{
"NDC": [
{
"NDCCode": "70756-410-11",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (70756-410-11) ",
"NDC11Code": "70756-0410-11",
"ProductNDC": "70756-410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrofurantoin Macrocrystals",
"NonProprietaryName": "Nitrofurantoin Macrocrystals",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20230321",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217272",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "NITROFURANTOIN",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrofuran Antibacterial [EPC], Nitrofurans [CS]",
"Status": "Active",
"LastUpdate": "2026-10-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230321",
"SamplePackage": "N",
"IndicationAndUsage": "Nitrofurantoin capsules (macrocrystals) are specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin capsules (macrocrystals) and other antibacterial drugs, nitrofurantoin capsules (macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin capsules (macrocrystals) are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin capsules (macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin capsules (macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.",
"Description": "Nitrofurantoin capsules, USP (macrocrystals) are a synthetic chemical of controlled crystal size. It is a stable, lemon yellow, crystalline compound. Nitrofurantoin capsules, USP (macrocrystals) are an antibacterial agent for specific urinary tract infections. It is available in 25 mg, 50 mg, and 100 mg capsules for oral administration. Each capsule contains 25 mg, 50 mg, or 100 mg of nitrofurantoin, USP (macrocrystals). Molecular Formula: C8H6N4O5 Molecular Weight: 238.16 g/mole. 1-[[(5-nitro-2-furanyl)methylene] amino]-2,4-imidazolidinedione. Inactive Ingredients: Each capsule contains: corn starch, gelatin, lactose monohydrate, talc and titanium dioxide. Additionally, each 50 mg and 100 mg capsule shell contains FD&C Blue no. 1 and FD&C Red no. 3. The capsule is printed with black pharmaceutical ink which contains ferrosoferric oxide, potassium hydroxide, and shellac."
},
{
"NDCCode": "43744-410-11",
"PackageDescription": "5 g in 1 DRUM (43744-410-11)",
"NDC11Code": "43744-0410-11",
"ProductNDC": "43744-410",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Flucytosine",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130110",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "FLUCYTOSINE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "46987-410-11",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46987-410-11)",
"NDC11Code": "46987-0410-11",
"ProductNDC": "46987-410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Kadian",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20090407",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020616",
"LabelerName": "Actavis Kadian LLC",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "47682-410-11",
"PackageDescription": "473 mL in 1 BOTTLE, DISPENSING (47682-410-11)",
"NDC11Code": "47682-0410-11",
"ProductNDC": "47682-410",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Green Guard First Aid Eye Wash",
"NonProprietaryName": "Water",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20111202",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "Unifirst First Aid Corporation",
"SubstanceName": "WATER",
"StrengthNumber": ".983",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "51759-410-11",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (51759-410-11) / .21 mL in 1 SYRINGE, GLASS",
"NDC11Code": "51759-0410-11",
"ProductNDC": "51759-410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Uzedy",
"NonProprietaryName": "Risperidone",
"DosageFormName": "INJECTION, SUSPENSION, EXTENDED RELEASE",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213586",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "75",
"StrengthUnit": "mg/.21mL",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230501",
"SamplePackage": "Y",
"IndicationAndUsage": "UZEDY is an atypical antipsychotic indicated: 1 for the treatment of schizophrenia in adults. (1.1), 2 as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. (1.2).",
"Description": "UZEDY contains risperidone, an atypical antipsychotic. Risperidone belongs to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl) piperidin-1yl] ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.5 g/mol. The structural formula is. Risperidone is a white to off-white powder. It is practically insoluble in water and soluble in methanol and 0.1 N HCl. It has the following pKa values: 8.28 (piperidine moiety) and 3.12 (pyrimidine moiety). UZEDY (risperidone) extended-release injectable suspension, for subcutaneous use, is a sterile, preservative free, white to off-white opaque viscous suspension. It is available in the following strengths (and deliverable volumes from a single-dose prefilled syringe): 50 mg (0.14 mL), 75 mg (0.21 mL), 100 mg (0.28 mL), 125 mg (0.35 mL), 150 mg (0.42 mL), 200 mg (0.56 mL), and 250 mg (0.7 mL). The inactive ingredients include dimethyl sulfoxide (45% w/w), methoxy-poly(ethylene glycol)-co-poly(D,L-lactide) (15% w/w), and poly(D,L-lactide)-co-poly(ethylene glycol)-co-poly(D,L-lactide) (10% w/w)."
},
{
"NDCCode": "55570-410-11",
"PackageDescription": "12 kg in 1 PAIL (55570-410-11) ",
"NDC11Code": "55570-0410-11",
"ProductNDC": "55570-410",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sodium Carbonate Anhydrous",
"DosageFormName": "GRANULE",
"StartMarketingDate": "20080313",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Jost Chemical Co.",
"SubstanceName": "SODIUM CARBONATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "13-MAR-08"
},
{
"NDCCode": "60687-410-94",
"PackageDescription": "20 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-410-94) / 1 TABLET in 1 BLISTER PACK (60687-410-11) ",
"NDC11Code": "60687-0410-94",
"ProductNDC": "60687-410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylergonovine Maleate",
"NonProprietaryName": "Methylergonovine Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181101",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210424",
"LabelerName": "American Health Packaging",
"SubstanceName": "METHYLERGONOVINE MALEATE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Ergolines [CS], Ergot Derivative [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181101",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N",
"IndicationAndUsage": "Following delivery of placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.",
"Description": "Methylergonovine Maleate Tablets, USP is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage. Methylergonovine Maleate Tablets, USP is available in tablets for oral ingestion containing 0.2 mg methylergonovine maleate. TabletsActive ingredient: Methylergonovine maleate, USP, 0.2 mg. Inactive ingredients: acacia, corn starch, gelatin, lactose monohydrate, methylparaben, microcrystalline cellulose, povidone, propylparaben, stearic acid, and tartaric acid. Chemically, methylergonovine maleate is designated as ergoline-8-carboxamide, 9, 10-didehydro-N-[1-(hydroxymethyl) propyl]-6-methyl-, [8β(S)]-, (Z)-2-butenedioate (1:1) (salt). Its structural formula is. C 20H 25N 3O 2C 4H 4O 4 Mol Wt: 455.51."
},
{
"NDCCode": "63307-410-11",
"PackageDescription": "25 g in 1 BOTTLE (63307-410-11)",
"NDC11Code": "63307-0410-11",
"ProductNDC": "63307-410",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Progesterone",
"DosageFormName": "POWDER",
"StartMarketingDate": "20151130",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Total Pharmacy Supply, Inc.",
"SubstanceName": "PROGESTERONE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "63776-410-11",
"PackageDescription": ".5 mL in 1 AMPULE (63776-410-11) ",
"NDC11Code": "63776-0410-11",
"ProductNDC": "63776-410",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Viatrexx-pigmentation",
"NonProprietaryName": "Adrenal, Azelaic, Copper, Cutis, Cysteine, Epithelial Gf, Fumaric Acid, Glutathione, Glycolic Acid, Kalium Aspariticum, Lymph Node, Melanine, Natrum Oxalaceticum, Natrum Pyruvicum, Phenylalanine, Quinhydrone, Succinic Acid, Thuja, Tyrosine, Vitamin C, Zinc",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ASCORBIC ACID; AZELAIC ACID; BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH VESSEL; BOS TAURUS SKIN; COPPER; CYSTEINE; FUMARIC ACID; GLUTATHIONE; GLYCOLIC ACID; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); NEPIDERMIN; PHENYLALANINE; POTASSIUM ASPARTATE; QUINHYDRONE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUCCINIC ACID; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH VESSEL; SUS SCROFA SKIN; THUJA OCCIDENTALIS LEAFY TWIG; TYROSINE; ZINC",
"StrengthNumber": "30; 30; 30; 200; 30; 200; 30; 30; 200; 30; 200; 200; 200; 30; 30; 30; 30; 30; 30; 200; 30; 30; 30; 30",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Cells, Epidermal [EXT], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE], Decreased Sperm Motility [PE], Depigmenting Activity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Inhibit Ovum Fertilization [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Non-Standardized Animal Skin Allergenic Extract [EPC], Non-Standardized Animal Skin Allergenic Extract [EPC], Vitamin C [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190329",
"SamplePackage": "N",
"IndicationAndUsage": "Skin Issues.",
"Description": "Viatrexx-Pigmentation is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These nano particles are designed to nourish the system."
},
{
"NDCCode": "67777-410-12",
"PackageDescription": "36 JAR in 1 CASE (67777-410-12) / 71 g in 1 JAR (67777-410-11) ",
"NDC11Code": "67777-0410-12",
"ProductNDC": "67777-410",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lanashield",
"NonProprietaryName": "Lanolin",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141012",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Dynarex Corporation",
"SubstanceName": "LANOLIN",
"StrengthNumber": "50",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2026-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141012",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily protects minor cuts scrapes burns. Temporarily protects and helps relieve chafed, chapped, or cracked skin and lips. Helps prevent and protect from the drying effects of wind and cold weather."
},
{
"NDCCode": "68428-410-11",
"PackageDescription": "300 PELLET in 1 BOTTLE, GLASS (68428-410-11) ",
"NDC11Code": "68428-0410-11",
"ProductNDC": "68428-410",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gossypium Herbaceum",
"NonProprietaryName": "Gossypium Herbaceum Root Bark",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110110",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "GOSSYPIUM HERBACEUM ROOT BARK",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2022-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20110110",
"SamplePackage": "N"
},
{
"NDCCode": "69543-410-11",
"PackageDescription": "1000 TABLET in 1 BOTTLE (69543-410-11) ",
"NDC11Code": "69543-0410-11",
"ProductNDC": "69543-410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phendimetrazine Tartrate",
"NonProprietaryName": "Phendimetrazine Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085588",
"LabelerName": "Virtus Pharmaceuticals, LLC",
"SubstanceName": "PHENDIMETRAZINE TARTRATE",
"StrengthNumber": "35",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2026-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180701",
"EndMarketingDatePackage": "20260930",
"SamplePackage": "N",
"IndicationAndUsage": "Phendimetrazine tartrate tablets are indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction. The limited usefulness of agents of this class (see CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below.",
"Description": "Phendimetrazine tartrate, as the dextro isomer, has the chemical name of (2s,3s,)-3,4-dimethyl-2-phenylmorpholine L-(+)-tartrate (1:1). The structural formula is as follows. Phendimetrazine tartrate is a white, odorless crystalline powder. It is freely soluble in water; sparingly soluble in warm alcohol; insoluble in chloroform, acetone, ether and benzene. Each tablet, for oral administration, contains 35 mg of phendimetrazine tartrate. Inactive Ingredients: confectioner’s sugar (sucrose and corn starch), lactose monohydrate, povidone, pregelatinized starch, silicon dioxide and stearic acid. The yellow tablets also contain: FD&C yellow No. 5 (see PRECAUTIONS)."
},
{
"NDCCode": "73069-410-11",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 BOX (73069-410-11) > 1 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0410-11",
"ProductNDC": "73069-410",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-pigmentation",
"NonProprietaryName": "Adrenal, Azelaic, Copper, Cutis, Cysteine, Epithelial Gf, Fumaric Acid, Glutathione, Glycolic Acid, Kalium Aspariticum, Lymph Node, Melanine, Natrum Oxalaceticum, Natrum Pyruvicum, Phenylalanin, Quinhydrone, Succinic Acid, Thuja, Tyrosine, Vitamin C, Zinc",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; AZELAIC ACID; BOS TAURUS SKIN; COPPER; CYSTEINE; FUMARIC ACID; GLUTATHIONE; GLYCOLIC ACID; POTASSIUM ASPARTATE; NEPIDERMIN; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; PHENYLALANINE; QUINHYDRONE; SUCCINIC ACID; THUJA OCCIDENTALIS LEAFY TWIG; TYROSINE; ASCORBIC ACID; ZINC; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); SUS SCROFA SKIN",
"StrengthNumber": "31; 31; 31; 31; 201; 31; 31; 201; 31; 31; 201; 201; 201; 31; 31; 201; 31; 31; 31; 31; 31; 31; 201; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Vitamin C [EPC],Ascorbic Acid [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Non-Standardized Animal Skin Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190628",
"SamplePackage": "N"
},
{
"NDCCode": "70756-001-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (70756-001-11) ",
"NDC11Code": "70756-0001-11",
"ProductNDC": "70756-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Haloperidol",
"NonProprietaryName": "Haloperidol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240411",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216918",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "HALOPERIDOL",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Typical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240411",
"SamplePackage": "N",
"IndicationAndUsage": "Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.",
"Description": "Haloperidol, USP is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula. Haloperidol, USP is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch (corn). In addition, the 1 mg, 2 mg, 5 mg, and 10 mg tablets also contains D&C Yellow #10 Aluminum Lake. The 10 mg and 20 mg tablets also contains FD&C Blue #1 Aluminum Lake, 2 mg and 5 mg tablets also contains FD&C Red #40 Aluminum Lake, and 1 mg, 2 mg, 5 mg and 20 mg tablets also contains FD&C Yellow #6 Aluminum Lake."
},
{
"NDCCode": "70756-002-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (70756-002-11) ",
"NDC11Code": "70756-0002-11",
"ProductNDC": "70756-002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Haloperidol",
"NonProprietaryName": "Haloperidol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240411",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216918",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "HALOPERIDOL",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Typical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240411",
"SamplePackage": "N",
"IndicationAndUsage": "Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.",
"Description": "Haloperidol, USP is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula. Haloperidol, USP is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch (corn). In addition, the 1 mg, 2 mg, 5 mg, and 10 mg tablets also contains D&C Yellow #10 Aluminum Lake. The 10 mg and 20 mg tablets also contains FD&C Blue #1 Aluminum Lake, 2 mg and 5 mg tablets also contains FD&C Red #40 Aluminum Lake, and 1 mg, 2 mg, 5 mg and 20 mg tablets also contains FD&C Yellow #6 Aluminum Lake."
},
{
"NDCCode": "70756-003-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (70756-003-11) ",
"NDC11Code": "70756-0003-11",
"ProductNDC": "70756-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Haloperidol",
"NonProprietaryName": "Haloperidol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240411",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216918",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "HALOPERIDOL",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Typical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240411",
"SamplePackage": "N",
"IndicationAndUsage": "Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.",
"Description": "Haloperidol, USP is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula. Haloperidol, USP is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch (corn). In addition, the 1 mg, 2 mg, 5 mg, and 10 mg tablets also contains D&C Yellow #10 Aluminum Lake. The 10 mg and 20 mg tablets also contains FD&C Blue #1 Aluminum Lake, 2 mg and 5 mg tablets also contains FD&C Red #40 Aluminum Lake, and 1 mg, 2 mg, 5 mg and 20 mg tablets also contains FD&C Yellow #6 Aluminum Lake."
