{
"NDC": [
{
"NDCCode": "55111-799-84",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (55111-799-84) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "55111-0799-84",
"ProductNDC": "55111-799",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Guaifenesin And Pseudoephedrine Hcl",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"StartMarketingDate": "20171229",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "1200; 120",
"StrengthUnit": "mg/1; mg/1",
"Status": "Unfinished",
"LastUpdate": "2024-07-04",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "29-DEC-17"
},
{
"NDCCode": "71610-799-54",
"PackageDescription": "84 CAPSULE in 1 BOTTLE (71610-799-54) ",
"NDC11Code": "71610-0799-54",
"ProductNDC": "71610-799",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20210824",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208677",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2024-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240222",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline powder with a pK a1of 4.2 and a pK a2of 10.6. It is sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide and sodium lauryl sulfate. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain the colorants FD&C Blue 1, FD&C Red 40 and FD&C Yellow 6. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide."
},
{
"NDCCode": "55111-799-04",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (55111-799-04) / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (55111-799-06) ",
"NDC11Code": "55111-0799-04",
"ProductNDC": "55111-799",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guaifenesin And Pseudoephedrine Hcl",
"NonProprietaryName": "Guaifenesin And Pseudoephedrine Hcl",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20171229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208369",
"LabelerName": "Dr. Reddys Laboratories Limited",
"SubstanceName": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "1200; 120",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171229",
"SamplePackage": "N",
"IndicationAndUsage": "■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bother some mucus and make coughs more productive. ■ temporarily relieves nasal congestion due to:. ■ common cold. ■ hay fever. ■ upper respiratory allergies. ■ temporarily restores freer breathing through the nose. ■ promotes nasal and/or sinus drainage. ■ temporarily relieves sinus congestion and pressure."
},
{
"NDCCode": "55111-799-12",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (55111-799-12) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "55111-0799-12",
"ProductNDC": "55111-799",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guaifenesin And Pseudoephedrine Hcl",
"NonProprietaryName": "Guaifenesin And Pseudoephedrine Hcl",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20171229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208369",
"LabelerName": "Dr. Reddys Laboratories Limited",
"SubstanceName": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "1200; 120",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171229",
"SamplePackage": "N",
"IndicationAndUsage": "■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bother some mucus and make coughs more productive. ■ temporarily relieves nasal congestion due to:. ■ common cold. ■ hay fever. ■ upper respiratory allergies. ■ temporarily restores freer breathing through the nose. ■ promotes nasal and/or sinus drainage. ■ temporarily relieves sinus congestion and pressure."
},
{
"NDCCode": "55111-799-24",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (55111-799-24) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "55111-0799-24",
"ProductNDC": "55111-799",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guaifenesin And Pseudoephedrine Hcl",
"NonProprietaryName": "Guaifenesin And Pseudoephedrine Hcl",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20171229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208369",
"LabelerName": "Dr. Reddys Laboratories Limited",
"SubstanceName": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "1200; 120",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171229",
"SamplePackage": "N",
"IndicationAndUsage": "■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bother some mucus and make coughs more productive. ■ temporarily relieves nasal congestion due to:. ■ common cold. ■ hay fever. ■ upper respiratory allergies. ■ temporarily restores freer breathing through the nose. ■ promotes nasal and/or sinus drainage. ■ temporarily relieves sinus congestion and pressure."
},
{
"NDCCode": "55111-799-36",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (55111-799-36) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "55111-0799-36",
"ProductNDC": "55111-799",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guaifenesin And Pseudoephedrine Hcl",
"NonProprietaryName": "Guaifenesin And Pseudoephedrine Hcl",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20171229",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208369",
"LabelerName": "Dr. Reddys Laboratories Limited",
"SubstanceName": "GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "1200; 120",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171229",
"SamplePackage": "N",
"IndicationAndUsage": "■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bother some mucus and make coughs more productive. ■ temporarily relieves nasal congestion due to:. ■ common cold. ■ hay fever. ■ upper respiratory allergies. ■ temporarily restores freer breathing through the nose. ■ promotes nasal and/or sinus drainage. ■ temporarily relieves sinus congestion and pressure."
},
{
"NDCCode": "55111-659-05",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-659-05) ",
"NDC11Code": "55111-0659-05",
"ProductNDC": "55111-659",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120606",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201576",
"LabelerName": "Dr. Reddys Laboratories Limited",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120606",
"SamplePackage": "N",
"Description": "Ropinirole extended-release tablets, USP contains 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 USP is a pale cream to light pinkish – yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Ropinirole extended-release tablets, USP are formulated as a monolithic slow release matrix tablet with coating. Each biconvex, capsule-shaped tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg of ropinirole hydrochloride USP equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients consist of anhydrous lactose, carboxy methylcellulose sodium, colloidal silicon dioxide, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and triethyl citrate. Additionally red iron oxide (for 2 mg and 8 mg tablet), FD&C Yellow #6 (for 4 mg tablet), FD&C Blue #2 (for 4 mg and 12 mg tablet), yellow iron oxide (for 8 mg and 12 mg tablet) and black iron oxide (for 8 mg tablet). Ropinirole extended-release tablets meets USP Dissolution Test 4."
},
{
"NDCCode": "55111-659-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-659-30) ",
"NDC11Code": "55111-0659-30",
"ProductNDC": "55111-659",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120606",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201576",
"LabelerName": "Dr. Reddys Laboratories Limited",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120606",
"SamplePackage": "N",
"Description": "Ropinirole extended-release tablets, USP contains 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 USP is a pale cream to light pinkish – yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Ropinirole extended-release tablets, USP are formulated as a monolithic slow release matrix tablet with coating. Each biconvex, capsule-shaped tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg of ropinirole hydrochloride USP equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients consist of anhydrous lactose, carboxy methylcellulose sodium, colloidal silicon dioxide, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and triethyl citrate. Additionally red iron oxide (for 2 mg and 8 mg tablet), FD&C Yellow #6 (for 4 mg tablet), FD&C Blue #2 (for 4 mg and 12 mg tablet), yellow iron oxide (for 8 mg and 12 mg tablet) and black iron oxide (for 8 mg tablet). Ropinirole extended-release tablets meets USP Dissolution Test 4."
},
{
"NDCCode": "55111-659-90",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-659-90) ",
"NDC11Code": "55111-0659-90",
"ProductNDC": "55111-659",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120606",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201576",
"LabelerName": "Dr. Reddys Laboratories Limited",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120606",
"SamplePackage": "N",
"Description": "Ropinirole extended-release tablets, USP contains 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 USP is a pale cream to light pinkish – yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Ropinirole extended-release tablets, USP are formulated as a monolithic slow release matrix tablet with coating. Each biconvex, capsule-shaped tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg of ropinirole hydrochloride USP equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients consist of anhydrous lactose, carboxy methylcellulose sodium, colloidal silicon dioxide, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and triethyl citrate. Additionally red iron oxide (for 2 mg and 8 mg tablet), FD&C Yellow #6 (for 4 mg tablet), FD&C Blue #2 (for 4 mg and 12 mg tablet), yellow iron oxide (for 8 mg and 12 mg tablet) and black iron oxide (for 8 mg tablet). Ropinirole extended-release tablets meets USP Dissolution Test 4."
},
{
"NDCCode": "55111-661-05",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-661-05) ",
"NDC11Code": "55111-0661-05",
"ProductNDC": "55111-661",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120606",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201576",
"LabelerName": "Dr. Reddys Laboratories Limited",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120606",
"SamplePackage": "N",
"Description": "Ropinirole extended-release tablets, USP contains 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 USP is a pale cream to light pinkish – yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Ropinirole extended-release tablets, USP are formulated as a monolithic slow release matrix tablet with coating. Each biconvex, capsule-shaped tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg of ropinirole hydrochloride USP equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients consist of anhydrous lactose, carboxy methylcellulose sodium, colloidal silicon dioxide, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and triethyl citrate. Additionally red iron oxide (for 2 mg and 8 mg tablet), FD&C Yellow #6 (for 4 mg tablet), FD&C Blue #2 (for 4 mg and 12 mg tablet), yellow iron oxide (for 8 mg and 12 mg tablet) and black iron oxide (for 8 mg tablet). Ropinirole extended-release tablets meets USP Dissolution Test 4."
},
{
"NDCCode": "55111-661-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-661-30) ",
"NDC11Code": "55111-0661-30",
"ProductNDC": "55111-661",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120606",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201576",
"LabelerName": "Dr. Reddys Laboratories Limited",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120606",
"SamplePackage": "N",
"Description": "Ropinirole extended-release tablets, USP contains 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 USP is a pale cream to light pinkish – yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Ropinirole extended-release tablets, USP are formulated as a monolithic slow release matrix tablet with coating. Each biconvex, capsule-shaped tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg of ropinirole hydrochloride USP equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients consist of anhydrous lactose, carboxy methylcellulose sodium, colloidal silicon dioxide, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and triethyl citrate. Additionally red iron oxide (for 2 mg and 8 mg tablet), FD&C Yellow #6 (for 4 mg tablet), FD&C Blue #2 (for 4 mg and 12 mg tablet), yellow iron oxide (for 8 mg and 12 mg tablet) and black iron oxide (for 8 mg tablet). Ropinirole extended-release tablets meets USP Dissolution Test 4."
},
{
"NDCCode": "55111-661-90",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-661-90) ",
"NDC11Code": "55111-0661-90",
"ProductNDC": "55111-661",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120606",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201576",
"LabelerName": "Dr. Reddys Laboratories Limited",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120606",
"SamplePackage": "N",
"Description": "Ropinirole extended-release tablets, USP contains 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 USP is a pale cream to light pinkish – yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Ropinirole extended-release tablets, USP are formulated as a monolithic slow release matrix tablet with coating. Each biconvex, capsule-shaped tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg of ropinirole hydrochloride USP equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients consist of anhydrous lactose, carboxy methylcellulose sodium, colloidal silicon dioxide, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and triethyl citrate. Additionally red iron oxide (for 2 mg and 8 mg tablet), FD&C Yellow #6 (for 4 mg tablet), FD&C Blue #2 (for 4 mg and 12 mg tablet), yellow iron oxide (for 8 mg and 12 mg tablet) and black iron oxide (for 8 mg tablet). Ropinirole extended-release tablets meets USP Dissolution Test 4."
},
{
"NDCCode": "55111-662-05",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-662-05) ",
"NDC11Code": "55111-0662-05",
"ProductNDC": "55111-662",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120606",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201576",
"LabelerName": "Dr. Reddys Laboratories Limited",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120606",
"SamplePackage": "N",
"Description": "Ropinirole extended-release tablets, USP contains 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 USP is a pale cream to light pinkish – yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Ropinirole extended-release tablets, USP are formulated as a monolithic slow release matrix tablet with coating. Each biconvex, capsule-shaped tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg of ropinirole hydrochloride USP equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients consist of anhydrous lactose, carboxy methylcellulose sodium, colloidal silicon dioxide, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and triethyl citrate. Additionally red iron oxide (for 2 mg and 8 mg tablet), FD&C Yellow #6 (for 4 mg tablet), FD&C Blue #2 (for 4 mg and 12 mg tablet), yellow iron oxide (for 8 mg and 12 mg tablet) and black iron oxide (for 8 mg tablet). Ropinirole extended-release tablets meets USP Dissolution Test 4."
},
{
"NDCCode": "55111-662-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-662-30) ",
"NDC11Code": "55111-0662-30",
"ProductNDC": "55111-662",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120606",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201576",
"LabelerName": "Dr. Reddys Laboratories Limited",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120606",
"SamplePackage": "N",
"Description": "Ropinirole extended-release tablets, USP contains 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 USP is a pale cream to light pinkish – yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Ropinirole extended-release tablets, USP are formulated as a monolithic slow release matrix tablet with coating. Each biconvex, capsule-shaped tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg of ropinirole hydrochloride USP equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients consist of anhydrous lactose, carboxy methylcellulose sodium, colloidal silicon dioxide, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and triethyl citrate. Additionally red iron oxide (for 2 mg and 8 mg tablet), FD&C Yellow #6 (for 4 mg tablet), FD&C Blue #2 (for 4 mg and 12 mg tablet), yellow iron oxide (for 8 mg and 12 mg tablet) and black iron oxide (for 8 mg tablet). Ropinirole extended-release tablets meets USP Dissolution Test 4."
},
{
"NDCCode": "55111-662-90",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-662-90) ",
"NDC11Code": "55111-0662-90",
"ProductNDC": "55111-662",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120606",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201576",
"LabelerName": "Dr. Reddys Laboratories Limited",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120606",
"SamplePackage": "N",
"Description": "Ropinirole extended-release tablets, USP contains 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 USP is a pale cream to light pinkish – yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Ropinirole extended-release tablets, USP are formulated as a monolithic slow release matrix tablet with coating. Each biconvex, capsule-shaped tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg of ropinirole hydrochloride USP equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients consist of anhydrous lactose, carboxy methylcellulose sodium, colloidal silicon dioxide, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and triethyl citrate. Additionally red iron oxide (for 2 mg and 8 mg tablet), FD&C Yellow #6 (for 4 mg tablet), FD&C Blue #2 (for 4 mg and 12 mg tablet), yellow iron oxide (for 8 mg and 12 mg tablet) and black iron oxide (for 8 mg tablet). Ropinirole extended-release tablets meets USP Dissolution Test 4."
},
{
"NDCCode": "55111-727-05",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-727-05) ",
"NDC11Code": "55111-0727-05",
"ProductNDC": "55111-727",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120606",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201576",
"LabelerName": "Dr. Reddys Laboratories Limited",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120606",
"SamplePackage": "N",
"Description": "Ropinirole extended-release tablets, USP contains 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 USP is a pale cream to light pinkish – yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Ropinirole extended-release tablets, USP are formulated as a monolithic slow release matrix tablet with coating. Each biconvex, capsule-shaped tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg of ropinirole hydrochloride USP equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients consist of anhydrous lactose, carboxy methylcellulose sodium, colloidal silicon dioxide, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and triethyl citrate. Additionally red iron oxide (for 2 mg and 8 mg tablet), FD&C Yellow #6 (for 4 mg tablet), FD&C Blue #2 (for 4 mg and 12 mg tablet), yellow iron oxide (for 8 mg and 12 mg tablet) and black iron oxide (for 8 mg tablet). Ropinirole extended-release tablets meets USP Dissolution Test 4."
},
{
"NDCCode": "55111-727-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-727-30) ",
"NDC11Code": "55111-0727-30",
"ProductNDC": "55111-727",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120606",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201576",
"LabelerName": "Dr. Reddys Laboratories Limited",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120606",
"SamplePackage": "N",
"Description": "Ropinirole extended-release tablets, USP contains 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 USP is a pale cream to light pinkish – yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Ropinirole extended-release tablets, USP are formulated as a monolithic slow release matrix tablet with coating. Each biconvex, capsule-shaped tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg of ropinirole hydrochloride USP equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients consist of anhydrous lactose, carboxy methylcellulose sodium, colloidal silicon dioxide, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and triethyl citrate. Additionally red iron oxide (for 2 mg and 8 mg tablet), FD&C Yellow #6 (for 4 mg tablet), FD&C Blue #2 (for 4 mg and 12 mg tablet), yellow iron oxide (for 8 mg and 12 mg tablet) and black iron oxide (for 8 mg tablet). Ropinirole extended-release tablets meets USP Dissolution Test 4."
},
{
"NDCCode": "55111-727-90",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-727-90) ",
"NDC11Code": "55111-0727-90",
"ProductNDC": "55111-727",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120606",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201576",
"LabelerName": "Dr. Reddys Laboratories Limited",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120606",
"SamplePackage": "N",
"Description": "Ropinirole extended-release tablets, USP contains 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 USP is a pale cream to light pinkish – yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Ropinirole extended-release tablets, USP are formulated as a monolithic slow release matrix tablet with coating. Each biconvex, capsule-shaped tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg of ropinirole hydrochloride USP equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients consist of anhydrous lactose, carboxy methylcellulose sodium, colloidal silicon dioxide, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and triethyl citrate. Additionally red iron oxide (for 2 mg and 8 mg tablet), FD&C Yellow #6 (for 4 mg tablet), FD&C Blue #2 (for 4 mg and 12 mg tablet), yellow iron oxide (for 8 mg and 12 mg tablet) and black iron oxide (for 8 mg tablet). Ropinirole extended-release tablets meets USP Dissolution Test 4."
},
{
"NDCCode": "55111-728-05",
"PackageDescription": "500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-728-05) ",
"NDC11Code": "55111-0728-05",
"ProductNDC": "55111-728",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120606",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201576",
"LabelerName": "Dr. Reddys Laboratories Limited",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "12",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120606",
"SamplePackage": "N",
"Description": "Ropinirole extended-release tablets, USP contains 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 USP is a pale cream to light pinkish – yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Ropinirole extended-release tablets, USP are formulated as a monolithic slow release matrix tablet with coating. Each biconvex, capsule-shaped tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg of ropinirole hydrochloride USP equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients consist of anhydrous lactose, carboxy methylcellulose sodium, colloidal silicon dioxide, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and triethyl citrate. Additionally red iron oxide (for 2 mg and 8 mg tablet), FD&C Yellow #6 (for 4 mg tablet), FD&C Blue #2 (for 4 mg and 12 mg tablet), yellow iron oxide (for 8 mg and 12 mg tablet) and black iron oxide (for 8 mg tablet). Ropinirole extended-release tablets meets USP Dissolution Test 4."
},
{
"NDCCode": "55111-728-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-728-30) ",
"NDC11Code": "55111-0728-30",
"ProductNDC": "55111-728",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120606",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201576",
"LabelerName": "Dr. Reddys Laboratories Limited",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "12",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120606",
"SamplePackage": "N",
"Description": "Ropinirole extended-release tablets, USP contains 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 USP is a pale cream to light pinkish – yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Ropinirole extended-release tablets, USP are formulated as a monolithic slow release matrix tablet with coating. Each biconvex, capsule-shaped tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg of ropinirole hydrochloride USP equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients consist of anhydrous lactose, carboxy methylcellulose sodium, colloidal silicon dioxide, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and triethyl citrate. Additionally red iron oxide (for 2 mg and 8 mg tablet), FD&C Yellow #6 (for 4 mg tablet), FD&C Blue #2 (for 4 mg and 12 mg tablet), yellow iron oxide (for 8 mg and 12 mg tablet) and black iron oxide (for 8 mg tablet). Ropinirole extended-release tablets meets USP Dissolution Test 4."
},
{
"NDCCode": "55111-728-90",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-728-90) ",
"NDC11Code": "55111-0728-90",
"ProductNDC": "55111-728",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120606",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201576",
"LabelerName": "Dr. Reddys Laboratories Limited",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": "12",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120606",
"SamplePackage": "N",
"Description": "Ropinirole extended-release tablets, USP contains 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 USP is a pale cream to light pinkish – yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Ropinirole extended-release tablets, USP are formulated as a monolithic slow release matrix tablet with coating. Each biconvex, capsule-shaped tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg of ropinirole hydrochloride USP equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients consist of anhydrous lactose, carboxy methylcellulose sodium, colloidal silicon dioxide, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and triethyl citrate. Additionally red iron oxide (for 2 mg and 8 mg tablet), FD&C Yellow #6 (for 4 mg tablet), FD&C Blue #2 (for 4 mg and 12 mg tablet), yellow iron oxide (for 8 mg and 12 mg tablet) and black iron oxide (for 8 mg tablet). Ropinirole extended-release tablets meets USP Dissolution Test 4."
},
{
"NDCCode": "10135-799-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10135-799-60) ",
"NDC11Code": "10135-0799-60",
"ProductNDC": "10135-799",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lacosamide",
"NonProprietaryName": "Lacosamide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250523",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218014",
"LabelerName": "Marlex Pharmaceuticals, Inc",
"SubstanceName": "LACOSAMIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2025-07-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250701",
"SamplePackage": "N",
"IndicationAndUsage": "Lacosamide tablets are indicated for: Treatment of partial-onset seizures in patients 4 years of age and older (1.1). Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older (1.2).",
"Description": "The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3- methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C13H18N2O3 and its molecular weight is 250.30. The chemical structure is. Lacosamide, USP is a white to light yellow powder. Freely soluble in methanol, soluble in anhydrous ethanol, sparingly soluble in water, slightly soluble in acetonitrile and practically insoluble in heptane."
},
{
"NDCCode": "10135-799-86",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (10135-799-86) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "10135-0799-86",
"ProductNDC": "10135-799",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lacosamide",
"NonProprietaryName": "Lacosamide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250523",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218014",
"LabelerName": "Marlex Pharmaceuticals, Inc",
"SubstanceName": "LACOSAMIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2025-07-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250701",
"SamplePackage": "N",
"IndicationAndUsage": "Lacosamide tablets are indicated for: Treatment of partial-onset seizures in patients 4 years of age and older (1.1). Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older (1.2).",
"Description": "The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3- methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C13H18N2O3 and its molecular weight is 250.30. The chemical structure is. Lacosamide, USP is a white to light yellow powder. Freely soluble in methanol, soluble in anhydrous ethanol, sparingly soluble in water, slightly soluble in acetonitrile and practically insoluble in heptane."
},
{
"NDCCode": "10237-799-16",
"PackageDescription": "473.2 mL in 1 BOTTLE, PLASTIC (10237-799-16) ",
"NDC11Code": "10237-0799-16",
"ProductNDC": "10237-799",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Orajel 2x Gum Pain",
"ProprietaryNameSuffix": "Alcohol-free",
"NonProprietaryName": "Menthol And Hydrogen Peroxide",
"DosageFormName": "RINSE",
"RouteName": "ORAL",
"StartMarketingDate": "20230115",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "Church & Dwight Co., Inc.",
"SubstanceName": "MENTHOL, UNSPECIFIED FORM; HYDROGEN PEROXIDE",
"StrengthNumber": "1; 15",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2024-11-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230115",
"SamplePackage": "N",
"IndicationAndUsage": "first aid to help reduce bacteria in minor oral wounds. for temporary pain relief and. use in cleansing minor wounds or minor gum inflammation resulting from: minor dental proceduresaccidental injuryorthodontic appliancescanker soresdenturesother irritations of the mouth and gums."
},
{
"NDCCode": "10956-799-20",
"PackageDescription": "89 g in 1 PACKAGE (10956-799-20) ",
"NDC11Code": "10956-0799-20",
"ProductNDC": "10956-799",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Reeses",
"ProprietaryNameSuffix": "Pinworm Itch Relief",
"NonProprietaryName": "Pramoxine Hydrochloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130321",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part346",
"LabelerName": "Reese Pharmaceutical Co",
"SubstanceName": "PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "10",
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"StartMarketingDatePackage": "20171001",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves itching."
},
{
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"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Tylosin Phosphate",
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"StartMarketingDate": "20090529",
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},
{
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"ProductNDC": "11673-799",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up Adult Cough Formula Dm Max",
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"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
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},
{
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"SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
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},
{
"NDCCode": "16571-799-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (16571-799-01) ",
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"StartMarketingDatePackage": "20060222",
"SamplePackage": "N",
"IndicationAndUsage": "Lisinopril is an angiotensin converting enzyme (ACE) inhibitor indicated for: 1 Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1), 2 Adjunct therapy for heart failure (1.2), 3 Treatment of Acute Myocardial Infarction (1.3).",
"Description": "Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its molecular formula is C21H31N3O52H2O and its structural formula is:. Lisinopril USP is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients: 2.5 mg tablets – dibasic calcium phosphate, magnesium stearate, mannitol, pregelatinized starch (maize) and starch (maize). 5 mg tablets – dibasic calcium phosphate, ferric oxide red, magnesium stearate, mannitol, pregelatinized starch (maize) and starch (maize). 10 mg, 20 mg, 30 mg, and 40 mg tablets - dibasic calcium phosphate, ferric oxide yellow, magnesium stearate, mannitol, pregelatinized starch (maize) and starch (maize)."
