tramadol hydrochloride
These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE TABLETS.TRAMADOL HYDROCHLORIDE tablets, for oral use, C-IVInitial U.S. Approval: 1995
Approved
Approval ID
38bd9c16-f730-4953-a444-68a95498d83c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 1, 2023
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tramadol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71205-303
Application NumberANDA075964
Product Classification
M
Marketing Category
C73584
G
Generic Name
tramadol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2023
FDA Product Classification
INGREDIENTS (8)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TRAMADOL HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 9N7R477WCK
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT