection. Iron sucrose injection is available in 10 mL single-dose vials (200 mg elemental iron per 10 mL), 5 mL single-dose vials (100 mg elemental iron per 5 mL), and 2.5 mL single-dose vials (50 mg elemental iron per 2.5 mL). The drug product contains approximately 30% sucrose w/v (300 mg/mL) and sodium chloride for tonicity. Sodium hydroxide may be added to adjust pH to 10.5 to 11.1. The product contains no preservatives. The osmolarity of the injection is 1,250 mOsmol/L.</Description>
</NDC>
<NDC>
<NDCCode>0781-5177-16</NDCCode>
<PackageDescription>56 TABLET, FILM COATED in 1 BOTTLE (0781-5177-16)</PackageDescription>
<NDC11Code>00781-5177-16</NDC11Code>
<ProductNDC>0781-5177</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ribavirin</ProprietaryName>
<NonProprietaryName>Ribavirin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061003</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077743</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>RIBAVIRIN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nucleoside Analog [EXT],Nucleoside Analog Antiviral [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-30</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0781-7171-56</NDCCode>
<PackageDescription>56 AMPULE in 1 CARTON (0781-7171-56) > 5 mL in 1 AMPULE (0781-7171-75) </PackageDescription>
<NDC11Code>00781-7171-56</NDC11Code>
<ProductNDC>0781-7171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tobramycin</ProprietaryName>
<NonProprietaryName>Tobramycin</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140709</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA050753</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>TOBRAMYCIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140709</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71335-0781-6</NDCCode>
<PackageDescription>56 TABLET in 1 BOTTLE (71335-0781-6) </PackageDescription>
<NDC11Code>71335-0781-06</NDC11Code>
<ProductNDC>71335-0781</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nabumetone</ProprietaryName>
<NonProprietaryName>Nabumentone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020225</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075280</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>NABUMETONE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-10-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20061228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of nabumetone tablets, USP and other treatment options before deciding to use nabumetone tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Nabumetone tablets, USP are indicated: 1 For relief of the signs and symptoms of rheumatoid arthritis. , 2 For relief of the signs and symptoms of osteoarthritis.</IndicationAndUsage>
<Description>Nabumetone is a naphthylalkanone designated chemically as 4-(6-methoxy-2-naphthalenyl)-2-butanone. It has the following structure. nabumetone. Nabumetone is a white to off-white crystalline substance with a molecular weight of 228.3. It is nonacidic and practically insoluble in water, but soluble in alcohol and most organic solvents. It has an n-octanol:phosphate buffer partition coefficient of 2400 at pH 7.4.</Description>
</NDC>
<NDC>
<NDCCode>0781-5780-31</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0781-5780-31) </PackageDescription>
<NDC11Code>00781-5780-31</NDC11Code>
<ProductNDC>0781-5780</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole</ProprietaryName>
<NonProprietaryName>Ropinirole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201047</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease.</IndicationAndUsage>
<Description>Ropinirole extended-release tablets contain ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the molecular formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream colored crystalline powder with a melting range of 241° to 245°C and a solubility of 134 mg/mL in water. Ropinirole extended-release tablets are formulated as a single layer matrix tablets coated with functional polymer. Each biconvex, capsule-shaped tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg of ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethyl cellulose sodium, colloidal silicon dioxide, diethyl phthalate, ethyl cellulose, hydrogenated castor oil, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, maltodextrin, polyethylene glycol, talc, titanium dioxide and ferric oxide. The film coating contains: iron oxide red (for the 2 mg, 4 mg, and 8 mg strengths), iron oxide black (for the 4 mg and 8 mg strengths), iron oxide yellow (for the 4 mg, 8 mg, and 12 mg strengths), polysorbate 80 (for the 6 mg strength), and FD&C Blue No. 2 aluminum lake (for the 12 mg strength).</Description>
</NDC>
<NDC>
<NDCCode>0781-5780-92</NDCCode>
<PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0781-5780-92) </PackageDescription>
<NDC11Code>00781-5780-92</NDC11Code>
<ProductNDC>0781-5780</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole</ProprietaryName>
<NonProprietaryName>Ropinirole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201047</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease.</IndicationAndUsage>
