Tramadol Hydrochloride
TRAMADOL HYDROCHLORIDE TABLETS USPCIVRx Only
Approved
Approval ID
2993f70d-2359-443e-8d7b-68de5332f708
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 10, 2016
Manufacturers
FDA
BIOMES PHARMACEUTICALS LLC
DUNS: 078644310
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 Code69150-020
Application NumberANDA202075
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tramadol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 1, 2016
FDA Product Classification
INGREDIENTS (10)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TRAMADOL HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 9N7R477WCK
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT