TRAMADOL HYDROCHLORIDE
Approved
Approval ID
5d544cbc-94c1-6194-e053-2991aa0ada36
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 6, 2017
Manufacturers
FDA
H.J. Harkins Company Inc.
DUNS: 147681894
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 Code52959-688
Application NumberANDA090404
Product Classification
M
Marketing Category
C73584
G
Generic Name
TRAMADOL HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 6, 2017
FDA Product Classification
INGREDIENTS (1)
TRAMADOL HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 9N7R477WCK
Classification: ACTIB