<Description>Ropinirole extended-release tablets contain ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the molecular formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream colored crystalline powder with a melting range of 241° to 245°C and a solubility of 134 mg/mL in water. Ropinirole extended-release tablets are formulated as a single layer matrix tablets coated with functional polymer. Each biconvex, capsule-shaped tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg of ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethyl cellulose sodium, colloidal silicon dioxide, diethyl phthalate, ethyl cellulose, hydrogenated castor oil, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, maltodextrin, polyethylene glycol, talc, titanium dioxide and ferric oxide. The film coating contains: iron oxide red (for the 2 mg, 4 mg, and 8 mg strengths), iron oxide black (for the 4 mg and 8 mg strengths), iron oxide yellow (for the 4 mg, 8 mg, and 12 mg strengths), polysorbate 80 (for the 6 mg strength), and FD&C Blue No. 2 aluminum lake (for the 12 mg strength).</Description>
</NDC>
<NDC>
<NDCCode>0781-5782-31</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0781-5782-31) </PackageDescription>
<NDC11Code>00781-5782-31</NDC11Code>
<ProductNDC>0781-5782</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole</ProprietaryName>
<NonProprietaryName>Ropinirole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201047</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease.</IndicationAndUsage>
<Description>Ropinirole extended-release tablets contain ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the molecular formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream colored crystalline powder with a melting range of 241° to 245°C and a solubility of 134 mg/mL in water. Ropinirole extended-release tablets are formulated as a single layer matrix tablets coated with functional polymer. Each biconvex, capsule-shaped tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg of ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethyl cellulose sodium, colloidal silicon dioxide, diethyl phthalate, ethyl cellulose, hydrogenated castor oil, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, maltodextrin, polyethylene glycol, talc, titanium dioxide and ferric oxide. The film coating contains: iron oxide red (for the 2 mg, 4 mg, and 8 mg strengths), iron oxide black (for the 4 mg and 8 mg strengths), iron oxide yellow (for the 4 mg, 8 mg, and 12 mg strengths), polysorbate 80 (for the 6 mg strength), and FD&C Blue No. 2 aluminum lake (for the 12 mg strength).</Description>
</NDC>
<NDC>
<NDCCode>0781-5782-92</NDCCode>
<PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0781-5782-92) </PackageDescription>
<NDC11Code>00781-5782-92</NDC11Code>
<ProductNDC>0781-5782</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole</ProprietaryName>
<NonProprietaryName>Ropinirole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201047</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease.</IndicationAndUsage>
<Description>Ropinirole extended-release tablets contain ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the molecular formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream colored crystalline powder with a melting range of 241° to 245°C and a solubility of 134 mg/mL in water. Ropinirole extended-release tablets are formulated as a single layer matrix tablets coated with functional polymer. Each biconvex, capsule-shaped tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg of ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethyl cellulose sodium, colloidal silicon dioxide, diethyl phthalate, ethyl cellulose, hydrogenated castor oil, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, maltodextrin, polyethylene glycol, talc, titanium dioxide and ferric oxide. The film coating contains: iron oxide red (for the 2 mg, 4 mg, and 8 mg strengths), iron oxide black (for the 4 mg and 8 mg strengths), iron oxide yellow (for the 4 mg, 8 mg, and 12 mg strengths), polysorbate 80 (for the 6 mg strength), and FD&C Blue No. 2 aluminum lake (for the 12 mg strength).</Description>
</NDC>
<NDC>
<NDCCode>0781-5784-31</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0781-5784-31) </PackageDescription>
<NDC11Code>00781-5784-31</NDC11Code>
<ProductNDC>0781-5784</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole</ProprietaryName>
<NonProprietaryName>Ropinirole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201047</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease.</IndicationAndUsage>
<Description>Ropinirole extended-release tablets contain ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the molecular formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream colored crystalline powder with a melting range of 241° to 245°C and a solubility of 134 mg/mL in water. Ropinirole extended-release tablets are formulated as a single layer matrix tablets coated with functional polymer. Each biconvex, capsule-shaped tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg of ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethyl cellulose sodium, colloidal silicon dioxide, diethyl phthalate, ethyl cellulose, hydrogenated castor oil, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, maltodextrin, polyethylene glycol, talc, titanium dioxide and ferric oxide. The film coating contains: iron oxide red (for the 2 mg, 4 mg, and 8 mg strengths), iron oxide black (for the 4 mg and 8 mg strengths), iron oxide yellow (for the 4 mg, 8 mg, and 12 mg strengths), polysorbate 80 (for the 6 mg strength), and FD&C Blue No. 2 aluminum lake (for the 12 mg strength).</Description>
