Tizanidine HCL

Product NDC
80425-0090
11-digit product format
804250090
Labeler code
80425
Product ID
80425-0090_453cd7ac-cee0-2b91-e063-6294a90afcdc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine HCL
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA210267
Marketing category
ANDA
Marketing start
2019-03-20
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 · 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 HCL
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
485485Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b353cdb8-75fa-7e3c-e053-2a95a90ada58Available 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
80425-0090-1Tizanidine HCL60 in 1 BOTTLECAPSULE608
80425-0090-2Tizanidine HCL90 in 1 BOTTLECAPSULE908
80425-0090-3Tizanidine HCL30 in 1 BOTTLECAPSULE308
80425-0090-4Tizanidine HCL120 in 1 BOTTLECAPSULE1208

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0090-1EA - Each80425-0090fdad67c7-6325-4192-bb88-fe96fbc7804f12023-06-06
80425-0090-2EA - Each80425-0090fa1bee89-d9e8-4b98-9628-f492a2a9d1fa12023-06-06
80425-0090-3EA - Each80425-0090e9da92fe-d9ce-470f-8050-3e64530dc59d12023-04-07
80425-0090-4EA - Each80425-0090cb2031ff-544d-4cad-90a8-d29c6dc5b0b512026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0090TIZANIDINE HCL CAPSULE [ADVANCED RX OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 4 package rows20250101_b353cdb8-75fa-7e3c-e053-2a95a90ada58.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
ndc (product): 80425-0090
TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.ae9b6808-632f-4204-8581-bf146dcab69f2025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210267
application number: ANDA210267
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
485485tiZANidine HCl 4 MG Oral CapsulePSNb353cdb8-75fa-7e3c-e053-2a95a90ada588
485485tizanidine 4 MG Oral CapsuleSCDb353cdb8-75fa-7e3c-e053-2a95a90ada588
485485tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral CapsuleSYb353cdb8-75fa-7e3c-e053-2a95a90ada588

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0090-18042500900160 CAPSULE in 1 BOTTLE (80425-0090-1) 60 capsule2019-03-200000-00-00NoNoCurrent
80425-0090-28042500900290 CAPSULE in 1 BOTTLE (80425-0090-2) 90 capsule2019-03-200000-00-00NoNoCurrent
80425-0090-38042500900330 CAPSULE in 1 BOTTLE (80425-0090-3) 30 capsule2019-03-20NoNoCurrent
80425-0090-480425009004120 CAPSULE in 1 BOTTLE (80425-0090-4) 120 capsule2025-12-05NoNoCurrent