LABETALOL HYDROCHLORIDE - labetalol hydrochloride tablet, film coated 
Zydus Lifesciences Limited

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Labetalol Hydrochloride Tablets, USP
Rx only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1163-3

Labetalol  hydrochloride tablets, 100 mg

Rx only

30 tablets

Labetalol hydrochloride tablets

NDC 70771-1164-3

Labetalol  hydrochloride tablets, 200 mg

Rx only

30 tablets

Labetalol hydrochloride tablets

NDC 70771-1165-3

Labetalol  hydrochloride tablets, 300 mg

Rx only

30 tablets

Labetalol hydrochloride tablets
LABETALOL HYDROCHLORIDE 
labetalol hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1163
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LABETALOL HYDROCHLORIDE (UNII: 1GEV3BAW9J) (LABETALOL - UNII:R5H8897N95) LABETALOL HYDROCHLORIDE100 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorYELLOW (YELLOW) Score2 pieces
ShapeROUND (BICONVEX) Size8mm
FlavorImprint Code 7;98
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1163-330 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
2NDC:70771-1163-990 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
3NDC:70771-1163-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
4NDC:70771-1163-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20774312/05/2017
LABETALOL HYDROCHLORIDE 
labetalol hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1164
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LABETALOL HYDROCHLORIDE (UNII: 1GEV3BAW9J) (LABETALOL - UNII:R5H8897N95) LABETALOL HYDROCHLORIDE200 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (OFF-WHITE) Score2 pieces
ShapeROUND (BICONVEX) Size11mm
FlavorImprint Code 7;99
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1164-330 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
2NDC:70771-1164-990 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
3NDC:70771-1164-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
4NDC:70771-1164-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20774312/05/2017
LABETALOL HYDROCHLORIDE 
labetalol hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1165
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LABETALOL HYDROCHLORIDE (UNII: 1GEV3BAW9J) (LABETALOL - UNII:R5H8897N95) LABETALOL HYDROCHLORIDE300 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorGREEN (LIGHT GREEN) Scoreno score
ShapeROUND (BICONVEX) Size11mm
FlavorImprint Code 800
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1165-330 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
2NDC:70771-1165-990 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
3NDC:70771-1165-1100 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
4NDC:70771-1165-5500 in 1 BOTTLE; Type 0: Not a Combination Product12/05/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20774312/05/2017
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1163, 70771-1164, 70771-1165) , MANUFACTURE(70771-1163, 70771-1164, 70771-1165)

Revised: 10/2022
Document Id: 6c51333c-cf96-480d-a340-f5680400cef4
Set id: a3c0cc1e-1c01-4009-afdc-d35a66546aec
Version: 5
Effective Time: 20221018
 
Zydus Lifesciences Limited