</NDC>
<NDC>
<NDCCode>0781-5786-31</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0781-5786-31) </PackageDescription>
<NDC11Code>00781-5786-31</NDC11Code>
<ProductNDC>0781-5786</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole</ProprietaryName>
<NonProprietaryName>Ropinirole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201047</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease.</IndicationAndUsage>
<Description>Ropinirole extended-release tablets contain ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the molecular formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream colored crystalline powder with a melting range of 241° to 245°C and a solubility of 134 mg/mL in water. Ropinirole extended-release tablets are formulated as a single layer matrix tablets coated with functional polymer. Each biconvex, capsule-shaped tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg of ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethyl cellulose sodium, colloidal silicon dioxide, diethyl phthalate, ethyl cellulose, hydrogenated castor oil, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, maltodextrin, polyethylene glycol, talc, titanium dioxide and ferric oxide. The film coating contains: iron oxide red (for the 2 mg, 4 mg, and 8 mg strengths), iron oxide black (for the 4 mg and 8 mg strengths), iron oxide yellow (for the 4 mg, 8 mg, and 12 mg strengths), polysorbate 80 (for the 6 mg strength), and FD&C Blue No. 2 aluminum lake (for the 12 mg strength).</Description>
</NDC>
<NDC>
<NDCCode>0781-5786-92</NDCCode>
<PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0781-5786-92) </PackageDescription>
<NDC11Code>00781-5786-92</NDC11Code>
<ProductNDC>0781-5786</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole</ProprietaryName>
<NonProprietaryName>Ropinirole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201047</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease.</IndicationAndUsage>
<Description>Ropinirole extended-release tablets contain ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the molecular formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream colored crystalline powder with a melting range of 241° to 245°C and a solubility of 134 mg/mL in water. Ropinirole extended-release tablets are formulated as a single layer matrix tablets coated with functional polymer. Each biconvex, capsule-shaped tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg of ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethyl cellulose sodium, colloidal silicon dioxide, diethyl phthalate, ethyl cellulose, hydrogenated castor oil, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, maltodextrin, polyethylene glycol, talc, titanium dioxide and ferric oxide. The film coating contains: iron oxide red (for the 2 mg, 4 mg, and 8 mg strengths), iron oxide black (for the 4 mg and 8 mg strengths), iron oxide yellow (for the 4 mg, 8 mg, and 12 mg strengths), polysorbate 80 (for the 6 mg strength), and FD&C Blue No. 2 aluminum lake (for the 12 mg strength).</Description>
</NDC>
<NDC>
<NDCCode>0781-5788-31</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0781-5788-31) </PackageDescription>
<NDC11Code>00781-5788-31</NDC11Code>
<ProductNDC>0781-5788</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole</ProprietaryName>
<NonProprietaryName>Ropinirole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201047</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease.</IndicationAndUsage>
<Description>Ropinirole extended-release tablets contain ropinirole, a non-ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the molecular formula is C16H24N2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to cream colored crystalline powder with a melting range of 241° to 245°C and a solubility of 134 mg/mL in water. Ropinirole extended-release tablets are formulated as a single layer matrix tablets coated with functional polymer. Each biconvex, capsule-shaped tablet contains 2.28 mg, 4.56 mg, 6.84 mg, 9.12 mg, or 13.68 mg of ropinirole hydrochloride equivalent to ropinirole 2 mg, 4 mg, 6 mg, 8 mg, or 12 mg, respectively. Inactive ingredients consist of carboxymethyl cellulose sodium, colloidal silicon dioxide, diethyl phthalate, ethyl cellulose, hydrogenated castor oil, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, maltodextrin, polyethylene glycol, talc, titanium dioxide and ferric oxide. The film coating contains: iron oxide red (for the 2 mg, 4 mg, and 8 mg strengths), iron oxide black (for the 4 mg and 8 mg strengths), iron oxide yellow (for the 4 mg, 8 mg, and 12 mg strengths), polysorbate 80 (for the 6 mg strength), and FD&C Blue No. 2 aluminum lake (for the 12 mg strength).</Description>
</NDC>
<NDC>
<NDCCode>0781-6000-78</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0781-6000-78) / 5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00781-6000-78</NDC11Code>
<ProductNDC>0781-6000</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Difluprednate Ophthalmic</ProprietaryName>
<NonProprietaryName>Difluprednate Ophthalmic</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20130515</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA022212</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>DIFLUPREDNATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Difluprednate ophthalmic emulsion is a corticosteroid indicated for: 1 The treatment of inflammation and pain associated with ocular surgery. (1.1), 2 The treatment of endogenous anterior uveitis. (1.2).</IndicationAndUsage>
<Description>Difluprednate ophthalmic emulsion, 0.05% is a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. The chemical name is 6α,9difluoro-11β,17,21-trihydroxypregna-1,4- diene-3,20-dione 21-acetate 17-butyrate (CAS number 23674-86-4). Difluprednate is represented by the following structural formula. Difluprednate has a molecular weight of 508.56 g/mol, and the empirical formula is C27H34F2O7. Each mL of difluprednate ophthalmic emulsion contains:. Active: difluprednate 0.5 mg (0.05%);. Inactives: boric acid, castor oil, edetate disodium, glycerin, polysorbate 80, sodium acetate, sodium hydroxide (to adjust the pH to 5.2 to 5.8), water for injection. Preservative: sorbic acid 0.1%. The emulsion is essentially isotonic with a tonicity of 304 to 411 mOsm/kg.</Description>
</NDC>
<NDC>
<NDCCode>0781-7129-40</NDCCode>
<PackageDescription>3 PACKET in 1 CARTON (0781-7129-40) / 8 POUCH in 1 PACKET (0781-7129-83) / 1 PATCH in 1 POUCH (0781-7129-58) / 3.5 d in 1 PATCH</PackageDescription>
<NDC11Code>00781-7129-40</NDC11Code>
<ProductNDC>0781-7129</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20141222</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020538</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.025</StrengthNumber>
<StrengthUnit>mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol transdermal system is indicated for.</IndicationAndUsage>
<Description>Estradiol transdermal system contains estradiol in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm2 and contains 0.39, 0.585, 0.78, 1.17, or 1.56 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is. The molecular formula of estradiol is C18H2402. The molecular weight is 272.39 g/mol. Estradiol transdermal system is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film (2) an adhesive formulation containing estradiol, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive.</Description>
</NDC>
<NDC>
<NDCCode>0781-7129-83</NDCCode>
<PackageDescription>8 POUCH in 1 CARTON (0781-7129-83) / 1 PATCH in 1 POUCH (0781-7129-58) / 3.5 d in 1 PATCH</PackageDescription>
<NDC11Code>00781-7129-83</NDC11Code>
<ProductNDC>0781-7129</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20141222</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020538</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.025</StrengthNumber>
<StrengthUnit>mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol transdermal system is indicated for.</IndicationAndUsage>
<Description>Estradiol transdermal system contains estradiol in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm2 and contains 0.39, 0.585, 0.78, 1.17, or 1.56 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is. The molecular formula of estradiol is C18H2402. The molecular weight is 272.39 g/mol. Estradiol transdermal system is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film (2) an adhesive formulation containing estradiol, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive.</Description>
</NDC>
<NDC>
<NDCCode>0781-7138-40</NDCCode>
<PackageDescription>3 PACKET in 1 CARTON (0781-7138-40) / 8 POUCH in 1 PACKET (0781-7138-83) / 1 PATCH in 1 POUCH (0781-7138-58) / 3.5 d in 1 PATCH</PackageDescription>
<NDC11Code>00781-7138-40</NDC11Code>
<ProductNDC>0781-7138</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20141222</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020538</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.0375</StrengthNumber>
<StrengthUnit>mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol transdermal system is indicated for.</IndicationAndUsage>
<Description>Estradiol transdermal system contains estradiol in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm2 and contains 0.39, 0.585, 0.78, 1.17, or 1.56 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is. The molecular formula of estradiol is C18H2402. The molecular weight is 272.39 g/mol. Estradiol transdermal system is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film (2) an adhesive formulation containing estradiol, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive.</Description>
</NDC>
<NDC>
<NDCCode>0781-7138-83</NDCCode>
<PackageDescription>8 POUCH in 1 CARTON (0781-7138-83) / 1 PATCH in 1 POUCH (0781-7138-58) / 3.5 d in 1 PATCH</PackageDescription>
<NDC11Code>00781-7138-83</NDC11Code>
<ProductNDC>0781-7138</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20141222</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020538</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.0375</StrengthNumber>
<StrengthUnit>mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol transdermal system is indicated for.</IndicationAndUsage>
<Description>Estradiol transdermal system contains estradiol in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm2 and contains 0.39, 0.585, 0.78, 1.17, or 1.56 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is. The molecular formula of estradiol is C18H2402. The molecular weight is 272.39 g/mol. Estradiol transdermal system is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film (2) an adhesive formulation containing estradiol, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive.</Description>
</NDC>
<NDC>
<NDCCode>0781-7144-40</NDCCode>
<PackageDescription>3 PACKET in 1 CARTON (0781-7144-40) / 8 POUCH in 1 PACKET (0781-7144-83) / 1 PATCH in 1 POUCH (0781-7144-58) / 3.5 d in 1 PATCH</PackageDescription>
<NDC11Code>00781-7144-40</NDC11Code>
<ProductNDC>0781-7144</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20141222</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020538</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol transdermal system is indicated for.</IndicationAndUsage>
<Description>Estradiol transdermal system contains estradiol in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm2 and contains 0.39, 0.585, 0.78, 1.17, or 1.56 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is. The molecular formula of estradiol is C18H2402. The molecular weight is 272.39 g/mol. Estradiol transdermal system is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film (2) an adhesive formulation containing estradiol, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive.</Description>
</NDC>
<NDC>
<NDCCode>0781-7144-83</NDCCode>
<PackageDescription>8 POUCH in 1 CARTON (0781-7144-83) / 1 PATCH in 1 POUCH (0781-7144-58) / 3.5 d in 1 PATCH</PackageDescription>
<NDC11Code>00781-7144-83</NDC11Code>
<ProductNDC>0781-7144</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20141222</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020538</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol transdermal system is indicated for.</IndicationAndUsage>
<Description>Estradiol transdermal system contains estradiol in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm2 and contains 0.39, 0.585, 0.78, 1.17, or 1.56 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is. The molecular formula of estradiol is C18H2402. The molecular weight is 272.39 g/mol. Estradiol transdermal system is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film (2) an adhesive formulation containing estradiol, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive.</Description>
</NDC>
<NDC>
<NDCCode>0781-7156-40</NDCCode>
<PackageDescription>3 PACKET in 1 CARTON (0781-7156-40) / 8 POUCH in 1 PACKET (0781-7156-83) / 1 PATCH in 1 POUCH (0781-7156-58) / 3.5 d in 1 PATCH</PackageDescription>
<NDC11Code>00781-7156-40</NDC11Code>
<ProductNDC>0781-7156</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20141222</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020538</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.075</StrengthNumber>
<StrengthUnit>mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol transdermal system is indicated for.</IndicationAndUsage>
<Description>Estradiol transdermal system contains estradiol in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm2 and contains 0.39, 0.585, 0.78, 1.17, or 1.56 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is. The molecular formula of estradiol is C18H2402. The molecular weight is 272.39 g/mol. Estradiol transdermal system is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film (2) an adhesive formulation containing estradiol, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive.</Description>
</NDC>
<NDC>
<NDCCode>0781-7156-83</NDCCode>
<PackageDescription>8 POUCH in 1 CARTON (0781-7156-83) / 1 PATCH in 1 POUCH (0781-7156-58) / 3.5 d in 1 PATCH</PackageDescription>
<NDC11Code>00781-7156-83</NDC11Code>
<ProductNDC>0781-7156</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20141222</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020538</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.075</StrengthNumber>
<StrengthUnit>mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol transdermal system is indicated for.</IndicationAndUsage>
<Description>Estradiol transdermal system contains estradiol in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm2 and contains 0.39, 0.585, 0.78, 1.17, or 1.56 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is. The molecular formula of estradiol is C18H2402. The molecular weight is 272.39 g/mol. Estradiol transdermal system is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film (2) an adhesive formulation containing estradiol, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive.</Description>
</NDC>
<NDC>
<NDCCode>0781-7167-40</NDCCode>
<PackageDescription>3 PACKET in 1 CARTON (0781-7167-40) / 8 POUCH in 1 PACKET (0781-7167-83) / 1 PATCH in 1 POUCH (0781-7167-58) / 3.5 d in 1 PATCH</PackageDescription>
<NDC11Code>00781-7167-40</NDC11Code>
<ProductNDC>0781-7167</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20141222</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020538</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol transdermal system is indicated for.</IndicationAndUsage>
