FDA.reportPublic FDA data

Tizanidine

Product NDC
80425-0453
11-digit product format
804250453
Labeler code
80425
Product ID
80425-0453_2aabf642-2907-a735-e063-6394a90a83b5
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
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
80425-0453-1Tizanidine30 in 1 BOTTLETABLET303
80425-0453-2Tizanidine60 in 1 BOTTLETABLET603
80425-0453-3Tizanidine90 in 1 BOTTLETABLET903
80425-0453-4Tizanidine120 in 1 BOTTLETABLET1203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0453-1EA - Each80425-0453629091da-5edc-4210-a14b-50f76fd7f1e712025-02-10
80425-0453-2EA - Each80425-0453f75bf974-64f2-4790-8222-784ef290ed6012025-02-10
80425-0453-3EA - Each80425-0453a17c403b-a48d-4413-81c1-c5b8019520d912025-02-10
80425-0453-4EA - Each80425-045341dfd915-5362-464d-be3c-26e29d094e3212025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0453TIZANIDINE TABLET [ADVANCED RX OF TENNESSEE, LLC]3Current NDC, 4 package rows20250103_21b7c8a8-ee07-a204-e063-6394a90a285b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSN21b7c8a8-ee07-a204-e063-6394a90a285b3
313413tiZANidine HCl 4 MG Oral TabletPSN21b7c8a8-ee07-a204-e063-6394a90a285b3
313412tizanidine 2 MG Oral TabletSCD21b7c8a8-ee07-a204-e063-6394a90a285b3
313413tizanidine 4 MG Oral TabletSCD21b7c8a8-ee07-a204-e063-6394a90a285b3
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY21b7c8a8-ee07-a204-e063-6394a90a285b3
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY21b7c8a8-ee07-a204-e063-6394a90a285b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0453-18042504530130 TABLET in 1 BOTTLE (80425-0453-1) 30 tablet2024-11-22NoNoHistorical
80425-0453-28042504530260 TABLET in 1 BOTTLE (80425-0453-2) 60 tablet2024-11-22NoNoHistorical
80425-0453-38042504530390 TABLET in 1 BOTTLE (80425-0453-3) 90 tablet2024-11-22NoNoHistorical
80425-0453-480425045304120 TABLET in 1 BOTTLE (80425-0453-4) 120 tablet2024-11-22NoNoHistorical