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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Protex",
"ProprietaryNameSuffix": "Deep Clean",
"NonProprietaryName": "Triclocarban",
"DosageFormName": "SOAP",
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"LabelerName": "Colgate-Palmolive Company",
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},
{
"NDCCode": "35000-168-87",
"PackageDescription": "1 TUBE in 1 CARTON (35000-168-87) > 164 g in 1 TUBE",
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"ProductNDC": "35000-168",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Colgate Total Daily Repair",
"NonProprietaryName": "Sodium Fluoride And Triclosan",
"DosageFormName": "PASTE, DENTIFRICE",
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"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020231",
"LabelerName": "Colgate-Palmolive Company",
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"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N"
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{
"NDCCode": "35000-899-58",
"PackageDescription": "1 TUBE in 1 CARTON (35000-899-58) / 70.87 g in 1 TUBE",
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Colgate Max Fresh",
"ProprietaryNameSuffix": "Advanced Whitening",
"NonProprietaryName": "Sodium Fluoride",
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"RouteName": "DENTAL",
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"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "SODIUM FLUORIDE",
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"Status": "Deprecated",
"LastUpdate": "2025-11-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "helps protect against cavities."
},
{
"NDCCode": "35000-364-16",
"PackageDescription": "1 TUBE in 1 CARTON (35000-364-16) > 21 g in 1 TUBE",
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"ProductNDC": "35000-364",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Colgate",
"ProprietaryNameSuffix": "Total Advance Whitening",
"NonProprietaryName": "Sodium Fluoride And Triclosan",
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"StartMarketingDate": "20080809",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020231",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "SODIUM FLUORIDE; TRICLOSAN",
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"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20100121",
"EndMarketingDatePackage": "20220101",
"SamplePackage": "N"
},
{
"NDCCode": "35000-364-48",
"PackageDescription": "1 TUBE in 1 CARTON (35000-364-48) > 226 g in 1 TUBE",
"NDC11Code": "35000-0364-48",
"ProductNDC": "35000-364",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Colgate",
"ProprietaryNameSuffix": "Total Advance Whitening",
"NonProprietaryName": "Sodium Fluoride And Triclosan",
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"ApplicationNumber": "NDA020231",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "SODIUM FLUORIDE; TRICLOSAN",
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"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N"
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{
"NDCCode": "35000-364-66",
"PackageDescription": "1 TUBE in 1 CARTON (35000-364-66) > 164 g in 1 TUBE",
"NDC11Code": "35000-0364-66",
"ProductNDC": "35000-364",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Colgate",
"ProprietaryNameSuffix": "Total Advance Whitening",
"NonProprietaryName": "Sodium Fluoride And Triclosan",
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"RouteName": "DENTAL",
"StartMarketingDate": "20080809",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020231",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "SODIUM FLUORIDE; TRICLOSAN",
"StrengthNumber": "1.5; 3",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20101213",
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"SamplePackage": "N"
},
{
"NDCCode": "35000-364-67",
"PackageDescription": "1 TUBE in 1 CARTON (35000-364-67) > 215 g in 1 TUBE",
"NDC11Code": "35000-0364-67",
"ProductNDC": "35000-364",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Colgate",
"ProprietaryNameSuffix": "Total Advance Whitening",
"NonProprietaryName": "Sodium Fluoride And Triclosan",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20080809",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020231",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "SODIUM FLUORIDE; TRICLOSAN",
"StrengthNumber": "1.5; 3",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20130722",
"EndMarketingDatePackage": "20220101",
"SamplePackage": "N"
},
{
"NDCCode": "35000-364-69",
"PackageDescription": "1 TUBE in 1 CARTON (35000-364-69) > 113 g in 1 TUBE",
"NDC11Code": "35000-0364-69",
"ProductNDC": "35000-364",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Colgate",
"ProprietaryNameSuffix": "Total Advance Whitening",
"NonProprietaryName": "Sodium Fluoride And Triclosan",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20080809",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020231",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "SODIUM FLUORIDE; TRICLOSAN",
"StrengthNumber": "1.5; 3",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20101004",
"EndMarketingDatePackage": "20220101",
"SamplePackage": "N"
},
{
"NDCCode": "0143-9183-10",
"PackageDescription": "10 VIAL in 1 CARTON (0143-9183-10) / 4 mL in 1 VIAL (0143-9183-01) ",
"NDC11Code": "00143-9183-10",
"ProductNDC": "0143-9183",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hydrochloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250828",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213330",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250828",
"SamplePackage": "N",
"IndicationAndUsage": "Labetalol HCl Injection is indicated in severe hypertension, to lower blood pressure.",
"Description": "Labetalol HCl in Sodium Chloride Injection, Labetalol HCl in Dextrose Injection and Labetalol Hydrochloride Injection, USP contain labetalol HCl an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions. Labetalol hydrochloride (HCl) is a racemate chemically designated as 5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]-salicylamide monohydrochloride and it has the following structural formula. Labetalol HCl is a white or off-white crystalline powder, soluble in water. 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. Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are two preservative-free, ready- to use formulations of labetalol. Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are clear, colorless to pale yellow, aqueous, sterile, isotonic solution for intravenous injection. Each milliliter of Labetalol HCl in Sodium Chloride Injection contains 1 mg of labetalol HCl, 7.2 mg sodium chloride, 9 mg of anhydrous dextrose, 0.02 mg of edetate disodium; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.5 to 4.5. Each milliliter of Labetalol HCl in Dextrose Injection contains 1 mg of labetalol HCl, 45 mg of anhydrous dextrose, 0.02 mg of edetate disodium; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.5 to 4.5. Labetalol Hydrochloride Injection prefilled syringe and vial are two preservative-free, ready-to use formulations of labetalol. Labetalol Hydrochloride Injection is a clear, colorless to pale yellow, aqueous, sterile, isotonic solution for intravenous injection. Each milliliter of Labetalol Hydrochloride Injection, USP, contains 5 mg of labetalol HCI, 45 mg of anhydrous dextrose, 0.1 mg of edetate disodium, and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.0 to 4.5."
