FDA.reportPublic FDA data

Tizanidine

Product NDC
50090-0811
11-digit product format
500900811
Labeler code
50090
Product ID
50090-0811_5bcdf097-1022-4183-8571-402c2dc943f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076286
Marketing category
ANDA
Marketing start
2002-07-03
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, 313413

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
50090-0811-02023-02-07C16284748780-1f386c649-f7e7-0266-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
50090-0811-12023-02-07C16284748780-1f386c649-f7e7-0266-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
50090-0811-02023-01-30C16284748780-1f386c649-f7e7-0266-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
50090-0811-12023-01-30C16284748780-1f386c649-f7e7-0266-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
50090-0811-0Tizanidine30 in 1 BOTTLETABLET3028
50090-0811-1Tizanidine60 in 1 BOTTLETABLET6028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0811-0EA - Each50090-0811ecdc9428-787e-4b3a-917c-0330754ef9bb12021-08-05
50090-0811-1EA - Each50090-08111a611ee6-979e-4ffc-9e31-01333d9a288b12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0811TIZANIDINE TABLET [A-S MEDICATION SOLUTIONS]28Current NDC, Legacy NDC, 2 package rows20250425_180985f0-3fbd-4868-a826-b84101618a03.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSN180985f0-3fbd-4868-a826-b84101618a0328
313413tiZANidine HCl 4 MG Oral TabletPSN180985f0-3fbd-4868-a826-b84101618a0328
313412tizanidine 2 MG Oral TabletSCD180985f0-3fbd-4868-a826-b84101618a0328
313413tizanidine 4 MG Oral TabletSCD180985f0-3fbd-4868-a826-b84101618a0328
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY180985f0-3fbd-4868-a826-b84101618a0328
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY180985f0-3fbd-4868-a826-b84101618a0328

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0811-05009008110030 TABLET in 1 BOTTLE (50090-0811-0) 30 tablet2014-11-280000-00-00NoNoCurrent
50090-0811-15009008110160 TABLET in 1 BOTTLE (50090-0811-1) 60 tablet2021-03-150000-00-00NoNoCurrent