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TRAMADOL HYDROCHLORIDE

These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS. TRAMADOL hydrochloride extended-release tablets for oral use, C IVInitial U.S. Approval: 1995

Approved
Approval ID

46bb9ae6-3ee8-463c-badb-c7a45a89b84b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 16, 2024

Manufacturers
FDA

Lupin Pharmaceuticals, Inc.

DUNS: 089153071

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 Code68180-699
Application NumberANDA200503
Product Classification
M
Marketing Category
C73584
G
Generic Name
TRAMADOL HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 16, 2024
FDA Product Classification

INGREDIENTS (10)

SHELLACInactive
Code: 46N107B71O
Classification: IACT
TRAMADOL HYDROCHLORIDEActive
Quantity: 300 mg in 1 1
Code: 9N7R477WCK
Classification: ACTIB
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
DIBUTYL SEBACATEInactive
Code: 4W5IH7FLNY
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT

TRAMADOL HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68180-697
Application NumberANDA200503
Product Classification
M
Marketing Category
C73584
G
Generic Name
TRAMADOL HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 16, 2024
FDA Product Classification

INGREDIENTS (10)

TRAMADOL HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 9N7R477WCK
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
DIBUTYL SEBACATEInactive
Code: 4W5IH7FLNY
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT

TRAMADOL HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68180-698
Application NumberANDA200503
Product Classification
M
Marketing Category
C73584
G
Generic Name
TRAMADOL HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 16, 2024
FDA Product Classification

INGREDIENTS (10)

TRAMADOL HYDROCHLORIDEActive
Quantity: 200 mg in 1 1
Code: 9N7R477WCK
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
DIBUTYL SEBACATEInactive
Code: 4W5IH7FLNY
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT

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TRAMADOL HYDROCHLORIDE - FDA Drug Approval Details