{
"NDC": [
{
"NDCCode": "42023-259-00",
"PackageDescription": "1 CARTON in 1 KIT (42023-259-00) / 1 VIAL, MULTI-DOSE in 1 CARTON (42023-259-01) / 2.8 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "42023-0259-00",
"ProductNDC": "42023-259",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Leuprolide Acetate",
"NonProprietaryName": "Leuprolide Acetate",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20260630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217437",
"LabelerName": "Endo USA, Inc.",
"SubstanceName": "LEUPROLIDE ACETATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/.2mL",
"Pharm_Classes": "Gonadotropin Releasing Hormone Receptor Agonist [EPC], Gonadotropin Releasing Hormone Receptor Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20260630",
"SamplePackage": "N",
"IndicationAndUsage": "Leuprolide acetate injection is indicated in the palliative treatment of advanced prostatic cancer.",
"Description": "Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D- leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula. Leuprolide acetate injection is a sterile, aqueous solution intended for subcutaneous injection. It is available in a 2.8 mL multiple-dose vial containing leuprolide acetate (5 mg/mL), sodium chloride, USP (6.3 mg/mL) for tonicity adjustment, benzyl alcohol, NF as a preservative (9 mg/mL), and water for injection, USP. The pH may have been adjusted with sodium hydroxide, NF and/or acetic acid, NF."
},
{
"NDCCode": "33358-259-00",
"PackageDescription": "100 TABLET in 1 BOTTLE (33358-259-00)",
"NDC11Code": "33358-0259-00",
"ProductNDC": "33358-259",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen Sodium",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20141111",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078432",
"LabelerName": "RxChange Co.",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "550",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of Naproxen Sodium Tablets, USP and other treatment options before deciding to use Naproxen Sodium Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient's weight. Naproxen as naproxen sodium tablets are indicated. For the relief of the signs and symptoms of rheumatoid arthritis. For the relief of the signs and symptoms of osteoarthritis. For the relief of the signs and symptoms of ankylosing spondylitis. For the relief of the signs and symptoms of juvenile arthritis. For relief of the signs and symptoms of tendonitis. For relief of the signs and symptoms of bursitis. For relief of the signs and symptoms of acute gout. For the management of pain. For the management of primary dysmenorrhea.",
"Description": "Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen sodium is (S)-6-methoxy-〈-methyl-2-naphthalene acetic acid, sodium salt. Naproxen sodium has the following structure. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen sodium is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. Naproxen Sodium Tablets, USP are available as blue tablets containing 275 mg of naproxen sodium and as blue tablets containing 550 mg of naproxen sodium. The inactive ingredients are. croscarmellose sodium, macrogol, magnesium stearate, polyvinly alcohol, povidone, talc, titanium dioxide and FD&C Blue #2."
},
{
"NDCCode": "51862-258-00",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (51862-258-00) / 1 KIT in 1 BLISTER PACK * 24 TABLET, FILM COATED in 1 BLISTER PACK (51862-259-24) * 4 TABLET, FILM COATED in 1 BLISTER PACK (51862-261-04) ",
"NDC11Code": "51862-0258-00",
"ProductNDC": "51862-258",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nextstellis",
"NonProprietaryName": "Drospirenone And Estetrol",
"DosageFormName": "KIT",
"StartMarketingDate": "20210416",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214154",
"LabelerName": "Mayne Pharma",
"Status": "Active",
"LastUpdate": "2023-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210416",
"SamplePackage": "Y",
"IndicationAndUsage": "NEXTSTELLIS is indicated for use by females of reproductive potential to prevent pregnancy.",
"Description": "NEXTSTELLIS® (drospirenone and estetrol tablets) is an oral contraceptive. It is supplied in a transparent PVC/aluminum blister card containing 28 tablets: 1 24 pink active tablets contain 3 mg drospirenone and 14.2 mg of estetrol on the anhydrous basis. Drospirenone is a synthetic progestin and estetrol is a synthetic estrogen., 2 4 white inert tablets."
},
{
"NDCCode": "67457-259-05",
"PackageDescription": "6 VIAL, GLASS in 1 CARTON (67457-259-05) > 5 mL in 1 VIAL, GLASS (67457-259-00)",
"NDC11Code": "67457-0259-05",
"ProductNDC": "67457-259",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isosulfan Blue",
"NonProprietaryName": "Isosulfan Blue",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20130314",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090874",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "ISOSULFAN BLUE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2017-10-19"
},
{
"NDCCode": "68001-259-00",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68001-259-00) ",
"NDC11Code": "68001-0259-00",
"ProductNDC": "68001-259",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130623",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202128",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-07-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20130623",
"SamplePackage": "N"
},
{
"NDCCode": "68016-259-00",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (68016-259-00) ",
"NDC11Code": "68016-0259-00",
"ProductNDC": "68016-259",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Premier Value Fiber Laxative",
"NonProprietaryName": "Calcium Polycarbophil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20151028",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Chain Drug Consortium",
"SubstanceName": "CALCIUM POLYCARBOPHIL",
"StrengthNumber": "625",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20151028",
"SamplePackage": "N",
"IndicationAndUsage": "relieves occasional constipation to help restore and maintain regularity . this product generally produces bowel movement in 12 to 72 hours. ."
},
{
"NDCCode": "68577-259-00",
"PackageDescription": "1 TUBE in 1 CARTON (68577-259-00) / 50 mL in 1 TUBE",
"NDC11Code": "68577-0259-00",
"ProductNDC": "68577-259",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hello Sun Silky Glow Broad Spectrum Spf40",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250501",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Cosmax USA, Corporation",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "12.24",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250501",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. : 1 Helps prevent sunburn, 2 If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "75839-259-00",
"PackageDescription": "500 g in 1 BOTTLE (75839-259-00)",
"NDC11Code": "75839-0259-00",
"ProductNDC": "75839-259",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Zoledronic Acid",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130401",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Attix Pharmaceuticals",
"SubstanceName": "ZOLEDRONIC ACID",
"StrengthNumber": "500",
"StrengthUnit": "g/500g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "81159-259-00",
"PackageDescription": "100 mL in 1 TUBE (81159-259-00) ",
"NDC11Code": "81159-0259-00",
"ProductNDC": "81159-259",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Seaweed Bath Co Everyday Mineral Spf 40",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220103",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "The Seaweed Bath Co.",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Active",
"LastUpdate": "2024-06-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220103",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. Higher SPF gives more sunburn protection. Retains SPF after 80 minutes of swimming or sweating."
},
{
"NDCCode": "50090-5826-0",
"PackageDescription": "1 DOSE PACK in 1 CARTON (50090-5826-0) / 1 POWDER in 1 DOSE PACK",
"NDC11Code": "50090-5826-00",
"ProductNDC": "50090-5826",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fosfomycin Tromethamine",
"NonProprietaryName": "Granules For Oral",
"DosageFormName": "POWDER",
"RouteName": "ORAL",
"StartMarketingDate": "20201006",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212548",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "FOSFOMYCIN TROMETHAMINE",
"StrengthNumber": "3",
"StrengthUnit": "g/1",
"Status": "Active",
"LastUpdate": "2023-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211026",
"SamplePackage": "N",
"IndicationAndUsage": "Fosfomycin Tromethamine is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis. Fosfomycin Tromethamine is not indicated for the treatment of pyelonephritis or perinephric abscess. If persistence or reappearance of bacteriuria occurs after treatment with Fosfomycin Tromethamine, other therapeutic agents should be selected. (See PRECAUTIONS and CLINICAL STUDIES sections.).",
"Description": "Fosfomycin Tromethamine Granules for Oral Solution contains fosfomycin tromethamine, a synthetic, broad spectrum, bactericidal antibiotic for oral administration. It is available as a single-dose sachet which contains white granules consisting of 5.631 grams of fosfomycin tromethamine (equivalent to 3 grams of fosfomycin), and the following inactive ingredients: mandarin flavor, orange flavor, saccharin, and sucrose.The contents of the sachet must be dissolved in water. Fosfomycin tromethamine, a phosphonic acid derivative, is available as (1R,2S)-(1,2-epoxypropyl)phosphonic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1). It is a white granular compound with a molecular weight of 259.2. Its empirical formula is C3H7O4P.C4H11NO3, and its chemical structure is as follows."
},
{
"NDCCode": "50090-6130-0",
"PackageDescription": "1 PACKET in 1 CARTON (50090-6130-0) / 1 GRANULE, FOR SOLUTION in 1 PACKET",
"NDC11Code": "50090-6130-00",
"ProductNDC": "50090-6130",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fosfomycin Tromethamine",
"NonProprietaryName": "Fosfomycin Tromethamine",
"DosageFormName": "GRANULE, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20211022",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214554",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "FOSFOMYCIN TROMETHAMINE",
"StrengthNumber": "3",
"StrengthUnit": "g/1",
"Status": "Active",
"LastUpdate": "2023-11-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221003",
"SamplePackage": "N",
"IndicationAndUsage": "Fosfomycin tromethamine granules for oral solution is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis. Fosfomycin tromethamine granules for oral solution is not indicated for the treatment of pyelonephritis or perinephric abscess. If persistence or reappearance of bacteriuria occurs after treatment with fosfomycin tromethamine granules for oral solution, other therapeutic agents should be selected. (See PRECAUTIONS and CLINICAL STUDIES sections.).",
"Description": "Fosfomycin Tromethamine Granules for Oral Solution contains fosfomycin tromethamine, a synthetic, broad spectrum, bactericidal antibiotic for oral administration. It is available as a single-dose sachet which contains white granules consisting of 5.631 grams of fosfomycin tromethamine (equivalent to 3 grams of fosfomycin), and the following inactive ingredients: orange flavor, saccharin and sucrose. The contents of the sachet must be dissolved in water. Fosfomycin tromethamine, a phosphonic acid derivative, is available as (1R,2S)-(1,2-epoxypropyl)phosphonic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1). It is a white granular compound with a molecular weight of 259.2. Its empirical formula is C3H7O4P.C4H11NO3, and its chemical structure is as follows."
