TRAMADOL HYDROCHLORIDE- tramadol hydrochloride tablet, film coated 
Zydus Lifesciences Limited

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TRAMADOL HYDROCHLORIDE TABLETS C-IV

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tramadol Hydrochloride Tablets USP, 50 mg

NDC 65841-754-01 in bottle of 100 tablets

100 tablets

Rx only

Tramadol HCl Tablets
TRAMADOL HYDROCHLORIDE 
tramadol hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-754
Route of AdministrationORALDEA ScheduleCIV    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J) TRAMADOL HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeROUND (ROUND) Size9mm
FlavorImprint Code 319
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-754-3010 in 1 CARTON01/31/2011
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:65841-754-01100 in 1 BOTTLE; Type 0: Not a Combination Product01/31/2011
3NDC:65841-754-05500 in 1 BOTTLE; Type 0: Not a Combination Product01/31/2011
4NDC:65841-754-101000 in 1 BOTTLE; Type 0: Not a Combination Product01/31/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09040401/31/2011
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (677605858)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(65841-754) , MANUFACTURE(65841-754)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited677605858ANALYSIS(65841-754) , MANUFACTURE(65841-754)

Revised: 9/2023
Document Id: 0ced2b00-2184-4cc5-8247-a87f3a08115d
Set id: 6f3a2ab8-f437-456f-ae35-67a965396052
Version: 9
Effective Time: 20230927
 
Zydus Lifesciences Limited