TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN- tramadol hydrochloride and acetaminophen tablet, film coated 
Cadila Healthcare Limited

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TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS, C-IV

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tramadol Hydrochloride and Acetaminophen Tablets USP, 37.5 mg/325 mg

NDC 65841-758-01

100 Tablets

Rx only

labels
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN 
tramadol hydrochloride and acetaminophen tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-758
Route of AdministrationORALDEA ScheduleCIV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J) TRAMADOL HYDROCHLORIDE37.5 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE (WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size15mm
FlavorImprint Code 334
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-758-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/15/2012
2NDC:65841-758-05500 in 1 BOTTLE; Type 0: Not a Combination Product10/15/2012
3NDC:65841-758-101000 in 1 BOTTLE; Type 0: Not a Combination Product10/15/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09046010/15/2012
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(65841-758) , MANUFACTURE(65841-758)

Revised: 9/2020
Document Id: efa8dd54-5b5b-495c-a408-f5ffc9869431
Set id: 39945812-f776-4b13-8199-e846e37aa101
Version: 5
Effective Time: 20200914
 
Cadila Healthcare Limited