FDA.reportPublic FDA data

tizanidine

Product NDC
72578-096
11-digit product format
725780096
Labeler code
72578
Product ID
72578-096_8fd84300-3ed6-42ff-b20c-608ea5dc96eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA208187
Marketing category
ANDA
Marketing start
2021-03-04
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
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 HYDROCHLORIDE2 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
72578-096-06tizanidine30 in 1 BOTTLETABLET306
72578-096-10tizanidine1000 in 1 BOTTLETABLET10006
72578-096-21tizanidine150 in 1 BOTTLETABLET1506
72578-096-30tizanidine10 in 1 BLISTER PACKTABLET106
72578-096-77tizanidine10 in 1 CARTONTABLET106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-096-10EA - Each72578-096b1822fe3-201e-430e-b01e-4f5e1d46aa3012023-01-09
72578-096-21EA - Each72578-0960678ffd6-6f9d-4335-be42-6153255f377912023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-096TIZANIDINE TABLET [VIONA PHARMACEUTICALS INC]5Current NDC, Legacy NDC, 5 package rows20241220_8ac00d59-bb80-4530-afe7-90e04a2130b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSN8ac00d59-bb80-4530-afe7-90e04a2130b26
313413tiZANidine HCl 4 MG Oral TabletPSN8ac00d59-bb80-4530-afe7-90e04a2130b26
313412tizanidine 2 MG Oral TabletSCD8ac00d59-bb80-4530-afe7-90e04a2130b26
313413tizanidine 4 MG Oral TabletSCD8ac00d59-bb80-4530-afe7-90e04a2130b26
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY8ac00d59-bb80-4530-afe7-90e04a2130b26
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY8ac00d59-bb80-4530-afe7-90e04a2130b26
313412tiZANidine HCl 2 MG Oral TabletPSNc8278b4e-cca2-4880-8924-c8202ce084d63
313412tiZANidine HCl 2 MG Oral TabletPSN21b7c8a8-ee07-a204-e063-6394a90a285b3
313413tiZANidine HCl 4 MG Oral TabletPSNc8278b4e-cca2-4880-8924-c8202ce084d63
313413tiZANidine HCl 4 MG Oral TabletPSN21b7c8a8-ee07-a204-e063-6394a90a285b3
313412tizanidine 2 MG Oral TabletSCD21b7c8a8-ee07-a204-e063-6394a90a285b3
313412tizanidine 2 MG Oral TabletSCDc8278b4e-cca2-4880-8924-c8202ce084d63
313413tizanidine 4 MG Oral TabletSCD21b7c8a8-ee07-a204-e063-6394a90a285b3
313413tizanidine 4 MG Oral TabletSCDc8278b4e-cca2-4880-8924-c8202ce084d63
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY21b7c8a8-ee07-a204-e063-6394a90a285b3
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSYc8278b4e-cca2-4880-8924-c8202ce084d63
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY21b7c8a8-ee07-a204-e063-6394a90a285b3
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYc8278b4e-cca2-4880-8924-c8202ce084d63
313412tiZANidine HCl 2 MG Oral TabletPSN30caf3b3-8c1b-268e-e063-6294a90a3c8a1
313412tiZANidine HCl 2 MG Oral TabletPSNa9ba9023-0c3f-4c9b-ba8e-d39d23bf35d61
313413tiZANidine HCl 4 MG Oral TabletPSNa9ba9023-0c3f-4c9b-ba8e-d39d23bf35d61
313412tizanidine 2 MG Oral TabletSCDa9ba9023-0c3f-4c9b-ba8e-d39d23bf35d61
313412tizanidine 2 MG Oral TabletSCD30caf3b3-8c1b-268e-e063-6294a90a3c8a1
313413tizanidine 4 MG Oral TabletSCDa9ba9023-0c3f-4c9b-ba8e-d39d23bf35d61
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSYa9ba9023-0c3f-4c9b-ba8e-d39d23bf35d61
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY30caf3b3-8c1b-268e-e063-6294a90a3c8a1
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYa9ba9023-0c3f-4c9b-ba8e-d39d23bf35d61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72578-096-067257800960630 TABLET in 1 BOTTLE (72578-096-06) 30 tablet2021-03-040000-00-00NoNoCurrent
72578-096-10725780096101000 TABLET in 1 BOTTLE (72578-096-10) 1000 tablet2021-03-040000-00-00NoNoCurrent
72578-096-2172578009621150 TABLET in 1 BOTTLE (72578-096-21) 150 tablet2021-03-040000-00-00NoNoCurrent
72578-096-307257800963010 in 1 BLISTER PACKHistorical
72578-096-777257800967710 BLISTER PACK in 1 CARTON (72578-096-77) / 10 TABLET in 1 BLISTER PACK (72578-096-30) 10 blister pack2021-03-040000-00-00NoNoCurrent