},
{
"NDCCode": "54868-5649-0",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (54868-5649-0)",
"NDC11Code": "54868-5649-00",
"ProductNDC": "54868-5649",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rozerem",
"NonProprietaryName": "Ramelteon",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20060801",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021782",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "RAMELTEON",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Melatonin Receptor Agonist [EPC],Melatonin Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "ROZEREM is indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency were performed after 2 days of treatment during the crossover study (elderly only), at 5 weeks in the 6-week studies (adults and elderly), and at the end of the 6-month study (adults and elderly) [see Clinical Studies (14)].",
"Description": "ROZEREM (ramelteon) is an orally active hypnotic chemically designated as (S)-N-[2-(1,6,7,8-tetrahydro-2H-indeno-[5,4-b]furan-8-yl)ethyl]propionamide and containing one chiral center. The compound is produced as the (S)-enantiomer, with an empirical formula of C16H21NO2, molecular weight of 259.34, and the following chemical structure. Ramelteon is freely soluble in organic solvents, such as methanol, ethanol, and dimethyl sulfoxide; soluble in 1-octanol and acetonitrile; and very slightly soluble in water and in aqueous buffers from pH 3 to pH 11. Each ROZEREM tablet includes the following inactive ingredients: lactose monohydrate, starch, hydroxypropyl cellulose, magnesium stearate, hypromellose, copovidone, titanium dioxide, yellow ferric oxide, polyethylene glycol 8000, and ink containing shellac and synthetic iron oxide black."
},
{
"NDCCode": "59572-402-00",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (59572-402-00) ",
"NDC11Code": "59572-0402-00",
"ProductNDC": "59572-402",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Revlimid",
"NonProprietaryName": "Lenalidomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20120416",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021880",
"LabelerName": "Celgene Corporation",
"SubstanceName": "LENALIDOMIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thalidomide Analog [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120509",
"SamplePackage": "N",
"IndicationAndUsage": "REVLIMID is a thalidomide analogue indicated for the treatment of adult patients with: 1 Multiple myeloma (MM), in combination with dexamethasone (1.1)., 2 MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) (1.1)., 3 Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities (1.2)., 4 Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib (1.3)., 5 Previously treated follicular lymphoma (FL), in combination with a rituximab product (1.4)., 6 Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product (1.5).",
"Description": "REVLIMID, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure:. 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione. The empirical formula for lenalidomide is C13H13N3O3, and the gram molecular weight is 259.3. Lenalidomide is an off-white to pale-yellow solid powder. It is soluble in organic solvent/water mixtures, and buffered aqueous solvents. Lenalidomide is more soluble in organic solvents and low pH solutions. Solubility was significantly lower in less acidic buffers, ranging from about 0.4 to 0.5 mg/ml. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero. REVLIMID is available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The 5 mg and 25 mg capsule shell contains gelatin, titanium dioxide and black ink. The 2.5 mg and 10 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink. The 15 mg capsule shell contains gelatin, FD&C blue #2, titanium dioxide and black ink. The 20 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink."
},
{
"NDCCode": "59572-405-00",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (59572-405-00) ",
"NDC11Code": "59572-0405-00",
"ProductNDC": "59572-405",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Revlimid",
"NonProprietaryName": "Lenalidomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20051227",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021880",
"LabelerName": "Celgene Corporation",
"SubstanceName": "LENALIDOMIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thalidomide Analog [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20051227",
"SamplePackage": "N",
"IndicationAndUsage": "REVLIMID is a thalidomide analogue indicated for the treatment of adult patients with: 1 Multiple myeloma (MM), in combination with dexamethasone (1.1)., 2 MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) (1.1)., 3 Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities (1.2)., 4 Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib (1.3)., 5 Previously treated follicular lymphoma (FL), in combination with a rituximab product (1.4)., 6 Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product (1.5).",
"Description": "REVLIMID, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure:. 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione. The empirical formula for lenalidomide is C13H13N3O3, and the gram molecular weight is 259.3. Lenalidomide is an off-white to pale-yellow solid powder. It is soluble in organic solvent/water mixtures, and buffered aqueous solvents. Lenalidomide is more soluble in organic solvents and low pH solutions. Solubility was significantly lower in less acidic buffers, ranging from about 0.4 to 0.5 mg/ml. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero. REVLIMID is available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The 5 mg and 25 mg capsule shell contains gelatin, titanium dioxide and black ink. The 2.5 mg and 10 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink. The 15 mg capsule shell contains gelatin, FD&C blue #2, titanium dioxide and black ink. The 20 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink."
},
{
"NDCCode": "59572-410-00",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (59572-410-00) ",
"NDC11Code": "59572-0410-00",
"ProductNDC": "59572-410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Revlimid",
"NonProprietaryName": "Lenalidomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20051227",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021880",
"LabelerName": "Celgene Corporation",
"SubstanceName": "LENALIDOMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thalidomide Analog [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20051227",
"SamplePackage": "N",
"IndicationAndUsage": "REVLIMID is a thalidomide analogue indicated for the treatment of adult patients with: 1 Multiple myeloma (MM), in combination with dexamethasone (1.1)., 2 MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) (1.1)., 3 Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities (1.2)., 4 Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib (1.3)., 5 Previously treated follicular lymphoma (FL), in combination with a rituximab product (1.4)., 6 Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product (1.5).",
"Description": "REVLIMID, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure:. 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione. The empirical formula for lenalidomide is C13H13N3O3, and the gram molecular weight is 259.3. Lenalidomide is an off-white to pale-yellow solid powder. It is soluble in organic solvent/water mixtures, and buffered aqueous solvents. Lenalidomide is more soluble in organic solvents and low pH solutions. Solubility was significantly lower in less acidic buffers, ranging from about 0.4 to 0.5 mg/ml. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero. REVLIMID is available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The 5 mg and 25 mg capsule shell contains gelatin, titanium dioxide and black ink. The 2.5 mg and 10 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink. The 15 mg capsule shell contains gelatin, FD&C blue #2, titanium dioxide and black ink. The 20 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink."
},
{
"NDCCode": "59572-415-00",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (59572-415-00) ",
"NDC11Code": "59572-0415-00",
"ProductNDC": "59572-415",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Revlimid",
"NonProprietaryName": "Lenalidomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060629",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021880",
"LabelerName": "Celgene Corporation",
"SubstanceName": "LENALIDOMIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thalidomide Analog [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060707",
"SamplePackage": "N",
"IndicationAndUsage": "REVLIMID is a thalidomide analogue indicated for the treatment of adult patients with: 1 Multiple myeloma (MM), in combination with dexamethasone (1.1)., 2 MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) (1.1)., 3 Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities (1.2)., 4 Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib (1.3)., 5 Previously treated follicular lymphoma (FL), in combination with a rituximab product (1.4)., 6 Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product (1.5).",
"Description": "REVLIMID, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure:. 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione. The empirical formula for lenalidomide is C13H13N3O3, and the gram molecular weight is 259.3. Lenalidomide is an off-white to pale-yellow solid powder. It is soluble in organic solvent/water mixtures, and buffered aqueous solvents. Lenalidomide is more soluble in organic solvents and low pH solutions. Solubility was significantly lower in less acidic buffers, ranging from about 0.4 to 0.5 mg/ml. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero. REVLIMID is available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The 5 mg and 25 mg capsule shell contains gelatin, titanium dioxide and black ink. The 2.5 mg and 10 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink. The 15 mg capsule shell contains gelatin, FD&C blue #2, titanium dioxide and black ink. The 20 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink."
},
{
"NDCCode": "59572-420-00",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (59572-420-00) ",
"NDC11Code": "59572-0420-00",
"ProductNDC": "59572-420",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Revlimid",
"NonProprietaryName": "Lenalidomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130606",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021880",
"LabelerName": "Celgene Corporation",
"SubstanceName": "LENALIDOMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thalidomide Analog [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130610",
"SamplePackage": "N",
"IndicationAndUsage": "REVLIMID is a thalidomide analogue indicated for the treatment of adult patients with: 1 Multiple myeloma (MM), in combination with dexamethasone (1.1)., 2 MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) (1.1)., 3 Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities (1.2)., 4 Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib (1.3)., 5 Previously treated follicular lymphoma (FL), in combination with a rituximab product (1.4)., 6 Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product (1.5).",
"Description": "REVLIMID, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure:. 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione. The empirical formula for lenalidomide is C13H13N3O3, and the gram molecular weight is 259.3. Lenalidomide is an off-white to pale-yellow solid powder. It is soluble in organic solvent/water mixtures, and buffered aqueous solvents. Lenalidomide is more soluble in organic solvents and low pH solutions. Solubility was significantly lower in less acidic buffers, ranging from about 0.4 to 0.5 mg/ml. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero. REVLIMID is available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The 5 mg and 25 mg capsule shell contains gelatin, titanium dioxide and black ink. The 2.5 mg and 10 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink. The 15 mg capsule shell contains gelatin, FD&C blue #2, titanium dioxide and black ink. The 20 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink."
},
{
"NDCCode": "59572-425-00",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (59572-425-00) ",
"NDC11Code": "59572-0425-00",
"ProductNDC": "59572-425",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Revlimid",
"NonProprietaryName": "Lenalidomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20060629",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021880",
"LabelerName": "Celgene Corporation",
"SubstanceName": "LENALIDOMIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thalidomide Analog [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20060707",
"SamplePackage": "N",
"IndicationAndUsage": "REVLIMID is a thalidomide analogue indicated for the treatment of adult patients with: 1 Multiple myeloma (MM), in combination with dexamethasone (1.1)., 2 MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) (1.1)., 3 Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities (1.2)., 4 Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib (1.3)., 5 Previously treated follicular lymphoma (FL), in combination with a rituximab product (1.4)., 6 Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product (1.5).",
"Description": "REVLIMID, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure:. 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione. The empirical formula for lenalidomide is C13H13N3O3, and the gram molecular weight is 259.3. Lenalidomide is an off-white to pale-yellow solid powder. It is soluble in organic solvent/water mixtures, and buffered aqueous solvents. Lenalidomide is more soluble in organic solvents and low pH solutions. Solubility was significantly lower in less acidic buffers, ranging from about 0.4 to 0.5 mg/ml. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero. REVLIMID is available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The 5 mg and 25 mg capsule shell contains gelatin, titanium dioxide and black ink. The 2.5 mg and 10 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink. The 15 mg capsule shell contains gelatin, FD&C blue #2, titanium dioxide and black ink. The 20 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink."
},
{
"NDCCode": "70518-4257-0",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4257-0) ",
"NDC11Code": "70518-4257-00",
"ProductNDC": "70518-4257",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ramelteon",
"NonProprietaryName": "Ramelteon",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213815",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "RAMELTEON",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250120",
"SamplePackage": "N",
"IndicationAndUsage": "Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six month studies (adults and elderly), and at the end of the six month study (adults and elderly) [see Clinical Studies (14)] .",
"Description": "Ramelteon is an orally active hypnotic chemically designated as (S)-N-[2-(1,6,7,8- tetrahydro-2H-indeno-[5,4-b]furan-8-yl)ethyl]propionamide and containing one chiral center. The compound is produced as the (S)-enantiomer, with an empirical formula of C16H21NO2, molecular weight of 259.34, and the following chemical structure. Ramelteon is freely soluble in methanol and practically insoluble in water. Each ramelteon tablet contains the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, pregelatinized starch, titanium dioxide and yellow iron oxide."
},
{
"NDCCode": "71205-918-00",
"PackageDescription": "100 TABLET in 1 BOTTLE (71205-918-00) ",
"NDC11Code": "71205-0918-00",
"ProductNDC": "71205-918",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ramelteon",
"NonProprietaryName": "Ramelteon",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213186",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "RAMELTEON",
"StrengthNumber": "8",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2022-04-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210707",
"SamplePackage": "N",
"IndicationAndUsage": "Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see Clinical Studies (14)].",
"Description": "Ramelteon is an orally active hypnotic chemically designated as ( S)- N-[2-(1,6,7,8-tetrahydro-2 H-indeno-[5,4- b]furan-8-yl)ethyl]propionamide and containing one chiral center. The compound is produced as the ( S)-enantiomer, with an empirical formula of C 16 H 21 NO 2, molecular weight of 259.34, and the following chemical structure:. Ramelteon is freely soluble in organic solvents, such as methanol, ethanol, and dimethyl sulfoxide; soluble in 1-octanol and acetonitrile; and very slightly soluble in water and in aqueous buffers from pH 3 to pH 11. Each Ramelteon tablet includes the following inactive ingredients: copovidone, corn starch, hydroxypropyl cellulose, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "24357-011-13",
"PackageDescription": "1 KIT in 1 CARTON (24357-011-13) * 1 mL in 1 VIAL (42023-159-25) * 1 mL in 1 PACKET (68599-5804-1) ",
"NDC11Code": "24357-0011-13",
"ProductNDC": "24357-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epinephrine Professional",
"NonProprietaryName": "Epinephrine And Isopropyl Alcohol",
"DosageFormName": "KIT",
"RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
"StartMarketingDate": "20190701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204200",
"LabelerName": "Focus Health Group",
"Status": "Active",
"LastUpdate": "2026-02-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190701",
"SamplePackage": "N"
},
{
"NDCCode": "24357-012-12",
"PackageDescription": "1 KIT in 1 CARTON (24357-012-12) * 1 mL in 1 PACKET (68599-5804-1) * 1 mL in 1 VIAL (42023-159-01) ",
"NDC11Code": "24357-0012-12",
"ProductNDC": "24357-012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epinephrine Professional Ems",
"NonProprietaryName": "Epinephrine Convenience Kit",
"DosageFormName": "KIT",
"RouteName": "INTRAMUSCULAR; SUBCUTANEOUS",
"StartMarketingDate": "20190701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204200",
"LabelerName": "Focus Health Group",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190701",
"SamplePackage": "N"
},
{
"NDCCode": "24357-811-20",
"PackageDescription": "1 KIT in 1 KIT (24357-811-20) * 1 mL in 1 VIAL, GLASS (42023-159-25) ",
"NDC11Code": "24357-0811-20",
"ProductNDC": "24357-811",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Epinephrinesnap-v",
"NonProprietaryName": "Epinephrine Convenience Kit",
"DosageFormName": "KIT",
"StartMarketingDate": "20170505",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "FOCUS HEALTH GROUP",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20170505",
"SamplePackage": "N",
"IndicationAndUsage": "Adrenalin® is available as a single-use 1 mL vial and a multiple-use 30 mL vial for intramuscular and subcutaneous use. Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from allergic reactions to insect stings, biting insects, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. The signs and symptoms associated with anaphylaxis include flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with hypotension, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, airway swelling, laryngospasm, bronchospasm, pruritus, urticaria or angioedema, swelling of the eyelids, lips, and tongue.",
"Description": "Adrenalin® (epinephrine injection, USP) is a clear, colorless, sterile solution containing 1 mg/mL (1:1000) epinephrine, packaged as 1 mL of solution in a singleuse clear glass vial or 30 mL of solution in a multiple-dose amber glass vial. In the 1 mL vial, each 1 mL of Adrenalin® solution contains 1 mg epinephrine, 7.3 mg sodium chloride, 0.457 mg sodium metabisulfite, 1 mg sodium hydroxide, 2.25 mg tartaric acid, 0.20 mg disodium edetate dihydrate, hydrochloric acid to adjust pH, and water for injection. In the 30 mL vial, each 1 mL of Adrenalin® solution contains 1 mg epinephrine, 6.15 mg sodium chloride, 0.457 mg sodium metabisulfite, 0.920 mg sodium hydroxide, 2.25 mg tartaric acid, 0.20 mg disodium edetate dihydrate, hydrochloric acid to adjust pH, 5.25 mg chlorobutanol as a preservative and water for injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. The chemical name of epinephrine is: 1,2-Benzenediol, 4-[(1R)-1-hydroxy-2-(methylamino)ethyl]-, or (-)-3,4-Dihydroxy-α-[2-(methylamino)ethyl]benzyl alcohol. The chemical structure of epinephrine is:. The molecular weight of epinephrine is 183.2. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin."
},
{
"NDCCode": "42023-104-01",
"PackageDescription": "1 VIAL in 1 CARTON (42023-104-01) / 1 mL in 1 VIAL",
"NDC11Code": "42023-0104-01",
"ProductNDC": "42023-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aplisol",
"NonProprietaryName": "Tuberculin Purified Protein Derivative",
"DosageFormName": "INJECTION",
"RouteName": "INTRADERMAL",
"StartMarketingDate": "20080425",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103782",
"LabelerName": "ENDO USA, Inc.",
"SubstanceName": "TUBERCULIN PURIFIED PROTEIN DERIVATIVE",
"StrengthNumber": "5",
"StrengthUnit": "[iU]/.1mL",
"Pharm_Classes": "Antigens, Bacterial [CS], Cell-mediated Immunity [PE], Skin Test Antigen [EPC], Tuberculosis Skin Test [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080425",
"SamplePackage": "N",
"IndicationAndUsage": "Tuberculin PPD is indicated as an aid in the detection of infection with Mycobacterium tuberculosis. The standard tuberculin test employs the intradermal (Mantoux) test using a 5 TU dose of tuberculin PPD.7 The 0.1 mL test dose of Aplisol (tuberculin PPD, diluted) is equivalent to the 5 TU dose which has been clinically utilized and standardized with PPD-S. Tuberculin skin testing is not contraindicated for persons who have been vaccinated with BCG and the skin-test results of such persons are used to support or exclude the diagnosis of M. tuberculosis infections.4 HIV infection is a strong risk factor for the development of TB disease in persons having TB infection. All HIV-infected persons should receive a PPD-tuberculin skin test.3.",
"Description": "Aplisol (tuberculin PPD, diluted) is a sterile aqueous solution of a purified protein fraction for intradermal administration as an aid in the diagnosis of tuberculosis. The solution is stabilized with polysorbate (Tween) 80, buffered with potassium and sodium phosphates and contains approximately 0.25% phenol as a preservative. This product is ready for immediate use without further dilution. The purified protein fraction is isolated from culture media filtrates of a human strain of Mycobacterium tuberculosis by the method of F.B. Seibert.1,2 Tuberculin PPD, diluted, is prepared from Tuberculin PPD which is clinically bioequivalent in potency to the standard PPD-S* (5 TU** per 0.1mL) of the U.S. Public Health Service, National Centers for Disease Control. The potency of each lot of tuberculin PPD, diluted is determined in sensitized guinea pigs."
