Tizanidine

Product NDC
68788-8802
11-digit product format
687888802
Labeler code
68788
Product ID
68788-8802_6e97c1ba-8171-4707-98ee-61afed75daac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA091283
Marketing category
ANDA
Marketing start
2025-01-02
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
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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A091283-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2012-11-28caaa826d4ba7…
2026-08-18 06:07:402026-07A091283-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2012-11-28caaa826d4ba7…
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…

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 06:07:402026-07A091283-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A091283-002AB1caaa826d4ba7…
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…

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
6e97c1ba-8171-4707-98ee-61afed75daacAvailable 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
68788-8802-1Tizanidine100 in 1 BOTTLETABLET1001
68788-8802-2Tizanidine20 in 1 BOTTLETABLET201
68788-8802-3Tizanidine30 in 1 BOTTLETABLET301
68788-8802-6Tizanidine60 in 1 BOTTLETABLET601
68788-8802-8Tizanidine120 in 1 BOTTLETABLET1201
68788-8802-9Tizanidine90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8802-1EA - Each68788-8802447cf10c-121a-4232-9ccb-514ae6723e3f12025-03-04
68788-8802-2EA - Each68788-88025e0aadef-fe6d-419e-bce2-38157342a72612025-03-04
68788-8802-3EA - Each68788-8802cd1639ec-5889-44ae-b62f-3005a352abd112025-03-04
68788-8802-6EA - Each68788-880203f83ec8-bc3b-434c-b439-4de64870e32a12025-03-04
68788-8802-8EA - Each68788-8802e2713a27-a454-4794-a74e-62c45cd819a612025-03-04
68788-8802-9EA - Each68788-8802ca20b818-8045-4ce8-822d-cfeaa3d18e3612025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8802TIZANIDINE TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 6 package rows20250105_6e97c1ba-8171-4707-98ee-61afed75daac.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
ndc (product): 68788-8802
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 TabletPSN6e97c1ba-8171-4707-98ee-61afed75daac1
313413tizanidine 4 MG Oral TabletSCD6e97c1ba-8171-4707-98ee-61afed75daac1
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY6e97c1ba-8171-4707-98ee-61afed75daac1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8802-168788880201100 TABLET in 1 BOTTLE (68788-8802-1) 100 tablet2025-01-02NoNoCurrent
68788-8802-26878888020220 TABLET in 1 BOTTLE (68788-8802-2) 20 tablet2025-01-02NoNoCurrent
68788-8802-36878888020330 TABLET in 1 BOTTLE (68788-8802-3) 30 tablet2025-01-02NoNoCurrent
68788-8802-66878888020660 TABLET in 1 BOTTLE (68788-8802-6) 60 tablet2025-01-02NoNoCurrent
68788-8802-868788880208120 TABLET in 1 BOTTLE (68788-8802-8) 120 tablet2025-01-02NoNoCurrent
68788-8802-96878888020990 TABLET in 1 BOTTLE (68788-8802-9) 90 tablet2025-01-02NoNoCurrent