FDA.reportPublic FDA data

Tizanidine

Product NDC
50090-2078
11-digit product format
500902078
Labeler code
50090
Product ID
50090-2078_2d65e205-9519-4d3a-a010-38c83fd6d6b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091283
Marketing category
ANDA
Marketing start
2013-04-01
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
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 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
50090-2078-02024-01-31C16284748780-1f386c64a-340e-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
50090-2078-12024-01-31C16284748780-1f386c64a-340e-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
50090-2078-22024-01-31C16284748780-1f386c64a-340e-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
50090-2078-02023-01-30C16284748780-1f386c64a-340e-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
50090-2078-12023-01-30C16284748780-1f386c64a-340e-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
50090-2078-22023-01-30C16284748780-1f386c64a-340e-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
50090-2078-0Tizanidine30 in 1 BOTTLETABLET3018
50090-2078-1Tizanidine60 in 1 BOTTLETABLET6018
50090-2078-2Tizanidine90 in 1 BOTTLETABLET9018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2078-0EA - Each50090-20785cfc10f9-3ba2-42ce-9ce0-40c35318204b12019-02-13
50090-2078-1EA - Each50090-2078abbe83da-90cd-482f-8e6d-cf05e76bb2e212018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2078TIZANIDINE TABLET [A-S MEDICATION SOLUTIONS]18Current NDC, Legacy NDC, 3 package rows20250406_9678a98e-4aab-4d87-b5e1-37c3109e378e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSN9678a98e-4aab-4d87-b5e1-37c3109e378e18
313412tizanidine 2 MG Oral TabletSCD9678a98e-4aab-4d87-b5e1-37c3109e378e18
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY9678a98e-4aab-4d87-b5e1-37c3109e378e18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2078-05009020780030 TABLET in 1 BOTTLE (50090-2078-0) 30 tablet2015-10-080000-00-00NoNoCurrent
50090-2078-15009020780160 TABLET in 1 BOTTLE (50090-2078-1) 60 tablet2015-10-080000-00-00NoNoCurrent
50090-2078-25009020780290 TABLET in 1 BOTTLE (50090-2078-2) 90 tablet2015-10-080000-00-00NoNoCurrent