FDA.reportPublic FDA data

Tizanidine

Product NDC
63187-673
11-digit product format
631870673
Labeler code
63187
Product ID
63187-673_2b2e33aa-55ad-4969-85d1-9cbfb62cabbb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076416
Marketing category
ANDA
Marketing start
2003-12-11
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-673-14Tizanidine14 in 1 BOTTLETABLET145
63187-673-30Tizanidine30 in 1 BOTTLETABLET305
63187-673-60Tizanidine60 in 1 BOTTLETABLET605
63187-673-90Tizanidine90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-673-14EA - Each63187-673d36eb31b-14e4-4c71-bf4a-3e4ae3c930f712022-03-09
63187-673-30EA - Each63187-6730c1f8dc5-2a37-4db4-8efd-a58876238b2212016-07-19
63187-673-60EA - Each63187-67336d45357-f420-4a3f-ab72-3fa7617bbb5f12017-03-06
63187-673-90EA - Each63187-6734e28bbc8-b9df-4410-ab8d-a2311e0756c812016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-673TIZANIDINE TABLET [PROFICIENT RX LP]5Current NDC, Legacy NDC, 4 package rows20220413_76dc85bd-3cde-4940-a99b-663b70bf9f54.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSN76dc85bd-3cde-4940-a99b-663b70bf9f545
313413tizanidine 4 MG Oral TabletSCD76dc85bd-3cde-4940-a99b-663b70bf9f545
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY76dc85bd-3cde-4940-a99b-663b70bf9f545

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-673-146318706731414 TABLET in 1 BOTTLE (63187-673-14) 14 tablet2022-01-050000-00-00NoNoCurrent
63187-673-306318706733030 TABLET in 1 BOTTLE (63187-673-30) 30 tablet2018-12-010000-00-00NoNoCurrent
63187-673-606318706736060 TABLET in 1 BOTTLE (63187-673-60) 60 tablet2018-12-010000-00-00NoNoCurrent
63187-673-906318706739090 TABLET in 1 BOTTLE (63187-673-90) 90 tablet2018-12-010000-00-00NoNoCurrent