tizanidine

Product NDC
0904-6418
11-digit product format
009046418
Labeler code
0904
Product ID
0904-6418_922b5a2a-5a35-41e0-927c-836f2ff11523
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA076533
Marketing category
ANDA
Marketing start
2014-10-01
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
0904-6418-61tizanidine1 in 1 BLISTER PACKTABLET112
0904-6418-61tizanidine100 in 1 CARTONTABLET10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6418-61EA - Each0904-641822d6f6e0-847a-4b72-a9bd-89b1c6ae6b1812014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TIZANIDINE HYDROCHLORIDEACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [MAJOR PHARMACEUTICALS]2
TIZANIDINEACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [MAJOR PHARMACEUTICALS]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [MAJOR PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [MAJOR PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [MAJOR PHARMACEUTICALS]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE TABLET [MAJOR PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6418TIZANIDINE TABLET [MAJOR PHARMACEUTICALS]11Current NDC, Legacy NDC, 2 package rows20250213_d24e0cda-a22f-404f-b861-f85090cef099.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSNd24e0cda-a22f-404f-b861-f85090cef09912
313413tizanidine 4 MG Oral TabletSCDd24e0cda-a22f-404f-b861-f85090cef09912
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYd24e0cda-a22f-404f-b861-f85090cef09912
313413tiZANidine HCl 4 MG Oral TabletPSNeeb18068-75c8-42d0-a006-1b134648333f6
313413tizanidine 4 MG Oral TabletSCDeeb18068-75c8-42d0-a006-1b134648333f6
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYeeb18068-75c8-42d0-a006-1b134648333f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6418-6100904641861100 BLISTER PACK in 1 CARTON (0904-6418-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2014-10-010000-00-00NoNoCurrent