FDA.reportPublic FDA data

Tizanidine

Product NDC
70518-3181
11-digit product format
705183181
Labeler code
70518
Product ID
70518-3181_4ecb797f-e7d0-0305-e063-6394a90ad178
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076416
Marketing category
ANDA
Marketing start
2021-08-05
Substance
TIZANIDINE HYDROCHLORIDE
Active strength
2 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 HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui313412

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
70518-3181-0Tizanidine60 in 1 BOTTLE, PLASTICTABLET606
70518-3181-1Tizanidine30 in 1 BOTTLE, PLASTICTABLET306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3181TIZANIDINE TABLET [REMEDYREPACK INC.]4Current NDC, Legacy NDC, 2 package rows20240315_f041e5f7-c138-4622-98bf-881f9a649a26.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSNf041e5f7-c138-4622-98bf-881f9a649a266
313412tizanidine 2 MG Oral TabletSCDf041e5f7-c138-4622-98bf-881f9a649a266
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSYf041e5f7-c138-4622-98bf-881f9a649a266

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3181-07051831810060 TABLET in 1 BOTTLE, PLASTIC (70518-3181-0) 60 tablet2021-08-050000-00-00NoNoCurrent
70518-3181-17051831810130 TABLET in 1 BOTTLE, PLASTIC (70518-3181-1) 30 tablet2022-03-220000-00-00NoNoCurrent