FDA.reportPublic FDA data

Tizanidine

Product NDC
76420-338
11-digit product format
764200338
Labeler code
76420
Product ID
76420-338_3423349e-5bea-b5eb-e063-6394a90a6241
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA076416
Marketing category
ANDA
Marketing start
2003-12-11
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
76420-338-00Tizanidine1000 in 1 BOTTLETABLET10001
76420-338-15Tizanidine150 in 1 BOTTLETABLET1501
76420-338-30Tizanidine30 in 1 BOTTLETABLET301
76420-338-60Tizanidine60 in 1 BOTTLETABLET601
76420-338-90Tizanidine90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-338TIZANIDINE TABLET [ASCLEMED USA, INC.]1Current NDC, 5 package rows20250507_2f460275-565f-4737-a3df-bf80b9acc268.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSN2f460275-565f-4737-a3df-bf80b9acc2681
313413tiZANidine HCl 4 MG Oral TabletPSN2f460275-565f-4737-a3df-bf80b9acc2681
313412tizanidine 2 MG Oral TabletSCD2f460275-565f-4737-a3df-bf80b9acc2681
313413tizanidine 4 MG Oral TabletSCD2f460275-565f-4737-a3df-bf80b9acc2681
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY2f460275-565f-4737-a3df-bf80b9acc2681
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY2f460275-565f-4737-a3df-bf80b9acc2681

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-338-00764200338001000 TABLET in 1 BOTTLE (76420-338-00) 1000 tablet2025-05-02NoNoHistorical
76420-338-1576420033815150 TABLET in 1 BOTTLE (76420-338-15) 150 tablet2025-05-02NoNoHistorical
76420-338-307642003383030 TABLET in 1 BOTTLE (76420-338-30) 30 tablet2025-05-02NoNoHistorical
76420-338-607642003386060 TABLET in 1 BOTTLE (76420-338-60) 60 tablet2025-05-02NoNoHistorical
76420-338-907642003389090 TABLET in 1 BOTTLE (76420-338-90) 90 tablet2025-05-02NoNoHistorical