MedPath

ULTRACET

ULTRACET (TRAMADOL HYDROCHLORIDE/ACETAMINOPHEN) TABLETS

Approved
Approval ID

750e7372-022b-454e-86c4-e4b325fb9f42

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 1, 2010

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

tramadol hydrochloride and acetaminophen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-143
Application NumberNDA021123
Product Classification
M
Marketing Category
C73594
G
Generic Name
tramadol hydrochloride and acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateAugust 7, 2008
FDA Product Classification

INGREDIENTS (12)

POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
tramadol hydrochlorideActive
Quantity: 37.5 mg in 1 1
Code: 9N7R477WCK
Classification: ACTIB
POWDERED CELLULOSEInactive
Code: SMD1X3XO9M
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
acetaminophenActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT

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