{
"NDC": [
{
"NDCCode": "42508-364-00",
"PackageDescription": "1 KIT in 1 PACKAGE, COMBINATION (42508-364-00) * 3 mL in 1 TUBE * 3 mL in 1 TUBE * 3 g in 1 TUBE * 3 g in 1 TUBE * 3 mL in 1 TUBE * 3 g in 1 TUBE",
"NDC11Code": "42508-0364-00",
"ProductNDC": "42508-364",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Re9 Advanced Brightening",
"ProprietaryNameSuffix": "Sample Pack",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "KIT",
"StartMarketingDate": "20170301",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Arbonne International, LLC",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "42508-024-00",
"PackageDescription": "1 KIT in 1 CARTON (42508-024-00) * 3 mL in 1 TUBE * 3 g in 1 TUBE * 3 mL in 1 TUBE",
"NDC11Code": "42508-0024-00",
"ProductNDC": "42508-024",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Re9 Advanced For Men Anti-aging Skincare Line",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "KIT",
"StartMarketingDate": "20160414",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Arbonne International, LLC",
"Status": "Deprecated",
"LastUpdate": "2022-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20160414",
"SamplePackage": "N"
},
{
"NDCCode": "42508-133-00",
"PackageDescription": "1 KIT in 1 CARTON (42508-133-00) * 6 g in 1 TUBE * 44 mL in 1 TUBE * 15 mL in 1 TUBE * 30 mL in 1 TUBE * 15 mL in 1 TUBE",
"NDC11Code": "42508-0133-00",
"ProductNDC": "42508-133",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Re9 Advanced For Men Deluxe Try Me Set",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "KIT",
"StartMarketingDate": "20160414",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Arbonne International, LLC",
"Status": "Deprecated",
"LastUpdate": "2019-12-24",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "42508-979-00",
"PackageDescription": "1 KIT in 1 CARTON (42508-979-00) * 118 mL in 1 TUBE * 50 mL in 1 TUBE * 50 mL in 1 TUBE",
"NDC11Code": "42508-0979-00",
"ProductNDC": "42508-979",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fc5 Complexion Revitalizing Set",
"NonProprietaryName": "Avobenzone, Octinoxate, Octisalate, And Octrocrylene",
"DosageFormName": "KIT",
"StartMarketingDate": "20130401",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Arbonne International, LLC",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20130401",
"SamplePackage": "N"
},
{
"NDCCode": "61383-364-00",
"PackageDescription": "15 kg in 1 PAIL (61383-364-00) ",
"NDC11Code": "61383-0364-00",
"ProductNDC": "61383-364",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20260215",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Dimensional Merchandising Inc.",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "390000",
"StrengthUnit": "mg/kg",
"Status": "Unfinished",
"LastUpdate": "2026-04-17",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "15-FEB-26"
},
{
"NDCCode": "68001-364-00",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68001-364-00) ",
"NDC11Code": "68001-0364-00",
"ProductNDC": "68001-364",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metronidazole",
"NonProprietaryName": "Metronidazole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203458",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "METRONIDAZOLE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS]",
"Status": "Active",
"LastUpdate": "2026-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180801",
"SamplePackage": "N",
"IndicationAndUsage": "Symptomatic Trichomoniasis.Metronidazole tablets are indicated for the treatment of T. vaginalisinfection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis.Metronidazole tablets are indicated in the treatment of asymptomatic T. vaginalisinfection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners.T. vaginalisinfection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with metronidazole tablets in cases of reinfection. AmebiasisMetronidazole tablets are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, Metronidazole tablet therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections.Metronidazole tablets are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole tablet therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole tablets. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroidesspecies including the B. fragilisgroup ( B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridiumspecies, Eubacteriumspecies, Peptococcus species,and Peptostreptococcusspecies. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroidesspecies including the B. fragilisgroup, Clostridiumspecies, Peptococcus species, Peptostreptococcusspecies, and Fusobacteriumspecies. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroidesspecies including the B. fragilisgroup, Clostridiumspecies, Peptococcus species, Peptostreptococcusspecies, and Fusobacteriumspecies. BACTERIAL SEPTICEMIA caused by Bacteroidesspecies including the B. fragilisgroup and Clostridiumspecies. BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroidesspecies including the B. fragilisgroup. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroidesspecies including the B. fragilisgroup. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroidesspecies including the B. fragilisgroup. ENDOCARDITIS caused by Bacteroidesspecies including the B. fragilisgroup. To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets and other antibacterial drugs, metronidazole tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Metronidazole tablets, USP 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula. Metronidazole tablets USP contain 250 mg or 500 mg of metronidazole. Inactive ingredients include powdered cellulose, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, hypromellose, polyethylene glycol, stearic acid, and titanium dioxide."
},
{
"NDCCode": "68225-112-00",
"PackageDescription": "364 VIAL in 1 CASE (68225-112-00) / 2 mL in 1 VIAL",
"NDC11Code": "68225-0112-00",
"ProductNDC": "68225-112",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Meloxicam",
"DosageFormName": "INJECTION",
"StartMarketingDate": "20200224",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Patheon Italia S.p.A.",
"SubstanceName": "MELOXICAM",
"StrengthNumber": "30",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "24-FEB-20"
},
{
"NDCCode": "81923-364-00",
"PackageDescription": "15 mL in 1 BOTTLE, SPRAY (81923-364-00) ",
"NDC11Code": "81923-0364-00",
"ProductNDC": "81923-364",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Skins Delay Climax Control Lidocaine",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221003",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "SKINS SEXUAL HEALTH LIMITED",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2023-11-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221003",
"SamplePackage": "N",
"IndicationAndUsage": "Helps to temporarily prevent premature ejaculation."
