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Tizanidne hydrochloride

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

Approved
Approval ID

1ad6eaf6-bd32-4d05-bdd0-a6246e2afb9c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 7, 2022

Manufacturers
FDA

Asclemed USA, Inc.

DUNS: 059888437

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Tizanidne Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code76420-231
Application NumberANDA212196
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tizanidne Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 7, 2022
FDA Product Classification

INGREDIENTS (13)

CORN SYRUPInactive
Code: 9G5L16BK6N
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
TIZANIDINE HYDROCHLORIDEActive
Quantity: 6 mg in 1 1
Code: B53E3NMY5C
Classification: ACTIM

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Tizanidne hydrochloride - FDA Drug Approval Details