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FDA Approval

Labetalol Hydrochloride

CompanyZydus Lifesciences Limited (DUNS: 918596198)

Effective Date

October 18, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Labetalol(200 mg in 1 1)

Registrants (1)

Zydus Lifesciences Limited

DUNS Number

918596198

Manufacturing Establishments (1)

Zydus Lifesciences Limited

Labeler

Zydus Lifesciences Limited

Registrant

Zydus Lifesciences Limited

DUNS Number

863362789

Products (3)

Labetalol Hydrochloride

NDC Product Code

70771-1164

Application Number

ANDA207743

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 18, 2022

Ingredients

LabetalolActive

Code: 1GEV3BAW9JClass: ACTIBQuantity: 200 mg in 1 1

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

Labetalol Hydrochloride

NDC Product Code

70771-1165

Application Number

ANDA207743

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 18, 2022

Ingredients

LabetalolActive

Code: 1GEV3BAW9JClass: ACTIBQuantity: 300 mg in 1 1

FD&C BLUE NO. 1--ALUMINUM LAKEInactive

Code: J9EQA3S2JMClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

Labetalol Hydrochloride

NDC Product Code

70771-1163

Application Number

ANDA207743

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 18, 2022

Ingredients

LabetalolActive

Code: 1GEV3BAW9JClass: ACTIBQuantity: 100 mg in 1 1

ALUMINUM OXIDEInactive

Code: LMI26O6933Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

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