<Description>Estradiol transdermal system contains estradiol in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm2 and contains 0.39, 0.585, 0.78, 1.17, or 1.56 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is. The molecular formula of estradiol is C18H2402. The molecular weight is 272.39 g/mol. Estradiol transdermal system is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film (2) an adhesive formulation containing estradiol, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive.</Description>
</NDC>
<NDC>
<NDCCode>0781-7167-83</NDCCode>
<PackageDescription>8 POUCH in 1 CARTON (0781-7167-83) / 1 PATCH in 1 POUCH (0781-7167-58) / 3.5 d in 1 PATCH</PackageDescription>
<NDC11Code>00781-7167-83</NDC11Code>
<ProductNDC>0781-7167</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20141222</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020538</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol transdermal system is indicated for.</IndicationAndUsage>
<Description>Estradiol transdermal system contains estradiol in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm2 and contains 0.39, 0.585, 0.78, 1.17, or 1.56 mg of estradiol USP, respectively. The composition of the systems per unit area is identical. Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The structural formula is. The molecular formula of estradiol is C18H2402. The molecular weight is 272.39 g/mol. Estradiol transdermal system is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film (2) an adhesive formulation containing estradiol, acrylic adhesive, silicone adhesive, oleyl alcohol, NF, povidone, USP and dipropylene glycol, and (3) a polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive.</Description>
</NDC>
<NDC>
<NDCCode>31722-781-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (31722-781-30) / 30 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>31722-0781-30</NDC11Code>
<ProductNDC>31722-781</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Afatinib</ProprietaryName>
<NonProprietaryName>Afatinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260714</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210750</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AFATINIB DIMALEATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Afatinib tablets are a kinase inhibitor indicated for: First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test ( 1.1) Limitations of Use: Safety and efficacy of afatinib tablets were not established in patients whose tumors have resistant EGFR mutations ( 1.1) Treatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy ( 1.2).</IndicationAndUsage>
<Description>Afatinib tablets contain afatinib, a tyrosine kinase inhibitor which is a 4-anilinoquinazoline. Afatinib is presented as the dimaleate salt, with the chemical name 2-butenamide, N-[4-[(3-chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-,(2E)-,(2Z)-2-butenedioate(1:2). Its structural formula is. Afatinib dimaleate is an off-white to yellow color, hygroscopic powder, slightly soluble in dimethyl sulfoxide, dimethylformamide and very slightly soluble in water, with an empirical formula of C 24H 25ClFN 5O 3.2C 4H 4O 4(1:2), and a relative molecular mass of 718.09. Afatinib tablets for oral administration are available in 40 mg, 30 mg, or 20 mg of afatinib (equivalent to 59.12 mg, 44.34 mg, or 29.56 mg afatinib dimaleate, respectively). The inactive ingredients of afatinib tablets are the following: Tablet Core: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose and Coating: hypromellose, polyethylene glycol, polysorbate 80, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>76420-781-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (76420-781-01) </PackageDescription>
<NDC11Code>76420-0781-01</NDC11Code>
<ProductNDC>76420-781</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077206</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)] :.</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2HCl is represented by the following structural formula: Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloridetablets USPare supplied for oral administration as scored tablets contain 28 mg, 56 mg and 112 mg sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3.</Description>
</NDC>
<NDC>
<NDCCode>76420-781-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (76420-781-30) </PackageDescription>
<NDC11Code>76420-0781-30</NDC11Code>
<ProductNDC>76420-781</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077206</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)] :.</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2HCl is represented by the following structural formula: Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloridetablets USPare supplied for oral administration as scored tablets contain 28 mg, 56 mg and 112 mg sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3.</Description>
</NDC>
<NDC>
<NDCCode>76420-781-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (76420-781-60) </PackageDescription>
<NDC11Code>76420-0781-60</NDC11Code>
<ProductNDC>76420-781</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077206</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)] :.</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2HCl is represented by the following structural formula: Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloridetablets USPare supplied for oral administration as scored tablets contain 28 mg, 56 mg and 112 mg sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3.</Description>
</NDC>
</NDCList>