FDA.reportPublic FDA data

Tizanidine

Product NDC
70518-0133
11-digit product format
705180133
Labeler code
70518
Product ID
70518-0133_4cd77f47-a8ee-d06d-e063-6394a90a5661
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076286
Marketing category
ANDA
Marketing start
2017-01-07
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tizanidine
Listing expiration
2027-12-31

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
70518-0133-0Tizanidine60 in 1 BOTTLETABLET6020
70518-0133-1Tizanidine90 in 1 BOTTLE, PLASTICTABLET9020
70518-0133-2Tizanidine15 in 1 BOTTLE, PLASTICTABLET1520
70518-0133-3Tizanidine30 in 1 BOTTLE, PLASTICTABLET3020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-0133-0EA - Each70518-01331e70cbef-8da1-45cf-a8a6-d7107648b44512026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0133TIZANIDINE TABLET [REMEDYREPACK INC.]14Current NDC, Legacy NDC, 4 package rows20250529_59084f59-9a9b-49f0-a9f4-27f3eab9a228.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSN59084f59-9a9b-49f0-a9f4-27f3eab9a22820
313413tizanidine 4 MG Oral TabletSCD59084f59-9a9b-49f0-a9f4-27f3eab9a22820
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY59084f59-9a9b-49f0-a9f4-27f3eab9a22820

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0133-07051801330060 TABLET in 1 BOTTLE (70518-0133-0) 60 tablet2017-01-070000-00-00NoNoCurrent
70518-0133-17051801330190 TABLET in 1 BOTTLE, PLASTIC (70518-0133-1) 90 tablet2017-04-050000-00-00NoNoCurrent
70518-0133-27051801330215 TABLET in 1 BOTTLE, PLASTIC (70518-0133-2) 15 tablet2017-08-300000-00-00NoNoCurrent
70518-0133-37051801330330 TABLET in 1 BOTTLE, PLASTIC (70518-0133-3) 30 tablet2021-01-070000-00-00NoNoCurrent