FDA.reportPublic FDA data

Tizanidine

Product NDC
72189-599
11-digit product format
721890599
Labeler code
72189
Product ID
72189-599_4c5cfb10-cdfe-0055-e063-6394a90a8000
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Direct_rx
Application
ANDA076286
Marketing category
ANDA
Marketing start
2024-12-19
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-599-30Tizanidine30 in 1 BOTTLETABLET304
72189-599-60Tizanidine60 in 1 BOTTLETABLET604
72189-599-82Tizanidine180 in 1 BOTTLETABLET1804
72189-599-90Tizanidine90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-599-30EA - Each72189-5997ac16ef0-e3ee-4451-b73d-5f8ccf45f7f812025-01-14
72189-599-60EA - Each72189-599842af716-778d-45b9-baaa-6e57d91e861112025-08-11
72189-599-82EA - Each72189-59927c78c03-5ffc-438c-b44f-25cd61e2f95e12025-02-10
72189-599-90EA - Each72189-5995a0d3404-4135-4952-920a-672ab07c0dfa12026-03-17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-599TIZANIDINE TABLET [DIRECT_RX]2Current NDC, 4 package rows20250114_29a275f9-de6b-ee63-e063-6294a90aba28.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSN29a275f9-de6b-ee63-e063-6294a90aba284
313412tizanidine 2 MG Oral TabletSCD29a275f9-de6b-ee63-e063-6294a90aba284
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY29a275f9-de6b-ee63-e063-6294a90aba284

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-599-307218905993030 TABLET in 1 BOTTLE (72189-599-30) 30 tablet2024-12-19NoNoHistorical
72189-599-607218905996060 TABLET in 1 BOTTLE (72189-599-60) 60 tablet2024-12-19NoNoHistorical
72189-599-8272189059982180 TABLET in 1 BOTTLE (72189-599-82) 180 tablet2024-12-19NoNoHistorical
72189-599-907218905999090 TABLET in 1 BOTTLE (72189-599-90) 90 tablet2024-12-19NoNoHistorical