},
{
"NDCCode": "0143-9320-01",
"PackageDescription": "1 VIAL in 1 BOX, UNIT-DOSE (0143-9320-01) / 20 mL in 1 VIAL",
"NDC11Code": "00143-9320-01",
"ProductNDC": "0143-9320",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hydrochloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19991129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075303",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-09-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19991129",
"SamplePackage": "N",
"IndicationAndUsage": "Labetalol HCl Injection, USP is indicated for control of blood pressure in severe hypertension.",
"Description": "Labetalol Hydrochloride Injection, USP is an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride (HCl) is a racemate chemically designated as 5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]-salicylamide monohydrochloride and it 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 HCl Injection, USP is a clear, colorless to light yellow, aqueous, sterile, isotonic solution for intravenous injection. It has a pH range of 3 to 4. Each milliliter contains 5 mg of labetalol HCl, 45 mg of anhydrous dextrose, 0.1 mg of edetate disodium; 0.8 mg of methylparaben and 0.1 mg of propylparaben as preservatives; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range."
},
{
"NDCCode": "0143-9363-10",
"PackageDescription": "10 BAG in 1 BOX (0143-9363-10) / 100 mL in 1 BAG (0143-9363-01) ",
"NDC11Code": "00143-9363-10",
"ProductNDC": "0143-9363",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hcl In Sodium Chloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20201109",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213330",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201109",
"SamplePackage": "N",
"IndicationAndUsage": "Labetalol HCl Injection is indicated in severe hypertension, to lower blood pressure.",
"Description": "Labetalol HCl in Sodium Chloride Injection, Labetalol HCl in Dextrose Injection and Labetalol Hydrochloride Injection, USP contain labetalol HCl an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions. Labetalol hydrochloride (HCl) is a racemate chemically designated as 5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]-salicylamide monohydrochloride and it has the following structural formula. Labetalol HCl is a white or off-white crystalline powder, soluble in water. 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. Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are two preservative-free, ready- to use formulations of labetalol. Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are clear, colorless to pale yellow, aqueous, sterile, isotonic solution for intravenous injection. Each milliliter of Labetalol HCl in Sodium Chloride Injection contains 1 mg of labetalol HCl, 7.2 mg sodium chloride, 9 mg of anhydrous dextrose, 0.02 mg of edetate disodium; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.5 to 4.5. Each milliliter of Labetalol HCl in Dextrose Injection contains 1 mg of labetalol HCl, 45 mg of anhydrous dextrose, 0.02 mg of edetate disodium; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.5 to 4.5. Labetalol Hydrochloride Injection prefilled syringe and vial are two preservative-free, ready-to use formulations of labetalol. Labetalol Hydrochloride Injection is a clear, colorless to pale yellow, aqueous, sterile, isotonic solution for intravenous injection. Each milliliter of Labetalol Hydrochloride Injection, USP, contains 5 mg of labetalol HCI, 45 mg of anhydrous dextrose, 0.1 mg of edetate disodium, and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.0 to 4.5."
},
{
"NDCCode": "0143-9364-10",
"PackageDescription": "10 BAG in 1 BOX (0143-9364-10) / 200 mL in 1 BAG (0143-9364-01) ",
"NDC11Code": "00143-9364-10",
"ProductNDC": "0143-9364",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hcl In Sodium Chloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20201109",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213330",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201109",
"SamplePackage": "N",
"IndicationAndUsage": "Labetalol HCl Injection is indicated in severe hypertension, to lower blood pressure.",
"Description": "Labetalol HCl in Sodium Chloride Injection, Labetalol HCl in Dextrose Injection and Labetalol Hydrochloride Injection, USP contain labetalol HCl an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions. Labetalol hydrochloride (HCl) is a racemate chemically designated as 5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]-salicylamide monohydrochloride and it has the following structural formula. Labetalol HCl is a white or off-white crystalline powder, soluble in water. 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. Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are two preservative-free, ready- to use formulations of labetalol. Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are clear, colorless to pale yellow, aqueous, sterile, isotonic solution for intravenous injection. Each milliliter of Labetalol HCl in Sodium Chloride Injection contains 1 mg of labetalol HCl, 7.2 mg sodium chloride, 9 mg of anhydrous dextrose, 0.02 mg of edetate disodium; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.5 to 4.5. Each milliliter of Labetalol HCl in Dextrose Injection contains 1 mg of labetalol HCl, 45 mg of anhydrous dextrose, 0.02 mg of edetate disodium; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.5 to 4.5. Labetalol Hydrochloride Injection prefilled syringe and vial are two preservative-free, ready-to use formulations of labetalol. Labetalol Hydrochloride Injection is a clear, colorless to pale yellow, aqueous, sterile, isotonic solution for intravenous injection. Each milliliter of Labetalol Hydrochloride Injection, USP, contains 5 mg of labetalol HCI, 45 mg of anhydrous dextrose, 0.1 mg of edetate disodium, and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.0 to 4.5."
