FDA.reportPublic FDA data

tizanidine

Product NDC
68788-8741
11-digit product format
687888741
Labeler code
68788
Product ID
68788-8741_3c847e6e-2f52-43c6-9ba6-83729cb4662f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA076533
Marketing category
ANDA
Marketing start
2024-09-20
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
68788-8741-1tizanidine100 in 1 BOTTLETABLET1002
68788-8741-2tizanidine20 in 1 BOTTLETABLET202
68788-8741-3tizanidine30 in 1 BOTTLETABLET302
68788-8741-6tizanidine60 in 1 BOTTLETABLET602
68788-8741-8tizanidine120 in 1 BOTTLETABLET1202
68788-8741-9tizanidine90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8741-1EA - Each68788-87419f072945-e2ca-4c20-ac40-5fa4626b0e1712024-11-05
68788-8741-2EA - Each68788-874141d958a8-d7bb-407f-8185-d3cd3d1aec2012024-11-05
68788-8741-3EA - Each68788-87416e20413c-8f24-4339-8e56-7ef7f6f2479212024-11-05
68788-8741-6EA - Each68788-8741ee0e57d3-8446-411d-bcdd-ea446ce32db912024-12-10
68788-8741-8EA - Each68788-8741737a68e3-79ac-4040-8591-b3808ee4099f12024-12-10
68788-8741-9EA - Each68788-87411e59e21d-2953-4c0d-8e3c-c0f53595083c12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8741TIZANIDINE TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 6 package rows20240922_f0e4eb26-6733-4df6-bb3c-86bf4d976f42.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSNf0e4eb26-6733-4df6-bb3c-86bf4d976f422
313413tizanidine 4 MG Oral TabletSCDf0e4eb26-6733-4df6-bb3c-86bf4d976f422
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYf0e4eb26-6733-4df6-bb3c-86bf4d976f422

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8741-168788874101100 TABLET in 1 BOTTLE (68788-8741-1) 100 tablet2024-09-20NoNoHistorical
68788-8741-26878887410220 TABLET in 1 BOTTLE (68788-8741-2) 20 tablet2024-09-20NoNoHistorical
68788-8741-36878887410330 TABLET in 1 BOTTLE (68788-8741-3) 30 tablet2024-09-20NoNoHistorical
68788-8741-66878887410660 TABLET in 1 BOTTLE (68788-8741-6) 60 tablet2024-09-20NoNoHistorical
68788-8741-868788874108120 TABLET in 1 BOTTLE (68788-8741-8) 120 tablet2024-09-20NoNoHistorical
68788-8741-96878887410990 TABLET in 1 BOTTLE (68788-8741-9) 90 tablet2024-09-20NoNoHistorical