FDA.reportPublic FDA data

Tizanidine

Product NDC
71335-1799
11-digit product format
713351799
Labeler code
71335
Product ID
71335-1799_eee9769d-c60c-477c-bad4-01b3acb68abc
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
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

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
71335-1799-0Tizanidine40 in 1 BOTTLETABLET40102
71335-1799-1Tizanidine30 in 1 BOTTLETABLET30102
71335-1799-2Tizanidine60 in 1 BOTTLETABLET60102
71335-1799-3Tizanidine90 in 1 BOTTLETABLET90102
71335-1799-4Tizanidine120 in 1 BOTTLETABLET120102
71335-1799-5Tizanidine100 in 1 BOTTLETABLET100102
71335-1799-6Tizanidine84 in 1 BOTTLETABLET84102
71335-1799-7Tizanidine28 in 1 BOTTLETABLET28102
71335-1799-8Tizanidine21 in 1 BOTTLETABLET21102
71335-1799-9Tizanidine160 in 1 BOTTLETABLET160102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1799-1EA - Each71335-17993a98a33f-7286-4880-b31c-43edaee3a68312022-11-07
71335-1799-2EA - Each71335-17998e9787be-4bc1-4b38-b050-e1febd6569a812023-02-06
71335-1799-3EA - Each71335-179997ca2e6e-a34c-4d39-8ce2-49a7e56718fc12023-10-16
71335-1799-4EA - Each71335-1799b72a7a8a-3154-43cd-88ca-b4bf273fc1c612023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1799TIZANIDINE TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 10 package rows20240830_e13292b0-9858-4405-8787-a2392d1b6d75.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSNe13292b0-9858-4405-8787-a2392d1b6d75102
313412tizanidine 2 MG Oral TabletSCDe13292b0-9858-4405-8787-a2392d1b6d75102
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSYe13292b0-9858-4405-8787-a2392d1b6d75102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1799-07133517990040 TABLET in 1 BOTTLE (71335-1799-0) 40 tablet2021-12-200000-00-00NoNoCurrent
71335-1799-17133517990130 TABLET in 1 BOTTLE (71335-1799-1) 30 tablet2021-12-200000-00-00NoNoCurrent
71335-1799-27133517990260 TABLET in 1 BOTTLE (71335-1799-2) 60 tablet2021-12-200000-00-00NoNoCurrent
71335-1799-37133517990390 TABLET in 1 BOTTLE (71335-1799-3) 90 tablet2021-12-200000-00-00NoNoCurrent
71335-1799-471335179904120 TABLET in 1 BOTTLE (71335-1799-4) 120 tablet2021-12-200000-00-00NoNoCurrent
71335-1799-571335179905100 TABLET in 1 BOTTLE (71335-1799-5) 100 tablet2021-12-200000-00-00NoNoCurrent
71335-1799-67133517990684 TABLET in 1 BOTTLE (71335-1799-6) 84 tablet2021-12-200000-00-00NoNoCurrent
71335-1799-77133517990728 TABLET in 1 BOTTLE (71335-1799-7) 28 tablet2021-12-200000-00-00NoNoCurrent
71335-1799-87133517990821 TABLET in 1 BOTTLE (71335-1799-8) 21 tablet2021-12-200000-00-00NoNoCurrent
71335-1799-971335179909160 TABLET in 1 BOTTLE (71335-1799-9) 160 tablet2021-12-200000-00-00NoNoCurrent