},
{
"NDCCode": "0143-9365-10",
"PackageDescription": "10 BAG in 1 BOX (0143-9365-10) / 300 mL in 1 BAG (0143-9365-01) ",
"NDC11Code": "00143-9365-10",
"ProductNDC": "0143-9365",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hcl In Sodium Chloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20201109",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213330",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201109",
"SamplePackage": "N",
"IndicationAndUsage": "Labetalol HCl Injection is indicated in severe hypertension, to lower blood pressure.",
"Description": "Labetalol HCl in Sodium Chloride Injection, Labetalol HCl in Dextrose Injection and Labetalol Hydrochloride Injection, USP contain labetalol HCl an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions. Labetalol hydrochloride (HCl) is a racemate chemically designated as 5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]-salicylamide monohydrochloride and it has the following structural formula. Labetalol HCl is a white or off-white crystalline powder, soluble in water. 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. Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are two preservative-free, ready- to use formulations of labetalol. Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are clear, colorless to pale yellow, aqueous, sterile, isotonic solution for intravenous injection. Each milliliter of Labetalol HCl in Sodium Chloride Injection contains 1 mg of labetalol HCl, 7.2 mg sodium chloride, 9 mg of anhydrous dextrose, 0.02 mg of edetate disodium; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.5 to 4.5. Each milliliter of Labetalol HCl in Dextrose Injection contains 1 mg of labetalol HCl, 45 mg of anhydrous dextrose, 0.02 mg of edetate disodium; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.5 to 4.5. Labetalol Hydrochloride Injection prefilled syringe and vial are two preservative-free, ready-to use formulations of labetalol. Labetalol Hydrochloride Injection is a clear, colorless to pale yellow, aqueous, sterile, isotonic solution for intravenous injection. Each milliliter of Labetalol Hydrochloride Injection, USP, contains 5 mg of labetalol HCI, 45 mg of anhydrous dextrose, 0.1 mg of edetate disodium, and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.0 to 4.5."
},
{
"NDCCode": "0143-9366-10",
"PackageDescription": "10 BAG in 1 BOX (0143-9366-10) / 200 mL in 1 BAG (0143-9366-01) ",
"NDC11Code": "00143-9366-10",
"ProductNDC": "0143-9366",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hcl In Dextrose",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "INJECTION",
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"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "Labetalol HCl Injection is indicated in severe hypertension, to lower blood pressure.",
"Description": "Labetalol HCl in Sodium Chloride Injection, Labetalol HCl in Dextrose Injection and Labetalol Hydrochloride Injection, USP contain labetalol HCl an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions. Labetalol hydrochloride (HCl) is a racemate chemically designated as 5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]-salicylamide monohydrochloride and it has the following structural formula. Labetalol HCl is a white or off-white crystalline powder, soluble in water. 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. Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are two preservative-free, ready- to use formulations of labetalol. Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are clear, colorless to pale yellow, aqueous, sterile, isotonic solution for intravenous injection. Each milliliter of Labetalol HCl in Sodium Chloride Injection contains 1 mg of labetalol HCl, 7.2 mg sodium chloride, 9 mg of anhydrous dextrose, 0.02 mg of edetate disodium; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.5 to 4.5. Each milliliter of Labetalol HCl in Dextrose Injection contains 1 mg of labetalol HCl, 45 mg of anhydrous dextrose, 0.02 mg of edetate disodium; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.5 to 4.5. Labetalol Hydrochloride Injection prefilled syringe and vial are two preservative-free, ready-to use formulations of labetalol. Labetalol Hydrochloride Injection is a clear, colorless to pale yellow, aqueous, sterile, isotonic solution for intravenous injection. Each milliliter of Labetalol Hydrochloride Injection, USP, contains 5 mg of labetalol HCI, 45 mg of anhydrous dextrose, 0.1 mg of edetate disodium, and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.0 to 4.5."
},
{
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"ProductNDC": "0143-9622",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hydrochloride",
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"ApplicationNumber": "ANDA075303",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Labetalol HCl Injection, USP is indicated for control of blood pressure in severe hypertension.",
"Description": "Labetalol Hydrochloride Injection, USP is an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride (HCl) is a racemate chemically designated as 5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]-salicylamide monohydrochloride and it 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 HCl Injection, USP is a clear, colorless to light yellow, aqueous, sterile, isotonic solution for intravenous injection. It has a pH range of 3 to 4. Each milliliter contains 5 mg of labetalol HCl, 45 mg of anhydrous dextrose, 0.1 mg of edetate disodium; 0.8 mg of methylparaben and 0.1 mg of propylparaben as preservatives; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range."
},
{
"NDCCode": "0143-9623-01",
"PackageDescription": "1 VIAL in 1 BOX, UNIT-DOSE (0143-9623-01) / 40 mL in 1 VIAL",
"NDC11Code": "00143-9623-01",
"ProductNDC": "0143-9623",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hydrochloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19991129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075303",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-07-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "19991129",
"SamplePackage": "N",
"IndicationAndUsage": "Labetalol HCl Injection, USP is indicated for control of blood pressure in severe hypertension.",
"Description": "Labetalol Hydrochloride Injection, USP is an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride (HCl) is a racemate chemically designated as 5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]-salicylamide monohydrochloride and it 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 HCl Injection, USP is a clear, colorless to light yellow, aqueous, sterile, isotonic solution for intravenous injection. It has a pH range of 3 to 4. Each milliliter contains 5 mg of labetalol HCl, 45 mg of anhydrous dextrose, 0.1 mg of edetate disodium; 0.8 mg of methylparaben and 0.1 mg of propylparaben as preservatives; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range."
