Tramadol Hydrochloride
Tramadol Hydrochloride Tablets
Approved
Approval ID
1a545dca-978d-4091-9917-9074cf6957b2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 14, 2011
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
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 Code42549-527
Application NumberANDA076003
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tramadol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 14, 2012
FDA Product Classification
INGREDIENTS (1)
TRAMADOL HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 9N7R477WCK
Classification: ACTIB