},
{
"NDCCode": "21695-994-00",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (21695-994-00)",
"NDC11Code": "21695-0994-00",
"ProductNDC": "21695-994",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hydrochloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19980803",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075133",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Labetalol hydrochloride tablets are indicated in the management of hypertension. Labetalol hydrochloride tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.",
"Description": "Labetalol hydrochloride (HCl) is an adrenergic receptor blocking agent that has both selective alpha1- and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol HCl is a racemate chemically designated as 5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl) amino] ethyl] salicylamide monohydrochloride, and has the following structural formula. Labetalol HCl has the molecular formula C19H24N2O3HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R’ stereoisomer, makes up 25% of racemic labetalol. Labetalol HCl is a white or off-white crystalline powder, soluble in water. Labetalol Hydrochloride Tablets USP for oral administration contain 100 mg, 200 mg, or 300 mg labetalol HCl. Each tablet also contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, purified water, and titanium dioxide. Labetalol HCl Tablets 100 mg also contain synthetic red iron oxide and synthetic yellow iron oxide. Labetalol HCl Tablets 300 mg also contain FD & C blue No. 2 aluminum lake."
},
{
"NDCCode": "50090-1161-0",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-1161-0) ",
"NDC11Code": "50090-1161-00",
"ProductNDC": "50090-1161",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hcl",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200908",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141128",
"SamplePackage": "N",
"IndicationAndUsage": "Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets, USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.",
"Description": "Labetalol hydrochloride tablets, USP are adrenergic receptor blocking agents that have both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride (HCl) is a racemate chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl) amino] ethyl] benzamide monohydrochloride, and it has the following structure. Labetalol HCl has the molecular formula C19H24N2O3HCl and a molecular weight of 364.9. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R, R´stereoisomer, makes up 25% of racemic labetalol. Labetalol HCl is a white or off-white crystalline powder, soluble in water. Labetalol hydrochloride tablets contain 100, 200, or 300 mg of labetalol HCl and are taken orally. The tablets also contain the inactive ingredients lactose monohydrate, corn starch, crospovidone, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, polyethylene glycol, titanium dioxide and talc."
},
{
"NDCCode": "50090-1290-0",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-1290-0) ",
"NDC11Code": "50090-1290-00",
"ProductNDC": "50090-1290",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hcl",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200908",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141128",
"SamplePackage": "N",
"IndicationAndUsage": "Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets, USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.",
"Description": "Labetalol hydrochloride tablets, USP are adrenergic receptor blocking agents that have both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride (HCl) is a racemate chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl) amino] ethyl] benzamide monohydrochloride, and it has the following structure. Labetalol HCl has the molecular formula C19H24N2O3HCl and a molecular weight of 364.9. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R, R´stereoisomer, makes up 25% of racemic labetalol. Labetalol HCl is a white or off-white crystalline powder, soluble in water. Labetalol hydrochloride tablets contain 100, 200, or 300 mg of labetalol HCl and are taken orally. The tablets also contain the inactive ingredients lactose monohydrate, corn starch, crospovidone, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, polyethylene glycol, titanium dioxide and talc."
},
{
"NDCCode": "50090-1291-0",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-1291-0) ",
"NDC11Code": "50090-1291-00",
"ProductNDC": "50090-1291",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hcl",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200908",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20141128",
"SamplePackage": "N",
"IndicationAndUsage": "Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets, USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.",
"Description": "Labetalol hydrochloride tablets, USP are adrenergic receptor blocking agents that have both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance.Labetalol hydrochloride (HCl) is a racemate chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl) amino] ethyl] benzamide monohydrochloride, and it has the following structure. Labetalol HCl has the molecular formula C19H24N2O3HCl and a molecular weight of 364.9. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R, R´stereoisomer, makes up 25% of racemic labetalol.Labetalol HCl is a white or off-white crystalline powder, soluble in water.Labetalol hydrochloride tablets contain 100, 200, or 300 mg of labetalol HCl and are taken orally. The tablets also contain the inactive ingredients lactose monohydrate, corn starch, crospovidone, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, polyethylene glycol, titanium dioxide and talc."
},
{
"NDCCode": "50090-3584-0",
"PackageDescription": "60 TABLET in 1 BOTTLE (50090-3584-0) ",
"NDC11Code": "50090-3584-00",
"ProductNDC": "50090-3584",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hydrochloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20141201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018716",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20180921",
"SamplePackage": "N",
"IndicationAndUsage": "Labetalol Hydrochloride Tablets are indicated in the management of hypertension. Labetalol Hydrochloride Tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.",
"Description": "Labetalol Hydrochloride Tablets are adrenergic receptor blocking agents that have both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride (HCl) is a racemate chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]benzamide monohydrochloride, and it has the following structure. Labetalol HCl has the empirical formula C19H24N2O3∙HCl and a molecular weight of 364.9. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R´ stereoisomer, makes up 25% of racemic labetalol. Labetalol HCl is a white or off-white crystalline powder, soluble in water. Labetalol Hydrochloride Tablets contain 100 mg, 200 mg, or 300 mg of labetalol HCl and are taken orally. The tablets also contain the inactive ingredients corn starch, FD&C Yellow No. 6 (100 mg- and 300mg tablets only), hydroxypropyl methylcellulose, lactose, magnesium stearate, pregelatinized corn starch, sodium benzoate (200-mg tablet only), talc (100-mg tablet only), and titanium dioxide."
},
{
"NDCCode": "50090-4149-0",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (50090-4149-0) ",
"NDC11Code": "50090-4149-00",
"ProductNDC": "50090-4149",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hydrochloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180301",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018716",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190220",
"SamplePackage": "N",
"IndicationAndUsage": "Labetalol Hydrochloride Tablets are indicated in the management of hypertension. Labetalol Hydrochloride Tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.",
"Description": "Labetalol Hydrochloride Tablets are adrenergic receptor blocking agents that have both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride (HCl) is a racemate chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]benzamide monohydrochloride, and it has the following structure. Labetalol HCl has the empirical formula C19H24N2O3∙HCl and a molecular weight of 364.9. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R´ stereoisomer, makes up 25% of racemic labetalol. Labetalol HCl is a white or off-white crystalline powder, soluble in water. Labetalol Hydrochloride Tablets contain 100 mg, 200 mg, or 300 mg of labetalol HCl and are taken orally. The tablets also contain the inactive ingredients corn starch, FD&C Yellow No. 6 (100-mg and 300-mg tablets only), hydroxypropyl methylcellulose, lactose, magnesium stearate, pregelatinized corn starch, sodium benzoate (200-mg tablet only), talc (100-mg tablet only), and titanium dioxide."
},
{
"NDCCode": "50090-5064-0",
"PackageDescription": "90 TABLET in 1 BOTTLE (50090-5064-0) ",
"NDC11Code": "50090-5064-00",
"ProductNDC": "50090-5064",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bumetanide",
"NonProprietaryName": "Bumetanide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151015",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA018225",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "BUMETANIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200528",
"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 is a loop diuretic available as 0.5 mg (light green), 1 mg (yellow) and 2 mg (peach) tablets for oral administration; each tablet also contains anhydrous lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc, with the following dye systems: 0.5 mg—D&C Yellow No. 10 aluminum lake and FD&C Blue No. 1 aluminum lake; 1 mg—D&C Yellow No. 10 aluminum lake; 2 mg—red iron oxide. 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."
},
{
"NDCCode": "50090-5123-0",
"PackageDescription": "90 TABLET in 1 BOTTLE (50090-5123-0) ",
"NDC11Code": "50090-5123-00",
"ProductNDC": "50090-5123",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bumetanide",
"NonProprietaryName": "Bumetanide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202900",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "BUMETANIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200807",
"SamplePackage": "N",
"IndicationAndUsage": "Bumetanide tablets USP 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 USP following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.",
"Description": "Bumetanide is a loop diuretic, available as scored tablets. 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."
},
{
"NDCCode": "50090-5124-0",
"PackageDescription": "90 TABLET in 1 BOTTLE (50090-5124-0) ",
"NDC11Code": "50090-5124-00",
"ProductNDC": "50090-5124",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bumetanide",
"NonProprietaryName": "Bumetanide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202900",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "BUMETANIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20200807",
"SamplePackage": "N",
"IndicationAndUsage": "Bumetanide tablets USP 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 USP following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.",
"Description": "Bumetanide is a loop diuretic, available as scored tablets. 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."
},
{
"NDCCode": "50090-5663-0",
"PackageDescription": "90 TABLET in 1 BOTTLE (50090-5663-0) ",
"NDC11Code": "50090-5663-00",
"ProductNDC": "50090-5663",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bumetanide",
"NonProprietaryName": "Bumetanide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209724",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "BUMETANIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210915",
"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 is a loop diuretic available as 0.5 mg, 1 mg and 2 mg tablets for oral administration; each tablet also contains the following inactive ingredients: anhydrous lactose, magnesium stearate, maize starch, microcrystalline cellulose, pregelatinized starch 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. C17H20N2O5S. Meets USP Dissolution Test 2."
},
{
"NDCCode": "50090-5664-0",
"PackageDescription": "90 TABLET in 1 BOTTLE (50090-5664-0) ",
"NDC11Code": "50090-5664-00",
"ProductNDC": "50090-5664",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bumetanide",
"NonProprietaryName": "Bumetanide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209724",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "BUMETANIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210915",
"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 is a loop diuretic available as 0.5 mg, 1 mg and 2 mg tablets for oral administration; each tablet also contains the following inactive ingredients: anhydrous lactose, magnesium stearate, maize starch, microcrystalline cellulose, pregelatinized starch 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. C17H20N2O5S. Meets USP Dissolution Test 2."
},
{
"NDCCode": "50090-5666-0",
"PackageDescription": "30 TABLET in 1 BOTTLE (50090-5666-0) ",
"NDC11Code": "50090-5666-00",
"ProductNDC": "50090-5666",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bumetanide",
"NonProprietaryName": "Bumetanide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209724",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "BUMETANIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2023-12-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210915",
"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 is a loop diuretic available as 0.5 mg, 1 mg and 2 mg tablets for oral administration; each tablet also contains the following inactive ingredients: anhydrous lactose, magnesium stearate, maize starch, microcrystalline cellulose, pregelatinized starch 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. C17H20N2O5S. Meets USP Dissolution Test 2."
},
{
"NDCCode": "50090-6137-0",
"PackageDescription": "90 TABLET in 1 BOTTLE (50090-6137-0) ",
"NDC11Code": "50090-6137-00",
"ProductNDC": "50090-6137",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bumetanide",
"NonProprietaryName": "Bumetanide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202900",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "BUMETANIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221003",
"SamplePackage": "N",
"IndicationAndUsage": "Bumetanide tablets USP 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 USP following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.",
"Description": "Bumetanide is a loop diuretic, available as scored tablets. 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."
},
{
"NDCCode": "50090-6139-0",
"PackageDescription": "90 TABLET in 1 BOTTLE (50090-6139-0) ",
"NDC11Code": "50090-6139-00",
"ProductNDC": "50090-6139",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bumetanide",
"NonProprietaryName": "Bumetanide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202900",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "BUMETANIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20221003",
"SamplePackage": "N",
"IndicationAndUsage": "Bumetanide tablets USP 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 USP following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.",
"Description": "Bumetanide is a loop diuretic, available as scored tablets. 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."
},
{
"NDCCode": "50090-6304-0",
"PackageDescription": "90 TABLET in 1 BOTTLE (50090-6304-0) ",
"NDC11Code": "50090-6304-00",
"ProductNDC": "50090-6304",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bumetanide",
"NonProprietaryName": "Bumetanide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19961121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074700",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "BUMETANIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221229",
"SamplePackage": "N",
"IndicationAndUsage": "Bumetanide tablets, USP 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, USP following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.",
"Description": "Bumetanide is a loop diuretic, available as scored tablets. Each tablet for oral administration contains 0.5 mg, 1 mg or 2 mg of bumetanide. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, corn starch, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), talc, with the following dye systems: 0.5 mg- D&C yellow No. 10 aluminum lake, FD&C blue No. 1 aluminum lake and FD&C red No. 40 aluminum lake; 1 mg- D&C yellow No. 10 aluminum lake; 2 mg- synthetic black iron oxide, synthetic red iron oxide and synthetic yellow iron oxide. 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."
},
{
"NDCCode": "50090-6308-0",
"PackageDescription": "90 TABLET in 1 BOTTLE (50090-6308-0) ",
"NDC11Code": "50090-6308-00",
"ProductNDC": "50090-6308",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bumetanide",
"NonProprietaryName": "Bumetanide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19961121",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074700",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "BUMETANIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221230",
"SamplePackage": "N",
"IndicationAndUsage": "Bumetanide tablets, USP 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, USP following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.",
"Description": "Bumetanide is a loop diuretic, available as scored tablets. Each tablet for oral administration contains 0.5 mg, 1 mg or 2 mg of bumetanide. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, corn starch, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), talc, with the following dye systems: 0.5 mg- D&C yellow No. 10 aluminum lake, FD&C blue No. 1 aluminum lake and FD&C red No. 40 aluminum lake; 1 mg- D&C yellow No. 10 aluminum lake; 2 mg- synthetic black iron oxide, synthetic red iron oxide and synthetic yellow iron oxide. 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."
},
{
"NDCCode": "50090-6741-0",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (50090-6741-0) ",
"NDC11Code": "50090-6741-00",
"ProductNDC": "50090-6741",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hydrochloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210818",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211953",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-10-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231013",
"SamplePackage": "N",
"IndicationAndUsage": "Labetalol hydrochloride tablets USP are indicated in the management of hypertension. Labetalol hydrochloride tablets USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.",
"Description": "Labetalol hydrochloride tablets, USP are an adrenergic receptor blocking agent that has both selective alpha 1 -adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride, USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl] benzamide monohydrochloride, and it has the following structure. Labetalol hydrochloride, USP has the molecular formula C 19H 24N 2O 3 HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride, USP is a white or off-white crystalline powder, soluble in water. Labetalol hydrochloride tablets, USP, for oral administration, contain 100 mg, 200 mg or 300 mg labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, maize starch, hypromellose (Methocel E5), sodium starch glycolate, magnesium stearate, titanium dioxide, polyethylene glycol, polysorbate 80, hypromellose (3 mPas) and hypromellose (6 mPas)."
},
{
"NDCCode": "50090-6774-0",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (50090-6774-0) ",
"NDC11Code": "50090-6774-00",
"ProductNDC": "50090-6774",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hydrochloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210818",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211953",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231024",
"SamplePackage": "N",
"IndicationAndUsage": "Labetalol hydrochloride tablets USP are indicated in the management of hypertension. Labetalol hydrochloride tablets USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.",
"Description": "Labetalol hydrochloride tablets, USP are an adrenergic receptor blocking agent that has both selective alpha 1 -adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride, USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl] benzamide monohydrochloride, and it has the following structure. Labetalol hydrochloride, USP has the molecular formula C 19H 24N 2O 3 HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride, USP is a white or off-white crystalline powder, soluble in water. Labetalol hydrochloride tablets, USP, for oral administration, contain 100 mg, 200 mg or 300 mg labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, maize starch, hypromellose (Methocel E5), sodium starch glycolate, magnesium stearate, titanium dioxide, polyethylene glycol, polysorbate 80, hypromellose (3 mPas) and hypromellose (6 mPas)."
},
{
"NDCCode": "50090-6777-0",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (50090-6777-0) ",
"NDC11Code": "50090-6777-00",
"ProductNDC": "50090-6777",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hydrochloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19980803",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075133",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20231025",
"SamplePackage": "N",
"IndicationAndUsage": "Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets, USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.",
"Description": "Labetalol hydrochloride (HCl) is an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol HCl is a racemate chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]benzamide monohydrochloride, and it has the following structure. Labetalol HCl has the empirical formula C19H24N2O3HCl and a molecular weight of 364.9. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R’ stereoisomer, makes up 25% of racemic labetalol. Labetalol HCl is a white or off-white crystalline powder, soluble in water. Labetalol Hydrochloride Tablets, USP for oral administration contain 100 mg, 200 mg, or 300 mg of labetalol HCl. Each tablet also contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, purified water, and titanium dioxide. Labetalol HCl Tablets, USP 100 mg also contain synthetic red iron oxide and synthetic yellow iron oxide. Labetalol HCl Tablets, USP 300 mg also contain FD & C blue No. 2 aluminum lake."
},
{
"NDCCode": "50090-6778-0",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (50090-6778-0) ",
"NDC11Code": "50090-6778-00",
"ProductNDC": "50090-6778",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hydrochloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19980803",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075133",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "200",
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"IndicationAndUsage": "Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets, USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.",
"Description": "Labetalol hydrochloride (HCl) is an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol HCl is a racemate chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]benzamide monohydrochloride, and it has the following structure. Labetalol HCl has the empirical formula C19H24N2O3HCl and a molecular weight of 364.9. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R’ stereoisomer, makes up 25% of racemic labetalol. Labetalol HCl is a white or off-white crystalline powder, soluble in water. Labetalol Hydrochloride Tablets, USP for oral administration contain 100 mg, 200 mg, or 300 mg of labetalol HCl. Each tablet also contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, purified water, and titanium dioxide. Labetalol HCl Tablets, USP 100 mg also contain synthetic red iron oxide and synthetic yellow iron oxide. Labetalol HCl Tablets, USP 300 mg also contain FD & C blue No. 2 aluminum lake."
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"Description": "Labetalol hydrochloride (HCl) is an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol HCl is a racemate chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]benzamide monohydrochloride, and it has the following structure. Labetalol HCl has the empirical formula C19H24N2O3HCl and a molecular weight of 364.9. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R’ stereoisomer, makes up 25% of racemic labetalol. Labetalol HCl is a white or off-white crystalline powder, soluble in water. Labetalol Hydrochloride Tablets, USP for oral administration contain 100 mg, 200 mg, or 300 mg of labetalol HCl. Each tablet also contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, purified water, and titanium dioxide. Labetalol HCl Tablets, USP 100 mg also contain synthetic red iron oxide and synthetic yellow iron oxide. Labetalol HCl Tablets, USP 300 mg also contain FD & C blue No. 2 aluminum lake."
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"Description": "Labetalol hydrochloride tablets, USP are an adrenergic receptor blocking agent that has both selective alpha 1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride, USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl] benzamide monohydrochloride, and it has the following structure. Labetalol hydrochloride, USP has the molecular formula C 19H 24N 2O 3HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R’ stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride, USP is a white or off-white crystalline powder, soluble in water. Labetalol hydrochloride tablets, USP for oral administration, contain 100 mg, 200 mg or 300 mg labetalol hydrochloride, USP. In addition, each 100 mg tablet contains the following inactive ingredients: anhydrous lactose, carnauba wax, hypromellose, magnesium stearate,polyethylene glycol, polysorbate 80, pregelatinized starch (corn), red iron oxide, titanium dioxide and yellow iron oxide. In addition, each 200 mg tablet contains the following inactive ingredients: anhydrous lactose, carnauba wax, hypromellose, magnesium stearate, polydextrose, polyethylene glycol, pregelatinized starch (corn), titanium dioxide and triacetin. In addition, each 300 mg tablet contains the following inactive ingredients: anhydrous lactose, carnauba wax, FD&C Blue #2 aluminum lake, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, pregelatinized starch (corn) and titanium dioxide."
}
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<IndicationAndUsage>Symptomatic Trichomoniasis.Metronidazole tablets are indicated for the treatment of T. vaginalisinfection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis.Metronidazole tablets are indicated in the treatment of asymptomatic T. vaginalisinfection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners.T. vaginalisinfection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with metronidazole tablets in cases of reinfection. AmebiasisMetronidazole tablets are indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, Metronidazole tablet therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections.Metronidazole tablets are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole tablet therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole tablets. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroidesspecies including the B. fragilisgroup ( B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostridiumspecies, Eubacteriumspecies, Peptococcus species,and Peptostreptococcusspecies. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroidesspecies including the B. fragilisgroup, Clostridiumspecies, Peptococcus species, Peptostreptococcusspecies, and Fusobacteriumspecies. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroidesspecies including the B. fragilisgroup, Clostridiumspecies, Peptococcus species, Peptostreptococcusspecies, and Fusobacteriumspecies. BACTERIAL SEPTICEMIA caused by Bacteroidesspecies including the B. fragilisgroup and Clostridiumspecies. BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroidesspecies including the B. fragilisgroup. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroidesspecies including the B. fragilisgroup. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroidesspecies including the B. fragilisgroup. ENDOCARDITIS caused by Bacteroidesspecies including the B. fragilisgroup. To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets and other antibacterial drugs, metronidazole tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Metronidazole tablets, USP 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula. Metronidazole tablets USP contain 250 mg or 500 mg of metronidazole. Inactive ingredients include powdered cellulose, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, hypromellose, polyethylene glycol, stearic acid, and titanium dioxide.</Description>
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<IndicationAndUsage>Helps to temporarily prevent premature ejaculation.</IndicationAndUsage>
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<IndicationAndUsage>Labetalol hydrochloride tablets are indicated in the management of hypertension. Labetalol hydrochloride tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.</IndicationAndUsage>
<Description>Labetalol hydrochloride (HCl) is an adrenergic receptor blocking agent that has both selective alpha1- and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol HCl is a racemate chemically designated as 5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl) amino] ethyl] salicylamide monohydrochloride, and has the following structural formula. Labetalol HCl has the molecular formula C19H24N2O3HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R’ stereoisomer, makes up 25% of racemic labetalol. Labetalol HCl is a white or off-white crystalline powder, soluble in water. Labetalol Hydrochloride Tablets USP for oral administration contain 100 mg, 200 mg, or 300 mg labetalol HCl. Each tablet also contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, purified water, and titanium dioxide. Labetalol HCl Tablets 100 mg also contain synthetic red iron oxide and synthetic yellow iron oxide. Labetalol HCl Tablets 300 mg also contain FD & C blue No. 2 aluminum lake.</Description>
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<IndicationAndUsage>Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets, USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.</IndicationAndUsage>
<Description>Labetalol hydrochloride tablets, USP are adrenergic receptor blocking agents that have both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride (HCl) is a racemate chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl) amino] ethyl] benzamide monohydrochloride, and it has the following structure. Labetalol HCl has the molecular formula C19H24N2O3HCl and a molecular weight of 364.9. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R, R´stereoisomer, makes up 25% of racemic labetalol. Labetalol HCl is a white or off-white crystalline powder, soluble in water. Labetalol hydrochloride tablets contain 100, 200, or 300 mg of labetalol HCl and are taken orally. The tablets also contain the inactive ingredients lactose monohydrate, corn starch, crospovidone, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, polyethylene glycol, titanium dioxide and talc.</Description>
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<ApplicationNumber>ANDA200908</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets, USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.</IndicationAndUsage>
<Description>Labetalol hydrochloride tablets, USP are adrenergic receptor blocking agents that have both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride (HCl) is a racemate chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl) amino] ethyl] benzamide monohydrochloride, and it has the following structure. Labetalol HCl has the molecular formula C19H24N2O3HCl and a molecular weight of 364.9. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R, R´stereoisomer, makes up 25% of racemic labetalol. Labetalol HCl is a white or off-white crystalline powder, soluble in water. Labetalol hydrochloride tablets contain 100, 200, or 300 mg of labetalol HCl and are taken orally. The tablets also contain the inactive ingredients lactose monohydrate, corn starch, crospovidone, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, polyethylene glycol, titanium dioxide and talc.</Description>
</NDC>
<NDC>
<NDCCode>50090-1291-0</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-1291-0) </PackageDescription>
<NDC11Code>50090-1291-00</NDC11Code>
<ProductNDC>50090-1291</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hcl</ProprietaryName>
<NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200908</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets, USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.</IndicationAndUsage>
<Description>Labetalol hydrochloride tablets, USP are adrenergic receptor blocking agents that have both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance.Labetalol hydrochloride (HCl) is a racemate chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl) amino] ethyl] benzamide monohydrochloride, and it has the following structure. Labetalol HCl has the molecular formula C19H24N2O3HCl and a molecular weight of 364.9. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R, R´stereoisomer, makes up 25% of racemic labetalol.Labetalol HCl is a white or off-white crystalline powder, soluble in water.Labetalol hydrochloride tablets contain 100, 200, or 300 mg of labetalol HCl and are taken orally. The tablets also contain the inactive ingredients lactose monohydrate, corn starch, crospovidone, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, polyethylene glycol, titanium dioxide and talc.</Description>
</NDC>
<NDC>
<NDCCode>50090-3584-0</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (50090-3584-0) </PackageDescription>
<NDC11Code>50090-3584-00</NDC11Code>
<ProductNDC>50090-3584</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
<NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018716</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Labetalol Hydrochloride Tablets are indicated in the management of hypertension. Labetalol Hydrochloride Tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.</IndicationAndUsage>
<Description>Labetalol Hydrochloride Tablets are adrenergic receptor blocking agents that have both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride (HCl) is a racemate chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]benzamide monohydrochloride, and it has the following structure. Labetalol HCl has the empirical formula C19H24N2O3∙HCl and a molecular weight of 364.9. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R´ stereoisomer, makes up 25% of racemic labetalol. Labetalol HCl is a white or off-white crystalline powder, soluble in water. Labetalol Hydrochloride Tablets contain 100 mg, 200 mg, or 300 mg of labetalol HCl and are taken orally. The tablets also contain the inactive ingredients corn starch, FD&C Yellow No. 6 (100 mg- and 300mg tablets only), hydroxypropyl methylcellulose, lactose, magnesium stearate, pregelatinized corn starch, sodium benzoate (200-mg tablet only), talc (100-mg tablet only), and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>50090-4149-0</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (50090-4149-0) </PackageDescription>
<NDC11Code>50090-4149-00</NDC11Code>
<ProductNDC>50090-4149</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
<NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180301</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018716</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Labetalol Hydrochloride Tablets are indicated in the management of hypertension. Labetalol Hydrochloride Tablets may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.</IndicationAndUsage>
<Description>Labetalol Hydrochloride Tablets are adrenergic receptor blocking agents that have both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride (HCl) is a racemate chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]benzamide monohydrochloride, and it has the following structure. Labetalol HCl has the empirical formula C19H24N2O3∙HCl and a molecular weight of 364.9. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R´ stereoisomer, makes up 25% of racemic labetalol. Labetalol HCl is a white or off-white crystalline powder, soluble in water. Labetalol Hydrochloride Tablets contain 100 mg, 200 mg, or 300 mg of labetalol HCl and are taken orally. The tablets also contain the inactive ingredients corn starch, FD&C Yellow No. 6 (100-mg and 300-mg tablets only), hydroxypropyl methylcellulose, lactose, magnesium stearate, pregelatinized corn starch, sodium benzoate (200-mg tablet only), talc (100-mg tablet only), and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>50090-5064-0</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (50090-5064-0) </PackageDescription>
<NDC11Code>50090-5064-00</NDC11Code>
<ProductNDC>50090-5064</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bumetanide</ProprietaryName>
<NonProprietaryName>Bumetanide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151015</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA018225</ApplicationNumber>
<LabelerName>A-S Medication Solutions</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>Deprecated</Status>
<LastUpdate>2024-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200528</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 is a loop diuretic available as 0.5 mg (light green), 1 mg (yellow) and 2 mg (peach) tablets for oral administration; each tablet also contains anhydrous lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch and talc, with the following dye systems: 0.5 mg—D&C Yellow No. 10 aluminum lake and FD&C Blue No. 1 aluminum lake; 1 mg—D&C Yellow No. 10 aluminum lake; 2 mg—red iron oxide. 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.</Description>
</NDC>
<NDC>
<NDCCode>50090-5123-0</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (50090-5123-0) </PackageDescription>
<NDC11Code>50090-5123-00</NDC11Code>
<ProductNDC>50090-5123</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bumetanide</ProprietaryName>
<NonProprietaryName>Bumetanide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202900</ApplicationNumber>
<LabelerName>A-S Medication Solutions</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>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bumetanide tablets USP 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 USP following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.</IndicationAndUsage>
<Description>Bumetanide is a loop diuretic, available as scored tablets. 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.</Description>
</NDC>
<NDC>
<NDCCode>50090-5124-0</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (50090-5124-0) </PackageDescription>
<NDC11Code>50090-5124-00</NDC11Code>
<ProductNDC>50090-5124</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bumetanide</ProprietaryName>
<NonProprietaryName>Bumetanide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202900</ApplicationNumber>
<LabelerName>A-S Medication Solutions</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>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bumetanide tablets USP 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 USP following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.</IndicationAndUsage>
<Description>Bumetanide is a loop diuretic, available as scored tablets. 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.</Description>
</NDC>
<NDC>
<NDCCode>50090-5663-0</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (50090-5663-0) </PackageDescription>
<NDC11Code>50090-5663-00</NDC11Code>
<ProductNDC>50090-5663</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bumetanide</ProprietaryName>
