FAMOTIDINE - famotidine tablet, film coated 
Zydus Lifesciences Limited

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Famotidine Tablets, USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1702-3

Famotidine Tablets USP, 20 mg

30 Tablets

Rx only

20 mg label

NDC 70771-1703-3

Famotidine Tablets USP, 40 mg

30 Tablets

Rx only

40 mg label
FAMOTIDINE 
famotidine tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1702
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE20 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (off white) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code Z21
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1702-330 in 1 BOTTLE; Type 0: Not a Combination Product06/06/2022
2NDC:70771-1702-1100 in 1 BOTTLE; Type 0: Not a Combination Product06/06/2022
3NDC:70771-1702-5500 in 1 BOTTLE; Type 0: Not a Combination Product06/06/2022
4NDC:70771-1702-01000 in 1 BOTTLE; Type 0: Not a Combination Product06/06/2022
5NDC:70771-1702-410 in 1 CARTON06/06/2022
5NDC:70771-1702-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21644106/06/2022
FAMOTIDINE 
famotidine tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1703
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE40 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (off white) Scoreno score
ShapeROUNDSize8mm
FlavorImprint Code Z41
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1703-330 in 1 BOTTLE; Type 0: Not a Combination Product06/06/2022
2NDC:70771-1703-1100 in 1 BOTTLE; Type 0: Not a Combination Product06/06/2022
3NDC:70771-1703-5500 in 1 BOTTLE; Type 0: Not a Combination Product06/06/2022
4NDC:70771-1703-410 in 1 CARTON06/06/2022
4NDC:70771-1703-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:70771-1703-01000 in 1 BOTTLE; Type 0: Not a Combination Product06/06/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21644106/06/2022
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1702, 70771-1703) , MANUFACTURE(70771-1702, 70771-1703)

Revised: 8/2022
Document Id: 3e6a7405-b4c9-4034-8be6-41d8499ee9b2
Set id: 8c17f9e3-9827-4bf9-85ca-72e08a8518ca
Version: 2
Effective Time: 20220826
 
Zydus Lifesciences Limited