},
{
"NDCCode": "42023-104-05",
"PackageDescription": "1 VIAL in 1 CARTON (42023-104-05) / 5 mL in 1 VIAL",
"NDC11Code": "42023-0104-05",
"ProductNDC": "42023-104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aplisol",
"NonProprietaryName": "Tuberculin Purified Protein Derivative",
"DosageFormName": "INJECTION",
"RouteName": "INTRADERMAL",
"StartMarketingDate": "20080425",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103782",
"LabelerName": "ENDO USA, Inc.",
"SubstanceName": "TUBERCULIN PURIFIED PROTEIN DERIVATIVE",
"StrengthNumber": "5",
"StrengthUnit": "[iU]/.1mL",
"Pharm_Classes": "Antigens, Bacterial [CS], Cell-mediated Immunity [PE], Skin Test Antigen [EPC], Tuberculosis Skin Test [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080425",
"SamplePackage": "N",
"IndicationAndUsage": "Tuberculin PPD is indicated as an aid in the detection of infection with Mycobacterium tuberculosis. The standard tuberculin test employs the intradermal (Mantoux) test using a 5 TU dose of tuberculin PPD.7 The 0.1 mL test dose of Aplisol (tuberculin PPD, diluted) is equivalent to the 5 TU dose which has been clinically utilized and standardized with PPD-S. Tuberculin skin testing is not contraindicated for persons who have been vaccinated with BCG and the skin-test results of such persons are used to support or exclude the diagnosis of M. tuberculosis infections.4 HIV infection is a strong risk factor for the development of TB disease in persons having TB infection. All HIV-infected persons should receive a PPD-tuberculin skin test.3.",
"Description": "Aplisol (tuberculin PPD, diluted) is a sterile aqueous solution of a purified protein fraction for intradermal administration as an aid in the diagnosis of tuberculosis. The solution is stabilized with polysorbate (Tween) 80, buffered with potassium and sodium phosphates and contains approximately 0.25% phenol as a preservative. This product is ready for immediate use without further dilution. The purified protein fraction is isolated from culture media filtrates of a human strain of Mycobacterium tuberculosis by the method of F.B. Seibert.1,2 Tuberculin PPD, diluted, is prepared from Tuberculin PPD which is clinically bioequivalent in potency to the standard PPD-S* (5 TU** per 0.1mL) of the U.S. Public Health Service, National Centers for Disease Control. The potency of each lot of tuberculin PPD, diluted is determined in sensitized guinea pigs."
},
{
"NDCCode": "42023-105-01",
"PackageDescription": "1 VIAL in 1 CARTON (42023-105-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL",
"NDC11Code": "42023-0105-01",
"ProductNDC": "42023-105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brevital Sodium",
"NonProprietaryName": "Methohexital Sodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; RECTAL",
"StartMarketingDate": "20071101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA011559",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "METHOHEXITAL SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Barbiturate [EPC], Barbiturates [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-05-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20071101",
"SamplePackage": "N",
"IndicationAndUsage": "BREVITAL can be used in adults as follows. 1. For intravenous induction of anesthesia prior to the use of other general anesthetic agents. 2. For intravenous induction of anesthesia and as an adjunct to subpotent inhalational anesthetic agents (such as nitrous oxide in oxygen) for short surgical procedures; BREVITAL may be given by infusion or intermittent injection. 3. For use along with other parenteral agents, usually narcotic analgesics, to supplement subpotent inhalational anesthetic agents (such as nitrous oxide in oxygen) for longer surgical procedures. 4. As intravenous anesthesia for short surgical, diagnostic, or therapeutic procedures associated with minimal painful stimuli (see WARNINGS). 5. As an agent for inducing a hypnotic state. BREVITAL can be used in pediatric patients older than 1 month as follows. 1. For rectal or intramuscular induction of anesthesia prior to the use of other general anesthetic agents. 2. For rectal or intramuscular induction of anesthesia and as an adjunct to subpotent inhalational anesthetic agents for short surgical procedures. 3. As rectal or intramuscular anesthesia for short surgical, diagnostic, or therapeutic procedures associated with minimal painful stimuli.",
"Description": "BREVITAL® (methohexital sodium, USP) for injection, is 2,4,6 (1H, 3H, 5H)-Pyrimidinetrione, 1-methyl-5-(1-methyl-2-pentynyl)-5-(2-propenyl)-, (±)-, monosodium salt and has the empirical formula C14H17N2NaO3. Its molecular weight is 284.29. The structural formula is as follows. Methohexital sodium is a rapid, ultrashort-acting barbiturate anesthetic. Methohexital sodium for injection is a freeze-dried, sterile, nonpyrogenic mixture of methohexital sodium with 6% anhydrous sodium carbonate added as a buffer. It contains not less than 90% and not more than 110% of the labeled amount of methohexital sodium. It occurs as a white, freeze-dried plug that is freely soluble in water. This product is oxygen sensitive. The pH of the 1% solution is between 10 and 11; the pH of the 0.2% solution in 5% dextrose is between 9.5 and 10.5. Methohexital sodium may be administered by direct intravenous injection or continuous intravenous drip, intramuscular or rectal routes (see PRECAUTIONS/Pediatric Use). Reconstituting instructions vary depending on the route of administration (see DOSAGE AND ADMINISTRATION)."
},
{
"NDCCode": "42023-106-01",
"PackageDescription": "1 VIAL in 1 CARTON (42023-106-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL",
"NDC11Code": "42023-0106-01",
"ProductNDC": "42023-106",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brevital Sodium",
"NonProprietaryName": "Methohexital Sodium",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; RECTAL",
"StartMarketingDate": "20071101",
"EndMarketingDate": "20210131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA011559",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "METHOHEXITAL SODIUM",
"StrengthNumber": "2.5",
"StrengthUnit": "g/1",
"Pharm_Classes": "Barbiturate [EPC],Barbiturates [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2021-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20071101",
"EndMarketingDatePackage": "20210131",
"SamplePackage": "N"
},
{
"NDCCode": "42023-107-01",
"PackageDescription": "1 VIAL in 1 CARTON (42023-107-01) / 2 mL in 1 VIAL",
"NDC11Code": "42023-0107-01",
"ProductNDC": "42023-107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Coly-mycin",
"ProprietaryNameSuffix": "M",
"NonProprietaryName": "Colistimethate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20071101",
"EndMarketingDate": "20270531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050108",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "COLISTIMETHATE SODIUM",
"StrengthNumber": "150",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20071101",
"EndMarketingDatePackage": "20270531",
"SamplePackage": "N",
"IndicationAndUsage": "Coly-Mycin M Parenteral is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli. It is particularly indicated when the infection is caused by sensitive strains of Pseudomonas aeruginosa. This antibiotic is not indicated for infections due to Proteus or Neisseria. Coly-Mycin M Parenteral has proven clinically effective in treatment of infections due to the following gram-negative organisms: Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa. Coly-Mycin M Parenteral may be used to initiate therapy in serious infections that are suspected to be due to gram-negative organisms and in the treatment of infections due to susceptible gram-negative pathogenic bacilli. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Coly-Mycin M and other antibacterial drugs, Coly-Mycin M 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.",
"Description": "Coly-Mycin® M Parenteral (Colistimethate for Injection, USP) is a sterile parenteral antibiotic product which, when reconstituted (see Reconstitution), is suitable for intramuscular or intravenous administration. Each vial contains colistimethate sodium or pentasodium colistinmethanesulfonate (150 mg colistin base activity). Colistimethate sodium is a polypeptide antibiotic with an approximate molecular weight of 1750. The empirical formula is C58H105N16Na5O28S5 and the structural formula is represented below."
},
{
"NDCCode": "42023-107-06",
"PackageDescription": "6 VIAL in 1 CARTON (42023-107-06) > 2 mL in 1 VIAL",
"NDC11Code": "42023-0107-06",
"ProductNDC": "42023-107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Coly-mycin",
"ProprietaryNameSuffix": "M",
"NonProprietaryName": "Colistimethate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20071101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050108",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "COLISTIMETHATE SODIUM",
"StrengthNumber": "150",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20071101",
"EndMarketingDatePackage": "20221031",
"SamplePackage": "N",
"IndicationAndUsage": "Coly-Mycin M Parenteral is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli. It is particularly indicated when the infection is caused by sensitive strains of Pseudomonas aeruginosa. This antibiotic is not indicated for infections due to Proteus or Neisseria. Coly-Mycin M Parenteral has proven clinically effective in treatment of infections due to the following gram-negative organisms: Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa. Coly-Mycin M Parenteral may be used to initiate therapy in serious infections that are suspected to be due to gram-negative organisms and in the treatment of infections due to susceptible gram-negative pathogenic bacilli. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Coly-Mycin M and other antibacterial drugs, Coly-Mycin M 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.",
"Description": "Coly-Mycin® M Parenteral (Colistimethate for Injection, USP) is a sterile parenteral antibiotic product which, when reconstituted (see Reconstitution), is suitable for intramuscular or intravenous administration. Each vial contains colistimethate sodium or pentasodium colistinmethanesulfonate (150 mg colistin base activity). Colistimethate sodium is a polypeptide antibiotic with an approximate molecular weight of 1750. The empirical formula is C58H105N16Na5O28S5 and the structural formula is represented below."
