Tizanidine

Product NDC
50090-5767
11-digit product format
500905767
Labeler code
50090
Product ID
50090-5767_e68d46ad-efb1-4422-9320-154acf969626
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091283
Marketing category
ANDA
Marketing start
2013-04-01
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

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
A091283-001TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2012-11-28
A091283-002TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2012-11-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091283-001AB
A091283-002AB

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091283-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2012-11-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091283-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2012-11-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091283-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2012-11-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091283-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2012-11-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A091283-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2012-11-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091283-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2012-11-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091283-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2012-11-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091283-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2012-11-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091283-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2012-11-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091283-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2012-11-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091283-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2012-11-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091283-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2012-11-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091283-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2012-11-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091283-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2012-11-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091283-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2012-11-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091283-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2012-11-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091283-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2012-11-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091283-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2012-11-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091283-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2012-11-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A091283-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2012-11-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091283-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2012-11-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091283-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2012-11-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091283-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2012-11-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091283-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2012-11-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091283-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2012-11-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091283-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2012-11-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091283-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2012-11-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091283-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2012-11-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091283-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2012-11-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091283-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2012-11-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091283-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2012-11-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091283-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2012-11-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091283-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2012-11-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091283-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2012-11-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091283-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2012-11-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091283-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2012-11-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091283-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2012-11-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091283-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2012-11-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091283-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2012-11-28782e0a99824c…
2021-12-28 21:50 UTC2021-12A091283-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2012-11-28782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091283-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091283-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091283-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091283-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091283-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091283-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091283-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091283-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091283-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091283-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091283-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091283-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091283-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091283-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091283-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091283-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091283-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091283-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091283-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091283-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091283-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091283-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091283-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091283-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091283-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091283-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091283-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091283-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091283-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091283-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091283-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091283-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091283-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091283-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091283-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091283-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091283-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091283-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091283-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A091283-002AB1782e0a99824c…

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 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
308d2fdc-6136-4e75-95d3-342497add66cAvailable 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
50090-5767-0Tizanidine120 in 1 BOTTLETABLET1207
50090-5767-2Tizanidine60 in 1 BOTTLETABLET607
50090-5767-3Tizanidine15 in 1 BOTTLETABLET157
50090-5767-4Tizanidine30 in 1 BOTTLETABLET307
50090-5767-6Tizanidine90 in 1 BOTTLETABLET907
50090-5767-7Tizanidine14 in 1 BOTTLETABLET147

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5767-0EA - Each50090-576757ee21dc-8c4c-47cb-a724-3f05abfdaac712022-12-07
50090-5767-2EA - Each50090-57672f5b75ce-3795-4430-ae9d-616b4e27bb3b12022-12-07
50090-5767-3EA - Each50090-57675dc4f0b8-6fd2-431d-816a-d1a15acb977112022-12-07
50090-5767-4EA - Each50090-5767aaf06a0b-988e-4c8f-ad5e-4dac4676861712022-12-07
50090-5767-6EA - Each50090-576713a8f35d-5e2e-4a20-99e4-978580c4cf2f12022-12-07
50090-5767-7EA - Each50090-5767293a4765-efd6-41cc-bd45-080afea5ed0c12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5767TIZANIDINE TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 6 package rows20231204_308d2fdc-6136-4e75-95d3-342497add66c.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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TizanidineTIZANIDINENuCare Pharmaceuticals,Inc.6dd9946f-b2a4-1732-e053-2a91aa0a648f2026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091283
application number: ANDA091283
TizanidineTIZANIDINEREMEDYREPACK INC.b14bd166-9f53-4f2e-be05-c447af04ef692026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091283
application number: ANDA091283
TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDE047c67cd-7a63-49c9-b100-71651d3537ba2026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091283
application number: ANDA091283
TIZANDINETIZANDINEDirect_Rx9003cb5d-f9d6-7183-e053-2995a90ad6e82026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091283
application number: ANDA091283
TizanidineTIZANIDINEA-S Medication Solutions308d2fdc-6136-4e75-95d3-342497add66c2026-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091283
application number: ANDA091283
ndc (product): 50090-5767
TizanidineTIZANIDINEA-S Medication Solutions9fd932fb-033c-4774-ac09-c823db8f97392026-02-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091283
application number: ANDA091283
TizanidineTIZANIDINERedpharm Drug49adcfc8-3b1d-7f7e-e063-6294a90a361e2026-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091283
application number: ANDA091283
TizanidineTIZANIDINEPD-Rx Pharmaceuticals, Inc.615dfd5c-125a-40e2-a6da-afacde3052822025-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091283
application number: ANDA091283
TizanidineTIZANIDINEUnichem Pharmaceuticals (USA), Inc.a3fa9c69-4baf-44f5-bac4-a19c34b0e1cb2025-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091283
application number: ANDA091283
TizanidineTIZANIDINEA-S Medication Solutions9678a98e-4aab-4d87-b5e1-37c3109e378e2025-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091283
application number: ANDA091283
TizanidineTIZANIDINEBryant Ranch Prepackf87e30ce-a60a-41e3-b5d6-7e29661439612025-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091283
application number: ANDA091283
TizanidineTIZANIDINEPreferred Pharmaceuticals Inc.6e97c1ba-8171-4707-98ee-61afed75daac2025-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091283
application number: ANDA091283
Tizanidine HCLTIZANIDINE HCLAdvanced Rx of Tennessee, LLCafc96ee6-c99b-7283-e053-2a95a90ad14d2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091283
application number: ANDA091283
TizanidineTIZANIDINEAdvanced Rx Pharmacy of Tennessee, LLCd2961d1c-5de2-0a2b-e053-2995a90ad2fc2024-09-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091283
application number: ANDA091283
TizanidineTIZANIDINEProficient Rx LPe13b111a-25b7-4fdd-a102-30f2996722f32024-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091283
application number: ANDA091283
TizanidineTIZANIDINEProficient Rx LP5b7b4721-e6fa-4586-ac40-091ad363ee852022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091283
application number: ANDA091283
TizanidineTIZANIDINEAphena Pharma Solutions - Tennessee, LLCea242c7d-b101-4197-8e65-b2b079e3b2b62019-02-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091283
application number: ANDA091283

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSN308d2fdc-6136-4e75-95d3-342497add66c7
313413tizanidine 4 MG Oral TabletSCD308d2fdc-6136-4e75-95d3-342497add66c7
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY308d2fdc-6136-4e75-95d3-342497add66c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5767-050090576700120 TABLET in 1 BOTTLE (50090-5767-0) 120 tablet2021-10-040000-00-00NoNoCurrent
50090-5767-25009057670260 TABLET in 1 BOTTLE (50090-5767-2) 60 tablet2021-10-040000-00-00NoNoCurrent
50090-5767-35009057670315 TABLET in 1 BOTTLE (50090-5767-3) 15 tablet2021-10-040000-00-00NoNoCurrent
50090-5767-45009057670430 TABLET in 1 BOTTLE (50090-5767-4) 30 tablet2021-10-040000-00-00NoNoCurrent
50090-5767-65009057670690 TABLET in 1 BOTTLE (50090-5767-6) 90 tablet2021-10-040000-00-00NoNoCurrent
50090-5767-75009057670714 TABLET in 1 BOTTLE (50090-5767-7) 14 tablet2021-10-040000-00-00NoNoCurrent