TRAMADOL HYDROCHLORIDE
RX Only
Approved
Approval ID
246a45d0-0953-4f4f-8175-dab3bafac2db
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 10, 2009
Manufacturers
FDA
Rebel Distributors Corp.
DUNS: 118802834
Products 2
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 Code21695-700
Application NumberANDA078783
Product Classification
M
Marketing Category
C73584
G
Generic Name
tramadol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2009
FDA Product Classification
INGREDIENTS (12)
TRAMADOL HYDROCHLORIDEActive
Quantity: 200 mg in 1 1
Code: 9N7R477WCK
Classification: ACTIB
DIBUTYL SEBACATEInactive
Code: 4W5IH7FLNY
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ETHYLCELLULOSEInactive
Code: 7Z8S9VYZ4B
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERRIC OXIDE BLACKInactive
Code: XM0M87F357
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
tramadol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-699
Application NumberANDA078783
Product Classification
M
Marketing Category
C73584
G
Generic Name
tramadol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2009
FDA Product Classification
INGREDIENTS (12)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TRAMADOL HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 9N7R477WCK
Classification: ACTIB
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DIBUTYL SEBACATEInactive
Code: 4W5IH7FLNY
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
ETHYLCELLULOSEInactive
Code: 7Z8S9VYZ4B
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERRIC OXIDE BLACKInactive
Code: XM0M87F357
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT