FDA.reportPublic FDA data

Tizanidine

Product NDC
70518-3112
11-digit product format
705183112
Labeler code
70518
Product ID
70518-3112_4e91cc2a-3e8d-7bf2-e063-6394a90aea6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076286
Marketing category
ANDA
Marketing start
2021-06-04
Substance
TIZANIDINE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tizanidine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui313412

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
70518-3112-02023-03-16C16284748780-1f386c64a-4184-0266-e053-dadaa90a7c1aThese 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
70518-3112-02023-03-16C16284748780-1f386c64a-4184-0266-e053-dadaa90a7c1aThese 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
70518-3112-02023-01-30C16284748780-1f386c64a-4184-0266-e053-dadaa90a7c1aThese 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
70518-3112-02023-01-30C16284748780-1f386c64a-4184-0266-e053-dadaa90a7c1aThese 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3112-0Tizanidine60 in 1 BOTTLE, PLASTICTABLET606

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSN7bbc81e5-ad3e-496b-908f-e6f500f6ad7e6
313412tizanidine 2 MG Oral TabletSCD7bbc81e5-ad3e-496b-908f-e6f500f6ad7e6
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY7bbc81e5-ad3e-496b-908f-e6f500f6ad7e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3112-07051831120060 TABLET in 1 BOTTLE, PLASTIC (70518-3112-0) 60 tablet2021-06-040000-00-00NoNoCurrent