FDA.reportPublic FDA data

tizanidine

Product NDC
80425-0454
11-digit product format
804250454
Labeler code
80425
Product ID
80425-0454_27889dea-01b2-ed7b-e063-6394a90acbc8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA208187
Marketing category
ANDA
Marketing start
2024-11-22
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
80425-0454-1tizanidine30 in 1 BOTTLETABLET301
80425-0454-2tizanidine60 in 1 BOTTLETABLET601
80425-0454-3tizanidine90 in 1 BOTTLETABLET901
80425-0454-4tizanidine120 in 1 BOTTLETABLET1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0454-1EA - Each80425-045459314f61-3ca9-4dbf-9c20-a68026d9372412025-02-10
80425-0454-2EA - Each80425-0454df3b3567-7543-4523-acd5-5da277072ab212025-02-10
80425-0454-3EA - Each80425-0454a04c2047-b453-4d36-abf0-d1703d6cd9fd12025-02-10
80425-0454-4EA - Each80425-045442607073-6ce8-4ace-9e95-e3cc12b5860a12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0454TIZANIDINE TABLET [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 4 package rows20241207_2788942d-87fa-e514-e063-6294a90a0971.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSN2788942d-87fa-e514-e063-6294a90a09711
313413tizanidine 4 MG Oral TabletSCD2788942d-87fa-e514-e063-6294a90a09711
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY2788942d-87fa-e514-e063-6294a90a09711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0454-18042504540130 TABLET in 1 BOTTLE (80425-0454-1) 30 tablet2024-11-22NoNoHistorical
80425-0454-28042504540260 TABLET in 1 BOTTLE (80425-0454-2) 60 tablet2024-11-22NoNoHistorical
80425-0454-38042504540390 TABLET in 1 BOTTLE (80425-0454-3) 90 tablet2024-11-22NoNoHistorical
80425-0454-480425045404120 TABLET in 1 BOTTLE (80425-0454-4) 120 tablet2024-11-22NoNoHistorical