},
{
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"PackageDescription": "1000 TABLET in 1 BOTTLE (16571-799-10) ",
"NDC11Code": "16571-0799-10",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
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"Description": "Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its molecular formula is C21H31N3O52H2O and its structural formula is:. Lisinopril USP is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients: 2.5 mg tablets – dibasic calcium phosphate, magnesium stearate, mannitol, pregelatinized starch (maize) and starch (maize). 5 mg tablets – dibasic calcium phosphate, ferric oxide red, magnesium stearate, mannitol, pregelatinized starch (maize) and starch (maize). 10 mg, 20 mg, 30 mg, and 40 mg tablets - dibasic calcium phosphate, ferric oxide yellow, magnesium stearate, mannitol, pregelatinized starch (maize) and starch (maize)."
}
]
}
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<ProductNDC>55111-799</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Guaifenesin And Pseudoephedrine Hcl</NonProprietaryName>
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<StartMarketingDatePackage>29-DEC-17</StartMarketingDatePackage>
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<NDCCode>71610-799-54</NDCCode>
<PackageDescription>84 CAPSULE in 1 BOTTLE (71610-799-54) </PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
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<DEASchedule>CV</DEASchedule>
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<LastUpdate>2024-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240222</StartMarketingDatePackage>
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<IndicationAndUsage>Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older, 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline powder with a pK a1of 4.2 and a pK a2of 10.6. It is sparingly soluble in water. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, titanium dioxide and sodium lauryl sulfate. In addition, the orange capsule shells (75 mg, 100 mg, 200 mg, 225 mg and 300 mg strengths) contain the colorants FD&C Blue 1, FD&C Red 40 and FD&C Yellow 6. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide.</Description>
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<PackageDescription>4 BLISTER PACK in 1 CARTON (55111-799-04) / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (55111-799-06) </PackageDescription>
<NDC11Code>55111-0799-04</NDC11Code>
<ProductNDC>55111-799</ProductNDC>
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<StrengthNumber>1200; 120</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171229</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bother some mucus and make coughs more productive. ■ temporarily relieves nasal congestion due to:. ■ common cold. ■ hay fever. ■ upper respiratory allergies. ■ temporarily restores freer breathing through the nose. ■ promotes nasal and/or sinus drainage. ■ temporarily relieves sinus congestion and pressure.</IndicationAndUsage>
</NDC>
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<NDCCode>55111-799-12</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (55111-799-12) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55111-0799-12</NDC11Code>
<ProductNDC>55111-799</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20171229</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208369</ApplicationNumber>
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<SubstanceName>GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
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<Status>Active</Status>
<LastUpdate>2025-11-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171229</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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</NDC>
<NDC>
<NDCCode>55111-799-24</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (55111-799-24) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55111-0799-24</NDC11Code>
<ProductNDC>55111-799</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<SubstanceName>GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
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<Status>Active</Status>
<LastUpdate>2025-11-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171229</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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</NDC>
<NDC>
<NDCCode>55111-799-36</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (55111-799-36) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
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<SubstanceName>GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
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<Status>Active</Status>
<LastUpdate>2025-11-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171229</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bother some mucus and make coughs more productive. ■ temporarily relieves nasal congestion due to:. ■ common cold. ■ hay fever. ■ upper respiratory allergies. ■ temporarily restores freer breathing through the nose. ■ promotes nasal and/or sinus drainage. ■ temporarily relieves sinus congestion and pressure.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55111-659-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-659-05) </PackageDescription>
<NDC11Code>55111-0659-05</NDC11Code>
<ProductNDC>55111-659</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole</ProprietaryName>
<NonProprietaryName>Ropinirole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120606</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201576</ApplicationNumber>
<LabelerName>Dr. Reddys Laboratories Limited</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Ropinirole extended-release tablets, USP contains 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 USP is a pale cream to light pinkish – yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Ropinirole extended-release tablets, USP are formulated as a monolithic slow release matrix tablet with coating. Each biconvex, capsule-shaped tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg of ropinirole hydrochloride USP equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients consist of anhydrous lactose, carboxy methylcellulose sodium, colloidal silicon dioxide, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and triethyl citrate. Additionally red iron oxide (for 2 mg and 8 mg tablet), FD&C Yellow #6 (for 4 mg tablet), FD&C Blue #2 (for 4 mg and 12 mg tablet), yellow iron oxide (for 8 mg and 12 mg tablet) and black iron oxide (for 8 mg tablet). Ropinirole extended-release tablets meets USP Dissolution Test 4.</Description>
</NDC>
<NDC>
<NDCCode>55111-659-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-659-30) </PackageDescription>
<NDC11Code>55111-0659-30</NDC11Code>
<ProductNDC>55111-659</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole</ProprietaryName>
<NonProprietaryName>Ropinirole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120606</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201576</ApplicationNumber>
<LabelerName>Dr. Reddys Laboratories Limited</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Ropinirole extended-release tablets, USP contains 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 USP is a pale cream to light pinkish – yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Ropinirole extended-release tablets, USP are formulated as a monolithic slow release matrix tablet with coating. Each biconvex, capsule-shaped tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg of ropinirole hydrochloride USP equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients consist of anhydrous lactose, carboxy methylcellulose sodium, colloidal silicon dioxide, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and triethyl citrate. Additionally red iron oxide (for 2 mg and 8 mg tablet), FD&C Yellow #6 (for 4 mg tablet), FD&C Blue #2 (for 4 mg and 12 mg tablet), yellow iron oxide (for 8 mg and 12 mg tablet) and black iron oxide (for 8 mg tablet). Ropinirole extended-release tablets meets USP Dissolution Test 4.</Description>
