FDA.reportPublic FDA data

Tizanidine

Product NDC
70518-1598
11-digit product format
705181598
Labeler code
70518
Product ID
70518-1598_494e700b-3dad-f678-e063-6294a90abee0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA091283
Marketing category
ANDA
Marketing start
2018-10-26
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
70518-1598-0Tizanidine30 in 1 BLISTER PACKTABLET3012
70518-1598-1Tizanidine60 in 1 BOTTLE, PLASTICTABLET6012
70518-1598-2Tizanidine15 in 1 BOTTLE, PLASTICTABLET1512
70518-1598-3Tizanidine30 in 1 BOTTLE, PLASTICTABLET3012
70518-1598-4Tizanidine90 in 1 BOTTLE, PLASTICTABLET9012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSNb14bd166-9f53-4f2e-be05-c447af04ef6912
313413tizanidine 4 MG Oral TabletSCDb14bd166-9f53-4f2e-be05-c447af04ef6912
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYb14bd166-9f53-4f2e-be05-c447af04ef6912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1598-07051815980030 TABLET in 1 BLISTER PACK (70518-1598-0) 30 tablet2018-10-260000-00-00NoNoCurrent
70518-1598-17051815980160 TABLET in 1 BOTTLE, PLASTIC (70518-1598-1) 60 tablet2019-08-010000-00-00NoNoCurrent
70518-1598-27051815980215 TABLET in 1 BOTTLE, PLASTIC (70518-1598-2) 15 tablet2019-08-150000-00-00NoNoCurrent
70518-1598-37051815980330 TABLET in 1 BOTTLE, PLASTIC (70518-1598-3) 30 tablet2020-03-060000-00-00NoNoCurrent
70518-1598-47051815980490 TABLET in 1 BOTTLE, PLASTIC (70518-1598-4) 90 tablet2020-04-03NoNoCurrent