FDA.reportPublic FDA data

Tizanidine

Product NDC
51655-740
11-digit product format
516550740
Labeler code
51655
Product ID
51655-740_495152d8-6067-6142-e063-6394a90ae6b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA076416
Marketing category
ANDA
Marketing start
2022-09-23
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
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
51655-740-26Tizanidine90 in 1 BOTTLE, PLASTICTABLET902
51655-740-52Tizanidine30 in 1 BOTTLE, PLASTICTABLET302
51655-740-54Tizanidine15 in 1 BOTTLE, PLASTICTABLET152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-740TIZANIDINE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1Current NDC, 3 package rows20230301_f32f399f-42af-f0ba-e053-2a95a90a8c2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSNf32f399f-42af-f0ba-e053-2a95a90a8c2e2
313413tizanidine 4 MG Oral TabletSCDf32f399f-42af-f0ba-e053-2a95a90a8c2e2
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYf32f399f-42af-f0ba-e053-2a95a90a8c2e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-740-265165507402690 TABLET in 1 BOTTLE, PLASTIC (51655-740-26) 90 tablet2022-10-07NoNoHistorical
51655-740-525165507405230 TABLET in 1 BOTTLE, PLASTIC (51655-740-52) 30 tablet2022-09-26NoNoHistorical
51655-740-545165507405415 TABLET in 1 BOTTLE, PLASTIC (51655-740-54) 15 tablet2022-09-23NoNoHistorical