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 (tramadol hydrochloride) Extended-Release Capsules Initial U.S. Approval: 1995
Approved
Approval ID
23466565-6c73-2047-6f6f-64204d616e23
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 21, 2010
Manufacturers
FDA
Galephar Pharmaceutical Research Inc.
DUNS: 003551624
Products 3
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 Code66277-253
Application NumberNDA022370
Product Classification
M
Marketing Category
C73594
G
Generic Name
Tramadol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 21, 2010
FDA Product Classification
INGREDIENTS (15)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TRAMADOL HYDROCHLORIDEActive
Quantity: 200 mg in 1 1
Code: 9N7R477WCK
Classification: ACTIB
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K29/32Inactive
Code: 390RMW2PEQ
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYPROMELLOSE 2910 (6 CPS)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C RED NO. 7Inactive
Code: ECW0LZ41X8
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ETHYL ACRYLATE - METHYL METHACRYLATE COPOLYMERInactive
Code: P2OM2Q86BI
Classification: IACT
Tramadol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66277-252
Application NumberNDA022370
Product Classification
M
Marketing Category
C73594
G
Generic Name
Tramadol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 21, 2010
FDA Product Classification
INGREDIENTS (14)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TRAMADOL HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 9N7R477WCK
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K29/32Inactive
Code: 390RMW2PEQ
Classification: IACT
HYPROMELLOSE 2910 (6 CPS)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ETHYL ACRYLATE - METHYL METHACRYLATE COPOLYMERInactive
Code: P2OM2Q86BI
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Tramadol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66277-254
Application NumberNDA022370
Product Classification
M
Marketing Category
C73594
G
Generic Name
Tramadol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 21, 2010
FDA Product Classification
INGREDIENTS (15)
TRAMADOL HYDROCHLORIDEActive
Quantity: 300 mg in 1 1
Code: 9N7R477WCK
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C RED NO. 7Inactive
Code: ECW0LZ41X8
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
POVIDONE K29/32Inactive
Code: 390RMW2PEQ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE 2910 (6 CPS)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
ETHYL ACRYLATE - METHYL METHACRYLATE COPOLYMERInactive
Code: P2OM2Q86BI
Classification: IACT