},
{
"NDCCode": "70756-004-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (70756-004-11) ",
"NDC11Code": "70756-0004-11",
"ProductNDC": "70756-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Haloperidol",
"NonProprietaryName": "Haloperidol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240411",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216918",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "HALOPERIDOL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Typical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240411",
"SamplePackage": "N",
"IndicationAndUsage": "Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.",
"Description": "Haloperidol, USP is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula. Haloperidol, USP is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch (corn). In addition, the 1 mg, 2 mg, 5 mg, and 10 mg tablets also contains D&C Yellow #10 Aluminum Lake. The 10 mg and 20 mg tablets also contains FD&C Blue #1 Aluminum Lake, 2 mg and 5 mg tablets also contains FD&C Red #40 Aluminum Lake, and 1 mg, 2 mg, 5 mg and 20 mg tablets also contains FD&C Yellow #6 Aluminum Lake."
},
{
"NDCCode": "70756-010-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (70756-010-11) ",
"NDC11Code": "70756-0010-11",
"ProductNDC": "70756-010",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Midodrine Hydrochloride",
"NonProprietaryName": "Midodrine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217271",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "MIDODRINE HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231101",
"SamplePackage": "N",
"IndicationAndUsage": "Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets can cause marked elevation of supine blood pressure (BP>200 mmHg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. The indication is based on midodrine hydrochloride tablets's effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine hydrochloride tablets, principally improved ability to perform life activities, have not been established. Further clinical trials are underway to verify and describe the clinical benefits of midodrine hydrochloride tablets. After initiation of treatment, midodrine hydrochloride tablets should be continued only for patients who report significant symptomatic improvement.",
"Description": "Name: Midodrine hydrochloride tablets, USP. Dosage Form: 2.5 mg, 5 mg and 10 mg tablets for oral administration. Active Ingredient: Midodrine hydrochloride, USP 2.5 mg, 5 mg and 10 mg. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), and talc. Pharmacological Classification: Vasopressor/Antihypotensive. Chemical Names (USAN: Midodrine Hydrochloride): (1) Acetamide, 2-amino-N-[2-(2,5 dimethoxyphenyl)-2-hydroxyethyl]-monohydrochloride, (±)-; (2) (±)-2-amino-N-(ß-hydroxy-2,5-dimethoxyphenethyl)acetamide monohydrochloride BAN, INN, JAN: Midodrine. Structural formula. Molecular formula: C12H18N2O4HCl; Molecular Weight: 290.75. Organoleptic Properties: White to off-white crystalline powder. Solubility: Water: Soluble. pKa: 7.8 (0.3% aqueous solution). pH: 4.0 to 5.0. Melting Range: 192°C to 203°C."
},
{
"NDCCode": "70756-011-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (70756-011-11) ",
"NDC11Code": "70756-0011-11",
"ProductNDC": "70756-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorthalidone",
"NonProprietaryName": "Chlorthalidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220805",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215587",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "CHLORTHALIDONE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide-like Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220805",
"SamplePackage": "N",
"IndicationAndUsage": "Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.",
"Description": "Chlorthalidone an oral antihypertensive/diuretic. It is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double-ring system is incorporated in its structure. It is 2-Chloro-5(1- hydroxy-3-oxo-1- isoindolinyl) benzenesulfonamide with the following structural formula. Molecular Formula: C14H11ClN2O4S Molecular weight: 338.76. Chlorthalidone, USP is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in ethanol. Chlorthalidone tablets are available containing either 25 mg or 50 mg of chlorthalidone, USP and the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch (maize), sodium starch glycolate Type A, stearic acid. Meets USP Dissolution Test 2."
},
{
"NDCCode": "70756-013-11",
"PackageDescription": "1 BOTTLE in 1 CARTON (70756-013-11) / 100 TABLET in 1 BOTTLE",
"NDC11Code": "70756-0013-11",
"ProductNDC": "70756-013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitroglycerin",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20231205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217970",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": ".3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231205",
"SamplePackage": "N",
"IndicationAndUsage": "Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.",
"Description": "Nitroglycerin sublingual tablets, USP are stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin. The sublingual tablets also contains inactive ingredients calcium stearate, colloidal silicon dioxide, hydrogenated vegetable oil, lactose monohydrate, pregelatinized starch (corn). Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is. C3H5N309. Molecular weight: 227.09."
},
{
"NDCCode": "70756-014-11",
"PackageDescription": "1 BOTTLE in 1 CARTON (70756-014-11) / 100 TABLET in 1 BOTTLE",
"NDC11Code": "70756-0014-11",
"ProductNDC": "70756-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitroglycerin",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20231205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217970",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": ".4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231205",
"SamplePackage": "N",
"IndicationAndUsage": "Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.",
"Description": "Nitroglycerin sublingual tablets, USP are stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin. The sublingual tablets also contains inactive ingredients calcium stearate, colloidal silicon dioxide, hydrogenated vegetable oil, lactose monohydrate, pregelatinized starch (corn). Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is. C3H5N309. Molecular weight: 227.09."
},
{
"NDCCode": "70756-016-11",
"PackageDescription": "1 BOTTLE in 1 CARTON (70756-016-11) / 100 TABLET in 1 BOTTLE",
"NDC11Code": "70756-0016-11",
"ProductNDC": "70756-016",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitroglycerin",
"NonProprietaryName": "Nitroglycerin",
"DosageFormName": "TABLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20231205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217970",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "NITROGLYCERIN",
"StrengthNumber": ".6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231205",
"SamplePackage": "N",
"IndicationAndUsage": "Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.",
"Description": "Nitroglycerin sublingual tablets, USP are stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin. The sublingual tablets also contains inactive ingredients calcium stearate, colloidal silicon dioxide, hydrogenated vegetable oil, lactose monohydrate, pregelatinized starch (corn). Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is. C3H5N309. Molecular weight: 227.09."
},
{
"NDCCode": "70756-020-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (70756-020-11) ",
"NDC11Code": "70756-0020-11",
"ProductNDC": "70756-020",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorthalidone",
"NonProprietaryName": "Chlorthalidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220805",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215587",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "CHLORTHALIDONE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis [PE], Thiazide-like Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220805",
"SamplePackage": "N",
"IndicationAndUsage": "Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.",
"Description": "Chlorthalidone an oral antihypertensive/diuretic. It is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double-ring system is incorporated in its structure. It is 2-Chloro-5(1- hydroxy-3-oxo-1- isoindolinyl) benzenesulfonamide with the following structural formula. Molecular Formula: C14H11ClN2O4S Molecular weight: 338.76. Chlorthalidone, USP is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in ethanol. Chlorthalidone tablets are available containing either 25 mg or 50 mg of chlorthalidone, USP and the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch (maize), sodium starch glycolate Type A, stearic acid. Meets USP Dissolution Test 2."
},
{
"NDCCode": "70756-049-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (70756-049-11) ",
"NDC11Code": "70756-0049-11",
"ProductNDC": "70756-049",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Midodrine Hydrochloride",
"NonProprietaryName": "Midodrine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217271",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "MIDODRINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231101",
"SamplePackage": "N",
"IndicationAndUsage": "Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets can cause marked elevation of supine blood pressure (BP>200 mmHg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. The indication is based on midodrine hydrochloride tablets's effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine hydrochloride tablets, principally improved ability to perform life activities, have not been established. Further clinical trials are underway to verify and describe the clinical benefits of midodrine hydrochloride tablets. After initiation of treatment, midodrine hydrochloride tablets should be continued only for patients who report significant symptomatic improvement.",
"Description": "Name: Midodrine hydrochloride tablets, USP. Dosage Form: 2.5 mg, 5 mg and 10 mg tablets for oral administration. Active Ingredient: Midodrine hydrochloride, USP 2.5 mg, 5 mg and 10 mg. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), and talc. Pharmacological Classification: Vasopressor/Antihypotensive. Chemical Names (USAN: Midodrine Hydrochloride): (1) Acetamide, 2-amino-N-[2-(2,5 dimethoxyphenyl)-2-hydroxyethyl]-monohydrochloride, (±)-; (2) (±)-2-amino-N-(ß-hydroxy-2,5-dimethoxyphenethyl)acetamide monohydrochloride BAN, INN, JAN: Midodrine. Structural formula. Molecular formula: C12H18N2O4HCl; Molecular Weight: 290.75. Organoleptic Properties: White to off-white crystalline powder. Solubility: Water: Soluble. pKa: 7.8 (0.3% aqueous solution). pH: 4.0 to 5.0. Melting Range: 192°C to 203°C."
},
{
"NDCCode": "70756-050-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (70756-050-11) ",
"NDC11Code": "70756-0050-11",
"ProductNDC": "70756-050",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Midodrine Hydrochloride",
"NonProprietaryName": "Midodrine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217271",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "MIDODRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231101",
"SamplePackage": "N",
"IndicationAndUsage": "Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets can cause marked elevation of supine blood pressure (BP>200 mmHg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. The indication is based on midodrine hydrochloride tablets's effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine hydrochloride tablets, principally improved ability to perform life activities, have not been established. Further clinical trials are underway to verify and describe the clinical benefits of midodrine hydrochloride tablets. After initiation of treatment, midodrine hydrochloride tablets should be continued only for patients who report significant symptomatic improvement.",
"Description": "Name: Midodrine hydrochloride tablets, USP. Dosage Form: 2.5 mg, 5 mg and 10 mg tablets for oral administration. Active Ingredient: Midodrine hydrochloride, USP 2.5 mg, 5 mg and 10 mg. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), and talc. Pharmacological Classification: Vasopressor/Antihypotensive. Chemical Names (USAN: Midodrine Hydrochloride): (1) Acetamide, 2-amino-N-[2-(2,5 dimethoxyphenyl)-2-hydroxyethyl]-monohydrochloride, (±)-; (2) (±)-2-amino-N-(ß-hydroxy-2,5-dimethoxyphenethyl)acetamide monohydrochloride BAN, INN, JAN: Midodrine. Structural formula. Molecular formula: C12H18N2O4HCl; Molecular Weight: 290.75. Organoleptic Properties: White to off-white crystalline powder. Solubility: Water: Soluble. pKa: 7.8 (0.3% aqueous solution). pH: 4.0 to 5.0. Melting Range: 192°C to 203°C."
},
{
"NDCCode": "70756-051-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (70756-051-11) ",
"NDC11Code": "70756-0051-11",
"ProductNDC": "70756-051",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Famotidine",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231019",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075302",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231019",
"SamplePackage": "N",
"IndicationAndUsage": "Famotidinetablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: 1 active duodenal ulcer (DU)., 2 active gastric ulcer (GU)., 3 symptomatic nonerosive gastroesophageal reflux disease (GERD)., 4 erosive esophagitis due to GERD, diagnosed by biopsy.",
"Description": "The active ingredient in famotidine tablets, USP is a histamine-2 (H2) receptor antagonist. Famotidine is N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The molecular formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.45. Its structural formula is. Each famotidine tablet, USP for oral administration contains either 20 mg or 40 mg of famotidine, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, ferric oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. Famotidine, USP is a white to pale yellowish-white crystalline powder that is freely soluble in dimethyl formamide and in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, practically insoluble in acetone, in alcohol, in chloroform, in ether and in ethyl acetate."
},
{
"NDCCode": "70756-052-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (70756-052-11) ",
"NDC11Code": "70756-0052-11",
"ProductNDC": "70756-052",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Famotidine",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231019",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075302",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231019",
"SamplePackage": "N",
"IndicationAndUsage": "Famotidinetablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: 1 active duodenal ulcer (DU)., 2 active gastric ulcer (GU)., 3 symptomatic nonerosive gastroesophageal reflux disease (GERD)., 4 erosive esophagitis due to GERD, diagnosed by biopsy.",
"Description": "The active ingredient in famotidine tablets, USP is a histamine-2 (H2) receptor antagonist. Famotidine is N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The molecular formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.45. Its structural formula is. Each famotidine tablet, USP for oral administration contains either 20 mg or 40 mg of famotidine, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, ferric oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. Famotidine, USP is a white to pale yellowish-white crystalline powder that is freely soluble in dimethyl formamide and in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, practically insoluble in acetone, in alcohol, in chloroform, in ether and in ethyl acetate."
},
{
"NDCCode": "70756-079-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (70756-079-11) ",
"NDC11Code": "70756-0079-11",
"ProductNDC": "70756-079",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bumetanide",
"NonProprietaryName": "Bumetanide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250403",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219291",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "BUMETANIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250403",
"SamplePackage": "N",
"IndicationAndUsage": "Bumetanide tablets are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide tablets following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.",
"Description": "Bumetanide tablets USP are loop diuretics available as 0.5 mg, 1 mg, and 2 mg (white to off white) tablets for oral administration; each tablet also contains corn starch, lactose monohydrate, magnesium oxide light, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, and talc. Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white powder having a calculated molecular weight of 364.42, and the following structural formula. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "70756-080-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (70756-080-11) ",
"NDC11Code": "70756-0080-11",
"ProductNDC": "70756-080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bumetanide",
"NonProprietaryName": "Bumetanide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250403",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219291",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "BUMETANIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250403",
"SamplePackage": "N",
"IndicationAndUsage": "Bumetanide tablets are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide tablets following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.",
"Description": "Bumetanide tablets USP are loop diuretics available as 0.5 mg, 1 mg, and 2 mg (white to off white) tablets for oral administration; each tablet also contains corn starch, lactose monohydrate, magnesium oxide light, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, and talc. Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white powder having a calculated molecular weight of 364.42, and the following structural formula. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "70756-081-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (70756-081-11) ",
"NDC11Code": "70756-0081-11",
"ProductNDC": "70756-081",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bumetanide",
"NonProprietaryName": "Bumetanide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250403",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219291",
"LabelerName": "Lifestar Pharma LLC",
"SubstanceName": "BUMETANIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250403",
"SamplePackage": "N",
"IndicationAndUsage": "Bumetanide tablets are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide tablets following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.",
"Description": "Bumetanide tablets USP are loop diuretics available as 0.5 mg, 1 mg, and 2 mg (white to off white) tablets for oral administration; each tablet also contains corn starch, lactose monohydrate, magnesium oxide light, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, and talc. Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white powder having a calculated molecular weight of 364.42, and the following structural formula. FDA approved dissolution test specifications differ from USP."
}
]
}
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<NDCList>
<NDC>
<NDCCode>70756-410-11</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (70756-410-11) </PackageDescription>
<NDC11Code>70756-0410-11</NDC11Code>
<ProductNDC>70756-410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrofurantoin Macrocrystals</ProprietaryName>
<NonProprietaryName>Nitrofurantoin Macrocrystals</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230321</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217272</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>NITROFURANTOIN</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrofuran Antibacterial [EPC], Nitrofurans [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230321</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nitrofurantoin capsules (macrocrystals) are specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin capsules (macrocrystals) and other antibacterial drugs, nitrofurantoin capsules (macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin capsules (macrocrystals) are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin capsules (macrocrystals), other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin capsules (macrocrystals), lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized.</IndicationAndUsage>
<Description>Nitrofurantoin capsules, USP (macrocrystals) are a synthetic chemical of controlled crystal size. It is a stable, lemon yellow, crystalline compound. Nitrofurantoin capsules, USP (macrocrystals) are an antibacterial agent for specific urinary tract infections. It is available in 25 mg, 50 mg, and 100 mg capsules for oral administration. Each capsule contains 25 mg, 50 mg, or 100 mg of nitrofurantoin, USP (macrocrystals). Molecular Formula: C8H6N4O5 Molecular Weight: 238.16 g/mole. 1-[[(5-nitro-2-furanyl)methylene] amino]-2,4-imidazolidinedione. Inactive Ingredients: Each capsule contains: corn starch, gelatin, lactose monohydrate, talc and titanium dioxide. Additionally, each 50 mg and 100 mg capsule shell contains FD&C Blue no. 1 and FD&C Red no. 3. The capsule is printed with black pharmaceutical ink which contains ferrosoferric oxide, potassium hydroxide, and shellac.</Description>
</NDC>
<NDC>
<NDCCode>43744-410-11</NDCCode>
<PackageDescription>5 g in 1 DRUM (43744-410-11)</PackageDescription>
<NDC11Code>43744-0410-11</NDC11Code>
<ProductNDC>43744-410</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Flucytosine</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20130110</StartMarketingDate>
<EndMarketingDate>20130624</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>FLUCYTOSINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>46987-410-11</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (46987-410-11)</PackageDescription>
<NDC11Code>46987-0410-11</NDC11Code>
<ProductNDC>46987-410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Kadian</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090407</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020616</ApplicationNumber>
<LabelerName>Actavis Kadian LLC</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>47682-410-11</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, DISPENSING (47682-410-11)</PackageDescription>
<NDC11Code>47682-0410-11</NDC11Code>
<ProductNDC>47682-410</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Green Guard First Aid Eye Wash</ProprietaryName>
<NonProprietaryName>Water</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20111202</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part349</ApplicationNumber>
<LabelerName>Unifirst First Aid Corporation</LabelerName>
<SubstanceName>WATER</SubstanceName>
<StrengthNumber>.983</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>51759-410-11</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (51759-410-11) / .21 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>51759-0410-11</NDC11Code>
<ProductNDC>51759-410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Uzedy</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION, EXTENDED RELEASE</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230501</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213586</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/.21mL</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230501</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>UZEDY is an atypical antipsychotic indicated: 1 for the treatment of schizophrenia in adults. (1.1), 2 as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. (1.2).</IndicationAndUsage>
<Description>UZEDY contains risperidone, an atypical antipsychotic. Risperidone belongs to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl) piperidin-1yl] ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.5 g/mol. The structural formula is. Risperidone is a white to off-white powder. It is practically insoluble in water and soluble in methanol and 0.1 N HCl. It has the following pKa values: 8.28 (piperidine moiety) and 3.12 (pyrimidine moiety). UZEDY (risperidone) extended-release injectable suspension, for subcutaneous use, is a sterile, preservative free, white to off-white opaque viscous suspension. It is available in the following strengths (and deliverable volumes from a single-dose prefilled syringe): 50 mg (0.14 mL), 75 mg (0.21 mL), 100 mg (0.28 mL), 125 mg (0.35 mL), 150 mg (0.42 mL), 200 mg (0.56 mL), and 250 mg (0.7 mL). The inactive ingredients include dimethyl sulfoxide (45% w/w), methoxy-poly(ethylene glycol)-co-poly(D,L-lactide) (15% w/w), and poly(D,L-lactide)-co-poly(ethylene glycol)-co-poly(D,L-lactide) (10% w/w).</Description>
</NDC>
<NDC>
<NDCCode>55570-410-11</NDCCode>
<PackageDescription>12 kg in 1 PAIL (55570-410-11) </PackageDescription>
<NDC11Code>55570-0410-11</NDC11Code>
<ProductNDC>55570-410</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Sodium Carbonate Anhydrous</NonProprietaryName>
<DosageFormName>GRANULE</DosageFormName>
<StartMarketingDate>20080313</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Jost Chemical Co.</LabelerName>
<SubstanceName>SODIUM CARBONATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>13-MAR-08</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>60687-410-94</NDCCode>
<PackageDescription>20 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-410-94) / 1 TABLET in 1 BLISTER PACK (60687-410-11) </PackageDescription>
<NDC11Code>60687-0410-94</NDC11Code>
<ProductNDC>60687-410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylergonovine Maleate</ProprietaryName>
<NonProprietaryName>Methylergonovine Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181101</StartMarketingDate>
<EndMarketingDate>20241231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210424</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>METHYLERGONOVINE MALEATE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Ergolines [CS], Ergot Derivative [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20181101</StartMarketingDatePackage>
<EndMarketingDatePackage>20241231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Following delivery of placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.</IndicationAndUsage>
<Description>Methylergonovine Maleate Tablets, USP is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage. Methylergonovine Maleate Tablets, USP is available in tablets for oral ingestion containing 0.2 mg methylergonovine maleate. TabletsActive ingredient: Methylergonovine maleate, USP, 0.2 mg. Inactive ingredients: acacia, corn starch, gelatin, lactose monohydrate, methylparaben, microcrystalline cellulose, povidone, propylparaben, stearic acid, and tartaric acid. Chemically, methylergonovine maleate is designated as ergoline-8-carboxamide, 9, 10-didehydro-N-[1-(hydroxymethyl) propyl]-6-methyl-, [8β(S)]-, (Z)-2-butenedioate (1:1) (salt). Its structural formula is. C 20H 25N 3O 2C 4H 4O 4 Mol Wt: 455.51.</Description>
</NDC>
<NDC>
<NDCCode>63307-410-11</NDCCode>
<PackageDescription>25 g in 1 BOTTLE (63307-410-11)</PackageDescription>
<NDC11Code>63307-0410-11</NDC11Code>
<ProductNDC>63307-410</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Progesterone</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20151130</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Total Pharmacy Supply, Inc.</LabelerName>
<SubstanceName>PROGESTERONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63776-410-11</NDCCode>
<PackageDescription>.5 mL in 1 AMPULE (63776-410-11) </PackageDescription>
<NDC11Code>63776-0410-11</NDC11Code>
<ProductNDC>63776-410</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-pigmentation</ProprietaryName>
<NonProprietaryName>Adrenal, Azelaic, Copper, Cutis, Cysteine, Epithelial Gf, Fumaric Acid, Glutathione, Glycolic Acid, Kalium Aspariticum, Lymph Node, Melanine, Natrum Oxalaceticum, Natrum Pyruvicum, Phenylalanine, Quinhydrone, Succinic Acid, Thuja, Tyrosine, Vitamin C, Zinc</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ASCORBIC ACID; AZELAIC ACID; BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH VESSEL; BOS TAURUS SKIN; COPPER; CYSTEINE; FUMARIC ACID; GLUTATHIONE; GLYCOLIC ACID; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); NEPIDERMIN; PHENYLALANINE; POTASSIUM ASPARTATE; QUINHYDRONE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUCCINIC ACID; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH VESSEL; SUS SCROFA SKIN; THUJA OCCIDENTALIS LEAFY TWIG; TYROSINE; ZINC</SubstanceName>
<StrengthNumber>30; 30; 30; 200; 30; 200; 30; 30; 200; 30; 200; 200; 200; 30; 30; 30; 30; 30; 30; 200; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Cells, Epidermal [EXT], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE], Decreased Sperm Motility [PE], Depigmenting Activity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Inhibit Ovum Fertilization [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Non-Standardized Animal Skin Allergenic Extract [EPC], Non-Standardized Animal Skin Allergenic Extract [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Skin Issues.</IndicationAndUsage>
<Description>Viatrexx-Pigmentation is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These nano particles are designed to nourish the system.</Description>
</NDC>
<NDC>
<NDCCode>67777-410-12</NDCCode>
<PackageDescription>36 JAR in 1 CASE (67777-410-12) / 71 g in 1 JAR (67777-410-11) </PackageDescription>
<NDC11Code>67777-0410-12</NDC11Code>
<ProductNDC>67777-410</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lanashield</ProprietaryName>
<NonProprietaryName>Lanolin</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141012</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Dynarex Corporation</LabelerName>
<SubstanceName>LANOLIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141012</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily protects minor cuts scrapes burns. Temporarily protects and helps relieve chafed, chapped, or cracked skin and lips. Helps prevent and protect from the drying effects of wind and cold weather.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68428-410-11</NDCCode>
<PackageDescription>300 PELLET in 1 BOTTLE, GLASS (68428-410-11) </PackageDescription>
<NDC11Code>68428-0410-11</NDC11Code>
<ProductNDC>68428-410</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gossypium Herbaceum</ProprietaryName>
<NonProprietaryName>Gossypium Herbaceum Root Bark</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110110</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>GOSSYPIUM HERBACEUM ROOT BARK</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>69543-410-11</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (69543-410-11) </PackageDescription>
<NDC11Code>69543-0410-11</NDC11Code>
<ProductNDC>69543-410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phendimetrazine Tartrate</ProprietaryName>
<NonProprietaryName>Phendimetrazine Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085588</ApplicationNumber>
<LabelerName>Virtus Pharmaceuticals, LLC</LabelerName>
<SubstanceName>PHENDIMETRAZINE TARTRATE</SubstanceName>
<StrengthNumber>35</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180701</StartMarketingDatePackage>
<EndMarketingDatePackage>20260930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phendimetrazine tartrate tablets are indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction. The limited usefulness of agents of this class (see CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below.</IndicationAndUsage>
<Description>Phendimetrazine tartrate, as the dextro isomer, has the chemical name of (2s,3s,)-3,4-dimethyl-2-phenylmorpholine L-(+)-tartrate (1:1). The structural formula is as follows. Phendimetrazine tartrate is a white, odorless crystalline powder. It is freely soluble in water; sparingly soluble in warm alcohol; insoluble in chloroform, acetone, ether and benzene. Each tablet, for oral administration, contains 35 mg of phendimetrazine tartrate. Inactive Ingredients: confectioner’s sugar (sucrose and corn starch), lactose monohydrate, povidone, pregelatinized starch, silicon dioxide and stearic acid. The yellow tablets also contain: FD&C yellow No. 5 (see PRECAUTIONS).</Description>
</NDC>
<NDC>
<NDCCode>73069-410-11</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 BOX (73069-410-11) > 1 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>73069-0410-11</NDC11Code>
<ProductNDC>73069-410</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-pigmentation</ProprietaryName>
<NonProprietaryName>Adrenal, Azelaic, Copper, Cutis, Cysteine, Epithelial Gf, Fumaric Acid, Glutathione, Glycolic Acid, Kalium Aspariticum, Lymph Node, Melanine, Natrum Oxalaceticum, Natrum Pyruvicum, Phenylalanin, Quinhydrone, Succinic Acid, Thuja, Tyrosine, Vitamin C, Zinc</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>SUS SCROFA ADRENAL GLAND; BOS TAURUS ADRENAL GLAND; AZELAIC ACID; BOS TAURUS SKIN; COPPER; CYSTEINE; FUMARIC ACID; GLUTATHIONE; GLYCOLIC ACID; POTASSIUM ASPARTATE; NEPIDERMIN; SUS SCROFA LYMPH VESSEL; BOS TAURUS LYMPH VESSEL; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; PHENYLALANINE; QUINHYDRONE; SUCCINIC ACID; THUJA OCCIDENTALIS LEAFY TWIG; TYROSINE; ASCORBIC ACID; ZINC; MELANIN SYNTHETIC (TYROSINE, PEROXIDE); SUS SCROFA SKIN</SubstanceName>
<StrengthNumber>31; 31; 31; 31; 201; 31; 31; 201; 31; 31; 201; 201; 201; 31; 31; 201; 31; 31; 31; 31; 31; 31; 201; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE],Non-Standardized Animal Skin Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE],Melanin Synthesis Inhibitor [EPC],Melanin Synthesis Inhibitors [MoA],Depigmenting Activity [PE],Vitamin C [EPC],Ascorbic Acid [CS],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Cells, Epidermal [EXT],Allergens [CS],Non-Standardized Animal Skin Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70756-001-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70756-001-11) </PackageDescription>
<NDC11Code>70756-0001-11</NDC11Code>
<ProductNDC>70756-001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Haloperidol</ProprietaryName>
<NonProprietaryName>Haloperidol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240411</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216918</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>HALOPERIDOL</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.</IndicationAndUsage>
<Description>Haloperidol, USP is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula. Haloperidol, USP is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch (corn). In addition, the 1 mg, 2 mg, 5 mg, and 10 mg tablets also contains D&C Yellow #10 Aluminum Lake. The 10 mg and 20 mg tablets also contains FD&C Blue #1 Aluminum Lake, 2 mg and 5 mg tablets also contains FD&C Red #40 Aluminum Lake, and 1 mg, 2 mg, 5 mg and 20 mg tablets also contains FD&C Yellow #6 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>70756-002-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70756-002-11) </PackageDescription>
<NDC11Code>70756-0002-11</NDC11Code>
<ProductNDC>70756-002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Haloperidol</ProprietaryName>
<NonProprietaryName>Haloperidol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240411</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216918</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>HALOPERIDOL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.</IndicationAndUsage>
<Description>Haloperidol, USP is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula. Haloperidol, USP is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch (corn). In addition, the 1 mg, 2 mg, 5 mg, and 10 mg tablets also contains D&C Yellow #10 Aluminum Lake. The 10 mg and 20 mg tablets also contains FD&C Blue #1 Aluminum Lake, 2 mg and 5 mg tablets also contains FD&C Red #40 Aluminum Lake, and 1 mg, 2 mg, 5 mg and 20 mg tablets also contains FD&C Yellow #6 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>70756-003-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70756-003-11) </PackageDescription>
<NDC11Code>70756-0003-11</NDC11Code>
<ProductNDC>70756-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Haloperidol</ProprietaryName>
<NonProprietaryName>Haloperidol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240411</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216918</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>HALOPERIDOL</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.</IndicationAndUsage>
<Description>Haloperidol, USP is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula. Haloperidol, USP is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch (corn). In addition, the 1 mg, 2 mg, 5 mg, and 10 mg tablets also contains D&C Yellow #10 Aluminum Lake. The 10 mg and 20 mg tablets also contains FD&C Blue #1 Aluminum Lake, 2 mg and 5 mg tablets also contains FD&C Red #40 Aluminum Lake, and 1 mg, 2 mg, 5 mg and 20 mg tablets also contains FD&C Yellow #6 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>70756-004-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70756-004-11) </PackageDescription>
<NDC11Code>70756-0004-11</NDC11Code>
<ProductNDC>70756-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Haloperidol</ProprietaryName>
<NonProprietaryName>Haloperidol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240411</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216918</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>HALOPERIDOL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults. Haloperidol tablets are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.</IndicationAndUsage>
<Description>Haloperidol, USP is the first of the butyrophenone series of major tranquilizers. The chemical designation is 4-[4-(p-chloro-phenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula. Haloperidol, USP is supplied as tablets for oral administration containing 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg or 20 mg of haloperidol, USP and contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch (corn). In addition, the 1 mg, 2 mg, 5 mg, and 10 mg tablets also contains D&C Yellow #10 Aluminum Lake. The 10 mg and 20 mg tablets also contains FD&C Blue #1 Aluminum Lake, 2 mg and 5 mg tablets also contains FD&C Red #40 Aluminum Lake, and 1 mg, 2 mg, 5 mg and 20 mg tablets also contains FD&C Yellow #6 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>70756-010-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70756-010-11) </PackageDescription>
<NDC11Code>70756-0010-11</NDC11Code>
<ProductNDC>70756-010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Midodrine Hydrochloride</ProprietaryName>
<NonProprietaryName>Midodrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217271</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>MIDODRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets can cause marked elevation of supine blood pressure (BP>200 mmHg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. The indication is based on midodrine hydrochloride tablets's effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine hydrochloride tablets, principally improved ability to perform life activities, have not been established. Further clinical trials are underway to verify and describe the clinical benefits of midodrine hydrochloride tablets. After initiation of treatment, midodrine hydrochloride tablets should be continued only for patients who report significant symptomatic improvement.</IndicationAndUsage>
<Description>Name: Midodrine hydrochloride tablets, USP. Dosage Form: 2.5 mg, 5 mg and 10 mg tablets for oral administration. Active Ingredient: Midodrine hydrochloride, USP 2.5 mg, 5 mg and 10 mg. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), and talc. Pharmacological Classification: Vasopressor/Antihypotensive. Chemical Names (USAN: Midodrine Hydrochloride): (1) Acetamide, 2-amino-N-[2-(2,5 dimethoxyphenyl)-2-hydroxyethyl]-monohydrochloride, (±)-; (2) (±)-2-amino-N-(ß-hydroxy-2,5-dimethoxyphenethyl)acetamide monohydrochloride BAN, INN, JAN: Midodrine. Structural formula. Molecular formula: C12H18N2O4HCl; Molecular Weight: 290.75. Organoleptic Properties: White to off-white crystalline powder. Solubility: Water: Soluble. pKa: 7.8 (0.3% aqueous solution). pH: 4.0 to 5.0. Melting Range: 192°C to 203°C.</Description>
</NDC>
<NDC>
<NDCCode>70756-011-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70756-011-11) </PackageDescription>
<NDC11Code>70756-0011-11</NDC11Code>
<ProductNDC>70756-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorthalidone</ProprietaryName>
<NonProprietaryName>Chlorthalidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220805</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215587</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>CHLORTHALIDONE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide-like Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220805</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.</IndicationAndUsage>
<Description>Chlorthalidone an oral antihypertensive/diuretic. It is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double-ring system is incorporated in its structure. It is 2-Chloro-5(1- hydroxy-3-oxo-1- isoindolinyl) benzenesulfonamide with the following structural formula. Molecular Formula: C14H11ClN2O4S Molecular weight: 338.76. Chlorthalidone, USP is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in ethanol. Chlorthalidone tablets are available containing either 25 mg or 50 mg of chlorthalidone, USP and the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch (maize), sodium starch glycolate Type A, stearic acid. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>70756-013-11</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (70756-013-11) / 100 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>70756-0013-11</NDC11Code>
<ProductNDC>70756-013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitroglycerin</ProprietaryName>
<NonProprietaryName>Nitroglycerin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20231205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217970</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>.3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.</IndicationAndUsage>
<Description>Nitroglycerin sublingual tablets, USP are stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin. The sublingual tablets also contains inactive ingredients calcium stearate, colloidal silicon dioxide, hydrogenated vegetable oil, lactose monohydrate, pregelatinized starch (corn). Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is. C3H5N309. Molecular weight: 227.09.</Description>
</NDC>
<NDC>
<NDCCode>70756-014-11</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (70756-014-11) / 100 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>70756-0014-11</NDC11Code>
<ProductNDC>70756-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitroglycerin</ProprietaryName>
<NonProprietaryName>Nitroglycerin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20231205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217970</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.</IndicationAndUsage>
<Description>Nitroglycerin sublingual tablets, USP are stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin. The sublingual tablets also contains inactive ingredients calcium stearate, colloidal silicon dioxide, hydrogenated vegetable oil, lactose monohydrate, pregelatinized starch (corn). Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is. C3H5N309. Molecular weight: 227.09.</Description>
</NDC>
<NDC>
<NDCCode>70756-016-11</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (70756-016-11) / 100 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>70756-0016-11</NDC11Code>
<ProductNDC>70756-016</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitroglycerin</ProprietaryName>
<NonProprietaryName>Nitroglycerin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20231205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217970</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>NITROGLYCERIN</SubstanceName>
<StrengthNumber>.6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.</IndicationAndUsage>
<Description>Nitroglycerin sublingual tablets, USP are stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin. The sublingual tablets also contains inactive ingredients calcium stearate, colloidal silicon dioxide, hydrogenated vegetable oil, lactose monohydrate, pregelatinized starch (corn). Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is. C3H5N309. Molecular weight: 227.09.</Description>
</NDC>
<NDC>
<NDCCode>70756-020-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70756-020-11) </PackageDescription>
<NDC11Code>70756-0020-11</NDC11Code>
<ProductNDC>70756-020</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorthalidone</ProprietaryName>
<NonProprietaryName>Chlorthalidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220805</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215587</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>CHLORTHALIDONE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE], Thiazide-like Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220805</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.</IndicationAndUsage>
<Description>Chlorthalidone an oral antihypertensive/diuretic. It is a monosulfamyl diuretic that differs chemically from thiazide diuretics in that a double-ring system is incorporated in its structure. It is 2-Chloro-5(1- hydroxy-3-oxo-1- isoindolinyl) benzenesulfonamide with the following structural formula. Molecular Formula: C14H11ClN2O4S Molecular weight: 338.76. Chlorthalidone, USP is practically insoluble in water, in ether, and in chloroform; soluble in methanol; slightly soluble in ethanol. Chlorthalidone tablets are available containing either 25 mg or 50 mg of chlorthalidone, USP and the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch (maize), sodium starch glycolate Type A, stearic acid. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>70756-049-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70756-049-11) </PackageDescription>
<NDC11Code>70756-0049-11</NDC11Code>
<ProductNDC>70756-049</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Midodrine Hydrochloride</ProprietaryName>
<NonProprietaryName>Midodrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217271</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>MIDODRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets can cause marked elevation of supine blood pressure (BP>200 mmHg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. The indication is based on midodrine hydrochloride tablets's effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine hydrochloride tablets, principally improved ability to perform life activities, have not been established. Further clinical trials are underway to verify and describe the clinical benefits of midodrine hydrochloride tablets. After initiation of treatment, midodrine hydrochloride tablets should be continued only for patients who report significant symptomatic improvement.</IndicationAndUsage>
<Description>Name: Midodrine hydrochloride tablets, USP. Dosage Form: 2.5 mg, 5 mg and 10 mg tablets for oral administration. Active Ingredient: Midodrine hydrochloride, USP 2.5 mg, 5 mg and 10 mg. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), and talc. Pharmacological Classification: Vasopressor/Antihypotensive. Chemical Names (USAN: Midodrine Hydrochloride): (1) Acetamide, 2-amino-N-[2-(2,5 dimethoxyphenyl)-2-hydroxyethyl]-monohydrochloride, (±)-; (2) (±)-2-amino-N-(ß-hydroxy-2,5-dimethoxyphenethyl)acetamide monohydrochloride BAN, INN, JAN: Midodrine. Structural formula. Molecular formula: C12H18N2O4HCl; Molecular Weight: 290.75. Organoleptic Properties: White to off-white crystalline powder. Solubility: Water: Soluble. pKa: 7.8 (0.3% aqueous solution). pH: 4.0 to 5.0. Melting Range: 192°C to 203°C.</Description>
</NDC>
<NDC>
<NDCCode>70756-050-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70756-050-11) </PackageDescription>
<NDC11Code>70756-0050-11</NDC11Code>
<ProductNDC>70756-050</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Midodrine Hydrochloride</ProprietaryName>
<NonProprietaryName>Midodrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217271</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>MIDODRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH). Because midodrine hydrochloride tablets can cause marked elevation of supine blood pressure (BP>200 mmHg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. The indication is based on midodrine hydrochloride tablets's effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of midodrine hydrochloride tablets, principally improved ability to perform life activities, have not been established. Further clinical trials are underway to verify and describe the clinical benefits of midodrine hydrochloride tablets. After initiation of treatment, midodrine hydrochloride tablets should be continued only for patients who report significant symptomatic improvement.</IndicationAndUsage>
<Description>Name: Midodrine hydrochloride tablets, USP. Dosage Form: 2.5 mg, 5 mg and 10 mg tablets for oral administration. Active Ingredient: Midodrine hydrochloride, USP 2.5 mg, 5 mg and 10 mg. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), and talc. Pharmacological Classification: Vasopressor/Antihypotensive. Chemical Names (USAN: Midodrine Hydrochloride): (1) Acetamide, 2-amino-N-[2-(2,5 dimethoxyphenyl)-2-hydroxyethyl]-monohydrochloride, (±)-; (2) (±)-2-amino-N-(ß-hydroxy-2,5-dimethoxyphenethyl)acetamide monohydrochloride BAN, INN, JAN: Midodrine. Structural formula. Molecular formula: C12H18N2O4HCl; Molecular Weight: 290.75. Organoleptic Properties: White to off-white crystalline powder. Solubility: Water: Soluble. pKa: 7.8 (0.3% aqueous solution). pH: 4.0 to 5.0. Melting Range: 192°C to 203°C.</Description>
</NDC>
<NDC>
<NDCCode>70756-051-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70756-051-11) </PackageDescription>
<NDC11Code>70756-0051-11</NDC11Code>
<ProductNDC>70756-051</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Famotidine</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231019</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075302</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231019</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Famotidinetablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: 1 active duodenal ulcer (DU)., 2 active gastric ulcer (GU)., 3 symptomatic nonerosive gastroesophageal reflux disease (GERD)., 4 erosive esophagitis due to GERD, diagnosed by biopsy.</IndicationAndUsage>
<Description>The active ingredient in famotidine tablets, USP is a histamine-2 (H2) receptor antagonist. Famotidine is N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The molecular formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.45. Its structural formula is. Each famotidine tablet, USP for oral administration contains either 20 mg or 40 mg of famotidine, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, ferric oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. Famotidine, USP is a white to pale yellowish-white crystalline powder that is freely soluble in dimethyl formamide and in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, practically insoluble in acetone, in alcohol, in chloroform, in ether and in ethyl acetate.</Description>
</NDC>
<NDC>
<NDCCode>70756-052-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70756-052-11) </PackageDescription>
<NDC11Code>70756-0052-11</NDC11Code>
<ProductNDC>70756-052</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Famotidine</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231019</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075302</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231019</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Famotidinetablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: 1 active duodenal ulcer (DU)., 2 active gastric ulcer (GU)., 3 symptomatic nonerosive gastroesophageal reflux disease (GERD)., 4 erosive esophagitis due to GERD, diagnosed by biopsy.</IndicationAndUsage>
<Description>The active ingredient in famotidine tablets, USP is a histamine-2 (H2) receptor antagonist. Famotidine is N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The molecular formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.45. Its structural formula is. Each famotidine tablet, USP for oral administration contains either 20 mg or 40 mg of famotidine, USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ferric oxide red, ferric oxide yellow, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. Famotidine, USP is a white to pale yellowish-white crystalline powder that is freely soluble in dimethyl formamide and in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, practically insoluble in acetone, in alcohol, in chloroform, in ether and in ethyl acetate.</Description>
</NDC>
<NDC>
<NDCCode>70756-079-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70756-079-11) </PackageDescription>
<NDC11Code>70756-0079-11</NDC11Code>
<ProductNDC>70756-079</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bumetanide</ProprietaryName>
<NonProprietaryName>Bumetanide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250403</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219291</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>BUMETANIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bumetanide tablets are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide tablets following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.</IndicationAndUsage>
<Description>Bumetanide tablets USP are loop diuretics available as 0.5 mg, 1 mg, and 2 mg (white to off white) tablets for oral administration; each tablet also contains corn starch, lactose monohydrate, magnesium oxide light, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, and talc. Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white powder having a calculated molecular weight of 364.42, and the following structural formula. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>70756-080-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70756-080-11) </PackageDescription>
<NDC11Code>70756-0080-11</NDC11Code>
<ProductNDC>70756-080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bumetanide</ProprietaryName>
<NonProprietaryName>Bumetanide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250403</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219291</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>BUMETANIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bumetanide tablets are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide tablets following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.</IndicationAndUsage>
<Description>Bumetanide tablets USP are loop diuretics available as 0.5 mg, 1 mg, and 2 mg (white to off white) tablets for oral administration; each tablet also contains corn starch, lactose monohydrate, magnesium oxide light, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, and talc. Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white powder having a calculated molecular weight of 364.42, and the following structural formula. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>70756-081-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70756-081-11) </PackageDescription>
<NDC11Code>70756-0081-11</NDC11Code>
<ProductNDC>70756-081</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bumetanide</ProprietaryName>
<NonProprietaryName>Bumetanide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250403</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219291</ApplicationNumber>
<LabelerName>Lifestar Pharma LLC</LabelerName>
<SubstanceName>BUMETANIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bumetanide tablets are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. Almost equal diuretic response occurs after oral and parenteral administration of bumetanide. Therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. Successful treatment with bumetanide tablets following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.</IndicationAndUsage>
<Description>Bumetanide tablets USP are loop diuretics available as 0.5 mg, 1 mg, and 2 mg (white to off white) tablets for oral administration; each tablet also contains corn starch, lactose monohydrate, magnesium oxide light, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate, and talc. Chemically, bumetanide is 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoic acid. It is a practically white powder having a calculated molecular weight of 364.42, and the following structural formula. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
</NDCList>