Tizanidine

Product NDC
70518-3181
Requested package NDC
70518-3181-1
11-digit product format
705183181
Labeler code
70518
Product ID
70518-3181_4ecb797f-e7d0-0305-e063-6394a90ad178
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076416
Marketing category
ANDA
Marketing start
2021-08-05
Substance
TIZANIDINE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076416-001TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2003-09-29
A076416-002TIZANIDINE HYDROCHLORIDETIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2003-09-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076416-001AB
A076416-002AB

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076416-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2003-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076416-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2003-09-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076416-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2003-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076416-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2003-09-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A076416-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2003-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076416-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2003-09-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076416-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2003-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076416-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2003-09-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076416-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2003-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076416-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2003-09-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076416-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2003-09-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076416-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2003-09-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076416-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2003-09-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076416-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2003-09-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076416-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2003-09-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076416-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2003-09-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076416-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2003-09-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076416-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2003-09-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076416-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2003-09-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A076416-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2003-09-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076416-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2003-09-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076416-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2003-09-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076416-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2003-09-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076416-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2003-09-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076416-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2003-09-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076416-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2003-09-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076416-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2003-09-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076416-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2003-09-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076416-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2003-09-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076416-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2003-09-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076416-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2003-09-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076416-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2003-09-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076416-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2003-09-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076416-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2003-09-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076416-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2003-09-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076416-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2003-09-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076416-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2003-09-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076416-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2003-09-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076416-001TIZANIDINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2003-09-29782e0a99824c…
2021-12-28 21:50 UTC2021-12A076416-002TIZANIDINE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2003-09-29782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076416-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076416-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076416-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076416-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076416-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076416-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076416-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076416-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076416-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076416-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076416-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076416-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076416-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076416-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076416-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076416-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076416-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076416-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076416-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076416-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076416-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076416-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076416-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076416-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076416-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076416-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076416-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076416-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076416-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076416-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076416-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076416-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076416-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076416-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076416-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076416-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076416-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076416-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076416-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A076416-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Tizanidine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE2 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
313412Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f041e5f7-c138-4622-98bf-881f9a649a26Available 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
70518-3181-0Tizanidine60 in 1 BOTTLE, PLASTICTABLET606
70518-3181-1Tizanidine30 in 1 BOTTLE, PLASTICTABLET306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3181-0EA - Each70518-3181203ba518-a23d-4005-be2b-75cdf64820d212026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3181TIZANIDINE TABLET [REMEDYREPACK INC.]4Current NDC, Legacy NDC, 2 package rows20240315_f041e5f7-c138-4622-98bf-881f9a649a26.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 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TizanidineTIZANIDINEMedcore LLC14bcfbac-8f6a-42af-b3a4-ba10d99f24682026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076416
application number: ANDA076416
TizanidineTIZANIDINEREMEDYREPACK INC.f041e5f7-c138-4622-98bf-881f9a649a262026-04-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076416
application number: ANDA076416
ndc (package): 70518-3181-1
ndc (product): 70518-3181
ndc11 (package): 70518318101
TizanidineTIZANIDINEBryant Ranch Prepackfefe8332-32eb-4b81-978f-b23b334d7d572026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076416
application number: ANDA076416
TizanidineTIZANIDINENorthwind Health Company, LLCf32f399f-42af-f0ba-e053-2a95a90a8c2e2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076416
application number: ANDA076416
TizanidineTIZANIDINEPD-Rx Pharmaceuticals, Inc.fd16a25c-67b6-ae6c-e053-6394a90aeee02025-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076416
application number: ANDA076416
TizanidineTIZANIDINEPD-Rx Pharmaceuticals, Inc.fdf4f09d-4537-a438-e053-6394a90a573d2025-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076416
application number: ANDA076416
TizanidineTIZANIDINEAphena Pharma Solutions - Tennessee, LLC25db7cc0-604c-3d6b-e063-6394a90a337f2025-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076416
application number: ANDA076416
TizanidineTIZANIDINEBryant Ranch Prepack73269d77-16b5-4787-9a7d-1b86886234362025-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076416
application number: ANDA076416
TizanidineTIZANIDINEAsclemed USA, Inc.2f460275-565f-4737-a3df-bf80b9acc2682025-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076416
application number: ANDA076416
TizanidineTIZANIDINEDirect_rx2a91884a-39c3-f7ac-e063-6394a90ade142025-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076416
application number: ANDA076416
Tizanidine HCLTIZANIDINE HCLAdvanced Rx of Tennessee, LLCaf73c6ab-6c1c-94d1-e053-2a95a90a4e3c2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076416
application number: ANDA076416
TizanidineTIZANIDINEBryant Ranch Prepacke13292b0-9858-4405-8787-a2392d1b6d752024-08-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076416
application number: ANDA076416
TizanidineTIZANIDINEBryant Ranch Prepack5f8a5b21-4adb-4f2c-91ae-bc33c38107522024-01-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076416
application number: ANDA076416
TizanidineTIZANIDINEBryant Ranch Prepackdd3bf952-50b1-4d50-9073-57fd6888053b2023-12-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076416
application number: ANDA076416
TizanidineTIZANIDINEBryant Ranch Prepack81501cb1-0a76-4bd0-8eee-dbd1e4a0b69f2023-12-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076416
application number: ANDA076416
TizanidineTIZANIDINEBryant Ranch Prepack51da17a0-63d2-44fb-a79d-a3bee862e0282023-11-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076416
application number: ANDA076416
TizanidineTIZANIDINEBryant Ranch Prepack03fa03a6-fd05-4f17-872a-3c123330935d2023-11-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076416
application number: ANDA076416
TizanidineTIZANIDINEBryant Ranch Prepack5a5b6614-038f-4e5b-9543-0497872c78822023-09-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076416
application number: ANDA076416
TizanidineTIZANIDINEProficient Rx LP76dc85bd-3cde-4940-a99b-663b70bf9f542022-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076416
application number: ANDA076416
TizanidineTIZANIDINEProficient Rx LP20424d92-5ca1-4114-bc51-1f07c3bed6be2021-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076416
application number: ANDA076416

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSNf041e5f7-c138-4622-98bf-881f9a649a266
313412tizanidine 2 MG Oral TabletSCDf041e5f7-c138-4622-98bf-881f9a649a266
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSYf041e5f7-c138-4622-98bf-881f9a649a266

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3181-17051831810130 TABLET in 1 BOTTLE, PLASTIC (70518-3181-1) 30 tablet2022-03-220000-00-00NoNoCurrent