},
{
"NDCCode": "42023-108-01",
"PackageDescription": "5 mL in 1 BOTTLE, DROPPER (42023-108-01)",
"NDC11Code": "42023-0108-01",
"ProductNDC": "42023-108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Coly-mycin S",
"NonProprietaryName": "Colistin Sulfate, Neomycin Sulfate, Thonzonium Bromide And Hydrocortisone Acetate",
"DosageFormName": "SUSPENSION",
"RouteName": "AURICULAR (OTIC)",
"StartMarketingDate": "20071101",
"EndMarketingDate": "20170618",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050356",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "COLISTIN SULFATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE; HYDROCORTISONE ACETATE",
"StrengthNumber": "3; 3.3; .5; 10",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-06-21"
}
]
}
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<NDC>
<NDCCode>42023-259-00</NDCCode>
<PackageDescription>1 CARTON in 1 KIT (42023-259-00) / 1 VIAL, MULTI-DOSE in 1 CARTON (42023-259-01) / 2.8 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>42023-0259-00</NDC11Code>
<ProductNDC>42023-259</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Leuprolide Acetate</ProprietaryName>
<NonProprietaryName>Leuprolide Acetate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20260630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217437</ApplicationNumber>
<LabelerName>Endo USA, Inc.</LabelerName>
<SubstanceName>LEUPROLIDE ACETATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/.2mL</StrengthUnit>
<Pharm_Classes>Gonadotropin Releasing Hormone Receptor Agonist [EPC], Gonadotropin Releasing Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Leuprolide acetate injection is indicated in the palliative treatment of advanced prostatic cancer.</IndicationAndUsage>
<Description>Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D- leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula. Leuprolide acetate injection is a sterile, aqueous solution intended for subcutaneous injection. It is available in a 2.8 mL multiple-dose vial containing leuprolide acetate (5 mg/mL), sodium chloride, USP (6.3 mg/mL) for tonicity adjustment, benzyl alcohol, NF as a preservative (9 mg/mL), and water for injection, USP. The pH may have been adjusted with sodium hydroxide, NF and/or acetic acid, NF.</Description>
</NDC>
<NDC>
<NDCCode>33358-259-00</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (33358-259-00)</PackageDescription>
<NDC11Code>33358-0259-00</NDC11Code>
<ProductNDC>33358-259</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen Sodium</ProprietaryName>
<NonProprietaryName>Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141111</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078432</ApplicationNumber>
<LabelerName>RxChange Co.</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>550</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of Naproxen Sodium Tablets, USP and other treatment options before deciding to use Naproxen Sodium Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient's weight. Naproxen as naproxen sodium tablets are indicated. For the relief of the signs and symptoms of rheumatoid arthritis. For the relief of the signs and symptoms of osteoarthritis. For the relief of the signs and symptoms of ankylosing spondylitis. For the relief of the signs and symptoms of juvenile arthritis. For relief of the signs and symptoms of tendonitis. For relief of the signs and symptoms of bursitis. For relief of the signs and symptoms of acute gout. For the management of pain. For the management of primary dysmenorrhea.</IndicationAndUsage>
<Description>Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen sodium is (S)-6-methoxy-〈-methyl-2-naphthalene acetic acid, sodium salt. Naproxen sodium has the following structure. Naproxen sodium has a molecular weight of 252.23 and a molecular formula of C14H13NaO3. Naproxen sodium is a white to creamy white, crystalline solid, freely soluble in water at neutral pH. Naproxen Sodium Tablets, USP are available as blue tablets containing 275 mg of naproxen sodium and as blue tablets containing 550 mg of naproxen sodium. The inactive ingredients are. croscarmellose sodium, macrogol, magnesium stearate, polyvinly alcohol, povidone, talc, titanium dioxide and FD&C Blue #2.</Description>
</NDC>
<NDC>
<NDCCode>51862-258-00</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (51862-258-00) / 1 KIT in 1 BLISTER PACK * 24 TABLET, FILM COATED in 1 BLISTER PACK (51862-259-24) * 4 TABLET, FILM COATED in 1 BLISTER PACK (51862-261-04) </PackageDescription>
<NDC11Code>51862-0258-00</NDC11Code>
<ProductNDC>51862-258</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nextstellis</ProprietaryName>
<NonProprietaryName>Drospirenone And Estetrol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20210416</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214154</ApplicationNumber>
<LabelerName>Mayne Pharma</LabelerName>
<Status>Active</Status>
<LastUpdate>2023-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210416</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>NEXTSTELLIS is indicated for use by females of reproductive potential to prevent pregnancy.</IndicationAndUsage>
<Description>NEXTSTELLIS® (drospirenone and estetrol tablets) is an oral contraceptive. It is supplied in a transparent PVC/aluminum blister card containing 28 tablets: 1 24 pink active tablets contain 3 mg drospirenone and 14.2 mg of estetrol on the anhydrous basis. Drospirenone is a synthetic progestin and estetrol is a synthetic estrogen., 2 4 white inert tablets.</Description>
</NDC>
<NDC>
<NDCCode>67457-259-05</NDCCode>
<PackageDescription>6 VIAL, GLASS in 1 CARTON (67457-259-05) > 5 mL in 1 VIAL, GLASS (67457-259-00)</PackageDescription>
<NDC11Code>67457-0259-05</NDC11Code>
<ProductNDC>67457-259</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isosulfan Blue</ProprietaryName>
<NonProprietaryName>Isosulfan Blue</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20130314</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090874</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>ISOSULFAN BLUE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-10-19</LastUpdate>
</NDC>
<NDC>
<NDCCode>68001-259-00</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68001-259-00) </PackageDescription>
<NDC11Code>68001-0259-00</NDC11Code>
<ProductNDC>68001-259</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130623</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202128</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130623</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68016-259-00</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (68016-259-00) </PackageDescription>
<NDC11Code>68016-0259-00</NDC11Code>
<ProductNDC>68016-259</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Premier Value Fiber Laxative</ProprietaryName>
<NonProprietaryName>Calcium Polycarbophil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151028</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Chain Drug Consortium</LabelerName>
<SubstanceName>CALCIUM POLYCARBOPHIL</SubstanceName>
<StrengthNumber>625</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves occasional constipation to help restore and maintain regularity . this product generally produces bowel movement in 12 to 72 hours. .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68577-259-00</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (68577-259-00) / 50 mL in 1 TUBE</PackageDescription>
<NDC11Code>68577-0259-00</NDC11Code>
<ProductNDC>68577-259</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hello Sun Silky Glow Broad Spectrum Spf40</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Cosmax USA, Corporation</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>12.24</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. : 1 Helps prevent sunburn, 2 If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75839-259-00</NDCCode>
<PackageDescription>500 g in 1 BOTTLE (75839-259-00)</PackageDescription>
<NDC11Code>75839-0259-00</NDC11Code>
<ProductNDC>75839-259</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Zoledronic Acid</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20130401</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Attix Pharmaceuticals</LabelerName>
<SubstanceName>ZOLEDRONIC ACID</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>g/500g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>81159-259-00</NDCCode>
<PackageDescription>100 mL in 1 TUBE (81159-259-00) </PackageDescription>
<NDC11Code>81159-0259-00</NDC11Code>
<ProductNDC>81159-259</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Seaweed Bath Co Everyday Mineral Spf 40</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220103</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>The Seaweed Bath Co.</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. Higher SPF gives more sunburn protection. Retains SPF after 80 minutes of swimming or sweating.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50090-5826-0</NDCCode>
<PackageDescription>1 DOSE PACK in 1 CARTON (50090-5826-0) / 1 POWDER in 1 DOSE PACK</PackageDescription>
<NDC11Code>50090-5826-00</NDC11Code>
<ProductNDC>50090-5826</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fosfomycin Tromethamine</ProprietaryName>
<NonProprietaryName>Granules For Oral</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201006</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212548</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>FOSFOMYCIN TROMETHAMINE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-11-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fosfomycin Tromethamine is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis. Fosfomycin Tromethamine is not indicated for the treatment of pyelonephritis or perinephric abscess. If persistence or reappearance of bacteriuria occurs after treatment with Fosfomycin Tromethamine, other therapeutic agents should be selected. (See PRECAUTIONS and CLINICAL STUDIES sections.).</IndicationAndUsage>
<Description>Fosfomycin Tromethamine Granules for Oral Solution contains fosfomycin tromethamine, a synthetic, broad spectrum, bactericidal antibiotic for oral administration. It is available as a single-dose sachet which contains white granules consisting of 5.631 grams of fosfomycin tromethamine (equivalent to 3 grams of fosfomycin), and the following inactive ingredients: mandarin flavor, orange flavor, saccharin, and sucrose.The contents of the sachet must be dissolved in water. Fosfomycin tromethamine, a phosphonic acid derivative, is available as (1R,2S)-(1,2-epoxypropyl)phosphonic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1). It is a white granular compound with a molecular weight of 259.2. Its empirical formula is C3H7O4P.C4H11NO3, and its chemical structure is as follows.</Description>
</NDC>
<NDC>
<NDCCode>50090-6130-0</NDCCode>
<PackageDescription>1 PACKET in 1 CARTON (50090-6130-0) / 1 GRANULE, FOR SOLUTION in 1 PACKET</PackageDescription>
<NDC11Code>50090-6130-00</NDC11Code>
<ProductNDC>50090-6130</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fosfomycin Tromethamine</ProprietaryName>
<NonProprietaryName>Fosfomycin Tromethamine</NonProprietaryName>
<DosageFormName>GRANULE, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211022</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214554</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>FOSFOMYCIN TROMETHAMINE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-11-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221003</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fosfomycin tromethamine granules for oral solution is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis. Fosfomycin tromethamine granules for oral solution is not indicated for the treatment of pyelonephritis or perinephric abscess. If persistence or reappearance of bacteriuria occurs after treatment with fosfomycin tromethamine granules for oral solution, other therapeutic agents should be selected. (See PRECAUTIONS and CLINICAL STUDIES sections.).</IndicationAndUsage>