</NDC>
<NDC>
<NDCCode>55111-659-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-659-90) </PackageDescription>
<NDC11Code>55111-0659-90</NDC11Code>
<ProductNDC>55111-659</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole</ProprietaryName>
<NonProprietaryName>Ropinirole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120606</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201576</ApplicationNumber>
<LabelerName>Dr. Reddys Laboratories Limited</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-04</LastUpdate>
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<Description>Ropinirole extended-release tablets, USP contains 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 USP is a pale cream to light pinkish – yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Ropinirole extended-release tablets, USP are formulated as a monolithic slow release matrix tablet with coating. Each biconvex, capsule-shaped tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg of ropinirole hydrochloride USP equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients consist of anhydrous lactose, carboxy methylcellulose sodium, colloidal silicon dioxide, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and triethyl citrate. Additionally red iron oxide (for 2 mg and 8 mg tablet), FD&C Yellow #6 (for 4 mg tablet), FD&C Blue #2 (for 4 mg and 12 mg tablet), yellow iron oxide (for 8 mg and 12 mg tablet) and black iron oxide (for 8 mg tablet). Ropinirole extended-release tablets meets USP Dissolution Test 4.</Description>
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<Description>Ropinirole extended-release tablets, USP contains 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 USP is a pale cream to light pinkish – yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Ropinirole extended-release tablets, USP are formulated as a monolithic slow release matrix tablet with coating. Each biconvex, capsule-shaped tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg of ropinirole hydrochloride USP equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients consist of anhydrous lactose, carboxy methylcellulose sodium, colloidal silicon dioxide, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and triethyl citrate. Additionally red iron oxide (for 2 mg and 8 mg tablet), FD&C Yellow #6 (for 4 mg tablet), FD&C Blue #2 (for 4 mg and 12 mg tablet), yellow iron oxide (for 8 mg and 12 mg tablet) and black iron oxide (for 8 mg tablet). Ropinirole extended-release tablets meets USP Dissolution Test 4.</Description>
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<Description>Ropinirole extended-release tablets, USP contains 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 USP is a pale cream to light pinkish – yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Ropinirole extended-release tablets, USP are formulated as a monolithic slow release matrix tablet with coating. Each biconvex, capsule-shaped tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg of ropinirole hydrochloride USP equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients consist of anhydrous lactose, carboxy methylcellulose sodium, colloidal silicon dioxide, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and triethyl citrate. Additionally red iron oxide (for 2 mg and 8 mg tablet), FD&C Yellow #6 (for 4 mg tablet), FD&C Blue #2 (for 4 mg and 12 mg tablet), yellow iron oxide (for 8 mg and 12 mg tablet) and black iron oxide (for 8 mg tablet). Ropinirole extended-release tablets meets USP Dissolution Test 4.</Description>
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<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
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<Description>Ropinirole extended-release tablets, USP contains 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 USP is a pale cream to light pinkish – yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Ropinirole extended-release tablets, USP are formulated as a monolithic slow release matrix tablet with coating. Each biconvex, capsule-shaped tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg of ropinirole hydrochloride USP equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients consist of anhydrous lactose, carboxy methylcellulose sodium, colloidal silicon dioxide, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and triethyl citrate. Additionally red iron oxide (for 2 mg and 8 mg tablet), FD&C Yellow #6 (for 4 mg tablet), FD&C Blue #2 (for 4 mg and 12 mg tablet), yellow iron oxide (for 8 mg and 12 mg tablet) and black iron oxide (for 8 mg tablet). Ropinirole extended-release tablets meets USP Dissolution Test 4.</Description>
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<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
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<Description>Ropinirole extended-release tablets, USP contains 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 USP is a pale cream to light pinkish – yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Ropinirole extended-release tablets, USP are formulated as a monolithic slow release matrix tablet with coating. Each biconvex, capsule-shaped tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg of ropinirole hydrochloride USP equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients consist of anhydrous lactose, carboxy methylcellulose sodium, colloidal silicon dioxide, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and triethyl citrate. Additionally red iron oxide (for 2 mg and 8 mg tablet), FD&C Yellow #6 (for 4 mg tablet), FD&C Blue #2 (for 4 mg and 12 mg tablet), yellow iron oxide (for 8 mg and 12 mg tablet) and black iron oxide (for 8 mg tablet). Ropinirole extended-release tablets meets USP Dissolution Test 4.</Description>
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<Description>Ropinirole extended-release tablets, USP contains 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 USP is a pale cream to light pinkish – yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Ropinirole extended-release tablets, USP are formulated as a monolithic slow release matrix tablet with coating. Each biconvex, capsule-shaped tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg of ropinirole hydrochloride USP equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients consist of anhydrous lactose, carboxy methylcellulose sodium, colloidal silicon dioxide, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and triethyl citrate. Additionally red iron oxide (for 2 mg and 8 mg tablet), FD&C Yellow #6 (for 4 mg tablet), FD&C Blue #2 (for 4 mg and 12 mg tablet), yellow iron oxide (for 8 mg and 12 mg tablet) and black iron oxide (for 8 mg tablet). Ropinirole extended-release tablets meets USP Dissolution Test 4.</Description>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
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<Description>Ropinirole extended-release tablets, USP contains 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 USP is a pale cream to light pinkish – yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Ropinirole extended-release tablets, USP are formulated as a monolithic slow release matrix tablet with coating. Each biconvex, capsule-shaped tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg of ropinirole hydrochloride USP equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients consist of anhydrous lactose, carboxy methylcellulose sodium, colloidal silicon dioxide, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and triethyl citrate. Additionally red iron oxide (for 2 mg and 8 mg tablet), FD&C Yellow #6 (for 4 mg tablet), FD&C Blue #2 (for 4 mg and 12 mg tablet), yellow iron oxide (for 8 mg and 12 mg tablet) and black iron oxide (for 8 mg tablet). Ropinirole extended-release tablets meets USP Dissolution Test 4.</Description>
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<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
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<Description>Ropinirole extended-release tablets, USP contains 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 USP is a pale cream to light pinkish – yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Ropinirole extended-release tablets, USP are formulated as a monolithic slow release matrix tablet with coating. Each biconvex, capsule-shaped tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg of ropinirole hydrochloride USP equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients consist of anhydrous lactose, carboxy methylcellulose sodium, colloidal silicon dioxide, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and triethyl citrate. Additionally red iron oxide (for 2 mg and 8 mg tablet), FD&C Yellow #6 (for 4 mg tablet), FD&C Blue #2 (for 4 mg and 12 mg tablet), yellow iron oxide (for 8 mg and 12 mg tablet) and black iron oxide (for 8 mg tablet). Ropinirole extended-release tablets meets USP Dissolution Test 4.</Description>
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<Description>Ropinirole extended-release tablets, USP contains 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 USP is a pale cream to light pinkish – yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Ropinirole extended-release tablets, USP are formulated as a monolithic slow release matrix tablet with coating. Each biconvex, capsule-shaped tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg of ropinirole hydrochloride USP equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients consist of anhydrous lactose, carboxy methylcellulose sodium, colloidal silicon dioxide, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and triethyl citrate. Additionally red iron oxide (for 2 mg and 8 mg tablet), FD&C Yellow #6 (for 4 mg tablet), FD&C Blue #2 (for 4 mg and 12 mg tablet), yellow iron oxide (for 8 mg and 12 mg tablet) and black iron oxide (for 8 mg tablet). Ropinirole extended-release tablets meets USP Dissolution Test 4.</Description>
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<Description>Ropinirole extended-release tablets, USP contains 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 USP is a pale cream to light pinkish – yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Ropinirole extended-release tablets, USP are formulated as a monolithic slow release matrix tablet with coating. Each biconvex, capsule-shaped tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg of ropinirole hydrochloride USP equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients consist of anhydrous lactose, carboxy methylcellulose sodium, colloidal silicon dioxide, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and triethyl citrate. Additionally red iron oxide (for 2 mg and 8 mg tablet), FD&C Yellow #6 (for 4 mg tablet), FD&C Blue #2 (for 4 mg and 12 mg tablet), yellow iron oxide (for 8 mg and 12 mg tablet) and black iron oxide (for 8 mg tablet). Ropinirole extended-release tablets meets USP Dissolution Test 4.</Description>
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<NDCCode>55111-728-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-728-05) </PackageDescription>
<NDC11Code>55111-0728-05</NDC11Code>
<ProductNDC>55111-728</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole</ProprietaryName>
<NonProprietaryName>Ropinirole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120606</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201576</ApplicationNumber>
<LabelerName>Dr. Reddys Laboratories Limited</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Ropinirole extended-release tablets, USP contains 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 USP is a pale cream to light pinkish – yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Ropinirole extended-release tablets, USP are formulated as a monolithic slow release matrix tablet with coating. Each biconvex, capsule-shaped tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg of ropinirole hydrochloride USP equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients consist of anhydrous lactose, carboxy methylcellulose sodium, colloidal silicon dioxide, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and triethyl citrate. Additionally red iron oxide (for 2 mg and 8 mg tablet), FD&C Yellow #6 (for 4 mg tablet), FD&C Blue #2 (for 4 mg and 12 mg tablet), yellow iron oxide (for 8 mg and 12 mg tablet) and black iron oxide (for 8 mg tablet). Ropinirole extended-release tablets meets USP Dissolution Test 4.</Description>
</NDC>
<NDC>
<NDCCode>55111-728-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-728-30) </PackageDescription>
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<ProductNDC>55111-728</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole</ProprietaryName>
<NonProprietaryName>Ropinirole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120606</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201576</ApplicationNumber>
<LabelerName>Dr. Reddys Laboratories Limited</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Ropinirole extended-release tablets, USP contains 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 USP is a pale cream to light pinkish – yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Ropinirole extended-release tablets, USP are formulated as a monolithic slow release matrix tablet with coating. Each biconvex, capsule-shaped tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg of ropinirole hydrochloride USP equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients consist of anhydrous lactose, carboxy methylcellulose sodium, colloidal silicon dioxide, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and triethyl citrate. Additionally red iron oxide (for 2 mg and 8 mg tablet), FD&C Yellow #6 (for 4 mg tablet), FD&C Blue #2 (for 4 mg and 12 mg tablet), yellow iron oxide (for 8 mg and 12 mg tablet) and black iron oxide (for 8 mg tablet). Ropinirole extended-release tablets meets USP Dissolution Test 4.</Description>
</NDC>
<NDC>
<NDCCode>55111-728-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-728-90) </PackageDescription>
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<ProductNDC>55111-728</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole</ProprietaryName>
<NonProprietaryName>Ropinirole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120606</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201576</ApplicationNumber>
<LabelerName>Dr. Reddys Laboratories Limited</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Ropinirole extended-release tablets, USP contains 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 USP is a pale cream to light pinkish – yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Ropinirole extended-release tablets, USP are formulated as a monolithic slow release matrix tablet with coating. Each biconvex, capsule-shaped tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg of ropinirole hydrochloride USP equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients consist of anhydrous lactose, carboxy methylcellulose sodium, colloidal silicon dioxide, ethyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, povidone, titanium dioxide and triethyl citrate. Additionally red iron oxide (for 2 mg and 8 mg tablet), FD&C Yellow #6 (for 4 mg tablet), FD&C Blue #2 (for 4 mg and 12 mg tablet), yellow iron oxide (for 8 mg and 12 mg tablet) and black iron oxide (for 8 mg tablet). Ropinirole extended-release tablets meets USP Dissolution Test 4.</Description>
</NDC>
<NDC>
<NDCCode>10135-799-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10135-799-60) </PackageDescription>
<NDC11Code>10135-0799-60</NDC11Code>
<ProductNDC>10135-799</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lacosamide</ProprietaryName>
<NonProprietaryName>Lacosamide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250523</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218014</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals, Inc</LabelerName>
<SubstanceName>LACOSAMIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-07-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lacosamide tablets are indicated for: Treatment of partial-onset seizures in patients 4 years of age and older (1.1). Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older (1.2).</IndicationAndUsage>
<Description>The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3- methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C13H18N2O3 and its molecular weight is 250.30. The chemical structure is. Lacosamide, USP is a white to light yellow powder. Freely soluble in methanol, soluble in anhydrous ethanol, sparingly soluble in water, slightly soluble in acetonitrile and practically insoluble in heptane.</Description>
</NDC>
<NDC>
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<NDC11Code>10135-0799-86</NDC11Code>
<ProductNDC>10135-799</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lacosamide</ProprietaryName>
<NonProprietaryName>Lacosamide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250523</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218014</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals, Inc</LabelerName>
<SubstanceName>LACOSAMIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-07-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lacosamide tablets are indicated for: Treatment of partial-onset seizures in patients 4 years of age and older (1.1). Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older (1.2).</IndicationAndUsage>
<Description>The chemical name of lacosamide, the single (R)-enantiomer, is (R)-2-acetamido-N-benzyl-3- methoxypropionamide (IUPAC). Lacosamide is a functionalized amino acid. Its molecular formula is C13H18N2O3 and its molecular weight is 250.30. The chemical structure is. Lacosamide, USP is a white to light yellow powder. Freely soluble in methanol, soluble in anhydrous ethanol, sparingly soluble in water, slightly soluble in acetonitrile and practically insoluble in heptane.</Description>
</NDC>
<NDC>
<NDCCode>10237-799-16</NDCCode>
<PackageDescription>473.2 mL in 1 BOTTLE, PLASTIC (10237-799-16) </PackageDescription>
<NDC11Code>10237-0799-16</NDC11Code>
<ProductNDC>10237-799</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Orajel 2x Gum Pain</ProprietaryName>
<ProprietaryNameSuffix>Alcohol-free</ProprietaryNameSuffix>
<NonProprietaryName>Menthol And Hydrogen Peroxide</NonProprietaryName>
<DosageFormName>RINSE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230115</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<SubstanceName>MENTHOL, UNSPECIFIED FORM; HYDROGEN PEROXIDE</SubstanceName>
<StrengthNumber>1; 15</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-11-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>first aid to help reduce bacteria in minor oral wounds. for temporary pain relief and. use in cleansing minor wounds or minor gum inflammation resulting from: minor dental proceduresaccidental injuryorthodontic appliancescanker soresdenturesother irritations of the mouth and gums.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10956-799-20</NDCCode>
<PackageDescription>89 g in 1 PACKAGE (10956-799-20) </PackageDescription>
<NDC11Code>10956-0799-20</NDC11Code>
<ProductNDC>10956-799</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Reeses</ProprietaryName>
<ProprietaryNameSuffix>Pinworm Itch Relief</ProprietaryNameSuffix>
<NonProprietaryName>Pramoxine Hydrochloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130321</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part346</ApplicationNumber>
<LabelerName>Reese Pharmaceutical Co</LabelerName>
<SubstanceName>PRAMOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves itching.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11311-799-25</NDCCode>
<PackageDescription>25 kg in 1 DRUM (11311-799-25)</PackageDescription>
<NDC11Code>11311-0799-25</NDC11Code>
<ProductNDC>11311-799</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Tylosin Phosphate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20090529</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Biovet Joint Stock Company</LabelerName>
<SubstanceName>TYLOSIN PHOSPHATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>11673-799-26</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (11673-799-26) > 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>11673-0799-26</NDC11Code>
<ProductNDC>11673-799</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up Adult Cough Formula Dm Max</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hbr, Guaifenesin</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100728</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>20; 400</StrengthNumber>
<StrengthUnit>mg/10mL; mg/10mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>11673-799-34</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (11673-799-34) > 236 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>11673-0799-34</NDC11Code>
<ProductNDC>11673-799</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up Adult Cough Formula Dm Max</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hbr, Guaifenesin</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100728</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>20; 400</StrengthNumber>
<StrengthUnit>mg/10mL; mg/10mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-11-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>16571-799-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (16571-799-01) </PackageDescription>
<NDC11Code>16571-0799-01</NDC11Code>
<ProductNDC>16571-799</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077622</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisinopril is an angiotensin converting enzyme (ACE) inhibitor indicated for: 1 Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1), 2 Adjunct therapy for heart failure (1.2), 3 Treatment of Acute Myocardial Infarction (1.3).</IndicationAndUsage>
<Description>Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its molecular formula is C21H31N3O52H2O and its structural formula is:. Lisinopril USP is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients: 2.5 mg tablets – dibasic calcium phosphate, magnesium stearate, mannitol, pregelatinized starch (maize) and starch (maize). 5 mg tablets – dibasic calcium phosphate, ferric oxide red, magnesium stearate, mannitol, pregelatinized starch (maize) and starch (maize). 10 mg, 20 mg, 30 mg, and 40 mg tablets - dibasic calcium phosphate, ferric oxide yellow, magnesium stearate, mannitol, pregelatinized starch (maize) and starch (maize).</Description>
</NDC>
<NDC>
<NDCCode>16571-799-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (16571-799-10) </PackageDescription>
<NDC11Code>16571-0799-10</NDC11Code>
<ProductNDC>16571-799</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060222</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077622</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisinopril is an angiotensin converting enzyme (ACE) inhibitor indicated for: 1 Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1), 2 Adjunct therapy for heart failure (1.2), 3 Treatment of Acute Myocardial Infarction (1.3).</IndicationAndUsage>
<Description>Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its molecular formula is C21H31N3O52H2O and its structural formula is:. Lisinopril USP is a white to off-white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril is supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients: 2.5 mg tablets – dibasic calcium phosphate, magnesium stearate, mannitol, pregelatinized starch (maize) and starch (maize). 5 mg tablets – dibasic calcium phosphate, ferric oxide red, magnesium stearate, mannitol, pregelatinized starch (maize) and starch (maize). 10 mg, 20 mg, 30 mg, and 40 mg tablets - dibasic calcium phosphate, ferric oxide yellow, magnesium stearate, mannitol, pregelatinized starch (maize) and starch (maize).</Description>
</NDC>
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