Tramadol Hydrochloride
Tramadol Hydrochloride Tablets, USP 50 mg CIV Rx only 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-IV Initial U.S. Approval – 1995
Approved
Approval ID
3606bf61-ad10-49b5-af85-27c7a8c06e70
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 18, 2019
Manufacturers
FDA
POLYGEN PHARMACEUTICALS INC.
DUNS: 962415720
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 Code52605-010
Application NumberANDA206706
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tramadol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 21, 2019
FDA Product Classification
INGREDIENTS (10)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TRAMADOL HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 9N7R477WCK
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT