FDA.reportPublic FDA data

Tizanidine

Product NDC
68071-4463
11-digit product format
680714463
Labeler code
68071
Product ID
68071-4463_3c1f1442-0b36-b32f-e063-6394a90af2b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA091283
Marketing category
ANDA
Marketing start
2013-04-01
Substance
TIZANIDINE HYDROCHLORIDE
Active strength
4 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tizanidine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui313413

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a0ff02d8-b711-423c-b7d1-ada00d81c743Product name120250805
9fd28b3a-d1bb-a2ce-ffa3-c3dd28536a01Product name820250313
b404127e-1c01-47bb-874e-db1e0b6bd9afProduct name420250313

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4463-32024-06-10C16284748780-1ba0f9c33-4e2f-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use Tizanidine Tablets USP safely and effectively. See full prescribing information forTizanidine Tablets USP. Tizanidine (tizanidine hydrochloride) Tablets USP, for oral use Initial U.S. Approval:1996
68071-4463-32023-01-30C16284748780-1ba0f9c33-4e2f-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use Tizanidine Tablets USP safely and effectively. See full prescribing information forTizanidine Tablets USP. Tizanidine (tizanidine hydrochloride) Tablets USP, for oral use Initial U.S. Approval:1996
68071-4463-32021-02-16C16284748780-1ba0f9c33-4e2f-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use Tizanidine Tablets USP safely and effectively. See full prescribing information forTizanidine Tablets USP. Tizanidine (tizanidine hydrochloride) Tablets USP, for oral use Initial U.S. Approval:1996
68071-4463-32021-01-29C16284748780-1ba0f9c33-4e2f-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use Tizanidine Tablets USP safely and effectively. See full prescribing information forTizanidine Tablets USP. Tizanidine (tizanidine hydrochloride) Tablets USP, for oral use Initial U.S. Approval:1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4463-3Tizanidine30 in 1 BOTTLETABLET307
68071-4463-6Tizanidine60 in 1 BOTTLETABLET607

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSN6dd9946f-b2a4-1732-e053-2a91aa0a648f7
313413tizanidine 4 MG Oral TabletSCD6dd9946f-b2a4-1732-e053-2a91aa0a648f7
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY6dd9946f-b2a4-1732-e053-2a91aa0a648f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4463-36807144630330 TABLET in 1 BOTTLE (68071-4463-3) 30 tablet2018-06-040000-00-00NoNoCurrent
68071-4463-66807144630660 TABLET in 1 BOTTLE (68071-4463-6) 60 tablet2025-08-11NoNoHistorical