FDA.reportPublic FDA data

Tizanidine

Product NDC
76420-228
11-digit product format
764200228
Labeler code
76420
Product ID
76420-228_3aa8c7f8-ee1a-be39-e063-6294a90a0e71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-228-10Tizanidine10 in 1 BOTTLETABLET105
76420-228-12Tizanidine120 in 1 BOTTLETABLET1205
76420-228-18Tizanidine180 in 1 BOTTLETABLET1805
76420-228-30Tizanidine30 in 1 BOTTLETABLET305
76420-228-60Tizanidine60 in 1 BOTTLETABLET605
76420-228-90Tizanidine90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-228-18EA - Each76420-228f1ad420a-5d17-4f75-8673-0ac0392f7f4012024-01-04
76420-228-30EA - Each76420-2285a486b98-66fc-4b16-8e7d-1e376103691512022-08-04
76420-228-60EA - Each76420-2282bf01a77-eb9e-4658-8494-f4670406e65112022-08-04
76420-228-90EA - Each76420-2281006d4bc-247e-43ec-a860-f78fbd732a0a12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-228TIZANIDINE TABLET [ASCLEMED USA, INC.]4Current NDC, Legacy NDC, 6 package rows20250330_24d8b33f-d1fb-4b4a-afbe-e2e7134dce29.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSN24d8b33f-d1fb-4b4a-afbe-e2e7134dce295
313413tiZANidine HCl 4 MG Oral TabletPSN24d8b33f-d1fb-4b4a-afbe-e2e7134dce295
313412tizanidine 2 MG Oral TabletSCD24d8b33f-d1fb-4b4a-afbe-e2e7134dce295
313413tizanidine 4 MG Oral TabletSCD24d8b33f-d1fb-4b4a-afbe-e2e7134dce295
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY24d8b33f-d1fb-4b4a-afbe-e2e7134dce295
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY24d8b33f-d1fb-4b4a-afbe-e2e7134dce295

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-228-107642002281010 TABLET in 1 BOTTLE (76420-228-10) 10 tablet2024-01-09NoNoHistorical
76420-228-1276420022812120 TABLET in 1 BOTTLE (76420-228-12) 120 tablet2025-07-24NoNoHistorical
76420-228-1876420022818180 TABLET in 1 BOTTLE (76420-228-18) 180 tablet2023-10-30NoNoHistorical
76420-228-307642002283030 TABLET in 1 BOTTLE (76420-228-30) 30 tablet2022-07-070000-00-00NoNoCurrent
76420-228-607642002286060 TABLET in 1 BOTTLE (76420-228-60) 60 tablet2022-07-070000-00-00NoNoCurrent
76420-228-907642002289090 TABLET in 1 BOTTLE (76420-228-90) 90 tablet2022-07-070000-00-00NoNoCurrent