<NonProprietaryName>Bumetanide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209724</ApplicationNumber>
<LabelerName>A-S Medication Solutions</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>2026-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210915</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 is a loop diuretic available as 0.5 mg, 1 mg and 2 mg tablets for oral administration; each tablet also contains the following inactive ingredients: anhydrous lactose, magnesium stearate, maize starch, microcrystalline cellulose, pregelatinized starch 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. C17H20N2O5S. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>50090-5664-0</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (50090-5664-0) </PackageDescription>
<NDC11Code>50090-5664-00</NDC11Code>
<ProductNDC>50090-5664</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bumetanide</ProprietaryName>
<NonProprietaryName>Bumetanide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209724</ApplicationNumber>
<LabelerName>A-S Medication Solutions</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>2026-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210915</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 is a loop diuretic available as 0.5 mg, 1 mg and 2 mg tablets for oral administration; each tablet also contains the following inactive ingredients: anhydrous lactose, magnesium stearate, maize starch, microcrystalline cellulose, pregelatinized starch 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. C17H20N2O5S. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>50090-5666-0</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (50090-5666-0) </PackageDescription>
<NDC11Code>50090-5666-00</NDC11Code>
<ProductNDC>50090-5666</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bumetanide</ProprietaryName>
<NonProprietaryName>Bumetanide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209724</ApplicationNumber>
<LabelerName>A-S Medication Solutions</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>2023-12-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210915</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 is a loop diuretic available as 0.5 mg, 1 mg and 2 mg tablets for oral administration; each tablet also contains the following inactive ingredients: anhydrous lactose, magnesium stearate, maize starch, microcrystalline cellulose, pregelatinized starch 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. C17H20N2O5S. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>50090-6137-0</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (50090-6137-0) </PackageDescription>
<NDC11Code>50090-6137-00</NDC11Code>
<ProductNDC>50090-6137</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bumetanide</ProprietaryName>
<NonProprietaryName>Bumetanide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202900</ApplicationNumber>
<LabelerName>A-S Medication Solutions</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>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221003</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bumetanide tablets USP 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 USP following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.</IndicationAndUsage>
<Description>Bumetanide is a loop diuretic, available as scored tablets. 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.</Description>
</NDC>
<NDC>
<NDCCode>50090-6139-0</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (50090-6139-0) </PackageDescription>
<NDC11Code>50090-6139-00</NDC11Code>
<ProductNDC>50090-6139</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bumetanide</ProprietaryName>
<NonProprietaryName>Bumetanide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202900</ApplicationNumber>
<LabelerName>A-S Medication Solutions</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>Deprecated</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<IndicationAndUsage>Bumetanide tablets USP 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 USP following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.</IndicationAndUsage>
<Description>Bumetanide is a loop diuretic, available as scored tablets. 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.</Description>
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<StrengthUnit>mg/1</StrengthUnit>
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<StartMarketingDatePackage>20221229</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bumetanide tablets, USP 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, USP following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.</IndicationAndUsage>
<Description>Bumetanide is a loop diuretic, available as scored tablets. Each tablet for oral administration contains 0.5 mg, 1 mg or 2 mg of bumetanide. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, corn starch, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), talc, with the following dye systems: 0.5 mg- D&C yellow No. 10 aluminum lake, FD&C blue No. 1 aluminum lake and FD&C red No. 40 aluminum lake; 1 mg- D&C yellow No. 10 aluminum lake; 2 mg- synthetic black iron oxide, synthetic red iron oxide and synthetic yellow iron oxide. 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.</Description>
</NDC>
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<LabelerName>A-S Medication Solutions</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
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<Status>Active</Status>
<LastUpdate>2023-01-07</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bumetanide tablets, USP 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, USP following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity.</IndicationAndUsage>
<Description>Bumetanide is a loop diuretic, available as scored tablets. Each tablet for oral administration contains 0.5 mg, 1 mg or 2 mg of bumetanide. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, corn starch, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), talc, with the following dye systems: 0.5 mg- D&C yellow No. 10 aluminum lake, FD&C blue No. 1 aluminum lake and FD&C red No. 40 aluminum lake; 1 mg- D&C yellow No. 10 aluminum lake; 2 mg- synthetic black iron oxide, synthetic red iron oxide and synthetic yellow iron oxide. 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.</Description>
</NDC>
<NDC>
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<NDC11Code>50090-6741-00</NDC11Code>
<ProductNDC>50090-6741</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
<NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210818</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211953</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Labetalol hydrochloride tablets USP are indicated in the management of hypertension. Labetalol hydrochloride tablets USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.</IndicationAndUsage>
<Description>Labetalol hydrochloride tablets, USP are an adrenergic receptor blocking agent that has both selective alpha 1 -adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride, USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl] benzamide monohydrochloride, and it has the following structure. Labetalol hydrochloride, USP has the molecular formula C 19H 24N 2O 3 HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride, USP is a white or off-white crystalline powder, soluble in water. Labetalol hydrochloride tablets, USP, for oral administration, contain 100 mg, 200 mg or 300 mg labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, maize starch, hypromellose (Methocel E5), sodium starch glycolate, magnesium stearate, titanium dioxide, polyethylene glycol, polysorbate 80, hypromellose (3 mPas) and hypromellose (6 mPas).</Description>
</NDC>
<NDC>
<NDCCode>50090-6774-0</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (50090-6774-0) </PackageDescription>
<NDC11Code>50090-6774-00</NDC11Code>
