Tizanidine

Product NDC
50090-6757
11-digit product format
500906757
Labeler code
50090
Product ID
50090-6757_79fb9e47-ef5b-41ac-935f-cc87a3e5d525
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076286
Marketing category
ANDA
Marketing start
2021-06-15
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 42.

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
A076286-001TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-03
A076286-002TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A076286-001AB
A076286-002AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-03caaa826d4ba7…
2026-08-18 06:07:402026-07A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-038072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-035d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-034b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-0374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076286-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2002-07-03bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076286-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2002-07-03bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076286-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076286-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076286-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076286-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076286-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076286-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076286-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076286-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076286-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076286-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076286-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076286-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076286-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076286-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076286-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076286-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076286-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076286-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076286-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076286-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076286-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076286-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076286-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076286-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076286-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076286-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076286-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076286-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076286-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076286-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076286-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076286-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076286-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076286-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076286-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076286-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076286-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076286-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076286-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076286-002AB1bb7c543d1eb4…

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
247ae1f4-6ec8-4e34-aae4-13495d8f64e5Available 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
50090-6757-0Tizanidine90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6757TIZANIDINE TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20231019_247ae1f4-6ec8-4e34-aae4-13495d8f64e5.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 2 · 31 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TizanidineTIZANIDINEREMEDYREPACK INC.9bcc7f09-d2b5-4602-aaf3-5410b55ce2752026-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINEHAWAII REPACK, INC.45de30ce-959f-4e2e-a974-6f90568139c92026-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINEREMEDYREPACK INC.59084f59-9a9b-49f0-a9f4-27f3eab9a2282026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINERedpharm Drug54ade0c7-4bf0-54d4-e063-6294a90a8b172026-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINESt. Mary's Medical Park Pharmacyc6b4486f-e847-64ee-e053-2995a90a855a2026-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINESt. Mary's Medical Park Pharmacycfd52c0c-a7c2-e23d-e053-2a95a90abbd12026-06-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINEREMEDYREPACK INC.7bbc81e5-ad3e-496b-908f-e6f500f6ad7e2026-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINEDirect_rx29a275f9-de6b-ee63-e063-6294a90aba282026-03-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINEAvPAKb694225c-1fa9-4726-89a6-fd3f870842482026-01-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINEPD-Rx Pharmaceuticals, Inc.ac897a5a-677b-4a6e-abb1-b810470200fc2026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINENorthwind Health Company, LLCda31fbeb-3781-5e75-e053-2a95a90adb732026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
Tizanidine HClTIZANIDINE HCLAdvanced Rx Pharmacy of Tennessee, LLCafc90292-c6bf-2d96-e053-2995a90abf002025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINEPreferred Pharmaceuticals Inc.3c993e3c-ee52-45a7-be39-60eaac7a10922025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINEPreferred Pharmaceuticals, Inc.32c3be66-5398-425c-ac65-e57ba819bb432025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINEAsclemed USA, Inc.24d8b33f-d1fb-4b4a-afbe-e2e7134dce292025-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINEPHOENIX RX LLC3a7b9b9a-9bf9-0b37-e063-6294a90a1c392025-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINEAmerican Health Packaging3670f9e3-988d-48e6-9df0-d403d699e08a2025-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINEA-S Medication Solutions180985f0-3fbd-4868-a826-b84101618a032025-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINENuCare Pharmaceuticals,Inc.fe2f5064-0b7c-d03d-e053-6294a90a96042025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286
TizanidineTIZANIDINEProficient Rx LPc2353d09-3cb4-486e-8ae7-29339c1ba76b2025-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076286
application number: ANDA076286

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSN247ae1f4-6ec8-4e34-aae4-13495d8f64e51
313413tizanidine 4 MG Oral TabletSCD247ae1f4-6ec8-4e34-aae4-13495d8f64e51
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY247ae1f4-6ec8-4e34-aae4-13495d8f64e51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6757-05009067570090 TABLET in 1 BOTTLE (50090-6757-0) 90 tablet2023-10-17NoNoCurrent