FDA.reportPublic FDA data

Tizanidine

Product NDC
51655-603
11-digit product format
516550603
Labeler code
51655
Product ID
51655-603_4a65db4c-b8f9-9bba-e063-6394a90aa8bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA076286
Marketing category
ANDA
Marketing start
2021-02-19
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-603-202026-01-29C16284748780-149896155-be60-586f-e063-e6dba90add90These highlights do not include all the information needed to use TIZANIDINE TABLETS safely and effectively. See full prescribing information for TIZANIDINE TABLETS. TIZANIDINE tablets, for oral use Initial U.S. Approval: 1996
51655-603-262026-01-29C16284748780-149896155-be60-586f-e063-e6dba90add90These highlights do not include all the information needed to use TIZANIDINE TABLETS safely and effectively. See full prescribing information for TIZANIDINE TABLETS. TIZANIDINE tablets, for oral use Initial U.S. Approval: 1996
51655-603-522026-01-29C16284748780-149896155-be60-586f-e063-e6dba90add90These highlights do not include all the information needed to use TIZANIDINE TABLETS safely and effectively. See full prescribing information for TIZANIDINE TABLETS. TIZANIDINE tablets, for oral use Initial U.S. Approval: 1996
51655-603-542026-01-29C16284748780-149896155-be60-586f-e063-e6dba90add90These highlights do not include all the information needed to use TIZANIDINE TABLETS safely and effectively. See full prescribing information for TIZANIDINE TABLETS. TIZANIDINE tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-603-20Tizanidine20 in 1 BOTTLE, PLASTICTABLET203
51655-603-26Tizanidine90 in 1 BOTTLE, PLASTICTABLET903
51655-603-52Tizanidine30 in 1 BOTTLE, PLASTICTABLET303
51655-603-54Tizanidine15 in 1 BOTTLE, PLASTICTABLET153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-603TIZANIDINE TABLET [NORTHWIND PHARMACEUTICALS]1Current NDC, 4 package rows20230320_da31fbeb-3781-5e75-e053-2a95a90adb73.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSNda31fbeb-3781-5e75-e053-2a95a90adb733
313413tizanidine 4 MG Oral TabletSCDda31fbeb-3781-5e75-e053-2a95a90adb733
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYda31fbeb-3781-5e75-e053-2a95a90adb733

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-603-205165506032020 TABLET in 1 BOTTLE, PLASTIC (51655-603-20) 20 tablet2021-02-19NoNoCurrent
51655-603-265165506032690 TABLET in 1 BOTTLE, PLASTIC (51655-603-26) 90 tablet2021-04-01NoNoCurrent
51655-603-525165506035230 TABLET in 1 BOTTLE, PLASTIC (51655-603-52) 30 tablet2021-04-07NoNoCurrent
51655-603-545165506035415 TABLET in 1 BOTTLE, PLASTIC (51655-603-54) 15 tablet2021-07-19NoNoCurrent