FDA.reportPublic FDA data

Tizanidine

Product NDC
63187-009
11-digit product format
631870009
Labeler code
63187
Product ID
63187-009_b14ca668-2a18-4300-b94c-b968aeac6402
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076286
Marketing category
ANDA
Marketing start
2002-07-03
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
63187-009-302019-12-06C16284748780-19855e2a2-3288-60a7-e053-dbdaa90a05bdTizanidine Tablets USP
63187-009-602019-12-06C16284748780-19855e2a2-3288-60a7-e053-dbdaa90a05bdTizanidine Tablets USP
63187-009-302019-11-27C16284748780-19855e2a2-3288-60a7-e053-dbdaa90a05bdTizanidine Tablets USP
63187-009-602019-11-27C16284748780-19855e2a2-3288-60a7-e053-dbdaa90a05bdTizanidine Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-009-30Tizanidine30 in 1 BOTTLETABLET304
63187-009-60Tizanidine60 in 1 BOTTLETABLET604
63187-009-90Tizanidine90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-009-30EA - Each63187-009d02f6ae1-763d-4f14-94aa-44ae3de4198912015-03-03
63187-009-60EA - Each63187-0099571431c-6221-4750-b8b6-7b431e00120412015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Tizanidine HydrochlorideACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [PROFICIENT RX LP]1
TizanidineACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [PROFICIENT RX LP]1
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [PROFICIENT RX LP]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [PROFICIENT RX LP]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [PROFICIENT RX LP]1
stearic acidINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE TABLET [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-009TIZANIDINE TABLET [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20250210_c2353d09-3cb4-486e-8ae7-29339c1ba76b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSNc2353d09-3cb4-486e-8ae7-29339c1ba76b4
313413tizanidine 4 MG Oral TabletSCDc2353d09-3cb4-486e-8ae7-29339c1ba76b4
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYc2353d09-3cb4-486e-8ae7-29339c1ba76b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-009-306318700093030 TABLET in 1 BOTTLE (63187-009-30) 30 tablet2014-05-010000-00-00NoNoCurrent
63187-009-606318700096060 TABLET in 1 BOTTLE (63187-009-60) 60 tablet2014-05-010000-00-00NoNoCurrent
63187-009-906318700099090 TABLET in 1 BOTTLE (63187-009-90) 90 tablet2020-10-230000-00-00NoNoCurrent