},
{
"NDCCode": "0409-0125-25",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 TRAY (0409-0125-25) / 20 mL in 1 VIAL, MULTI-DOSE (0409-0125-01) ",
"NDC11Code": "00409-0125-25",
"ProductNDC": "0409-0125",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hydrochloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230807",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075240",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-24",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Labetalol HCl injection is indicated for control of blood pressure in severe hypertension.",
"Description": "Labetalol hydrochloride 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 hydrochloride has the molecular formula C19H24N2O3 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 is a white or off-white crystalline powder, soluble in water. Labetalol hydrochloride injection is a clear, colorless to light yellow aqueous sterile isotonic solution for intravenous injection. It has a pH range of 3.0 to 4.5. Each mL contains 5 mg labetalol hydrochloride, USP, 45 mg anhydrous dextrose, 0.1 mg edetate disodium; 0.8 mg methylparaben and 0.1 mg propylparaben as preservatives; citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range."
},
{
"NDCCode": "0409-2267-20",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0409-2267-20) / 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00409-2267-20",
"ProductNDC": "0409-2267",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hydrochloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20051230",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075240",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20060201",
"SamplePackage": "N",
"IndicationAndUsage": "Labetalol HCl injection is indicated for control of blood pressure in severe hypertension.",
"Description": "Labetalol hydrochloride 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 hydrochloride has the molecular formula C19H24N2O3 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 is a white or off-white crystalline powder, soluble in water. Labetalol hydrochloride injection is a clear, colorless to light yellow aqueous sterile isotonic solution for intravenous injection. It has a pH range of 3.0 to 4.5. Each mL contains 5 mg labetalol hydrochloride, USP, 45 mg anhydrous dextrose, 0.1 mg edetate disodium; 0.8 mg methylparaben and 0.1 mg propylparaben as preservatives; citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range."
},
{
"NDCCode": "0409-2267-54",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0409-2267-54) / 40 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00409-2267-54",
"ProductNDC": "0409-2267",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hydrochloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20051230",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075240",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "Labetalol HCl injection is indicated for control of blood pressure in severe hypertension.",
"Description": "Labetalol hydrochloride 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 hydrochloride has the molecular formula C19H24N2O3 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 is a white or off-white crystalline powder, soluble in water. Labetalol hydrochloride injection is a clear, colorless to light yellow aqueous sterile isotonic solution for intravenous injection. It has a pH range of 3.0 to 4.5. Each mL contains 5 mg labetalol hydrochloride, USP, 45 mg anhydrous dextrose, 0.1 mg edetate disodium; 0.8 mg methylparaben and 0.1 mg propylparaben as preservatives; citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range."
},
{
"NDCCode": "0409-2339-34",
"PackageDescription": "10 CARTON in 1 PACKAGE (0409-2339-34) > 1 CARTRIDGE in 1 CARTON > 4 mL in 1 CARTRIDGE (0409-2339-24) ",
"NDC11Code": "00409-2339-34",
"ProductNDC": "0409-2339",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hydrochloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20051018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075239",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2021-06-02",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "Labetalol HCl injection is indicated for control of blood pressure in severe hypertension.",
"Description": "Labetalol hydrochloride 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 hydrochloride has the molecular formula C19H24N2O3 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 is a white or off-white crystalline powder, soluble in water. Labetalol hydrochloride injection is a clear, colorless to light yellow aqueous sterile isotonic solution for intravenous injection. It has a pH range of 3.0 to 4.5. Each mL contains 5 mg labetalol hydrochloride, USP, 45 mg anhydrous dextrose, 0.1 mg edetate disodium; 0.8 mg methylparaben and 0.1 mg propylparaben as preservatives; citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range."
},
{
"NDCCode": "0641-6252-10",
"PackageDescription": "10 SYRINGE, GLASS in 1 CARTON (0641-6252-10) / 2 mL in 1 SYRINGE, GLASS",
"NDC11Code": "00641-6252-10",
"ProductNDC": "0641-6252",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hydrochloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220318",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA213330",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20220318",
"SamplePackage": "N",
"IndicationAndUsage": "Labetalol HCl Injection is indicated in severe hypertension, to lower blood pressure.",
"Description": "Labetalol HCl in Sodium Chloride Injection, Labetalol HCl in Dextrose Injection and Labetalol Hydrochloride Injection, USP contain labetalol HCl an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride (HCl) is a racemate chemically designated as 5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]-salicylamide monohydrochloride and it has the following structural formula. Labetalol HCl is a white or off-white crystalline powder, soluble in water. 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. Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are two preservative-free, ready-to use formulations of labetalol.Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are clear, colorless to light yellow, aqueous, sterile, isotonic solution for intravenous injection. Each milliliter of Labetalol HCl in Sodium Chloride Injection contains 1 mg of labetalol HCl, 7.2 mg sodium chloride, 9 mg of anhydrous dextrose, 0.02 mg of edetate disodium; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.5 to 4.5. Each milliliter of Labetalol HCl in Dextrose Injection contains 1 mg of labetalol HCl, 45 mg of anhydrous dextrose, 0.02 mg of edetate disodium; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.5 to 4.5. Labetalol Hydrochloride Injection in a prefilled syringe is a preservative-free, ready-to use formulation of labetalol.Labetalol Hydrochloride Injection is a clear, colorless to light yellow, aqueous, sterile, isotonic solution for intravenous injection. Each milliliter of the Labetalol Hydrochloride Injection, USP 2 mL prefilled syringe contains labetalol hydrochloride 5 mg; anhydrous dextrose 45 mg; edetate disodium 0.1 mg; citric acid monohydrate and sodium hydroxide as necessary to bring the pH into a range of 3.0 to 4.5."
