FDA.reportPublic FDA data

Tizanidine

Product NDC
71335-0914
11-digit product format
713350914
Labeler code
71335
Product ID
71335-0914_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
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
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
71335-0914-0Tizanidine112 in 1 BOTTLETABLET11212
71335-0914-1Tizanidine30 in 1 BOTTLETABLET3012
71335-0914-2Tizanidine60 in 1 BOTTLETABLET6012
71335-0914-3Tizanidine90 in 1 BOTTLETABLET9012
71335-0914-4Tizanidine120 in 1 BOTTLETABLET12012
71335-0914-5Tizanidine20 in 1 BOTTLETABLET2012
71335-0914-6Tizanidine45 in 1 BOTTLETABLET4512
71335-0914-7Tizanidine140 in 1 BOTTLETABLET14012
71335-0914-8Tizanidine84 in 1 BOTTLETABLET8412
71335-0914-9Tizanidine28 in 1 BOTTLETABLET2812

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0914-0EA - Each71335-091484501de6-8555-45cb-8bd3-5bfd94a5ba1b12018-12-13
71335-0914-1EA - Each71335-0914ddf9b05a-6621-4cf8-af80-33f38dc396a012018-12-13
71335-0914-2EA - Each71335-0914fcdc6394-d17e-423e-9894-29a61564e88112018-12-13
71335-0914-3EA - Each71335-09144b744acb-ca81-40f6-92cf-7932e10af92e12018-12-13
71335-0914-4EA - Each71335-0914b44e8c60-71c8-4863-b4c3-3af0c57253ae12018-12-13
71335-0914-5EA - Each71335-09141b900523-bef1-405d-aa92-548c666b071312018-12-13
71335-0914-6EA - Each71335-0914405f282d-7a0a-45ab-93b1-bc0efe69738f12018-12-13
71335-0914-8EA - Each71335-0914f70598d8-3696-46a5-88c0-2abd2de2c08712018-12-13
71335-0914-9EA - Each71335-09146387f909-c67b-4e19-986b-97ed0514d7fa12018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0914TIZANIDINE 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
71335-0914-071335091400112 TABLET in 1 BOTTLE (71335-0914-0) 112 tablet2024-07-090000-00-00NoNoCurrent
71335-0914-17133509140130 TABLET in 1 BOTTLE (71335-0914-1) 30 tablet2024-07-090000-00-00NoNoCurrent
71335-0914-27133509140260 TABLET in 1 BOTTLE (71335-0914-2) 60 tablet2024-07-090000-00-00NoNoCurrent
71335-0914-37133509140390 TABLET in 1 BOTTLE (71335-0914-3) 90 tablet2024-07-090000-00-00NoNoCurrent
71335-0914-471335091404120 TABLET in 1 BOTTLE (71335-0914-4) 120 tablet2024-07-090000-00-00NoNoCurrent
71335-0914-57133509140520 TABLET in 1 BOTTLE (71335-0914-5) 20 tablet2024-07-090000-00-00NoNoCurrent
71335-0914-67133509140645 TABLET in 1 BOTTLE (71335-0914-6) 45 tablet2024-07-090000-00-00NoNoCurrent
71335-0914-771335091407140 TABLET in 1 BOTTLE (71335-0914-7) 140 tablet2024-07-090000-00-00NoNoCurrent
71335-0914-87133509140884 TABLET in 1 BOTTLE (71335-0914-8) 84 tablet2024-07-090000-00-00NoNoCurrent
71335-0914-97133509140928 TABLET in 1 BOTTLE (71335-0914-9) 28 tablet2024-07-090000-00-00NoNoCurrent