<Description>Fosfomycin Tromethamine Granules for Oral Solution contains fosfomycin tromethamine, a synthetic, broad spectrum, bactericidal antibiotic for oral administration. It is available as a single-dose sachet which contains white granules consisting of 5.631 grams of fosfomycin tromethamine (equivalent to 3 grams of fosfomycin), and the following inactive ingredients: orange flavor, saccharin and sucrose. The contents of the sachet must be dissolved in water. Fosfomycin tromethamine, a phosphonic acid derivative, is available as (1R,2S)-(1,2-epoxypropyl)phosphonic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1). It is a white granular compound with a molecular weight of 259.2. Its empirical formula is C3H7O4P.C4H11NO3, and its chemical structure is as follows.</Description>
</NDC>
<NDC>
<NDCCode>54868-5649-0</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (54868-5649-0)</PackageDescription>
<NDC11Code>54868-5649-00</NDC11Code>
<ProductNDC>54868-5649</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rozerem</ProprietaryName>
<NonProprietaryName>Ramelteon</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060801</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021782</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>RAMELTEON</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Melatonin Receptor Agonist [EPC],Melatonin Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>ROZEREM is indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency were performed after 2 days of treatment during the crossover study (elderly only), at 5 weeks in the 6-week studies (adults and elderly), and at the end of the 6-month study (adults and elderly) [see Clinical Studies (14)].</IndicationAndUsage>
<Description>ROZEREM (ramelteon) is an orally active hypnotic chemically designated as (S)-N-[2-(1,6,7,8-tetrahydro-2H-indeno-[5,4-b]furan-8-yl)ethyl]propionamide and containing one chiral center. The compound is produced as the (S)-enantiomer, with an empirical formula of C16H21NO2, molecular weight of 259.34, and the following chemical structure. Ramelteon is freely soluble in organic solvents, such as methanol, ethanol, and dimethyl sulfoxide; soluble in 1-octanol and acetonitrile; and very slightly soluble in water and in aqueous buffers from pH 3 to pH 11. Each ROZEREM tablet includes the following inactive ingredients: lactose monohydrate, starch, hydroxypropyl cellulose, magnesium stearate, hypromellose, copovidone, titanium dioxide, yellow ferric oxide, polyethylene glycol 8000, and ink containing shellac and synthetic iron oxide black.</Description>
</NDC>
<NDC>
<NDCCode>59572-402-00</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (59572-402-00) </PackageDescription>
<NDC11Code>59572-0402-00</NDC11Code>
<ProductNDC>59572-402</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Revlimid</ProprietaryName>
<NonProprietaryName>Lenalidomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120416</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021880</ApplicationNumber>
<LabelerName>Celgene Corporation</LabelerName>
<SubstanceName>LENALIDOMIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120509</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>REVLIMID is a thalidomide analogue indicated for the treatment of adult patients with: 1 Multiple myeloma (MM), in combination with dexamethasone (1.1)., 2 MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) (1.1)., 3 Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities (1.2)., 4 Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib (1.3)., 5 Previously treated follicular lymphoma (FL), in combination with a rituximab product (1.4)., 6 Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product (1.5).</IndicationAndUsage>
<Description>REVLIMID, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure:. 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione. The empirical formula for lenalidomide is C13H13N3O3, and the gram molecular weight is 259.3. Lenalidomide is an off-white to pale-yellow solid powder. It is soluble in organic solvent/water mixtures, and buffered aqueous solvents. Lenalidomide is more soluble in organic solvents and low pH solutions. Solubility was significantly lower in less acidic buffers, ranging from about 0.4 to 0.5 mg/ml. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero. REVLIMID is available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The 5 mg and 25 mg capsule shell contains gelatin, titanium dioxide and black ink. The 2.5 mg and 10 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink. The 15 mg capsule shell contains gelatin, FD&C blue #2, titanium dioxide and black ink. The 20 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink.</Description>
</NDC>
<NDC>
<NDCCode>59572-405-00</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (59572-405-00) </PackageDescription>
<NDC11Code>59572-0405-00</NDC11Code>
<ProductNDC>59572-405</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Revlimid</ProprietaryName>
<NonProprietaryName>Lenalidomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051227</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021880</ApplicationNumber>
<LabelerName>Celgene Corporation</LabelerName>
<SubstanceName>LENALIDOMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20051227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>REVLIMID is a thalidomide analogue indicated for the treatment of adult patients with: 1 Multiple myeloma (MM), in combination with dexamethasone (1.1)., 2 MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) (1.1)., 3 Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities (1.2)., 4 Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib (1.3)., 5 Previously treated follicular lymphoma (FL), in combination with a rituximab product (1.4)., 6 Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product (1.5).</IndicationAndUsage>
<Description>REVLIMID, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure:. 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione. The empirical formula for lenalidomide is C13H13N3O3, and the gram molecular weight is 259.3. Lenalidomide is an off-white to pale-yellow solid powder. It is soluble in organic solvent/water mixtures, and buffered aqueous solvents. Lenalidomide is more soluble in organic solvents and low pH solutions. Solubility was significantly lower in less acidic buffers, ranging from about 0.4 to 0.5 mg/ml. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero. REVLIMID is available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The 5 mg and 25 mg capsule shell contains gelatin, titanium dioxide and black ink. The 2.5 mg and 10 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink. The 15 mg capsule shell contains gelatin, FD&C blue #2, titanium dioxide and black ink. The 20 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink.</Description>
</NDC>
<NDC>
<NDCCode>59572-410-00</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (59572-410-00) </PackageDescription>
<NDC11Code>59572-0410-00</NDC11Code>
<ProductNDC>59572-410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Revlimid</ProprietaryName>
<NonProprietaryName>Lenalidomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051227</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021880</ApplicationNumber>
<LabelerName>Celgene Corporation</LabelerName>
<SubstanceName>LENALIDOMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20051227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>REVLIMID is a thalidomide analogue indicated for the treatment of adult patients with: 1 Multiple myeloma (MM), in combination with dexamethasone (1.1)., 2 MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) (1.1)., 3 Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities (1.2)., 4 Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib (1.3)., 5 Previously treated follicular lymphoma (FL), in combination with a rituximab product (1.4)., 6 Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product (1.5).</IndicationAndUsage>
<Description>REVLIMID, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure:. 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione. The empirical formula for lenalidomide is C13H13N3O3, and the gram molecular weight is 259.3. Lenalidomide is an off-white to pale-yellow solid powder. It is soluble in organic solvent/water mixtures, and buffered aqueous solvents. Lenalidomide is more soluble in organic solvents and low pH solutions. Solubility was significantly lower in less acidic buffers, ranging from about 0.4 to 0.5 mg/ml. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero. REVLIMID is available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The 5 mg and 25 mg capsule shell contains gelatin, titanium dioxide and black ink. The 2.5 mg and 10 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink. The 15 mg capsule shell contains gelatin, FD&C blue #2, titanium dioxide and black ink. The 20 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink.</Description>
</NDC>
<NDC>
<NDCCode>59572-415-00</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (59572-415-00) </PackageDescription>
<NDC11Code>59572-0415-00</NDC11Code>
<ProductNDC>59572-415</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Revlimid</ProprietaryName>
<NonProprietaryName>Lenalidomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060629</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021880</ApplicationNumber>
<LabelerName>Celgene Corporation</LabelerName>
<SubstanceName>LENALIDOMIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060707</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>REVLIMID is a thalidomide analogue indicated for the treatment of adult patients with: 1 Multiple myeloma (MM), in combination with dexamethasone (1.1)., 2 MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) (1.1)., 3 Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities (1.2)., 4 Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib (1.3)., 5 Previously treated follicular lymphoma (FL), in combination with a rituximab product (1.4)., 6 Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product (1.5).</IndicationAndUsage>
<Description>REVLIMID, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure:. 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione. The empirical formula for lenalidomide is C13H13N3O3, and the gram molecular weight is 259.3. Lenalidomide is an off-white to pale-yellow solid powder. It is soluble in organic solvent/water mixtures, and buffered aqueous solvents. Lenalidomide is more soluble in organic solvents and low pH solutions. Solubility was significantly lower in less acidic buffers, ranging from about 0.4 to 0.5 mg/ml. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero. REVLIMID is available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The 5 mg and 25 mg capsule shell contains gelatin, titanium dioxide and black ink. The 2.5 mg and 10 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink. The 15 mg capsule shell contains gelatin, FD&C blue #2, titanium dioxide and black ink. The 20 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink.</Description>
</NDC>
<NDC>
<NDCCode>59572-420-00</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (59572-420-00) </PackageDescription>
<NDC11Code>59572-0420-00</NDC11Code>
<ProductNDC>59572-420</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Revlimid</ProprietaryName>
<NonProprietaryName>Lenalidomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130606</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021880</ApplicationNumber>
<LabelerName>Celgene Corporation</LabelerName>
<SubstanceName>LENALIDOMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>REVLIMID is a thalidomide analogue indicated for the treatment of adult patients with: 1 Multiple myeloma (MM), in combination with dexamethasone (1.1)., 2 MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) (1.1)., 3 Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities (1.2)., 4 Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib (1.3)., 5 Previously treated follicular lymphoma (FL), in combination with a rituximab product (1.4)., 6 Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product (1.5).</IndicationAndUsage>