},
{
"NDCCode": "0904-7109-61",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0904-7109-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00904-7109-61",
"ProductNDC": "0904-7109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hydrochloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171205",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207743",
"LabelerName": "Major Pharmaceuticals",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20171205",
"EndMarketingDatePackage": "20241231",
"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 Alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl- 3-phenylpropyl)amino]ethyl]benzamide mono hydrochloride and it has the following structure. Labetalol hydrochloride has the molecular formula C19 H24 N2 O3 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 almost white powder. It is sparingly soluble in water and in ethanol (96%), practically insoluble in ether and in methylene chloride. Labetalol hydrochloride tablet, USP for oral administration contain 100 mg, 200 mg or 300 mg labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sodium starch glycolate (botanical source: potato) and titanium dioxide. Additionally, 100 mg tablets contain D&C yellow #10 Aluminum lake, iron oxide yellow, iron oxide red and talc. 300 mg tablets contain FD&C blue #1 Aluminum lake, iron oxide yellow and talc."
},
{
"NDCCode": "0904-7110-61",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0904-7110-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00904-7110-61",
"ProductNDC": "0904-7110",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hydrochloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171205",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207743",
"LabelerName": "Major Pharmaceuticals",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20171205",
"EndMarketingDatePackage": "20241231",
"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 Alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl- 3-phenylpropyl)amino]ethyl]benzamide mono hydrochloride and it has the following structure. Labetalol hydrochloride has the molecular formula C19 H24 N2 O3 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 almost white powder. It is sparingly soluble in water and in ethanol (96%), practically insoluble in ether and in methylene chloride. Labetalol hydrochloride tablet, USP for oral administration contain 100 mg, 200 mg or 300 mg labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sodium starch glycolate (botanical source: potato) and titanium dioxide. Additionally, 100 mg tablets contain D&C yellow #10 Aluminum lake, iron oxide yellow, iron oxide red and talc. 300 mg tablets contain FD&C blue #1 Aluminum lake, iron oxide yellow and talc."
},
{
"NDCCode": "0904-7111-61",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0904-7111-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00904-7111-61",
"ProductNDC": "0904-7111",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hydrochloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171205",
"EndMarketingDate": "20241130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207743",
"LabelerName": "Major Pharmaceuticals",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20171205",
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"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 Alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl- 3-phenylpropyl)amino]ethyl]benzamide mono hydrochloride and it has the following structure. Labetalol hydrochloride has the molecular formula C19 H24 N2 O3 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 almost white powder. It is sparingly soluble in water and in ethanol (96%), practically insoluble in ether and in methylene chloride. Labetalol hydrochloride tablet, USP for oral administration contain 100 mg, 200 mg or 300 mg labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sodium starch glycolate (botanical source: potato) and titanium dioxide. Additionally, 100 mg tablets contain D&C yellow #10 Aluminum lake, iron oxide yellow, iron oxide red and talc. 300 mg tablets contain FD&C blue #1 Aluminum lake, iron oxide yellow and talc."
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{
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"LabelerName": "Marlex Pharmaceuticals Inc",
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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, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, pregelatinized starch (corn), titanium dioxide."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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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 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, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, pregelatinized starch (corn), titanium dioxide."
},
{
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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, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, pregelatinized starch (corn), titanium dioxide."
},
{
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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 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, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, pregelatinized starch (corn), titanium dioxide."
},
{
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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, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, pregelatinized starch (corn), titanium dioxide."
}
]
}
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<Description>Labetalol HCl in Sodium Chloride Injection, Labetalol HCl in Dextrose Injection and Labetalol Hydrochloride Injection, USP contain labetalol HCl an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions. Labetalol hydrochloride (HCl) is a racemate chemically designated as 5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]-salicylamide monohydrochloride and it has the following structural formula. Labetalol HCl is a white or off-white crystalline powder, soluble in water. 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. Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are two preservative-free, ready- to use formulations of labetalol. Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are clear, colorless to pale yellow, aqueous, sterile, isotonic solution for intravenous injection. Each milliliter of Labetalol HCl in Sodium Chloride Injection contains 1 mg of labetalol HCl, 7.2 mg sodium chloride, 9 mg of anhydrous dextrose, 0.02 mg of edetate disodium; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.5 to 4.5. Each milliliter of Labetalol HCl in Dextrose Injection contains 1 mg of labetalol HCl, 45 mg of anhydrous dextrose, 0.02 mg of edetate disodium; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.5 to 4.5. Labetalol Hydrochloride Injection prefilled syringe and vial are two preservative-free, ready-to use formulations of labetalol. Labetalol Hydrochloride Injection is a clear, colorless to pale yellow, aqueous, sterile, isotonic solution for intravenous injection. Each milliliter of Labetalol Hydrochloride Injection, USP, contains 5 mg of labetalol HCI, 45 mg of anhydrous dextrose, 0.1 mg of edetate disodium, and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.0 to 4.5.</Description>
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<IndicationAndUsage>Labetalol HCl Injection, USP is indicated for control of blood pressure in severe hypertension.</IndicationAndUsage>
<Description>Labetalol Hydrochloride Injection, USP is an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride (HCl) is a racemate chemically designated as 5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]-salicylamide monohydrochloride and it 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 HCl Injection, USP is a clear, colorless to light yellow, aqueous, sterile, isotonic solution for intravenous injection. It has a pH range of 3 to 4. Each milliliter contains 5 mg of labetalol HCl, 45 mg of anhydrous dextrose, 0.1 mg of edetate disodium; 0.8 mg of methylparaben and 0.1 mg of propylparaben as preservatives; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range.</Description>
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<Description>Labetalol HCl in Sodium Chloride Injection, Labetalol HCl in Dextrose Injection and Labetalol Hydrochloride Injection, USP contain labetalol HCl an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions. Labetalol hydrochloride (HCl) is a racemate chemically designated as 5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]-salicylamide monohydrochloride and it has the following structural formula. Labetalol HCl is a white or off-white crystalline powder, soluble in water. 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. Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are two preservative-free, ready- to use formulations of labetalol. Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are clear, colorless to pale yellow, aqueous, sterile, isotonic solution for intravenous injection. Each milliliter of Labetalol HCl in Sodium Chloride Injection contains 1 mg of labetalol HCl, 7.2 mg sodium chloride, 9 mg of anhydrous dextrose, 0.02 mg of edetate disodium; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.5 to 4.5. Each milliliter of Labetalol HCl in Dextrose Injection contains 1 mg of labetalol HCl, 45 mg of anhydrous dextrose, 0.02 mg of edetate disodium; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.5 to 4.5. Labetalol Hydrochloride Injection prefilled syringe and vial are two preservative-free, ready-to use formulations of labetalol. Labetalol Hydrochloride Injection is a clear, colorless to pale yellow, aqueous, sterile, isotonic solution for intravenous injection. Each milliliter of Labetalol Hydrochloride Injection, USP, contains 5 mg of labetalol HCI, 45 mg of anhydrous dextrose, 0.1 mg of edetate disodium, and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.0 to 4.5.</Description>
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<Description>Labetalol HCl in Sodium Chloride Injection, Labetalol HCl in Dextrose Injection and Labetalol Hydrochloride Injection, USP contain labetalol HCl an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions. Labetalol hydrochloride (HCl) is a racemate chemically designated as 5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]-salicylamide monohydrochloride and it has the following structural formula. Labetalol HCl is a white or off-white crystalline powder, soluble in water. 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. Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are two preservative-free, ready- to use formulations of labetalol. Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are clear, colorless to pale yellow, aqueous, sterile, isotonic solution for intravenous injection. Each milliliter of Labetalol HCl in Sodium Chloride Injection contains 1 mg of labetalol HCl, 7.2 mg sodium chloride, 9 mg of anhydrous dextrose, 0.02 mg of edetate disodium; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.5 to 4.5. Each milliliter of Labetalol HCl in Dextrose Injection contains 1 mg of labetalol HCl, 45 mg of anhydrous dextrose, 0.02 mg of edetate disodium; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.5 to 4.5. Labetalol Hydrochloride Injection prefilled syringe and vial are two preservative-free, ready-to use formulations of labetalol. Labetalol Hydrochloride Injection is a clear, colorless to pale yellow, aqueous, sterile, isotonic solution for intravenous injection. Each milliliter of Labetalol Hydrochloride Injection, USP, contains 5 mg of labetalol HCI, 45 mg of anhydrous dextrose, 0.1 mg of edetate disodium, and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.0 to 4.5.</Description>
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<Description>Labetalol HCl in Sodium Chloride Injection, Labetalol HCl in Dextrose Injection and Labetalol Hydrochloride Injection, USP contain labetalol HCl an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions. Labetalol hydrochloride (HCl) is a racemate chemically designated as 5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]-salicylamide monohydrochloride and it has the following structural formula. Labetalol HCl is a white or off-white crystalline powder, soluble in water. 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. Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are two preservative-free, ready- to use formulations of labetalol. Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are clear, colorless to pale yellow, aqueous, sterile, isotonic solution for intravenous injection. Each milliliter of Labetalol HCl in Sodium Chloride Injection contains 1 mg of labetalol HCl, 7.2 mg sodium chloride, 9 mg of anhydrous dextrose, 0.02 mg of edetate disodium; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.5 to 4.5. Each milliliter of Labetalol HCl in Dextrose Injection contains 1 mg of labetalol HCl, 45 mg of anhydrous dextrose, 0.02 mg of edetate disodium; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.5 to 4.5. Labetalol Hydrochloride Injection prefilled syringe and vial are two preservative-free, ready-to use formulations of labetalol. Labetalol Hydrochloride Injection is a clear, colorless to pale yellow, aqueous, sterile, isotonic solution for intravenous injection. Each milliliter of Labetalol Hydrochloride Injection, USP, contains 5 mg of labetalol HCI, 45 mg of anhydrous dextrose, 0.1 mg of edetate disodium, and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.0 to 4.5.</Description>
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<Description>Labetalol HCl in Sodium Chloride Injection, Labetalol HCl in Dextrose Injection and Labetalol Hydrochloride Injection, USP contain labetalol HCl an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions. Labetalol hydrochloride (HCl) is a racemate chemically designated as 5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]-salicylamide monohydrochloride and it has the following structural formula. Labetalol HCl is a white or off-white crystalline powder, soluble in water. 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. Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are two preservative-free, ready- to use formulations of labetalol. Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are clear, colorless to pale yellow, aqueous, sterile, isotonic solution for intravenous injection. Each milliliter of Labetalol HCl in Sodium Chloride Injection contains 1 mg of labetalol HCl, 7.2 mg sodium chloride, 9 mg of anhydrous dextrose, 0.02 mg of edetate disodium; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.5 to 4.5. Each milliliter of Labetalol HCl in Dextrose Injection contains 1 mg of labetalol HCl, 45 mg of anhydrous dextrose, 0.02 mg of edetate disodium; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.5 to 4.5. Labetalol Hydrochloride Injection prefilled syringe and vial are two preservative-free, ready-to use formulations of labetalol. Labetalol Hydrochloride Injection is a clear, colorless to pale yellow, aqueous, sterile, isotonic solution for intravenous injection. Each milliliter of Labetalol Hydrochloride Injection, USP, contains 5 mg of labetalol HCI, 45 mg of anhydrous dextrose, 0.1 mg of edetate disodium, and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.0 to 4.5.</Description>
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<IndicationAndUsage>Labetalol HCl Injection, USP is indicated for control of blood pressure in severe hypertension.</IndicationAndUsage>
<Description>Labetalol Hydrochloride Injection, USP is an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride (HCl) is a racemate chemically designated as 5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]-salicylamide monohydrochloride and it 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 HCl Injection, USP is a clear, colorless to light yellow, aqueous, sterile, isotonic solution for intravenous injection. It has a pH range of 3 to 4. Each milliliter contains 5 mg of labetalol HCl, 45 mg of anhydrous dextrose, 0.1 mg of edetate disodium; 0.8 mg of methylparaben and 0.1 mg of propylparaben as preservatives; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range.</Description>
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<IndicationAndUsage>Labetalol HCl Injection, USP is indicated for control of blood pressure in severe hypertension.</IndicationAndUsage>
<Description>Labetalol Hydrochloride Injection, USP is an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride (HCl) is a racemate chemically designated as 5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]-salicylamide monohydrochloride and it 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 HCl Injection, USP is a clear, colorless to light yellow, aqueous, sterile, isotonic solution for intravenous injection. It has a pH range of 3 to 4. Each milliliter contains 5 mg of labetalol HCl, 45 mg of anhydrous dextrose, 0.1 mg of edetate disodium; 0.8 mg of methylparaben and 0.1 mg of propylparaben as preservatives; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range.</Description>
</NDC>
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<PackageDescription>25 VIAL, MULTI-DOSE in 1 TRAY (0409-0125-25) / 20 mL in 1 VIAL, MULTI-DOSE (0409-0125-01) </PackageDescription>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075240</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Labetalol HCl injection is indicated for control of blood pressure in severe hypertension.</IndicationAndUsage>
<Description>Labetalol hydrochloride 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 hydrochloride has the molecular formula C19H24N2O3 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 is a white or off-white crystalline powder, soluble in water. Labetalol hydrochloride injection is a clear, colorless to light yellow aqueous sterile isotonic solution for intravenous injection. It has a pH range of 3.0 to 4.5. Each mL contains 5 mg labetalol hydrochloride, USP, 45 mg anhydrous dextrose, 0.1 mg edetate disodium; 0.8 mg methylparaben and 0.1 mg propylparaben as preservatives; citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range.</Description>
</NDC>
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<ProductNDC>0409-2267</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Labetalol HCl injection is indicated for control of blood pressure in severe hypertension.</IndicationAndUsage>
<Description>Labetalol hydrochloride 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 hydrochloride has the molecular formula C19H24N2O3 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 is a white or off-white crystalline powder, soluble in water. Labetalol hydrochloride injection is a clear, colorless to light yellow aqueous sterile isotonic solution for intravenous injection. It has a pH range of 3.0 to 4.5. Each mL contains 5 mg labetalol hydrochloride, USP, 45 mg anhydrous dextrose, 0.1 mg edetate disodium; 0.8 mg methylparaben and 0.1 mg propylparaben as preservatives; citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range.</Description>
</NDC>
<NDC>
<NDCCode>0409-2267-54</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0409-2267-54) / 40 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
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<ProductNDC>0409-2267</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
<NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20051230</StartMarketingDate>
<EndMarketingDate>20260731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075240</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20051230</StartMarketingDatePackage>
<EndMarketingDatePackage>20260731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Labetalol HCl injection is indicated for control of blood pressure in severe hypertension.</IndicationAndUsage>
<Description>Labetalol hydrochloride 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 hydrochloride has the molecular formula C19H24N2O3 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 is a white or off-white crystalline powder, soluble in water. Labetalol hydrochloride injection is a clear, colorless to light yellow aqueous sterile isotonic solution for intravenous injection. It has a pH range of 3.0 to 4.5. Each mL contains 5 mg labetalol hydrochloride, USP, 45 mg anhydrous dextrose, 0.1 mg edetate disodium; 0.8 mg methylparaben and 0.1 mg propylparaben as preservatives; citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range.</Description>
</NDC>
<NDC>
<NDCCode>0409-2339-34</NDCCode>
<PackageDescription>10 CARTON in 1 PACKAGE (0409-2339-34) > 1 CARTRIDGE in 1 CARTON > 4 mL in 1 CARTRIDGE (0409-2339-24) </PackageDescription>
<NDC11Code>00409-2339-34</NDC11Code>
<ProductNDC>0409-2339</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
<NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20051018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075239</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20051018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Labetalol HCl injection is indicated for control of blood pressure in severe hypertension.</IndicationAndUsage>
<Description>Labetalol hydrochloride 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 hydrochloride has the molecular formula C19H24N2O3 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 is a white or off-white crystalline powder, soluble in water. Labetalol hydrochloride injection is a clear, colorless to light yellow aqueous sterile isotonic solution for intravenous injection. It has a pH range of 3.0 to 4.5. Each mL contains 5 mg labetalol hydrochloride, USP, 45 mg anhydrous dextrose, 0.1 mg edetate disodium; 0.8 mg methylparaben and 0.1 mg propylparaben as preservatives; citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range.</Description>
</NDC>
<NDC>
<NDCCode>0641-6252-10</NDCCode>
<PackageDescription>10 SYRINGE, GLASS in 1 CARTON (0641-6252-10) / 2 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>00641-6252-10</NDC11Code>
<ProductNDC>0641-6252</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
<NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220318</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA213330</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220318</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Labetalol HCl Injection is indicated in severe hypertension, to lower blood pressure.</IndicationAndUsage>
