FDA.reportPublic FDA data

Tizanidine

Product NDC
16714-172
11-digit product format
167140172
Labeler code
16714
Product ID
16714-172_a9995022-1f3f-f0dd-9672-60b074bfca01
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA076286
Marketing category
ANDA
Marketing start
2021-06-15
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tizanidine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui313412, 313413

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
16714-172-01Tizanidine150 in 1 BOTTLETABLET1502
16714-172-02Tizanidine1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-172-01EA - Each16714-17252cc5423-ca6e-4f2e-ac02-d01686a519d612021-09-07
16714-172-02EA - Each16714-172fb5d7b34-bb58-4db5-9cb7-3f4fb3a8dfe512021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-172TIZANIDINE TABLET [NORTHSTAR RX LLC]2Current NDC, Legacy NDC, 2 package rows20231227_eed74219-9d4a-fecd-1bb9-ad6c01ad3e9d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSN9bcc7f09-d2b5-4602-aaf3-5410b55ce2759
313413tizanidine 4 MG Oral TabletSCD9bcc7f09-d2b5-4602-aaf3-5410b55ce2759
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY9bcc7f09-d2b5-4602-aaf3-5410b55ce2759
313412tiZANidine HCl 2 MG Oral TabletPSNeed74219-9d4a-fecd-1bb9-ad6c01ad3e9d2
313413tiZANidine HCl 4 MG Oral TabletPSNeed74219-9d4a-fecd-1bb9-ad6c01ad3e9d2
313412tizanidine 2 MG Oral TabletSCDeed74219-9d4a-fecd-1bb9-ad6c01ad3e9d2
313413tizanidine 4 MG Oral TabletSCDeed74219-9d4a-fecd-1bb9-ad6c01ad3e9d2
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSYeed74219-9d4a-fecd-1bb9-ad6c01ad3e9d2
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYeed74219-9d4a-fecd-1bb9-ad6c01ad3e9d2
313412tiZANidine HCl 2 MG Oral TabletPSN81385ce2-1d82-4987-8e18-83c823e10b991
313413tiZANidine HCl 4 MG Oral TabletPSN81385ce2-1d82-4987-8e18-83c823e10b991
313413tiZANidine HCl 4 MG Oral TabletPSN67b2af93-92c9-4c33-8fa0-548bfcc9c5381
313413tiZANidine HCl 4 MG Oral TabletPSN247ae1f4-6ec8-4e34-aae4-13495d8f64e51
313412tizanidine 2 MG Oral TabletSCD81385ce2-1d82-4987-8e18-83c823e10b991
313413tizanidine 4 MG Oral TabletSCD81385ce2-1d82-4987-8e18-83c823e10b991
313413tizanidine 4 MG Oral TabletSCD67b2af93-92c9-4c33-8fa0-548bfcc9c5381
313413tizanidine 4 MG Oral TabletSCD247ae1f4-6ec8-4e34-aae4-13495d8f64e51
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY81385ce2-1d82-4987-8e18-83c823e10b991
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY247ae1f4-6ec8-4e34-aae4-13495d8f64e51
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY81385ce2-1d82-4987-8e18-83c823e10b991
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY67b2af93-92c9-4c33-8fa0-548bfcc9c5381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-172-0116714017201150 TABLET in 1 BOTTLE (16714-172-01) 150 tablet2021-06-150000-00-00NoNoCurrent
16714-172-02167140172021000 TABLET in 1 BOTTLE (16714-172-02) 1000 tablet2021-06-150000-00-00NoNoCurrent