<Description>REVLIMID, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure:. 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione. The empirical formula for lenalidomide is C13H13N3O3, and the gram molecular weight is 259.3. Lenalidomide is an off-white to pale-yellow solid powder. It is soluble in organic solvent/water mixtures, and buffered aqueous solvents. Lenalidomide is more soluble in organic solvents and low pH solutions. Solubility was significantly lower in less acidic buffers, ranging from about 0.4 to 0.5 mg/ml. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero. REVLIMID is available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The 5 mg and 25 mg capsule shell contains gelatin, titanium dioxide and black ink. The 2.5 mg and 10 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink. The 15 mg capsule shell contains gelatin, FD&C blue #2, titanium dioxide and black ink. The 20 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink.</Description>
</NDC>
<NDC>
<NDCCode>59572-425-00</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (59572-425-00) </PackageDescription>
<NDC11Code>59572-0425-00</NDC11Code>
<ProductNDC>59572-425</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Revlimid</ProprietaryName>
<NonProprietaryName>Lenalidomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060629</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021880</ApplicationNumber>
<LabelerName>Celgene Corporation</LabelerName>
<SubstanceName>LENALIDOMIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060707</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>REVLIMID is a thalidomide analogue indicated for the treatment of adult patients with: 1 Multiple myeloma (MM), in combination with dexamethasone (1.1)., 2 MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) (1.1)., 3 Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities (1.2)., 4 Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib (1.3)., 5 Previously treated follicular lymphoma (FL), in combination with a rituximab product (1.4)., 6 Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product (1.5).</IndicationAndUsage>
<Description>REVLIMID, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure:. 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione. The empirical formula for lenalidomide is C13H13N3O3, and the gram molecular weight is 259.3. Lenalidomide is an off-white to pale-yellow solid powder. It is soluble in organic solvent/water mixtures, and buffered aqueous solvents. Lenalidomide is more soluble in organic solvents and low pH solutions. Solubility was significantly lower in less acidic buffers, ranging from about 0.4 to 0.5 mg/ml. Lenalidomide has an asymmetric carbon atom and can exist as the optically active forms S(-) and R(+), and is produced as a racemic mixture with a net optical rotation of zero. REVLIMID is available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide as the active ingredient and the following inactive ingredients: lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The 5 mg and 25 mg capsule shell contains gelatin, titanium dioxide and black ink. The 2.5 mg and 10 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink. The 15 mg capsule shell contains gelatin, FD&C blue #2, titanium dioxide and black ink. The 20 mg capsule shell contains gelatin, FD&C blue #2, yellow iron oxide, titanium dioxide and black ink.</Description>
</NDC>
<NDC>
<NDCCode>70518-4257-0</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4257-0) </PackageDescription>
<NDC11Code>70518-4257-00</NDC11Code>
<ProductNDC>70518-4257</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ramelteon</ProprietaryName>
<NonProprietaryName>Ramelteon</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213815</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>RAMELTEON</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six month studies (adults and elderly), and at the end of the six month study (adults and elderly) [see Clinical Studies (14)] .</IndicationAndUsage>
<Description>Ramelteon is an orally active hypnotic chemically designated as (S)-N-[2-(1,6,7,8- tetrahydro-2H-indeno-[5,4-b]furan-8-yl)ethyl]propionamide and containing one chiral center. The compound is produced as the (S)-enantiomer, with an empirical formula of C16H21NO2, molecular weight of 259.34, and the following chemical structure. Ramelteon is freely soluble in methanol and practically insoluble in water. Each ramelteon tablet contains the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, pregelatinized starch, titanium dioxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>71205-918-00</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (71205-918-00) </PackageDescription>
<NDC11Code>71205-0918-00</NDC11Code>
<ProductNDC>71205-918</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ramelteon</ProprietaryName>
<NonProprietaryName>Ramelteon</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213186</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>RAMELTEON</SubstanceName>
<StrengthNumber>8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Melatonin Receptor Agonist [EPC], Melatonin Receptor Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-04-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210707</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Ramelteon is an orally active hypnotic chemically designated as ( S)- N-[2-(1,6,7,8-tetrahydro-2 H-indeno-[5,4- b]furan-8-yl)ethyl]propionamide and containing one chiral center. The compound is produced as the ( S)-enantiomer, with an empirical formula of C 16 H 21 NO 2, molecular weight of 259.34, and the following chemical structure:. Ramelteon is freely soluble in organic solvents, such as methanol, ethanol, and dimethyl sulfoxide; soluble in 1-octanol and acetonitrile; and very slightly soluble in water and in aqueous buffers from pH 3 to pH 11. Each Ramelteon tablet includes the following inactive ingredients: copovidone, corn starch, hydroxypropyl cellulose, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>24357-011-13</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (24357-011-13) * 1 mL in 1 VIAL (42023-159-25) * 1 mL in 1 PACKET (68599-5804-1) </PackageDescription>
<NDC11Code>24357-0011-13</NDC11Code>
<ProductNDC>24357-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epinephrine Professional</ProprietaryName>
<NonProprietaryName>Epinephrine And Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAMUSCULAR; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204200</ApplicationNumber>
<LabelerName>Focus Health Group</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>24357-012-12</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (24357-012-12) * 1 mL in 1 PACKET (68599-5804-1) * 1 mL in 1 VIAL (42023-159-01) </PackageDescription>
<NDC11Code>24357-0012-12</NDC11Code>
<ProductNDC>24357-012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epinephrine Professional Ems</ProprietaryName>
<NonProprietaryName>Epinephrine Convenience Kit</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INTRAMUSCULAR; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204200</ApplicationNumber>
<LabelerName>Focus Health Group</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>24357-811-20</NDCCode>
<PackageDescription>1 KIT in 1 KIT (24357-811-20) * 1 mL in 1 VIAL, GLASS (42023-159-25) </PackageDescription>
<NDC11Code>24357-0811-20</NDC11Code>
<ProductNDC>24357-811</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Epinephrinesnap-v</ProprietaryName>
<NonProprietaryName>Epinephrine Convenience Kit</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20170505</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>FOCUS HEALTH GROUP</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170505</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adrenalin® is available as a single-use 1 mL vial and a multiple-use 30 mL vial for intramuscular and subcutaneous use. Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from allergic reactions to insect stings, biting insects, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. The signs and symptoms associated with anaphylaxis include flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with hypotension, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, airway swelling, laryngospasm, bronchospasm, pruritus, urticaria or angioedema, swelling of the eyelids, lips, and tongue.</IndicationAndUsage>
<Description>Adrenalin® (epinephrine injection, USP) is a clear, colorless, sterile solution containing 1 mg/mL (1:1000) epinephrine, packaged as 1 mL of solution in a singleuse clear glass vial or 30 mL of solution in a multiple-dose amber glass vial. In the 1 mL vial, each 1 mL of Adrenalin® solution contains 1 mg epinephrine, 7.3 mg sodium chloride, 0.457 mg sodium metabisulfite, 1 mg sodium hydroxide, 2.25 mg tartaric acid, 0.20 mg disodium edetate dihydrate, hydrochloric acid to adjust pH, and water for injection. In the 30 mL vial, each 1 mL of Adrenalin® solution contains 1 mg epinephrine, 6.15 mg sodium chloride, 0.457 mg sodium metabisulfite, 0.920 mg sodium hydroxide, 2.25 mg tartaric acid, 0.20 mg disodium edetate dihydrate, hydrochloric acid to adjust pH, 5.25 mg chlorobutanol as a preservative and water for injection. The pH range is 2.2-5.0. Epinephrine is a sympathomimetic catecholamine. The chemical name of epinephrine is: 1,2-Benzenediol, 4-[(1R)-1-hydroxy-2-(methylamino)ethyl]-, or (-)-3,4-Dihydroxy-α-[2-(methylamino)ethyl]benzyl alcohol. The chemical structure of epinephrine is:. The molecular weight of epinephrine is 183.2. Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin.</Description>
</NDC>
<NDC>
<NDCCode>42023-104-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (42023-104-01) / 1 mL in 1 VIAL</PackageDescription>
<NDC11Code>42023-0104-01</NDC11Code>
<ProductNDC>42023-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aplisol</ProprietaryName>
<NonProprietaryName>Tuberculin Purified Protein Derivative</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRADERMAL</RouteName>
<StartMarketingDate>20080425</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103782</ApplicationNumber>
<LabelerName>ENDO USA, Inc.</LabelerName>
<SubstanceName>TUBERCULIN PURIFIED PROTEIN DERIVATIVE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>[iU]/.1mL</StrengthUnit>
<Pharm_Classes>Antigens, Bacterial [CS], Cell-mediated Immunity [PE], Skin Test Antigen [EPC], Tuberculosis Skin Test [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tuberculin PPD is indicated as an aid in the detection of infection with Mycobacterium tuberculosis. The standard tuberculin test employs the intradermal (Mantoux) test using a 5 TU dose of tuberculin PPD.7 The 0.1 mL test dose of Aplisol (tuberculin PPD, diluted) is equivalent to the 5 TU dose which has been clinically utilized and standardized with PPD-S. Tuberculin skin testing is not contraindicated for persons who have been vaccinated with BCG and the skin-test results of such persons are used to support or exclude the diagnosis of M. tuberculosis infections.4 HIV infection is a strong risk factor for the development of TB disease in persons having TB infection. All HIV-infected persons should receive a PPD-tuberculin skin test.3.</IndicationAndUsage>
<Description>Aplisol (tuberculin PPD, diluted) is a sterile aqueous solution of a purified protein fraction for intradermal administration as an aid in the diagnosis of tuberculosis. The solution is stabilized with polysorbate (Tween) 80, buffered with potassium and sodium phosphates and contains approximately 0.25% phenol as a preservative. This product is ready for immediate use without further dilution. The purified protein fraction is isolated from culture media filtrates of a human strain of Mycobacterium tuberculosis by the method of F.B. Seibert.1,2 Tuberculin PPD, diluted, is prepared from Tuberculin PPD which is clinically bioequivalent in potency to the standard PPD-S* (5 TU** per 0.1mL) of the U.S. Public Health Service, National Centers for Disease Control. The potency of each lot of tuberculin PPD, diluted is determined in sensitized guinea pigs.</Description>
