Tizanidine

Product NDC
71335-0424
11-digit product format
713350424
Labeler code
71335
Product ID
71335-0424_2ea6e19f-4a23-453c-b9e0-3a7a6a1be92e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091283
Marketing category
ANDA
Marketing start
2013-04-01
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
71335-0424-0Tizanidine40 in 1 BOTTLETABLET4012
71335-0424-1Tizanidine30 in 1 BOTTLETABLET3012
71335-0424-2Tizanidine60 in 1 BOTTLETABLET6012
71335-0424-3Tizanidine90 in 1 BOTTLETABLET9012
71335-0424-4Tizanidine120 in 1 BOTTLETABLET12012
71335-0424-5Tizanidine100 in 1 BOTTLETABLET10012
71335-0424-6Tizanidine84 in 1 BOTTLETABLET8412
71335-0424-7Tizanidine28 in 1 BOTTLETABLET2812
71335-0424-8Tizanidine21 in 1 BOTTLETABLET2112
71335-0424-9Tizanidine160 in 1 BOTTLETABLET16012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0424-1EA - Each71335-0424e7bb5ac7-f506-4daf-8911-50a2ec42eb2712022-11-07
71335-0424-2EA - Each71335-0424c6637346-b492-418a-bf08-6f1729687d5012018-09-05
71335-0424-3EA - Each71335-04241f7ca764-5bd8-4e9c-9b41-f54def16640112022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0424TIZANIDINE TABLET [BRYANT RANCH PREPACK]12Current NDC, Legacy NDC, 10 package rows20250221_f87e30ce-a60a-41e3-b5d6-7e2966143961.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSNf87e30ce-a60a-41e3-b5d6-7e296614396112
313413tiZANidine HCl 4 MG Oral TabletPSNf87e30ce-a60a-41e3-b5d6-7e296614396112
313412tizanidine 2 MG Oral TabletSCDf87e30ce-a60a-41e3-b5d6-7e296614396112
313413tizanidine 4 MG Oral TabletSCDf87e30ce-a60a-41e3-b5d6-7e296614396112
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSYf87e30ce-a60a-41e3-b5d6-7e296614396112
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYf87e30ce-a60a-41e3-b5d6-7e296614396112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0424-07133504240040 TABLET in 1 BOTTLE (71335-0424-0) 40 tablet2024-07-09NoNoHistorical
71335-0424-17133504240130 TABLET in 1 BOTTLE (71335-0424-1) 30 tablet2018-04-250000-00-00NoNoCurrent
71335-0424-27133504240260 TABLET in 1 BOTTLE (71335-0424-2) 60 tablet2018-04-180000-00-00NoNoCurrent
71335-0424-37133504240390 TABLET in 1 BOTTLE (71335-0424-3) 90 tablet2018-02-140000-00-00NoNoCurrent
71335-0424-471335042404120 TABLET in 1 BOTTLE (71335-0424-4) 120 tablet2018-04-250000-00-00NoNoCurrent
71335-0424-571335042405100 TABLET in 1 BOTTLE (71335-0424-5) 100 tablet2024-07-090000-00-00NoNoCurrent
71335-0424-67133504240684 TABLET in 1 BOTTLE (71335-0424-6) 84 tablet2024-07-090000-00-00NoNoCurrent
71335-0424-77133504240728 TABLET in 1 BOTTLE (71335-0424-7) 28 tablet2024-07-090000-00-00NoNoCurrent
71335-0424-87133504240821 TABLET in 1 BOTTLE (71335-0424-8) 21 tablet2024-07-090000-00-00NoNoCurrent
71335-0424-971335042409160 TABLET in 1 BOTTLE (71335-0424-9) 160 tablet2024-07-090000-00-00NoNoCurrent