Tramadol Hydrochloride
These highlights do not include all the information needed to use Tramadol Hydrochloride Extended- Release Capsules safely and effectively. See full prescribing information for Tramadol Hydrochloride Extended-Release Capsules. Tramadol Hydrochloride Extended-Release Capsules Initial U.S. Approval: 1995
Approved
Approval ID
5b3602f4-54f0-9461-e053-2a91aa0a99b9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 10, 2017
Manufacturers
FDA
Mas Management Group, Inc.
DUNS: 079363782
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 Code69677-316
Application NumberNDA022370
Product Classification
M
Marketing Category
C73594
G
Generic Name
Tramadol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 10, 2017
FDA Product Classification
INGREDIENTS (14)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRAMADOL HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: 9N7R477WCK
Classification: ACTIB
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)Inactive
Code: P2OM2Q86BI
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SUCROSE STEARATEInactive
Code: 274KW0O50M
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT