Tramadol ER
TRAMADOL HYDROCHLORIDE tablet, extended release
Approved
Approval ID
0f799e5c-f782-4f3d-bdb6-52bd413a19cf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 27, 2009
Manufacturers
FDA
Stat Rx USA
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tramadol ER
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-893
Application NumberANDA078783
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tramadol ER
Product Specifications
Route of AdministrationORAL
Effective DateOctober 27, 2009
FDA Product Classification
INGREDIENTS (1)
TRAMADOL HYDROCHLORIDEActive
Quantity: 200 mg in 1 1
Code: 9N7R477WCK
Classification: ACTIB