Tizanidine

Product NDC
67296-1192
11-digit product format
672961192
Labeler code
67296
Product ID
67296-1192_b8d064ea-f375-569d-e053-2995a90ab730
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA091283
Marketing category
ANDA
Marketing start
2019-10-29
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
2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67296-1192IInactivated by FDA2026-08-11
excluded packagepackage67296-119267296-1192-1IInactivated by FDA2026-08-11

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-1192-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-1192-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-1192-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-1192-11332a3947898…d4bfe170f9cd…

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…

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
67296-1192-12024-07-15C16284748780-1f386c64a-0a83-0266-e053-dadaa90a7c1aTizanidine 4mg
67296-1192-12023-01-30C16284748780-1f386c64a-0a83-0266-e053-dadaa90a7c1aTizanidine 4mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1192-1Tizanidine15 in 1 BOTTLETABLET1512

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1192TIZANIDINE TABLET [REDPHARM DRUG, INC.]12Legacy NDC, 1 package rows20240716_9612d19b-9362-61ec-e053-2a95a90a04ce.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSN9612d19b-9362-61ec-e053-2a95a90a04ce12
313413tizanidine 4 MG Oral TabletSCD9612d19b-9362-61ec-e053-2a95a90a04ce12
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY9612d19b-9362-61ec-e053-2a95a90a04ce12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1192-16729611920115 TABLET in 1 BOTTLE (67296-1192-1) 15 tablet2019-10-290000-00-00NoNoCurrent