TIZANIDINE

Product NDC
61919-221
Requested package NDC
61919-221-86
11-digit product format
619190221
Labeler code
61919
Product ID
61919-221_eac3d220-1419-7750-e053-2a95a90a6f04
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TIZANIDINE
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA076533
Marketing category
ANDA
Marketing start
2019-09-30
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage61919-22161919-221-86DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A076533-001TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2004-01-16
A076533-002TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2004-01-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076533-001AB
A076533-002AB

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.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076533-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2004-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07A076533-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2004-01-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076533-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2004-01-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076533-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2004-01-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076533-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2004-01-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076533-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2004-01-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A076533-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2004-01-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076533-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2004-01-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076533-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2004-01-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076533-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2004-01-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076533-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2004-01-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076533-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2004-01-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076533-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2004-01-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076533-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2004-01-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076533-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2004-01-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076533-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2004-01-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076533-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2004-01-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076533-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2004-01-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076533-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2004-01-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076533-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2004-01-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076533-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2004-01-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A076533-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2004-01-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076533-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2004-01-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076533-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2004-01-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076533-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2004-01-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076533-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2004-01-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076533-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2004-01-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076533-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2004-01-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076533-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2004-01-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076533-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2004-01-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076533-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2004-01-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076533-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2004-01-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076533-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2004-01-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076533-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2004-01-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076533-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2004-01-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076533-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2004-01-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076533-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2004-01-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076533-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2004-01-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076533-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2004-01-16bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076533-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2004-01-16bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076533-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076533-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076533-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076533-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076533-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076533-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076533-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076533-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076533-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076533-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076533-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076533-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076533-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076533-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076533-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076533-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076533-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076533-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076533-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076533-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076533-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076533-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076533-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076533-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076533-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076533-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076533-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076533-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076533-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076533-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076533-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076533-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076533-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076533-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076533-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076533-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076533-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076533-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076533-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076533-002AB1bb7c543d1eb4…

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
61919-221-722020-01-31C16284748780-19d75b9d0-7aad-f424-e053-dadaa90a57ceTIZANIDINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-221-30TIZANIDINE30 in 1 BOTTLETABLET302
61919-221-60TIZANIDINE60 in 1 BOTTLETABLET602
61919-221-72TIZANIDINE120 in 1 BOTTLETABLET1202
61919-221-90TIZANIDINE90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-221-15EA - Each61919-221215117cd-08bd-4a81-adc0-138a7beb7df112019-10-07
61919-221-30EA - Each61919-2212f58fb4b-1857-4b5d-b1a2-21b1f5adfca412014-07-02
61919-221-60EA - Each61919-2215dfe56f5-ffbc-4a49-a4e1-0df0d9c16dd612014-10-03
61919-221-72EA - Each61919-221f104c843-417f-4436-9227-e72cfdfefc6312014-07-02
61919-221-86EA - Each61919-2210fbd2fee-4a39-458c-a7ac-9926c6f60a1d12019-09-05
61919-221-90EA - Each61919-2218080cee6-a39a-4bc1-9868-cb20d50852f712014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TIZANIDINE HYDROCHLORIDEACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [DIRECT RX]2
TIZANIDINEACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [DIRECT RX]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [DIRECT RX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [DIRECT RX]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [DIRECT RX]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE TABLET [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-221TIZANIDINE TABLET [DIRECT RX]2Legacy NDC, 4 package rows20151106_54bd58ee-76f6-44e7-83bb-fe752c3cbf9a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
tizanidineTIZANIDINEMajor Pharmaceuticalsd24e0cda-a22f-404f-b861-f85090cef0992026-06-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076533
application number: ANDA076533
tizanidineTIZANIDINEPreferred Pharmaceuticals Inc.f0e4eb26-6733-4df6-bb3c-86bf4d976f422025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076533
application number: ANDA076533
tizanidineTIZANIDINECardinal Health 107, LLCeeb18068-75c8-42d0-a006-1b134648333f2025-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076533
application number: ANDA076533
tizanidineTIZANIDINEApotex Corp.01c0d3d3-2373-a1b7-822a-80a66291a2482025-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076533
application number: ANDA076533
tizanidineTIZANIDINEAphena Pharma Solutions - Tennessee, LLCef7673f4-e0c1-4d79-af36-2f2ed2cc28f72025-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076533
application number: ANDA076533
tizanidineTIZANIDINEProficient Rx LPcf77e63c-a62a-43fc-8705-0558925e04e82022-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076533
application number: ANDA076533
tizanidineTIZANIDINEAphena Pharma Solutions - Tennessee, LLCd3b8d863-d13d-467c-97bf-5db9708036db2020-08-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076533
application number: ANDA076533

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSN54bd58ee-76f6-44e7-83bb-fe752c3cbf9a2
313413tiZANidine HCl 4 MG Oral TabletPSN54bd58ee-76f6-44e7-83bb-fe752c3cbf9a2
313412tizanidine 2 MG Oral TabletSCD54bd58ee-76f6-44e7-83bb-fe752c3cbf9a2
313413tizanidine 4 MG Oral TabletSCD54bd58ee-76f6-44e7-83bb-fe752c3cbf9a2
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY54bd58ee-76f6-44e7-83bb-fe752c3cbf9a2
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY54bd58ee-76f6-44e7-83bb-fe752c3cbf9a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-221-8661919022186270 TABLET in 1 BOTTLE (61919-221-86) 270 tablet2019-08-130000-00-00NoNoCurrent