FDA.reportPublic FDA data

Tizanidine

Product NDC
71335-1016
11-digit product format
713351016
Labeler code
71335
Product ID
71335-1016_f623a735-841a-4e73-ae38-e4d5d27a055f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
71335-1016-0Tizanidine112 in 1 BOTTLETABLET1125
71335-1016-1Tizanidine30 in 1 BOTTLETABLET305
71335-1016-2Tizanidine60 in 1 BOTTLETABLET605
71335-1016-3Tizanidine90 in 1 BOTTLETABLET905
71335-1016-4Tizanidine120 in 1 BOTTLETABLET1205
71335-1016-5Tizanidine20 in 1 BOTTLETABLET205
71335-1016-6Tizanidine45 in 1 BOTTLETABLET455
71335-1016-7Tizanidine140 in 1 BOTTLETABLET1405
71335-1016-8Tizanidine84 in 1 BOTTLETABLET845
71335-1016-9Tizanidine28 in 1 BOTTLETABLET285

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1016TIZANIDINE TABLET [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 10 package rows20250519_03fa03a6-fd05-4f17-872a-3c123330935d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSN03fa03a6-fd05-4f17-872a-3c123330935d5
313413tizanidine 4 MG Oral TabletSCD03fa03a6-fd05-4f17-872a-3c123330935d5
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY03fa03a6-fd05-4f17-872a-3c123330935d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1016-071335101600112 TABLET in 1 BOTTLE (71335-1016-0) 112 tablet2022-02-020000-00-00NoNoCurrent
71335-1016-17133510160130 TABLET in 1 BOTTLE (71335-1016-1) 30 tablet2019-03-110000-00-00NoNoCurrent
71335-1016-27133510160260 TABLET in 1 BOTTLE (71335-1016-2) 60 tablet2019-01-150000-00-00NoNoCurrent
71335-1016-37133510160390 TABLET in 1 BOTTLE (71335-1016-3) 90 tablet2019-01-170000-00-00NoNoCurrent
71335-1016-471335101604120 TABLET in 1 BOTTLE (71335-1016-4) 120 tablet2019-03-050000-00-00NoNoCurrent
71335-1016-57133510160520 TABLET in 1 BOTTLE (71335-1016-5) 20 tablet2019-02-190000-00-00NoNoCurrent
71335-1016-67133510160645 TABLET in 1 BOTTLE (71335-1016-6) 45 tablet2019-06-210000-00-00NoNoCurrent
71335-1016-771335101607140 TABLET in 1 BOTTLE (71335-1016-7) 140 tablet2022-02-020000-00-00NoNoCurrent
71335-1016-87133510160884 TABLET in 1 BOTTLE (71335-1016-8) 84 tablet2022-02-020000-00-00NoNoCurrent
71335-1016-97133510160928 TABLET in 1 BOTTLE (71335-1016-9) 28 tablet2022-02-020000-00-00NoNoCurrent