Tizanidine

Basic Information

Product Name

Tizanidine

FDA Product Code

50436-6756

Regulatory Information

NDC Product Code

50436-6756

Application Number

ANDA076286

Marketing Category

C73584

Effective Date

June 20, 2017

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use TIZANIDINE TABLETS safely and effectively. See full prescribing information for TIZANIDINE TABLETS. TIZANIDINE tablets, for oral use Initial U.S. Approval: 1996

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

anhydrous lactose

Code: 3SY5LH9PMK

Class Code: IACT

TIZANIDINE HYDROCHLORIDE

Quantity: 4 mg in 1 1

Code: B53E3NMY5C

Class Code: ACTIM

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

silicon dioxide

Code: ETJ7Z6XBU4

Class Code: IACT

stearic acid

Code: 4ELV7Z65AP

Class Code: IACT

Active Moieties

Code: 6AI06C00GW

Tizanidine

Basic Information

Regulatory Information

Company Information

Active Ingredients

anhydrous lactose

MICROCRYSTALLINE CELLULOSE

silicon dioxide

stearic acid

Active Moieties

TIZANIDINE