TRAMADOL HYDROCHLORIDE

Basic Information

Product Name

FDA Product Code

50090-5106

Regulatory Information

NDC Product Code

50090-5106

Application Number

ANDA200503

Marketing Category

C73584

Effective Date

June 13, 2023

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

ETHYLCELLULOSE, UNSPECIFIED

Code: 7Z8S9VYZ4B

Class Code: IACT

POVIDONE, UNSPECIFIED

Code: FZ989GH94E

Class Code: IACT

DIBUTYL SEBACATE

Code: 4W5IH7FLNY

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

TRAMADOL HYDROCHLORIDE

Quantity: 200 mg in 1 1

Code: 9N7R477WCK

Class Code: ACTIB

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

SODIUM STEARYL FUMARATE

Code: 7CV7WJK4UI

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

Active Moieties

TRAMADOL

Code: 39J1LGJ30J

Basic Information

Regulatory Information

Company Information

Active Ingredients

ETHYLCELLULOSE, UNSPECIFIED

POVIDONE, UNSPECIFIED

DIBUTYL SEBACATE

FERROSOFERRIC OXIDE

PROPYLENE GLYCOL

SODIUM STEARYL FUMARATE

SHELLAC

SILICON DIOXIDE

MICROCRYSTALLINE CELLULOSE

Active Moieties

TRAMADOL