{
"NDC": [
{
"NDCCode": "52427-834-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (52427-834-01) / 100 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "52427-0834-01",
"ProductNDC": "52427-834",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Stalevo",
"NonProprietaryName": "Carbidopa, Levodopa, And Entacapone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20201005",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021485",
"LabelerName": "Almatica Pharma LLC",
"SubstanceName": "CARBIDOPA; ENTACAPONE; LEVODOPA",
"StrengthNumber": "37.5; 200; 150",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20201005",
"SamplePackage": "N",
"IndicationAndUsage": "Stalevo is indicated for the treatment of Parkinson's disease. Stalevo can be used: : 1 To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products., 2 To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose \"wearing-off\" and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias. .",
"Description": "Stalevo is a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson's disease. Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.3. It is designated chemically as (-)-L-(α-hydrazino-(α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C10H14N2O4∙H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3. Levodopa, an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C9H11NO4, and its structural formula is. Entacapone, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Stalevo is supplied as tablets in 6 strengths:. Stalevo 50:12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone. Stalevo 75: 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone. Stalevo 100: 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone. Stalevo125: 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone. Stalevo 150: 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone. Stalevo 200: 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone. Inactive Ingredients: corn starch, croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, mannitol, polysorbate 80, povidone, sucrose, red iron oxide, and titanium dioxide. Stalevo 50, Stalevo 100, and Stalevo 150 also contain yellow iron oxide."
},
{
"NDCCode": "52427-272-01",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (52427-272-01) ",
"NDC11Code": "52427-0272-01",
"ProductNDC": "52427-272",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naprelan",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140117",
"EndMarketingDate": "20270701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020353",
"LabelerName": "Almatica Pharma LLC",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "375",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140117",
"EndMarketingDatePackage": "20270701",
"SamplePackage": "N",
"IndicationAndUsage": "NAPRELAN Tablets are indicated for the treatment of. rheumatoid arthritis (RA) osteoarthritis (OA) ankylosing spondylitis (AS) tendinitis, bursitis acute gout primary dysmenorrhea (PD) the relief of mild to moderate pain. [see Warnings and Precautions (5)].",
"Description": "NAPRELAN (naproxen sodium) Controlled-Release Tablets is a nonsteroidal anti-inflammatory drug, available as controlled-release tablets in 375 mg, 500 mg, and 750 mg strengths for oral administration. The chemical name is 2-naphthaleneacetic acid, 6-methoxy-α-methyl-sodium salt, (S)-. The molecular weight is 252.24. Its molecular formula is C14H13NaO3, and it has the following chemical structure. Naproxen sodium is an odorless crystalline powder, white to creamy in color. It is soluble in methanol and water. NAPRELAN Tablets contain 412.5 mg, 550 mg, or 825 mg of naproxen sodium, equivalent to 375 mg, 500 mg, and 750 mg of naproxen, and 37.5 mg, 50 mg, and 75 mg sodium respectively. Each NAPRELAN Tablet also contains the following inactive ingredients: ammoniomethacrylate copolymer Type A, ammoniomethacrylate copolymer Type B, citric acid, crospovidone, magnesium stearate, methacrylic acid copolymer Type A, microcrystalline cellulose, povidone, and talc. The tablet coating contains hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "52427-285-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (52427-285-01) ",
"NDC11Code": "52427-0285-01",
"ProductNDC": "52427-285",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Macrobid",
"NonProprietaryName": "Nitrofurantoin Monohydrate/macrocrystalline",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20110531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020064",
"LabelerName": "Almatica Pharma LLC",
"SubstanceName": "NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE",
"StrengthNumber": "25; 75",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]",
"Status": "Active",
"LastUpdate": "2026-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110531",
"SamplePackage": "N"
},
{
"NDCCode": "52427-286-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (52427-286-01) ",
"NDC11Code": "52427-0286-01",
"ProductNDC": "52427-286",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Macrodantin",
"NonProprietaryName": "Nitrofurantoin Macrocrystals",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100927",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016620",
"LabelerName": "Almatica Pharma LLC",
"SubstanceName": "NITROFURANTOIN",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrofuran Antibacterial [EPC], Nitrofurans [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100927",
"SamplePackage": "N",
"IndicationAndUsage": "Macrodantin is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Macrodantin and other antibacterial drugs, Macrodantin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with Macrodantin are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with Macrodantin, other therapeutic agents with broader tissue distribution should be selected. In considering the use of Macrodantin, lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.",
"Description": "Macrodantin® (Nitrofurantoin Capsules, USP) (macrocrystals) is a synthetic chemical of controlled crystal size. It is a stable, yellow, crystalline compound. Macrodantin is an antibacterial agent for specific urinary tract infections. It is available in 25 mg, 50 mg, and 100 mg capsules for oral administration. Each capsule contains 25 mg, 50 mg, or 100 mg of nitrofurantoin macrocrystals. 1-[[(5-nitro-2-furanyl)methylene]amino]-2, 4-imidazolidinedione. Inactive Ingredients: Each capsule contains edible black ink, gelatin, lactose, starch, talc, titanium dioxide, and may contain FD&C Yellow No. 6 and D&C Yellow No. 10."
},
{
"NDCCode": "52427-287-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (52427-287-01) ",
"NDC11Code": "52427-0287-01",
"ProductNDC": "52427-287",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Macrodantin",
"NonProprietaryName": "Nitrofurantoin Macrocrystals",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100927",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016620",
"LabelerName": "Almatica Pharma LLC",
"SubstanceName": "NITROFURANTOIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrofuran Antibacterial [EPC], Nitrofurans [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100927",
"SamplePackage": "N",
"IndicationAndUsage": "Macrodantin is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Macrodantin and other antibacterial drugs, Macrodantin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with Macrodantin are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with Macrodantin, other therapeutic agents with broader tissue distribution should be selected. In considering the use of Macrodantin, lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.",
"Description": "Macrodantin® (Nitrofurantoin Capsules, USP) (macrocrystals) is a synthetic chemical of controlled crystal size. It is a stable, yellow, crystalline compound. Macrodantin is an antibacterial agent for specific urinary tract infections. It is available in 25 mg, 50 mg, and 100 mg capsules for oral administration. Each capsule contains 25 mg, 50 mg, or 100 mg of nitrofurantoin macrocrystals. 1-[[(5-nitro-2-furanyl)methylene]amino]-2, 4-imidazolidinedione. Inactive Ingredients: Each capsule contains edible black ink, gelatin, lactose, starch, talc, titanium dioxide, and may contain FD&C Yellow No. 6 and D&C Yellow No. 10."
},
{
"NDCCode": "52427-288-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (52427-288-01) ",
"NDC11Code": "52427-0288-01",
"ProductNDC": "52427-288",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Macrodantin",
"NonProprietaryName": "Nitrofurantoin Macrocrystals",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100927",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016620",
"LabelerName": "Almatica Pharma LLC",
"SubstanceName": "NITROFURANTOIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrofuran Antibacterial [EPC], Nitrofurans [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100927",
"SamplePackage": "N",
"IndicationAndUsage": "Macrodantin is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Macrodantin and other antibacterial drugs, Macrodantin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with Macrodantin are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with Macrodantin, other therapeutic agents with broader tissue distribution should be selected. In considering the use of Macrodantin, lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.",
"Description": "Macrodantin® (Nitrofurantoin Capsules, USP) (macrocrystals) is a synthetic chemical of controlled crystal size. It is a stable, yellow, crystalline compound. Macrodantin is an antibacterial agent for specific urinary tract infections. It is available in 25 mg, 50 mg, and 100 mg capsules for oral administration. Each capsule contains 25 mg, 50 mg, or 100 mg of nitrofurantoin macrocrystals. 1-[[(5-nitro-2-furanyl)methylene]amino]-2, 4-imidazolidinedione. Inactive Ingredients: Each capsule contains edible black ink, gelatin, lactose, starch, talc, titanium dioxide, and may contain FD&C Yellow No. 6 and D&C Yellow No. 10."
},
{
"NDCCode": "52427-494-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52427-494-01) ",
"NDC11Code": "52427-0494-01",
"ProductNDC": "52427-494",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adalat Cc",
"NonProprietaryName": "Nifedipine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170201",
"EndMarketingDate": "20200401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020198",
"LabelerName": "Almatica Pharma Inc.",
"SubstanceName": "NIFEDIPINE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170201",
"EndMarketingDatePackage": "20200401",
"SamplePackage": "N"
},
{
"NDCCode": "52427-495-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52427-495-01) ",
"NDC11Code": "52427-0495-01",
"ProductNDC": "52427-495",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adalat Cc",
"NonProprietaryName": "Nifedipine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170201",
"EndMarketingDate": "20200401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020198",
"LabelerName": "Almatica Pharma Inc.",
"SubstanceName": "NIFEDIPINE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170201",
"EndMarketingDatePackage": "20200401",
"SamplePackage": "N"
},
{
"NDCCode": "52427-496-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52427-496-01) ",
"NDC11Code": "52427-0496-01",
"ProductNDC": "52427-496",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adalat Cc",
"NonProprietaryName": "Nifedipine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170201",
"EndMarketingDate": "20200401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020198",
"LabelerName": "Almatica Pharma Inc.",
"SubstanceName": "NIFEDIPINE",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170201",
"EndMarketingDatePackage": "20200401",
"SamplePackage": "N"
},
{
"NDCCode": "52427-800-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (52427-800-01) / 100 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "52427-0800-01",
"ProductNDC": "52427-800",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Comtan",
"NonProprietaryName": "Entacapone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20201005",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020796",
"LabelerName": "Almatica Pharma LLC",
"SubstanceName": "ENTACAPONE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20201005",
"SamplePackage": "N",
"IndicationAndUsage": "Comtan is indicated as an adjunct to levodopa and carbidopa to treat end-of-dose \"wearing-off\" in patients with Parkinson's disease (see CLINICAL PHARMACOLOGY, Clinical Studies). Comtan's effectiveness has not been systematically evaluated in patients with Parkinson's disease who do not experience end-of-dose \"wearing-off\".",
"Description": "Comtan® (entacapone) is available as tablets containing 200 mg entacapone. Entacapone is an inhibitor of catechol-O-methyltransferase (COMT), used in the treatment of Parkinson's disease as an adjunct to levodopa and carbidopa therapy. It is a nitrocatechol-structured compound with a relative molecular mass of 305.29. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. The inactive ingredients of the Comtan tablet are microcrystalline cellulose, mannitol, croscarmellose sodium, hydrogenated vegetable oil, hydroxypropyl methylcellulose, polysorbate 80, glycerol 85%, sucrose, magnesium stearate, yellow iron oxide, red iron oxide, and titanium dioxide."
},
{
"NDCCode": "52427-805-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (52427-805-01) / 100 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "52427-0805-01",
"ProductNDC": "52427-805",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Stalevo",
"NonProprietaryName": "Carbidopa, Levodopa, And Entacapone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20201005",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021485",
"LabelerName": "Almatica Pharma LLC",
"SubstanceName": "CARBIDOPA; ENTACAPONE; LEVODOPA",
"StrengthNumber": "12.5; 200; 50",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20201005",
"SamplePackage": "N",
"IndicationAndUsage": "Stalevo is indicated for the treatment of Parkinson's disease. Stalevo can be used: : 1 To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products., 2 To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose \"wearing-off\" and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias. .",
"Description": "Stalevo is a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson's disease. Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.3. It is designated chemically as (-)-L-(α-hydrazino-(α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C10H14N2O4∙H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3. Levodopa, an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C9H11NO4, and its structural formula is. Entacapone, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Stalevo is supplied as tablets in 6 strengths:. Stalevo 50:12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone. Stalevo 75: 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone. Stalevo 100: 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone. Stalevo125: 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone. Stalevo 150: 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone. Stalevo 200: 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone. Inactive Ingredients: corn starch, croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, mannitol, polysorbate 80, povidone, sucrose, red iron oxide, and titanium dioxide. Stalevo 50, Stalevo 100, and Stalevo 150 also contain yellow iron oxide."
},
{
"NDCCode": "52427-809-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (52427-809-01) / 100 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "52427-0809-01",
"ProductNDC": "52427-809",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Stalevo",
"NonProprietaryName": "Carbidopa, Levodopa, And Entacapone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20201005",
"EndMarketingDate": "20260228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021485",
"LabelerName": "Almatica Pharma LLC",
"SubstanceName": "CARBIDOPA; ENTACAPONE; LEVODOPA",
"StrengthNumber": "18.75; 200; 75",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201005",
"EndMarketingDatePackage": "20260228",
"SamplePackage": "N"
},
{
"NDCCode": "52427-816-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (52427-816-01) / 100 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "52427-0816-01",
"ProductNDC": "52427-816",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Stalevo",
"NonProprietaryName": "Carbidopa, Levodopa, And Entacapone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20201005",
"EndMarketingDate": "20251231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021485",
"LabelerName": "Almatica Pharma LLC",
"SubstanceName": "CARBIDOPA; ENTACAPONE; LEVODOPA",
"StrengthNumber": "25; 200; 100",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201005",
"EndMarketingDatePackage": "20251231",
"SamplePackage": "N"
},
{
"NDCCode": "52427-827-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (52427-827-01) / 100 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "52427-0827-01",
"ProductNDC": "52427-827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Stalevo",
"NonProprietaryName": "Carbidopa, Levodopa, And Entacapone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20201005",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021485",
"LabelerName": "Almatica Pharma LLC",
"SubstanceName": "CARBIDOPA; ENTACAPONE; LEVODOPA",
"StrengthNumber": "31.25; 200; 125",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20201005",
"SamplePackage": "N",
"IndicationAndUsage": "Stalevo is indicated for the treatment of Parkinson's disease. Stalevo can be used: : 1 To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products., 2 To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose \"wearing-off\" and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias. .",
"Description": "Stalevo is a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson's disease. Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.3. It is designated chemically as (-)-L-(α-hydrazino-(α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C10H14N2O4∙H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3. Levodopa, an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C9H11NO4, and its structural formula is. Entacapone, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Stalevo is supplied as tablets in 6 strengths:. Stalevo 50:12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone. Stalevo 75: 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone. Stalevo 100: 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone. Stalevo125: 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone. Stalevo 150: 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone. Stalevo 200: 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone. Inactive Ingredients: corn starch, croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, mannitol, polysorbate 80, povidone, sucrose, red iron oxide, and titanium dioxide. Stalevo 50, Stalevo 100, and Stalevo 150 also contain yellow iron oxide."
},
{
"NDCCode": "52427-842-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (52427-842-01) / 100 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "52427-0842-01",
"ProductNDC": "52427-842",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Stalevo",
"NonProprietaryName": "Carbidopa, Levodopa, And Entacapone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20201005",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021485",
"LabelerName": "Almatica Pharma LLC",
"SubstanceName": "CARBIDOPA; ENTACAPONE; LEVODOPA",
"StrengthNumber": "50; 200; 200",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20201005",
"SamplePackage": "N",
"IndicationAndUsage": "Stalevo is indicated for the treatment of Parkinson's disease. Stalevo can be used: : 1 To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products., 2 To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose \"wearing-off\" and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias. .",
"Description": "Stalevo is a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson's disease. Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.3. It is designated chemically as (-)-L-(α-hydrazino-(α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C10H14N2O4∙H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3. Levodopa, an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C9H11NO4, and its structural formula is. Entacapone, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Stalevo is supplied as tablets in 6 strengths:. Stalevo 50:12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone. Stalevo 75: 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone. Stalevo 100: 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone. Stalevo125: 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone. Stalevo 150: 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone. Stalevo 200: 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone. Inactive Ingredients: corn starch, croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, mannitol, polysorbate 80, povidone, sucrose, red iron oxide, and titanium dioxide. Stalevo 50, Stalevo 100, and Stalevo 150 also contain yellow iron oxide."
},
{
"NDCCode": "10135-834-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (10135-834-01) ",
"NDC11Code": "10135-0834-01",
"ProductNDC": "10135-834",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Furosemide",
"NonProprietaryName": "Furosemide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260301",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018569",
"LabelerName": "Marlex Pharmaceuticals, Inc.",
"SubstanceName": "FUROSEMIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260301",
"SamplePackage": "N",
"Description": "Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-chloro- N-furfuryl-5-sulfamoylanthranilic acid. Furosemide is a white to off-white odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows. Furosemide is available in 20 mg, 40 mg and 80 mg tablets for oral administration. Inactive ingredients include lactose monohydrate, magnesium stearate, pregelatinized starch and starch (corn). Meets USP Dissolution Test 1."
},
{
"NDCCode": "10812-834-01",
"PackageDescription": "1 TUBE in 1 CARTON (10812-834-01) > 56 g in 1 TUBE",
"NDC11Code": "10812-0834-01",
"ProductNDC": "10812-834",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Norwegian Formula Age Shield Hand",
"ProprietaryNameSuffix": "Spf 30",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100601",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Neutrogena Corporation",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "20; 50; 50; 35.5; 30",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2014-10-10"
},
{
"NDCCode": "13537-834-02",
"PackageDescription": "1 TUBE in 1 BOX (13537-834-02) > 4 g in 1 TUBE (13537-834-01)",
"NDC11Code": "13537-0834-02",
"ProductNDC": "13537-834",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika Hydracolor 2 In 1 Highly Moisturizing And Coloring Spf 25",
"ProprietaryNameSuffix": "(coral Chic Exotic) - Orange",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161109",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".0664; .0151",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "14593-834-01",
"PackageDescription": "5 kg in 1 JAR (14593-834-01) ",
"NDC11Code": "14593-0834-01",
"ProductNDC": "14593-834",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Bendamustine Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20230921",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Emcure Pharmaceuticals Limited",
"SubstanceName": "BENDAMUSTINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "kg/5kg",
"Status": "Unfinished",
"LastUpdate": "2025-12-03",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "21-SEP-23"
},
{
"NDCCode": "14783-834-02",
"PackageDescription": "1 TUBE in 1 BOX (14783-834-02) > 3.8 g in 1 TUBE (14783-834-01)",
"NDC11Code": "14783-0834-02",
"ProductNDC": "14783-834",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika Pro Multi-gloss Dual With Triple Gloss Effect Spf 15",
"ProprietaryNameSuffix": "(cereza) - Pink",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150831",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": ".07",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "16571-834-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (16571-834-01) ",
"NDC11Code": "16571-0834-01",
"ProductNDC": "16571-834",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amantadine Hydrochloride",
"NonProprietaryName": "Amantadine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210129",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "AMANTADINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220905",
"SamplePackage": "N",
"IndicationAndUsage": "Amantadine hydrochloride capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules, USP are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis. Amantadine hydrochloride capsules, USP are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine does not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically related viruses. Following vaccination during an influenza A outbreak, amantadine prophylaxis should be considered for the 2- to 4- week time period required to develop an antibody response. Influenza A Treatment. Amantadine hydrochloride capsules, USP are also indicated in the treatment of uncomplicated respiratory tract illness caused by influenza A virus strains especially when administered early in the course of illness. There are no well-controlled clinical studies demonstrating that treatment with amantadine hydrochloride capsules, USP will avoid the development of influenza A virus pneumonitis or other complications in high risk patients. There is no clinical evidence indicating that amantadine hydrochloride capsules, USP are effective in the prophylaxis or treatment of viral respiratory tract illnesses other than those caused by influenza A virus strains. The following points should be considered before initiating treatment or prophylaxis with amantadine hydrochloride capsules, USP. : 1 Amantadine hydrochloride capsules, USP are not a substitute for early vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices., 2 Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use amantadine hydrochloride capsules, USP.",
"Description": "Amantadine hydrochloride, USP is designated chemically as 1-adamantanamine hydrochloride. Its molecular weight is 187.71 with a molecular formula C10H18NCl. It has the following structural formula. Amantadine hydrochloride, USP is a stable white or nearly white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform. Amantadine hydrochloride, USP has pharmacological actions as both an anti-Parkinson and an antiviral drug. Amantadine hydrochloride, USP is available as 100 mg capsules for oral administration. Inactive ingredients: magnesium stearate, microcrystalline cellulose, Povidone , Sodium Starch Glycolate, Colloidal Silicon Dioxide. The capsule shells and imprinting ink contain FD&C Blue #1, FD&C Red #40, gelatin, FD&C Yellow #6, sodium lauryl sulfate, and titanium dioxide. It meets USP Dissolution Test 2."
},
{
"NDCCode": "16714-834-01",
"PackageDescription": "1 VIAL, SINGLE-USE in 1 CARTON (16714-834-01) / 5 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "16714-0834-01",
"ProductNDC": "16714-834",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Palonosetron",
"NonProprietaryName": "Palonosetron",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20180529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201533",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "PALONOSETRON HYDROCHLORIDE",
"StrengthNumber": ".05",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180529",
"SamplePackage": "N",
"IndicationAndUsage": "Palonosetron hydrochloride injection is a serotonin-3 (5-HT3) receptor antagonist indicated in. Adults for prevention of: 1 acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). (1), 2 acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC). (1), 3 postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated (1).",
"Description": "Palonosetron hydrochloride injection contains palonosetron as palonosetron HCl, an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT3) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron hydrochloride is: (3aS)-2-[(S)-1-Azabicyclo [2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1Hbenz[ de]isoquinoline hydrochloride. The empirical formula is C19H24N2O.HCl, with a molecular weight of 332.87. Palonosetron hydrochloride exists as a single isomer and has the following structural formula. Palonosetron hydrochloride is a white to off-white crystalline powder. It is freely soluble in water and soluble in methanol. Palonosetron hydrochloride injection is a sterile, clear, colorless, non-pyrogenic, isotonic, buffered solution for intravenous administration. Palonosetron hydrochloride injection is available as a 5 mL single-dose vial. Each 5 mL vial contains: 0.25 mg palonosetron (equivalent to 0.28 mg palonosetron HCl), 207.5 mg mannitol, disodium edetate and sodium acetate trihydrate in water for intravenous administration. The pH of the solution in the 5 mL vials is 4.5 to 5.5, Hydrochloric acid or sodium hydroxide may have been added to adjust pH."
},
{
"NDCCode": "17478-834-01",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (17478-834-01) > 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "17478-0834-01",
"ProductNDC": "17478-834",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20130221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040730",
"LabelerName": "Akorn, Inc.",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20130221",
"SamplePackage": "N"
},
{
"NDCCode": "23155-834-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (23155-834-01) ",
"NDC11Code": "23155-0834-01",
"ProductNDC": "23155-834",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230802",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040858",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230802",
"SamplePackage": "N",
"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
"Description": "HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain magnesium stearate, microcrystalline cellulose, orange lake blend, silicon dioxide, and sodium starch glycolate. The orange lake blend consists of FD&C yellow #6."
},
{
"NDCCode": "35356-834-01",
"PackageDescription": "120 TABLET in 1 BOTTLE, PLASTIC (35356-834-01) ",
"NDC11Code": "35356-0834-01",
"ProductNDC": "35356-834",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methadone Hydrochloride",
"NonProprietaryName": "Methadone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA006134",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "METHADONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20080101",
"SamplePackage": "N"
},
{
"NDCCode": "37000-834-01",
"PackageDescription": "500 mL in 1 BOTTLE, PLASTIC (37000-834-01)",
"NDC11Code": "37000-0834-01",
"ProductNDC": "37000-834",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Crest Pro-health",
"ProprietaryNameSuffix": "For Me",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "RINSE",
"RouteName": "ORAL",
"StartMarketingDate": "20120723",
"EndMarketingDate": "20171201",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2017-12-07"
},
{
"NDCCode": "47335-834-01",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (47335-834-01) > 10 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "47335-0834-01",
"ProductNDC": "47335-834",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fosphenytoin Sodium",
"NonProprietaryName": "Fosphenytoin Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20090814",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078417",
"LabelerName": "Sun Pharma Global FZE",
"SubstanceName": "FOSPHENYTOIN SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-01-30"
},
{
"NDCCode": "49884-834-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49884-834-01) ",
"NDC11Code": "49884-0834-01",
"ProductNDC": "49884-834",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20121109",
"EndMarketingDate": "20190228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020616",
"LabelerName": "Par Pharmaceutical Inc.",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2019-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20121109",
"EndMarketingDatePackage": "20190228",
"SamplePackage": "N"
},
{
"NDCCode": "52125-834-01",
"PackageDescription": "2 mL in 1 VIAL, SINGLE-DOSE (52125-834-01)",
"NDC11Code": "52125-0834-01",
"ProductNDC": "52125-834",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
"NonProprietaryName": "Ondansetron Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140213",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202600",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-22"
},
{
"NDCCode": "55910-834-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (55910-834-01) / 100 TABLET in 1 BOTTLE",
"NDC11Code": "55910-0834-01",
"ProductNDC": "55910-834",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pain Relief Pm",
"NonProprietaryName": "Acetaminophen, Diphenhydramine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231225",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "DOLGENCORP, INC.",
"SubstanceName": "ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "500; 25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231225",
"SamplePackage": "N",
"IndicationAndUsage": "Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>52427-834-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (52427-834-01) / 100 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>52427-0834-01</NDC11Code>
<ProductNDC>52427-834</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Stalevo</ProprietaryName>
<NonProprietaryName>Carbidopa, Levodopa, And Entacapone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201005</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021485</ApplicationNumber>
<LabelerName>Almatica Pharma LLC</LabelerName>
<SubstanceName>CARBIDOPA; ENTACAPONE; LEVODOPA</SubstanceName>
<StrengthNumber>37.5; 200; 150</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201005</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Stalevo is indicated for the treatment of Parkinson's disease. Stalevo can be used: : 1 To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products., 2 To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose "wearing-off" and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias. .</IndicationAndUsage>
<Description>Stalevo is a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson's disease. Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.3. It is designated chemically as (-)-L-(α-hydrazino-(α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C10H14N2O4∙H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3. Levodopa, an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C9H11NO4, and its structural formula is. Entacapone, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Stalevo is supplied as tablets in 6 strengths:. Stalevo 50:12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone. Stalevo 75: 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone. Stalevo 100: 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone. Stalevo125: 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone. Stalevo 150: 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone. Stalevo 200: 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone. Inactive Ingredients: corn starch, croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, mannitol, polysorbate 80, povidone, sucrose, red iron oxide, and titanium dioxide. Stalevo 50, Stalevo 100, and Stalevo 150 also contain yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>52427-272-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (52427-272-01) </PackageDescription>
<NDC11Code>52427-0272-01</NDC11Code>
<ProductNDC>52427-272</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naprelan</ProprietaryName>
<NonProprietaryName>Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140117</StartMarketingDate>
<EndMarketingDate>20270701</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020353</ApplicationNumber>
<LabelerName>Almatica Pharma LLC</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>375</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140117</StartMarketingDatePackage>
<EndMarketingDatePackage>20270701</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NAPRELAN Tablets are indicated for the treatment of. rheumatoid arthritis (RA) osteoarthritis (OA) ankylosing spondylitis (AS) tendinitis, bursitis acute gout primary dysmenorrhea (PD) the relief of mild to moderate pain. [see Warnings and Precautions (5)].</IndicationAndUsage>
<Description>NAPRELAN (naproxen sodium) Controlled-Release Tablets is a nonsteroidal anti-inflammatory drug, available as controlled-release tablets in 375 mg, 500 mg, and 750 mg strengths for oral administration. The chemical name is 2-naphthaleneacetic acid, 6-methoxy-α-methyl-sodium salt, (S)-. The molecular weight is 252.24. Its molecular formula is C14H13NaO3, and it has the following chemical structure. Naproxen sodium is an odorless crystalline powder, white to creamy in color. It is soluble in methanol and water. NAPRELAN Tablets contain 412.5 mg, 550 mg, or 825 mg of naproxen sodium, equivalent to 375 mg, 500 mg, and 750 mg of naproxen, and 37.5 mg, 50 mg, and 75 mg sodium respectively. Each NAPRELAN Tablet also contains the following inactive ingredients: ammoniomethacrylate copolymer Type A, ammoniomethacrylate copolymer Type B, citric acid, crospovidone, magnesium stearate, methacrylic acid copolymer Type A, microcrystalline cellulose, povidone, and talc. The tablet coating contains hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>52427-285-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (52427-285-01) </PackageDescription>
<NDC11Code>52427-0285-01</NDC11Code>
<ProductNDC>52427-285</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Macrobid</ProprietaryName>
<NonProprietaryName>Nitrofurantoin Monohydrate/macrocrystalline</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110531</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020064</ApplicationNumber>
<LabelerName>Almatica Pharma LLC</LabelerName>
<SubstanceName>NITROFURANTOIN; NITROFURANTOIN MONOHYDRATE</SubstanceName>
<StrengthNumber>25; 75</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110531</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52427-286-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (52427-286-01) </PackageDescription>
<NDC11Code>52427-0286-01</NDC11Code>
<ProductNDC>52427-286</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Macrodantin</ProprietaryName>
<NonProprietaryName>Nitrofurantoin Macrocrystals</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100927</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016620</ApplicationNumber>
<LabelerName>Almatica Pharma LLC</LabelerName>
<SubstanceName>NITROFURANTOIN</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrofuran Antibacterial [EPC], Nitrofurans [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Macrodantin is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Macrodantin and other antibacterial drugs, Macrodantin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with Macrodantin are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with Macrodantin, other therapeutic agents with broader tissue distribution should be selected. In considering the use of Macrodantin, lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.</IndicationAndUsage>
<Description>Macrodantin® (Nitrofurantoin Capsules, USP) (macrocrystals) is a synthetic chemical of controlled crystal size. It is a stable, yellow, crystalline compound. Macrodantin is an antibacterial agent for specific urinary tract infections. It is available in 25 mg, 50 mg, and 100 mg capsules for oral administration. Each capsule contains 25 mg, 50 mg, or 100 mg of nitrofurantoin macrocrystals. 1-[[(5-nitro-2-furanyl)methylene]amino]-2, 4-imidazolidinedione. Inactive Ingredients: Each capsule contains edible black ink, gelatin, lactose, starch, talc, titanium dioxide, and may contain FD&C Yellow No. 6 and D&C Yellow No. 10.</Description>
</NDC>
<NDC>
<NDCCode>52427-287-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (52427-287-01) </PackageDescription>
<NDC11Code>52427-0287-01</NDC11Code>
<ProductNDC>52427-287</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Macrodantin</ProprietaryName>
<NonProprietaryName>Nitrofurantoin Macrocrystals</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100927</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016620</ApplicationNumber>
<LabelerName>Almatica Pharma LLC</LabelerName>
<SubstanceName>NITROFURANTOIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrofuran Antibacterial [EPC], Nitrofurans [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Macrodantin is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Macrodantin and other antibacterial drugs, Macrodantin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with Macrodantin are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with Macrodantin, other therapeutic agents with broader tissue distribution should be selected. In considering the use of Macrodantin, lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.</IndicationAndUsage>
<Description>Macrodantin® (Nitrofurantoin Capsules, USP) (macrocrystals) is a synthetic chemical of controlled crystal size. It is a stable, yellow, crystalline compound. Macrodantin is an antibacterial agent for specific urinary tract infections. It is available in 25 mg, 50 mg, and 100 mg capsules for oral administration. Each capsule contains 25 mg, 50 mg, or 100 mg of nitrofurantoin macrocrystals. 1-[[(5-nitro-2-furanyl)methylene]amino]-2, 4-imidazolidinedione. Inactive Ingredients: Each capsule contains edible black ink, gelatin, lactose, starch, talc, titanium dioxide, and may contain FD&C Yellow No. 6 and D&C Yellow No. 10.</Description>
</NDC>
<NDC>
<NDCCode>52427-288-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (52427-288-01) </PackageDescription>
<NDC11Code>52427-0288-01</NDC11Code>
<ProductNDC>52427-288</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Macrodantin</ProprietaryName>
<NonProprietaryName>Nitrofurantoin Macrocrystals</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100927</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016620</ApplicationNumber>
<LabelerName>Almatica Pharma LLC</LabelerName>
<SubstanceName>NITROFURANTOIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrofuran Antibacterial [EPC], Nitrofurans [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Macrodantin is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Macrodantin and other antibacterial drugs, Macrodantin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with Macrodantin are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with Macrodantin, other therapeutic agents with broader tissue distribution should be selected. In considering the use of Macrodantin, lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.</IndicationAndUsage>
<Description>Macrodantin® (Nitrofurantoin Capsules, USP) (macrocrystals) is a synthetic chemical of controlled crystal size. It is a stable, yellow, crystalline compound. Macrodantin is an antibacterial agent for specific urinary tract infections. It is available in 25 mg, 50 mg, and 100 mg capsules for oral administration. Each capsule contains 25 mg, 50 mg, or 100 mg of nitrofurantoin macrocrystals. 1-[[(5-nitro-2-furanyl)methylene]amino]-2, 4-imidazolidinedione. Inactive Ingredients: Each capsule contains edible black ink, gelatin, lactose, starch, talc, titanium dioxide, and may contain FD&C Yellow No. 6 and D&C Yellow No. 10.</Description>
</NDC>
<NDC>
<NDCCode>52427-494-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52427-494-01) </PackageDescription>
<NDC11Code>52427-0494-01</NDC11Code>
<ProductNDC>52427-494</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adalat Cc</ProprietaryName>
<NonProprietaryName>Nifedipine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170201</StartMarketingDate>
<EndMarketingDate>20200401</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020198</ApplicationNumber>
<LabelerName>Almatica Pharma Inc.</LabelerName>
<SubstanceName>NIFEDIPINE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170201</StartMarketingDatePackage>
<EndMarketingDatePackage>20200401</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52427-495-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52427-495-01) </PackageDescription>
<NDC11Code>52427-0495-01</NDC11Code>
<ProductNDC>52427-495</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adalat Cc</ProprietaryName>
<NonProprietaryName>Nifedipine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170201</StartMarketingDate>
<EndMarketingDate>20200401</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020198</ApplicationNumber>
<LabelerName>Almatica Pharma Inc.</LabelerName>
<SubstanceName>NIFEDIPINE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170201</StartMarketingDatePackage>
<EndMarketingDatePackage>20200401</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52427-496-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52427-496-01) </PackageDescription>
<NDC11Code>52427-0496-01</NDC11Code>
<ProductNDC>52427-496</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adalat Cc</ProprietaryName>
<NonProprietaryName>Nifedipine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170201</StartMarketingDate>
<EndMarketingDate>20200401</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020198</ApplicationNumber>
<LabelerName>Almatica Pharma Inc.</LabelerName>
<SubstanceName>NIFEDIPINE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170201</StartMarketingDatePackage>
<EndMarketingDatePackage>20200401</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52427-800-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (52427-800-01) / 100 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>52427-0800-01</NDC11Code>
<ProductNDC>52427-800</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Comtan</ProprietaryName>
<NonProprietaryName>Entacapone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201005</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020796</ApplicationNumber>
<LabelerName>Almatica Pharma LLC</LabelerName>
<SubstanceName>ENTACAPONE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201005</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Comtan is indicated as an adjunct to levodopa and carbidopa to treat end-of-dose "wearing-off" in patients with Parkinson's disease (see CLINICAL PHARMACOLOGY, Clinical Studies). Comtan's effectiveness has not been systematically evaluated in patients with Parkinson's disease who do not experience end-of-dose "wearing-off".</IndicationAndUsage>
<Description>Comtan® (entacapone) is available as tablets containing 200 mg entacapone. Entacapone is an inhibitor of catechol-O-methyltransferase (COMT), used in the treatment of Parkinson's disease as an adjunct to levodopa and carbidopa therapy. It is a nitrocatechol-structured compound with a relative molecular mass of 305.29. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. The inactive ingredients of the Comtan tablet are microcrystalline cellulose, mannitol, croscarmellose sodium, hydrogenated vegetable oil, hydroxypropyl methylcellulose, polysorbate 80, glycerol 85%, sucrose, magnesium stearate, yellow iron oxide, red iron oxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>52427-805-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (52427-805-01) / 100 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>52427-0805-01</NDC11Code>
<ProductNDC>52427-805</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Stalevo</ProprietaryName>
<NonProprietaryName>Carbidopa, Levodopa, And Entacapone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201005</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021485</ApplicationNumber>
<LabelerName>Almatica Pharma LLC</LabelerName>
<SubstanceName>CARBIDOPA; ENTACAPONE; LEVODOPA</SubstanceName>
<StrengthNumber>12.5; 200; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201005</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Stalevo is indicated for the treatment of Parkinson's disease. Stalevo can be used: : 1 To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products., 2 To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose "wearing-off" and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias. .</IndicationAndUsage>
<Description>Stalevo is a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson's disease. Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.3. It is designated chemically as (-)-L-(α-hydrazino-(α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C10H14N2O4∙H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3. Levodopa, an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C9H11NO4, and its structural formula is. Entacapone, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Stalevo is supplied as tablets in 6 strengths:. Stalevo 50:12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone. Stalevo 75: 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone. Stalevo 100: 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone. Stalevo125: 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone. Stalevo 150: 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone. Stalevo 200: 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone. Inactive Ingredients: corn starch, croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, mannitol, polysorbate 80, povidone, sucrose, red iron oxide, and titanium dioxide. Stalevo 50, Stalevo 100, and Stalevo 150 also contain yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>52427-809-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (52427-809-01) / 100 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>52427-0809-01</NDC11Code>
<ProductNDC>52427-809</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Stalevo</ProprietaryName>
<NonProprietaryName>Carbidopa, Levodopa, And Entacapone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201005</StartMarketingDate>
<EndMarketingDate>20260228</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021485</ApplicationNumber>
<LabelerName>Almatica Pharma LLC</LabelerName>
<SubstanceName>CARBIDOPA; ENTACAPONE; LEVODOPA</SubstanceName>
<StrengthNumber>18.75; 200; 75</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201005</StartMarketingDatePackage>
<EndMarketingDatePackage>20260228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52427-816-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (52427-816-01) / 100 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>52427-0816-01</NDC11Code>
<ProductNDC>52427-816</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Stalevo</ProprietaryName>
<NonProprietaryName>Carbidopa, Levodopa, And Entacapone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201005</StartMarketingDate>
<EndMarketingDate>20251231</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021485</ApplicationNumber>
<LabelerName>Almatica Pharma LLC</LabelerName>
<SubstanceName>CARBIDOPA; ENTACAPONE; LEVODOPA</SubstanceName>
<StrengthNumber>25; 200; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201005</StartMarketingDatePackage>
<EndMarketingDatePackage>20251231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52427-827-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (52427-827-01) / 100 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>52427-0827-01</NDC11Code>
<ProductNDC>52427-827</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Stalevo</ProprietaryName>
<NonProprietaryName>Carbidopa, Levodopa, And Entacapone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201005</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021485</ApplicationNumber>
<LabelerName>Almatica Pharma LLC</LabelerName>
<SubstanceName>CARBIDOPA; ENTACAPONE; LEVODOPA</SubstanceName>
<StrengthNumber>31.25; 200; 125</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201005</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Stalevo is indicated for the treatment of Parkinson's disease. Stalevo can be used: : 1 To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products., 2 To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose "wearing-off" and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias. .</IndicationAndUsage>
<Description>Stalevo is a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson's disease. Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.3. It is designated chemically as (-)-L-(α-hydrazino-(α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C10H14N2O4∙H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3. Levodopa, an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C9H11NO4, and its structural formula is. Entacapone, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Stalevo is supplied as tablets in 6 strengths:. Stalevo 50:12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone. Stalevo 75: 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone. Stalevo 100: 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone. Stalevo125: 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone. Stalevo 150: 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone. Stalevo 200: 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone. Inactive Ingredients: corn starch, croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, mannitol, polysorbate 80, povidone, sucrose, red iron oxide, and titanium dioxide. Stalevo 50, Stalevo 100, and Stalevo 150 also contain yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>52427-842-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (52427-842-01) / 100 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>52427-0842-01</NDC11Code>
<ProductNDC>52427-842</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Stalevo</ProprietaryName>
<NonProprietaryName>Carbidopa, Levodopa, And Entacapone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201005</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021485</ApplicationNumber>
<LabelerName>Almatica Pharma LLC</LabelerName>
<SubstanceName>CARBIDOPA; ENTACAPONE; LEVODOPA</SubstanceName>
<StrengthNumber>50; 200; 200</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC], Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201005</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Stalevo is indicated for the treatment of Parkinson's disease. Stalevo can be used: : 1 To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products., 2 To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose "wearing-off" and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias. .</IndicationAndUsage>
<Description>Stalevo is a combination of carbidopa, levodopa, and entacapone for the treatment of Parkinson's disease. Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.3. It is designated chemically as (-)-L-(α-hydrazino-(α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its empirical formula is C10H14N2O4∙H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3. Levodopa, an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is C9H11NO4, and its structural formula is. Entacapone, a COMT inhibitor, is a nitro-catechol-structured compound with a molecular weight of 305.3. The chemical name of entacapone is (E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide. Its empirical formula is C14H15N3O5 and its structural formula is. Stalevo is supplied as tablets in 6 strengths:. Stalevo 50:12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone. Stalevo 75: 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone. Stalevo 100: 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone. Stalevo125: 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone. Stalevo 150: 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone. Stalevo 200: 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone. Inactive Ingredients: corn starch, croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, mannitol, polysorbate 80, povidone, sucrose, red iron oxide, and titanium dioxide. Stalevo 50, Stalevo 100, and Stalevo 150 also contain yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>10135-834-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (10135-834-01) </PackageDescription>
<NDC11Code>10135-0834-01</NDC11Code>
<ProductNDC>10135-834</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Furosemide</ProprietaryName>
<NonProprietaryName>Furosemide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260301</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018569</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FUROSEMIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Furosemide is a diuretic which is an anthranilic acid derivative. Chemically, it is 4-chloro- N-furfuryl-5-sulfamoylanthranilic acid. Furosemide is a white to off-white odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows. Furosemide is available in 20 mg, 40 mg and 80 mg tablets for oral administration. Inactive ingredients include lactose monohydrate, magnesium stearate, pregelatinized starch and starch (corn). Meets USP Dissolution Test 1.</Description>
</NDC>
<NDC>
<NDCCode>10812-834-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (10812-834-01) > 56 g in 1 TUBE</PackageDescription>
<NDC11Code>10812-0834-01</NDC11Code>
<ProductNDC>10812-834</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Norwegian Formula Age Shield Hand</ProprietaryName>
<ProprietaryNameSuffix>Spf 30</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Neutrogena Corporation</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>20; 50; 50; 35.5; 30</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-10-10</LastUpdate>
</NDC>
<NDC>
<NDCCode>13537-834-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-834-02) > 4 g in 1 TUBE (13537-834-01)</PackageDescription>
<NDC11Code>13537-0834-02</NDC11Code>
<ProductNDC>13537-834</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika Hydracolor 2 In 1 Highly Moisturizing And Coloring Spf 25</ProprietaryName>
<ProprietaryNameSuffix>(coral Chic Exotic) - Orange</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161109</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>.0664; .0151</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14593-834-01</NDCCode>
<PackageDescription>5 kg in 1 JAR (14593-834-01) </PackageDescription>
<NDC11Code>14593-0834-01</NDC11Code>
<ProductNDC>14593-834</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Bendamustine Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20230921</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Emcure Pharmaceuticals Limited</LabelerName>
<SubstanceName>BENDAMUSTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>kg/5kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-03</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>21-SEP-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>14783-834-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (14783-834-02) > 3.8 g in 1 TUBE (14783-834-01)</PackageDescription>
<NDC11Code>14783-0834-02</NDC11Code>
<ProductNDC>14783-834</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika Pro Multi-gloss Dual With Triple Gloss Effect Spf 15</ProprietaryName>
<ProprietaryNameSuffix>(cereza) - Pink</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150831</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura International LTD</LabelerName>
<SubstanceName>OCTINOXATE</SubstanceName>
<StrengthNumber>.07</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16571-834-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (16571-834-01) </PackageDescription>
<NDC11Code>16571-0834-01</NDC11Code>
<ProductNDC>16571-834</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amantadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Amantadine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210129</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>AMANTADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220905</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amantadine hydrochloride capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules, USP are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis. Amantadine hydrochloride capsules, USP are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because amantadine does not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically related viruses. Following vaccination during an influenza A outbreak, amantadine prophylaxis should be considered for the 2- to 4- week time period required to develop an antibody response. Influenza A Treatment. Amantadine hydrochloride capsules, USP are also indicated in the treatment of uncomplicated respiratory tract illness caused by influenza A virus strains especially when administered early in the course of illness. There are no well-controlled clinical studies demonstrating that treatment with amantadine hydrochloride capsules, USP will avoid the development of influenza A virus pneumonitis or other complications in high risk patients. There is no clinical evidence indicating that amantadine hydrochloride capsules, USP are effective in the prophylaxis or treatment of viral respiratory tract illnesses other than those caused by influenza A virus strains. The following points should be considered before initiating treatment or prophylaxis with amantadine hydrochloride capsules, USP. : 1 Amantadine hydrochloride capsules, USP are not a substitute for early vaccination on an annual basis as recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices., 2 Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use amantadine hydrochloride capsules, USP.</IndicationAndUsage>
<Description>Amantadine hydrochloride, USP is designated chemically as 1-adamantanamine hydrochloride. Its molecular weight is 187.71 with a molecular formula C10H18NCl. It has the following structural formula. Amantadine hydrochloride, USP is a stable white or nearly white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform. Amantadine hydrochloride, USP has pharmacological actions as both an anti-Parkinson and an antiviral drug. Amantadine hydrochloride, USP is available as 100 mg capsules for oral administration. Inactive ingredients: magnesium stearate, microcrystalline cellulose, Povidone , Sodium Starch Glycolate, Colloidal Silicon Dioxide. The capsule shells and imprinting ink contain FD&C Blue #1, FD&C Red #40, gelatin, FD&C Yellow #6, sodium lauryl sulfate, and titanium dioxide. It meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>16714-834-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-USE in 1 CARTON (16714-834-01) / 5 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>16714-0834-01</NDC11Code>
<ProductNDC>16714-834</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Palonosetron</ProprietaryName>
<NonProprietaryName>Palonosetron</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20180529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201533</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>PALONOSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Palonosetron hydrochloride injection is a serotonin-3 (5-HT3) receptor antagonist indicated in. Adults for prevention of: 1 acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). (1), 2 acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC). (1), 3 postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated (1).</IndicationAndUsage>
<Description>Palonosetron hydrochloride injection contains palonosetron as palonosetron HCl, an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT3) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron hydrochloride is: (3aS)-2-[(S)-1-Azabicyclo [2.2.2]oct-3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1Hbenz[ de]isoquinoline hydrochloride. The empirical formula is C19H24N2O.HCl, with a molecular weight of 332.87. Palonosetron hydrochloride exists as a single isomer and has the following structural formula. Palonosetron hydrochloride is a white to off-white crystalline powder. It is freely soluble in water and soluble in methanol. Palonosetron hydrochloride injection is a sterile, clear, colorless, non-pyrogenic, isotonic, buffered solution for intravenous administration. Palonosetron hydrochloride injection is available as a 5 mL single-dose vial. Each 5 mL vial contains: 0.25 mg palonosetron (equivalent to 0.28 mg palonosetron HCl), 207.5 mg mannitol, disodium edetate and sodium acetate trihydrate in water for intravenous administration. The pH of the solution in the 5 mL vials is 4.5 to 5.5, Hydrochloric acid or sodium hydroxide may have been added to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>17478-834-01</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (17478-834-01) > 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>17478-0834-01</NDC11Code>
<ProductNDC>17478-834</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20130221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040730</ApplicationNumber>
<LabelerName>Akorn, Inc.</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>23155-834-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (23155-834-01) </PackageDescription>
<NDC11Code>23155-0834-01</NDC11Code>
<ProductNDC>23155-834</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230802</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040858</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230802</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain magnesium stearate, microcrystalline cellulose, orange lake blend, silicon dioxide, and sodium starch glycolate. The orange lake blend consists of FD&C yellow #6.</Description>
</NDC>
<NDC>
<NDCCode>35356-834-01</NDCCode>
<PackageDescription>120 TABLET in 1 BOTTLE, PLASTIC (35356-834-01) </PackageDescription>
<NDC11Code>35356-0834-01</NDC11Code>
<ProductNDC>35356-834</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methadone Hydrochloride</ProprietaryName>
<NonProprietaryName>Methadone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA006134</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>METHADONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37000-834-01</NDCCode>
<PackageDescription>500 mL in 1 BOTTLE, PLASTIC (37000-834-01)</PackageDescription>
<NDC11Code>37000-0834-01</NDC11Code>
<ProductNDC>37000-834</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Crest Pro-health</ProprietaryName>
<ProprietaryNameSuffix>For Me</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>RINSE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120723</StartMarketingDate>
<EndMarketingDate>20171201</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>47335-834-01</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (47335-834-01) > 10 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>47335-0834-01</NDC11Code>
<ProductNDC>47335-834</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fosphenytoin Sodium</ProprietaryName>
<NonProprietaryName>Fosphenytoin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20090814</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078417</ApplicationNumber>
<LabelerName>Sun Pharma Global FZE</LabelerName>
<SubstanceName>FOSPHENYTOIN SODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-30</LastUpdate>
</NDC>
<NDC>
<NDCCode>49884-834-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49884-834-01) </PackageDescription>
<NDC11Code>49884-0834-01</NDC11Code>
<ProductNDC>49884-834</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121109</StartMarketingDate>
<EndMarketingDate>20190228</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020616</ApplicationNumber>
<LabelerName>Par Pharmaceutical Inc.</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20121109</StartMarketingDatePackage>
<EndMarketingDatePackage>20190228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52125-834-01</NDCCode>
<PackageDescription>2 mL in 1 VIAL, SINGLE-DOSE (52125-834-01)</PackageDescription>
<NDC11Code>52125-0834-01</NDC11Code>
<ProductNDC>52125-834</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron</ProprietaryName>
<NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140213</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202600</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>55910-834-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (55910-834-01) / 100 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>55910-0834-01</NDC11Code>
<ProductNDC>55910-834</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pain Relief Pm</ProprietaryName>
<NonProprietaryName>Acetaminophen, Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231225</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>DOLGENCORP, INC.</LabelerName>
<SubstanceName>ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.</IndicationAndUsage>
</NDC>
</NDCList>