ALBUTEROL - albuterol tablet 
Zydus Lifesciences Limited

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Albuterol Tablets, USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1511-1 in bottle of 100 tablets

Albuterol tablets USP, 2 mg

Rx only

100 Tablets

label

NDC 70771-1512-1 in bottle of 100 tablets

Albuterol tablets USP, 4 mg

Rx only

100 Tablets

label
ALBUTEROL 
albuterol tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1511
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E) ALBUTEROL2 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE K30 (UNII: U725QWY32X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (white to off-white) Score2 pieces
ShapeROUND (ROUND) Size6mm
FlavorImprint Code 10;61
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1511-1100 in 1 BOTTLE; Type 0: Not a Combination Product10/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20888410/23/2020
ALBUTEROL 
albuterol tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1512
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E) ALBUTEROL4 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE K30 (UNII: U725QWY32X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
ShapeROUND (ROUND) Size9mm
FlavorImprint Code 10;62
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1512-1100 in 1 BOTTLE; Type 0: Not a Combination Product10/23/2020
2NDC:70771-1512-5500 in 1 BOTTLE; Type 0: Not a Combination Product10/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20888410/23/2020
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1511, 70771-1512) , MANUFACTURE(70771-1511, 70771-1512)

Revised: 7/2022
Document Id: f9c6f692-c79f-4a07-94e0-1d1e6e60b871
Set id: a4709eea-e4a2-46e2-850f-1e6afca01893
Version: 2
Effective Time: 20220727
 
Zydus Lifesciences Limited