FDA.reportPublic FDA data

tizanidine

Product NDC
72578-097
11-digit product format
725780097
Labeler code
72578
Product ID
72578-097_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
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208187-001TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2018-03-09
A208187-002TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2018-03-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A208187-001AB
A208187-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A208187-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2018-03-09a50c72e98297…
2026-08-01 22:54:322026-06A208187-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2018-03-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208187-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A208187-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
tizanidineTIZANIDINEREMEDYREPACK INC.63b7eba3-6dea-4d89-bc42-7e965ae9795d2025-09-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208187
application number: ANDA208187
tizanidineTIZANIDINEViona Pharmaceuticals Inc8ac00d59-bb80-4530-afe7-90e04a2130b22025-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208187
application number: ANDA208187
ndc (product): 72578-097
tizanidineTIZANIDINEAdvanced Rx of Tennessee, LLC30caf3b3-8c1b-268e-e063-6294a90a3c8a2025-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208187
application number: ANDA208187
tizanidineTIZANIDINECoupler LLC2d9a2492-d914-f87b-e063-6394a90a38c62025-02-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208187
application number: ANDA208187
tizanidineTIZANIDINENuCare Pharmaceuticals, Inc.26cffb1f-21a0-017f-e063-6394a90afb1a2025-01-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208187
application number: ANDA208187
TizanidineTIZANIDINEAdvanced Rx of Tennessee, LLC21b7c8a8-ee07-a204-e063-6394a90a285b2025-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208187
application number: ANDA208187
tizanidineTIZANIDINEAsclemed USA, Inc.a9ba9023-0c3f-4c9b-ba8e-d39d23bf35d62024-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208187
application number: ANDA208187
tizanidineTIZANIDINEZydus Lifesciences Limited89105a78-badb-469e-966e-195fa3a53f0a2024-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208187
application number: ANDA208187
tizanidineTIZANIDINEAdvanced Rx of Tennessee, LLC2788942d-87fa-e514-e063-6294a90a09712024-11-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208187
application number: ANDA208187
tizanidineTIZANIDINENCS HealthCare of KY, LLC dba Vangard Labsc8278b4e-cca2-4880-8924-c8202ce084d62024-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208187
application number: ANDA208187

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
B53E3NMY5CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313412Internal RxNorm lookup
313413Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ac00d59-bb80-4530-afe7-90e04a2130b2Available on FDA.report

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
72578-097-06tizanidine30 in 1 BOTTLETABLET306
72578-097-10tizanidine1000 in 1 BOTTLETABLET10006
72578-097-21tizanidine150 in 1 BOTTLETABLET1506
72578-097-30tizanidine10 in 1 BLISTER PACKTABLET106
72578-097-76tizanidine300 in 1 BOTTLETABLET3006
72578-097-77tizanidine10 in 1 CARTONTABLET106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-097-10EA - Each72578-097f497f04d-9804-4155-a8a5-7d7918c5452712023-01-09
72578-097-21EA - Each72578-097344ece01-3879-4b56-aba3-75b3257b523112023-01-09
72578-097-76EA - Each72578-09710c9be9e-bdeb-4dc3-9e8e-024b38373e3012023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-097TIZANIDINE TABLET [VIONA PHARMACEUTICALS INC]5Current NDC, Legacy NDC, 6 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
313413tiZANidine HCl 4 MG Oral TabletPSN63b7eba3-6dea-4d89-bc42-7e965ae9795d4
313413tizanidine 4 MG Oral TabletSCD63b7eba3-6dea-4d89-bc42-7e965ae9795d4
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY63b7eba3-6dea-4d89-bc42-7e965ae9795d4
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 TabletSYc8278b4e-cca2-4880-8924-c8202ce084d63
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY21b7c8a8-ee07-a204-e063-6394a90a285b3
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
313413tiZANidine HCl 4 MG Oral TabletPSN26cffb1f-21a0-017f-e063-6394a90afb1a2
313413tizanidine 4 MG Oral TabletSCD26cffb1f-21a0-017f-e063-6394a90afb1a2
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY26cffb1f-21a0-017f-e063-6394a90afb1a2
313412tiZANidine HCl 2 MG Oral TabletPSNa9ba9023-0c3f-4c9b-ba8e-d39d23bf35d61
313413tiZANidine HCl 4 MG Oral TabletPSNa9ba9023-0c3f-4c9b-ba8e-d39d23bf35d61
313413tiZANidine HCl 4 MG Oral TabletPSN2788942d-87fa-e514-e063-6294a90a09711
313413tiZANidine HCl 4 MG Oral TabletPSN2d9a2492-d914-f87b-e063-6394a90a38c61
313412tizanidine 2 MG Oral TabletSCDa9ba9023-0c3f-4c9b-ba8e-d39d23bf35d61
313413tizanidine 4 MG Oral TabletSCDa9ba9023-0c3f-4c9b-ba8e-d39d23bf35d61
313413tizanidine 4 MG Oral TabletSCD2788942d-87fa-e514-e063-6294a90a09711
313413tizanidine 4 MG Oral TabletSCD2d9a2492-d914-f87b-e063-6394a90a38c61
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSYa9ba9023-0c3f-4c9b-ba8e-d39d23bf35d61
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYa9ba9023-0c3f-4c9b-ba8e-d39d23bf35d61
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY2d9a2492-d914-f87b-e063-6394a90a38c61
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY2788942d-87fa-e514-e063-6294a90a09711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72578-097-067257800970630 TABLET in 1 BOTTLE (72578-097-06) 30 tablet2021-03-040000-00-00NoNoCurrent
72578-097-10725780097101000 TABLET in 1 BOTTLE (72578-097-10) 1000 tablet2021-03-040000-00-00NoNoCurrent
72578-097-2172578009721150 TABLET in 1 BOTTLE (72578-097-21) 150 tablet2021-03-040000-00-00NoNoCurrent
72578-097-307257800973010 in 1 BLISTER PACKHistorical
72578-097-7672578009776300 TABLET in 1 BOTTLE (72578-097-76) 300 tablet2021-03-040000-00-00NoNoCurrent
72578-097-777257800977710 BLISTER PACK in 1 CARTON (72578-097-77) / 10 TABLET in 1 BLISTER PACK (72578-097-30) 10 blister pack2021-03-040000-00-00NoNoCurrent