</NDC>
<NDC>
<NDCCode>42023-104-05</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (42023-104-05) / 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>42023-0104-05</NDC11Code>
<ProductNDC>42023-104</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aplisol</ProprietaryName>
<NonProprietaryName>Tuberculin Purified Protein Derivative</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRADERMAL</RouteName>
<StartMarketingDate>20080425</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103782</ApplicationNumber>
<LabelerName>ENDO USA, Inc.</LabelerName>
<SubstanceName>TUBERCULIN PURIFIED PROTEIN DERIVATIVE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>[iU]/.1mL</StrengthUnit>
<Pharm_Classes>Antigens, Bacterial [CS], Cell-mediated Immunity [PE], Skin Test Antigen [EPC], Tuberculosis Skin Test [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tuberculin PPD is indicated as an aid in the detection of infection with Mycobacterium tuberculosis. The standard tuberculin test employs the intradermal (Mantoux) test using a 5 TU dose of tuberculin PPD.7 The 0.1 mL test dose of Aplisol (tuberculin PPD, diluted) is equivalent to the 5 TU dose which has been clinically utilized and standardized with PPD-S. Tuberculin skin testing is not contraindicated for persons who have been vaccinated with BCG and the skin-test results of such persons are used to support or exclude the diagnosis of M. tuberculosis infections.4 HIV infection is a strong risk factor for the development of TB disease in persons having TB infection. All HIV-infected persons should receive a PPD-tuberculin skin test.3.</IndicationAndUsage>
<Description>Aplisol (tuberculin PPD, diluted) is a sterile aqueous solution of a purified protein fraction for intradermal administration as an aid in the diagnosis of tuberculosis. The solution is stabilized with polysorbate (Tween) 80, buffered with potassium and sodium phosphates and contains approximately 0.25% phenol as a preservative. This product is ready for immediate use without further dilution. The purified protein fraction is isolated from culture media filtrates of a human strain of Mycobacterium tuberculosis by the method of F.B. Seibert.1,2 Tuberculin PPD, diluted, is prepared from Tuberculin PPD which is clinically bioequivalent in potency to the standard PPD-S* (5 TU** per 0.1mL) of the U.S. Public Health Service, National Centers for Disease Control. The potency of each lot of tuberculin PPD, diluted is determined in sensitized guinea pigs.</Description>
</NDC>
<NDC>
<NDCCode>42023-105-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (42023-105-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>42023-0105-01</NDC11Code>
<ProductNDC>42023-105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Brevital Sodium</ProprietaryName>
<NonProprietaryName>Methohexital Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; RECTAL</RouteName>
<StartMarketingDate>20071101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA011559</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>METHOHEXITAL SODIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Barbiturate [EPC], Barbiturates [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BREVITAL can be used in adults as follows. 1. For intravenous induction of anesthesia prior to the use of other general anesthetic agents. 2. For intravenous induction of anesthesia and as an adjunct to subpotent inhalational anesthetic agents (such as nitrous oxide in oxygen) for short surgical procedures; BREVITAL may be given by infusion or intermittent injection. 3. For use along with other parenteral agents, usually narcotic analgesics, to supplement subpotent inhalational anesthetic agents (such as nitrous oxide in oxygen) for longer surgical procedures. 4. As intravenous anesthesia for short surgical, diagnostic, or therapeutic procedures associated with minimal painful stimuli (see WARNINGS). 5. As an agent for inducing a hypnotic state. BREVITAL can be used in pediatric patients older than 1 month as follows. 1. For rectal or intramuscular induction of anesthesia prior to the use of other general anesthetic agents. 2. For rectal or intramuscular induction of anesthesia and as an adjunct to subpotent inhalational anesthetic agents for short surgical procedures. 3. As rectal or intramuscular anesthesia for short surgical, diagnostic, or therapeutic procedures associated with minimal painful stimuli.</IndicationAndUsage>
<Description>BREVITAL® (methohexital sodium, USP) for injection, is 2,4,6 (1H, 3H, 5H)-Pyrimidinetrione, 1-methyl-5-(1-methyl-2-pentynyl)-5-(2-propenyl)-, (±)-, monosodium salt and has the empirical formula C14H17N2NaO3. Its molecular weight is 284.29. The structural formula is as follows. Methohexital sodium is a rapid, ultrashort-acting barbiturate anesthetic. Methohexital sodium for injection is a freeze-dried, sterile, nonpyrogenic mixture of methohexital sodium with 6% anhydrous sodium carbonate added as a buffer. It contains not less than 90% and not more than 110% of the labeled amount of methohexital sodium. It occurs as a white, freeze-dried plug that is freely soluble in water. This product is oxygen sensitive. The pH of the 1% solution is between 10 and 11; the pH of the 0.2% solution in 5% dextrose is between 9.5 and 10.5. Methohexital sodium may be administered by direct intravenous injection or continuous intravenous drip, intramuscular or rectal routes (see PRECAUTIONS/Pediatric Use). Reconstituting instructions vary depending on the route of administration (see DOSAGE AND ADMINISTRATION).</Description>
</NDC>
<NDC>
<NDCCode>42023-106-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (42023-106-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>42023-0106-01</NDC11Code>
<ProductNDC>42023-106</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Brevital Sodium</ProprietaryName>
<NonProprietaryName>Methohexital Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; RECTAL</RouteName>
<StartMarketingDate>20071101</StartMarketingDate>
<EndMarketingDate>20210131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA011559</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>METHOHEXITAL SODIUM</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Barbiturate [EPC],Barbiturates [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2021-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20071101</StartMarketingDatePackage>
<EndMarketingDatePackage>20210131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42023-107-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (42023-107-01) / 2 mL in 1 VIAL</PackageDescription>
<NDC11Code>42023-0107-01</NDC11Code>
<ProductNDC>42023-107</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Coly-mycin</ProprietaryName>
<ProprietaryNameSuffix>M</ProprietaryNameSuffix>
<NonProprietaryName>Colistimethate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20071101</StartMarketingDate>
<EndMarketingDate>20270531</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050108</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>COLISTIMETHATE SODIUM</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20071101</StartMarketingDatePackage>
<EndMarketingDatePackage>20270531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Coly-Mycin M Parenteral is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli. It is particularly indicated when the infection is caused by sensitive strains of Pseudomonas aeruginosa. This antibiotic is not indicated for infections due to Proteus or Neisseria. Coly-Mycin M Parenteral has proven clinically effective in treatment of infections due to the following gram-negative organisms: Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa. Coly-Mycin M Parenteral may be used to initiate therapy in serious infections that are suspected to be due to gram-negative organisms and in the treatment of infections due to susceptible gram-negative pathogenic bacilli. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Coly-Mycin M and other antibacterial drugs, Coly-Mycin M 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.</IndicationAndUsage>
<Description>Coly-Mycin® M Parenteral (Colistimethate for Injection, USP) is a sterile parenteral antibiotic product which, when reconstituted (see Reconstitution), is suitable for intramuscular or intravenous administration. Each vial contains colistimethate sodium or pentasodium colistinmethanesulfonate (150 mg colistin base activity). Colistimethate sodium is a polypeptide antibiotic with an approximate molecular weight of 1750. The empirical formula is C58H105N16Na5O28S5 and the structural formula is represented below.</Description>
</NDC>
<NDC>
<NDCCode>42023-107-06</NDCCode>
<PackageDescription>6 VIAL in 1 CARTON (42023-107-06) > 2 mL in 1 VIAL</PackageDescription>
<NDC11Code>42023-0107-06</NDC11Code>
<ProductNDC>42023-107</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Coly-mycin</ProprietaryName>
<ProprietaryNameSuffix>M</ProprietaryNameSuffix>
<NonProprietaryName>Colistimethate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20071101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050108</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>COLISTIMETHATE SODIUM</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071101</StartMarketingDatePackage>
<EndMarketingDatePackage>20221031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Coly-Mycin M Parenteral is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli. It is particularly indicated when the infection is caused by sensitive strains of Pseudomonas aeruginosa. This antibiotic is not indicated for infections due to Proteus or Neisseria. Coly-Mycin M Parenteral has proven clinically effective in treatment of infections due to the following gram-negative organisms: Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa. Coly-Mycin M Parenteral may be used to initiate therapy in serious infections that are suspected to be due to gram-negative organisms and in the treatment of infections due to susceptible gram-negative pathogenic bacilli. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Coly-Mycin M and other antibacterial drugs, Coly-Mycin M 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.</IndicationAndUsage>
<Description>Coly-Mycin® M Parenteral (Colistimethate for Injection, USP) is a sterile parenteral antibiotic product which, when reconstituted (see Reconstitution), is suitable for intramuscular or intravenous administration. Each vial contains colistimethate sodium or pentasodium colistinmethanesulfonate (150 mg colistin base activity). Colistimethate sodium is a polypeptide antibiotic with an approximate molecular weight of 1750. The empirical formula is C58H105N16Na5O28S5 and the structural formula is represented below.</Description>
</NDC>
<NDC>
<NDCCode>42023-108-01</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE, DROPPER (42023-108-01)</PackageDescription>
<NDC11Code>42023-0108-01</NDC11Code>
<ProductNDC>42023-108</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Coly-mycin S</ProprietaryName>
<NonProprietaryName>Colistin Sulfate, Neomycin Sulfate, Thonzonium Bromide And Hydrocortisone Acetate</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>AURICULAR (OTIC)</RouteName>
<StartMarketingDate>20071101</StartMarketingDate>
<EndMarketingDate>20170618</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050356</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>COLISTIN SULFATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE; HYDROCORTISONE ACETATE</SubstanceName>
<StrengthNumber>3; 3.3; .5; 10</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC],Aminoglycosides [Chemical/Ingredient],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-06-21</LastUpdate>
</NDC>
</NDCList>