<ProductNDC>50090-6774</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
<NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210818</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211953</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231024</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Labetalol hydrochloride tablets USP are indicated in the management of hypertension. Labetalol hydrochloride tablets USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.</IndicationAndUsage>
<Description>Labetalol hydrochloride tablets, USP are an adrenergic receptor blocking agent that has both selective alpha 1 -adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride, USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl] benzamide monohydrochloride, and it has the following structure. Labetalol hydrochloride, USP has the molecular formula C 19H 24N 2O 3 HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R' stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride, USP is a white or off-white crystalline powder, soluble in water. Labetalol hydrochloride tablets, USP, for oral administration, contain 100 mg, 200 mg or 300 mg labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, maize starch, hypromellose (Methocel E5), sodium starch glycolate, magnesium stearate, titanium dioxide, polyethylene glycol, polysorbate 80, hypromellose (3 mPas) and hypromellose (6 mPas).</Description>
</NDC>
<NDC>
<NDCCode>50090-6777-0</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (50090-6777-0) </PackageDescription>
<NDC11Code>50090-6777-00</NDC11Code>
<ProductNDC>50090-6777</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
<NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980803</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075133</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231025</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets, USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.</IndicationAndUsage>
<Description>Labetalol hydrochloride (HCl) is an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol HCl is a racemate chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]benzamide monohydrochloride, and it has the following structure. Labetalol HCl has the empirical formula C19H24N2O3HCl and a molecular weight of 364.9. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R’ stereoisomer, makes up 25% of racemic labetalol. Labetalol HCl is a white or off-white crystalline powder, soluble in water. Labetalol Hydrochloride Tablets, USP for oral administration contain 100 mg, 200 mg, or 300 mg of labetalol HCl. Each tablet also contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, purified water, and titanium dioxide. Labetalol HCl Tablets, USP 100 mg also contain synthetic red iron oxide and synthetic yellow iron oxide. Labetalol HCl Tablets, USP 300 mg also contain FD & C blue No. 2 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>50090-6778-0</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (50090-6778-0) </PackageDescription>
<NDC11Code>50090-6778-00</NDC11Code>
<ProductNDC>50090-6778</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
<NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980803</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075133</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231025</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets, USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.</IndicationAndUsage>
<Description>Labetalol hydrochloride (HCl) is an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol HCl is a racemate chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]benzamide monohydrochloride, and it has the following structure. Labetalol HCl has the empirical formula C19H24N2O3HCl and a molecular weight of 364.9. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R’ stereoisomer, makes up 25% of racemic labetalol. Labetalol HCl is a white or off-white crystalline powder, soluble in water. Labetalol Hydrochloride Tablets, USP for oral administration contain 100 mg, 200 mg, or 300 mg of labetalol HCl. Each tablet also contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, purified water, and titanium dioxide. Labetalol HCl Tablets, USP 100 mg also contain synthetic red iron oxide and synthetic yellow iron oxide. Labetalol HCl Tablets, USP 300 mg also contain FD & C blue No. 2 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>50090-6785-0</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (50090-6785-0) </PackageDescription>
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<ProductNDC>50090-6785</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
<NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980803</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075133</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets, USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.</IndicationAndUsage>
<Description>Labetalol hydrochloride (HCl) is an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol HCl is a racemate chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]benzamide monohydrochloride, and it has the following structure. Labetalol HCl has the empirical formula C19H24N2O3HCl and a molecular weight of 364.9. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R’ stereoisomer, makes up 25% of racemic labetalol. Labetalol HCl is a white or off-white crystalline powder, soluble in water. Labetalol Hydrochloride Tablets, USP for oral administration contain 100 mg, 200 mg, or 300 mg of labetalol HCl. Each tablet also contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, purified water, and titanium dioxide. Labetalol HCl Tablets, USP 100 mg also contain synthetic red iron oxide and synthetic yellow iron oxide. Labetalol HCl Tablets, USP 300 mg also contain FD & C blue No. 2 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>50090-7001-0</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (50090-7001-0) </PackageDescription>
<NDC11Code>50090-7001-00</NDC11Code>
<ProductNDC>50090-7001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
<NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210208</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075215</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets, USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.</IndicationAndUsage>
<Description>Labetalol hydrochloride tablets, USP are an adrenergic receptor blocking agent that has both selective alpha 1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride, USP is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl] benzamide monohydrochloride, and it has the following structure. Labetalol hydrochloride, USP has the molecular formula C 19H 24N 2O 3HCl and a molecular weight of 364.87. It has two asymmetric centers and therefore exists as a molecular complex of two diastereoisomeric pairs. Dilevalol, the R,R’ stereoisomer, makes up 25% of racemic labetalol. Labetalol hydrochloride, USP is a white or off-white crystalline powder, soluble in water. Labetalol hydrochloride tablets, USP for oral administration, contain 100 mg, 200 mg or 300 mg labetalol hydrochloride, USP. In addition, each 100 mg tablet contains the following inactive ingredients: anhydrous lactose, carnauba wax, hypromellose, magnesium stearate,polyethylene glycol, polysorbate 80, pregelatinized starch (corn), red iron oxide, titanium dioxide and yellow iron oxide. In addition, each 200 mg tablet contains the following inactive ingredients: anhydrous lactose, carnauba wax, hypromellose, magnesium stearate, polydextrose, polyethylene glycol, pregelatinized starch (corn), titanium dioxide and triacetin. In addition, each 300 mg tablet contains the following inactive ingredients: anhydrous lactose, carnauba wax, FD&C Blue #2 aluminum lake, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, pregelatinized starch (corn) and titanium dioxide.</Description>
</NDC>
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