FDA.reportPublic FDA data

tizanidine

Product NDC
70518-4181
11-digit product format
705184181
Labeler code
70518
Product ID
70518-4181_3ff1afa9-91d2-aab5-e063-6394a90a28d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA208187
Marketing category
ANDA
Marketing start
2024-09-23
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
70518-4181-0tizanidine90 in 1 BOTTLE, PLASTICTABLET904
70518-4181-1tizanidine30 in 1 BOTTLE, PLASTICTABLET304
70518-4181-2tizanidine30 in 1 BLISTER PACKTABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4181TIZANIDINE TABLET [REMEDYREPACK INC.]2Current NDC, 3 package rows20241102_63b7eba3-6dea-4d89-bc42-7e965ae9795d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSN63b7eba3-6dea-4d89-bc42-7e965ae9795d4
313413tizanidine 4 MG Oral TabletSCD63b7eba3-6dea-4d89-bc42-7e965ae9795d4
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY63b7eba3-6dea-4d89-bc42-7e965ae9795d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4181-07051841810090 TABLET in 1 BOTTLE, PLASTIC (70518-4181-0) 90 tablet2024-09-23NoNoCurrent
70518-4181-17051841810130 TABLET in 1 BOTTLE, PLASTIC (70518-4181-1) 30 tablet2024-10-30NoNoCurrent
70518-4181-27051841810230 TABLET in 1 BLISTER PACK (70518-4181-2) 30 tablet2025-08-10NoNoCurrent