ACETAMINOPHEN CAPLET- acetaminophen tablet 
Granules India Limited

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Acetaminophen Tablets USP 500 mg (Caplet)

Acetaminophen Tablets 500 mg (Caplet)

1-62207-177-85

2-62207-177-85

62207-177-85

ACETAMINOPHEN  CAPLET
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-177
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE K30 (UNII: U725QWY32X)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
Product Characteristics
Colorwhite (White to Off-white) Scoreno score
ShapeCAPSULE (Caplet Shape) Size17mm
FlavorImprint Code G551
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-177-81144144 in 1 BOX; Type 0: Not a Combination Product12/29/2017
2NDC:62207-177-8590000 in 1 BOX; Type 0: Not a Combination Product06/14/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only12/29/2017
Labeler - Granules India Limited (915000087)
Registrant - Granules India Limited (915000087)
Establishment
NameAddressID/FEIBusiness Operations
Granules India Limited918609236manufacture(62207-177) , pack(62207-177) , label(62207-177) , analysis(62207-177)
Establishment
NameAddressID/FEIBusiness Operations
GRANULES LIFE SCIENCES PRIVATE LIMITED644776835analysis(62207-177) , manufacture(62207-177) , pack(62207-177) , label(62207-177)

Revised: 2/2024
Document Id: 11f7fb52-ce2c-71c1-e063-6294a90a9d17
Set id: 6176f9a2-6f2a-dcf6-e053-2a91aa0aee34
Version: 7
Effective Time: 20240222
 
Granules India Limited