Tizanidine

Product NDC
71610-228
11-digit product format
716100228
Labeler code
71610
Product ID
71610-228_fb129009-348e-4512-a39f-e36fbf805c86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
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
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
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
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 · 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
ea242c7d-b101-4197-8e65-b2b079e3b2b6Available 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
71610-228-30Tizanidine30 in 1 BOTTLE, PLASTICTABLET301
71610-228-53Tizanidine60 in 1 BOTTLE, PLASTICTABLET601
71610-228-60Tizanidine90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-228-30EA - Each71610-228807fd5ae-d716-46e9-aaea-4d4ad03a2fc712019-04-11
71610-228-53EA - Each71610-228c2348246-0276-4ba1-be40-fa8bef22560012019-04-11
71610-228-60EA - Each71610-228ca87e753-3bf3-4dff-a575-d91d4dbafc3c12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-228TIZANIDINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 3 package rows20190214_ea242c7d-b101-4197-8e65-b2b079e3b2b6.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
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
ndc (product): 71610-228

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSNea242c7d-b101-4197-8e65-b2b079e3b2b61
313413tizanidine 4 MG Oral TabletSCDea242c7d-b101-4197-8e65-b2b079e3b2b61
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYea242c7d-b101-4197-8e65-b2b079e3b2b61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-228-307161002283030 TABLET in 1 BOTTLE, PLASTIC (71610-228-30) 30 tablet2019-01-310000-00-00NoNoCurrent
71610-228-537161002285360 TABLET in 1 BOTTLE, PLASTIC (71610-228-53) 60 tablet2019-01-310000-00-00NoNoCurrent
71610-228-607161002286090 TABLET in 1 BOTTLE, PLASTIC (71610-228-60) 90 tablet2019-01-310000-00-00NoNoCurrent