Tizanidne hydrochloride

Product NDC
67296-1793
Requested package NDC
67296-1793-7
11-digit product format
672961793
Labeler code
67296
Product ID
67296-1793_d61ccfc4-b180-7066-e053-2995a90a6318
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidne Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA212196
Marketing category
ANDA
Marketing start
2019-03-29
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
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 packagepackage67296-179367296-1793-7IInactivated by FDA2026-08-17

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 · 15 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…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212196-001TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-27
A212196-002TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-27
A212196-003TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A212196-001AB
A212196-002AB
A212196-003AB

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A212196-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A212196-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A212196-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212196-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212196-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212196-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212196-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212196-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212196-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A212196-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212196-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212196-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212196-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212196-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212196-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212196-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212196-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212196-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212196-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212196-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212196-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212196-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212196-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212196-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212196-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212196-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212196-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212196-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212196-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212196-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212196-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A212196-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A212196-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212196-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212196-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212196-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212196-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212196-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212196-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212196-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-271e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A212196-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A212196-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A212196-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212196-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212196-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212196-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212196-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212196-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212196-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212196-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212196-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212196-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212196-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212196-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212196-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212196-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212196-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212196-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212196-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212196-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212196-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212196-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212196-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212196-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212196-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212196-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212196-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212196-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212196-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212196-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212196-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212196-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212196-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212196-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212196-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212196-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212196-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212196-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212196-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212196-001AB11e350fbaab3a…

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
67296-1793-72024-01-30C16284748780-11030e365-668f-111a-e063-dadaa90a10e2Tizanidine 4mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1793-7Tizanidne hydrochloride15 in 1 BOTTLECAPSULE155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1793TIZANIDNE HYDROCHLORIDE CAPSULE [REDPHARM DRUG, INC.]5Legacy NDC, 1 package rows20220123_afd7e738-9cf4-7937-e053-2995a90a55bc.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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEBryant Ranch Prepack649f1f76-da33-4bdf-a38d-5ae3a9cb79872026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212196
application number: ANDA212196
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEBryant Ranch Prepack70b1a815-8549-4602-af35-fdbedf5fad512026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212196
application number: ANDA212196
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEBryant Ranch Prepack4fd5b1b8-ec86-42c2-9065-aee581f1bdd62026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212196
application number: ANDA212196
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEBryant Ranch Prepack226b506f-6f85-48e8-b8e5-86442d74d9512026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212196
application number: ANDA212196
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEBryant Ranch Prepack31b40276-099b-482c-a13c-8fbbf1ebc50a2026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212196
application number: ANDA212196
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEBryant Ranch Prepack04febb37-00d6-4279-8c5f-171950278c8f2026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212196
application number: ANDA212196
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEBryant Ranch Prepack3288d98d-aa49-4a36-a6d9-703645d8bcd72026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212196
application number: ANDA212196
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEPreferred Pharmaceuticals Inc.3f569c5a-ec9d-4356-ac04-c17714ff68d12026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212196
application number: ANDA212196
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEAscend Laboratories, LLCd7c97b79-da59-4e86-a01b-f91046d04f742025-12-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212196
application number: ANDA212196
Tizanidine HydrochlorideTIZANIDINE HYDROCHLORIDEAsclemed USA, Inc.07b8db58-d037-477e-a62f-025e8a5afcb42025-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212196
application number: ANDA212196
Tizanidine HCLTIZANIDINE HCLAdvanced Rx Pharmacy of Tennessee, LLCc46c7aa3-69db-82dc-e053-2995a90ac2512025-11-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212196
application number: ANDA212196
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEBryant Ranch Prepack00fcd792-18a4-45d9-9c6e-0634b54b152a2024-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212196
application number: ANDA212196
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEBryant Ranch Prepacka4233306-2954-496f-9686-22c48041710d2024-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212196
application number: ANDA212196
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEBryant Ranch Prepack30df9966-5076-449f-867b-28cb9b8356932024-05-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212196
application number: ANDA212196
Tizanidne hydrochlorideTIZANIDNE HYDROCHLORIDEAsclemed USA, Inc.1ad6eaf6-bd32-4d05-bdd0-a6246e2afb9c2022-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212196
application number: ANDA212196

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485485tiZANidine HCl 4 MG Oral CapsulePSNafd7e738-9cf4-7937-e053-2995a90a55bc5
485485tizanidine 4 MG Oral CapsuleSCDafd7e738-9cf4-7937-e053-2995a90a55bc5
485485tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral CapsuleSYafd7e738-9cf4-7937-e053-2995a90a55bc5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1793-76729617930715 CAPSULE in 1 BOTTLE (67296-1793-7) 15 capsule2020-09-210000-00-00NoNoCurrent