<Description>Labetalol HCl in Sodium Chloride Injection, Labetalol HCl in Dextrose Injection and Labetalol Hydrochloride Injection, USP contain labetalol HCl an adrenergic receptor blocking agent that has both selective alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride (HCl) is a racemate chemically designated as 5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]-salicylamide monohydrochloride and it has the following structural formula. Labetalol HCl is a white or off-white crystalline powder, soluble in water. 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. Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are two preservative-free, ready-to use formulations of labetalol.Labetalol HCl in Sodium Chloride Injection and Labetalol HCl in Dextrose Injection are clear, colorless to light yellow, aqueous, sterile, isotonic solution for intravenous injection. Each milliliter of Labetalol HCl in Sodium Chloride Injection contains 1 mg of labetalol HCl, 7.2 mg sodium chloride, 9 mg of anhydrous dextrose, 0.02 mg of edetate disodium; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.5 to 4.5. Each milliliter of Labetalol HCl in Dextrose Injection contains 1 mg of labetalol HCl, 45 mg of anhydrous dextrose, 0.02 mg of edetate disodium; and citric acid monohydrate and sodium hydroxide, as necessary, to bring the solution into the pH range of 3.5 to 4.5. Labetalol Hydrochloride Injection in a prefilled syringe is a preservative-free, ready-to use formulation of labetalol.Labetalol Hydrochloride Injection is a clear, colorless to light yellow, aqueous, sterile, isotonic solution for intravenous injection. Each milliliter of the Labetalol Hydrochloride Injection, USP 2 mL prefilled syringe contains labetalol hydrochloride 5 mg; anhydrous dextrose 45 mg; edetate disodium 0.1 mg; citric acid monohydrate and sodium hydroxide as necessary to bring the pH into a range of 3.0 to 4.5.</Description>
</NDC>
<NDC>
<NDCCode>0904-7109-61</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0904-7109-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00904-7109-61</NDC11Code>
<ProductNDC>0904-7109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
<NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171205</StartMarketingDate>
<EndMarketingDate>20241231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207743</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</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>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171205</StartMarketingDatePackage>
<EndMarketingDatePackage>20241231</EndMarketingDatePackage>
<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 Alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl- 3-phenylpropyl)amino]ethyl]benzamide mono hydrochloride and it has the following structure. Labetalol hydrochloride has the molecular formula C19 H24 N2 O3 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 almost white powder. It is sparingly soluble in water and in ethanol (96%), practically insoluble in ether and in methylene chloride. Labetalol hydrochloride tablet, USP for oral administration contain 100 mg, 200 mg or 300 mg labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sodium starch glycolate (botanical source: potato) and titanium dioxide. Additionally, 100 mg tablets contain D&C yellow #10 Aluminum lake, iron oxide yellow, iron oxide red and talc. 300 mg tablets contain FD&C blue #1 Aluminum lake, iron oxide yellow and talc.</Description>
</NDC>
<NDC>
<NDCCode>0904-7110-61</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0904-7110-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00904-7110-61</NDC11Code>
<ProductNDC>0904-7110</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
<NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171205</StartMarketingDate>
<EndMarketingDate>20241231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207743</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</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>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171205</StartMarketingDatePackage>
<EndMarketingDatePackage>20241231</EndMarketingDatePackage>
<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 Alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl- 3-phenylpropyl)amino]ethyl]benzamide mono hydrochloride and it has the following structure. Labetalol hydrochloride has the molecular formula C19 H24 N2 O3 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 almost white powder. It is sparingly soluble in water and in ethanol (96%), practically insoluble in ether and in methylene chloride. Labetalol hydrochloride tablet, USP for oral administration contain 100 mg, 200 mg or 300 mg labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sodium starch glycolate (botanical source: potato) and titanium dioxide. Additionally, 100 mg tablets contain D&C yellow #10 Aluminum lake, iron oxide yellow, iron oxide red and talc. 300 mg tablets contain FD&C blue #1 Aluminum lake, iron oxide yellow and talc.</Description>
</NDC>
<NDC>
<NDCCode>0904-7111-61</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0904-7111-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00904-7111-61</NDC11Code>
<ProductNDC>0904-7111</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
<NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171205</StartMarketingDate>
<EndMarketingDate>20241130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207743</ApplicationNumber>
<LabelerName>Major Pharmaceuticals</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>2024-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171205</StartMarketingDatePackage>
<EndMarketingDatePackage>20241130</EndMarketingDatePackage>
<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 Alpha1-adrenergic and nonselective beta-adrenergic receptor blocking actions in a single substance. Labetalol hydrochloride is a racemate, chemically designated as 2-hydroxy-5-[1-hydroxy-2-[(1-methyl- 3-phenylpropyl)amino]ethyl]benzamide mono hydrochloride and it has the following structure. Labetalol hydrochloride has the molecular formula C19 H24 N2 O3 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 almost white powder. It is sparingly soluble in water and in ethanol (96%), practically insoluble in ether and in methylene chloride. Labetalol hydrochloride tablet, USP for oral administration contain 100 mg, 200 mg or 300 mg labetalol hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sodium starch glycolate (botanical source: potato) and titanium dioxide. Additionally, 100 mg tablets contain D&C yellow #10 Aluminum lake, iron oxide yellow, iron oxide red and talc. 300 mg tablets contain FD&C blue #1 Aluminum lake, iron oxide yellow and talc.</Description>
</NDC>
<NDC>
<NDCCode>10135-711-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (10135-711-01) </PackageDescription>
<NDC11Code>10135-0711-01</NDC11Code>
<ProductNDC>10135-711</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
<NonProprietaryName>Labetalol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075215</ApplicationNumber>
<LabelerName>Marlex Pharmaceuticals Inc</LabelerName>
<SubstanceName>LABETALOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201001</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, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, pregelatinized starch (corn), titanium dioxide.</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 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, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, pregelatinized starch (corn), titanium dioxide.</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 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, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, pregelatinized starch (corn), titanium dioxide.</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 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, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, pregelatinized starch (corn), titanium dioxide.</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 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, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, pregelatinized starch (corn), titanium dioxide.</Description>
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