TIZANIDINE HYDROCHLORIDE

Product NDC
68788-8478
11-digit product format
687888478
Labeler code
68788
Product ID
68788-8478_07bad3ac-76c5-4a87-a0e2-e3d5baefee8b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tizanidine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA210267
Marketing category
ANDA
Marketing start
2023-07-06
Substance
TIZANIDINE HYDROCHLORIDE
Active strength
6 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210267-001TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-12
A210267-002TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-12
A210267-003TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210267-001AB
A210267-002AB
A210267-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210267-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210267-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210267-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210267-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210267-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210267-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A210267-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210267-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210267-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210267-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210267-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210267-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210267-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210267-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210267-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210267-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210267-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210267-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210267-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210267-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210267-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210267-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210267-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210267-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210267-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210267-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210267-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210267-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A210267-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A210267-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210267-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210267-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210267-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210267-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210267-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210267-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210267-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210267-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASECAPSULE / ORALAB2019-03-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210267-003TIZANIDINE HYDROCHLORIDEEQ 6MG BASECAPSULE / ORALAB2019-03-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210267-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASECAPSULE / ORALAB2019-03-128072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210267-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210267-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210267-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210267-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210267-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210267-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210267-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210267-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210267-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210267-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210267-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210267-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210267-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210267-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210267-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210267-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210267-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210267-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210267-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210267-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210267-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210267-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210267-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210267-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210267-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210267-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210267-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210267-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210267-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210267-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210267-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210267-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210267-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210267-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210267-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210267-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210267-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210267-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210267-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210267-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
TIZANIDINE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE6 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
485484Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ae9b6808-632f-4204-8581-bf146dcab69fAvailable 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
68788-8478-1TIZANIDINE HYDROCHLORIDE100 in 1 BOTTLE, PLASTICCAPSULE1003
68788-8478-3TIZANIDINE HYDROCHLORIDE30 in 1 BOTTLE, PLASTICCAPSULE303
68788-8478-6TIZANIDINE HYDROCHLORIDE60 in 1 BOTTLE, PLASTICCAPSULE603
68788-8478-9TIZANIDINE HYDROCHLORIDE90 in 1 BOTTLE, PLASTICCAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8478-1EA - Each68788-8478c305d5f8-05ce-463d-8304-c9389815481d12023-08-08
68788-8478-3EA - Each68788-8478d6be56e5-ee15-4fc3-85c4-18f1553ecfb312023-08-08
68788-8478-6EA - Each68788-847823d3d5fe-2c18-4888-85a6-4fa838341d0812023-08-08
68788-8478-9EA - Each68788-847830eae7a3-bc71-4001-8a70-f999ca18a9e212023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8478TIZANIDINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 4 package rows20240822_ae9b6808-632f-4204-8581-bf146dcab69f.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tizanidine HCLTIZANIDINE HCLAdvanced Rx of Tennessee, LLCb353cdb8-75fa-7e3c-e053-2a95a90ada582025-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210267
application number: ANDA210267
TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.ae9b6808-632f-4204-8581-bf146dcab69f2025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210267
application number: ANDA210267
ndc (product): 68788-8478
TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY4009c6cb-c183-2165-e063-6294a90aed782025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210267
application number: ANDA210267
TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.6439a7ef-1b22-4fa1-9be3-eedd3cd241912025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210267
application number: ANDA210267
TizanidineTIZANIDINEDirect_Rx0bdc188d-b895-acbc-e063-6294a90acd682025-08-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210267
application number: ANDA210267
TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEIngenus Pharmaceuticals, LLC99cc8f5f-b947-4ddc-99b6-1e4cef09b7172025-01-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210267
application number: ANDA210267
TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC26f8f233-5dc2-0013-e063-6394a90ab0f52024-10-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210267
application number: ANDA210267
TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEBryant Ranch Prepackff7a82ea-c03c-44f6-9b15-468cb8d15a9c2024-04-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210267
application number: ANDA210267

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485484tiZANidine HCl 6 MG Oral CapsulePSNae9b6808-632f-4204-8581-bf146dcab69f3
485484tizanidine 6 MG Oral CapsuleSCDae9b6808-632f-4204-8581-bf146dcab69f3
485484tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral CapsuleSYae9b6808-632f-4204-8581-bf146dcab69f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8478-168788847801100 CAPSULE in 1 BOTTLE, PLASTIC (68788-8478-1) 100 capsule2023-07-06NoNoCurrent
68788-8478-36878884780330 CAPSULE in 1 BOTTLE, PLASTIC (68788-8478-3) 30 capsule2023-07-06NoNoCurrent
68788-8478-66878884780660 CAPSULE in 1 BOTTLE, PLASTIC (68788-8478-6) 60 capsule2023-07-06NoNoCurrent
68788-8478-96878884780990 CAPSULE in 1 BOTTLE, PLASTIC (68788-8478-9) 90 capsule2023-07-06NoNoCurrent