Tramadol Hydrochloride
Tramadol Hydrochloride
Approved
Approval ID
1e2e4814-b916-46d5-99a3-3a0a3127e74e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 18, 2015
Manufacturers
FDA
Direct Rx
DUNS: 079254320
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
NDC Product Code61919-583
Application NumberNDA022370
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateSeptember 17, 2015
Generic NameTramadol Hydrochloride
INGREDIENTS (14)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SUCROSE STEARATEInactive
Code: 274KW0O50M
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRAMADOL HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: 9N7R477WCK
Classification: ACTIB
SHELLACInactive
Code: 46N107B71O
Classification: IACT
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)Inactive
Code: P2OM2Q86BI
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT