FDA.reportPublic FDA data

Tizanidine

Product NDC
57664-502
11-digit product format
576640502
Labeler code
57664
Product ID
57664-502_5e8ef5b3-9f58-46a7-833c-31ef018ea9a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA076416
Marketing category
ANDA
Marketing start
2003-12-11
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui313412, 313413

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
57664-502-18Tizanidine1000 in 1 BOTTLETABLET10009
57664-502-89Tizanidine150 in 1 BOTTLETABLET1509

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-502-13EA - Each57664-5021e422694-658b-4a05-ac19-e5a880a174ba12012-07-24
57664-502-18EA - Each57664-502525877d9-9d12-482f-9af8-e02ae2340d1712012-07-24
57664-502-83EA - Each57664-50254d2688d-3edf-4b3d-9b7a-59b9c5b039b312012-07-24
57664-502-88EA - Each57664-502d2fe2c19-0f3c-458a-82de-8756484aa71912012-07-24
57664-502-89EA - Each57664-5028d2a5683-5a01-4fe3-9c06-56a9e15a68fb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TIZANIDINE HYDROCHLORIDEACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6
TIZANIDINEACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTIZANIDINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57664-502TIZANIDINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]9Current NDC, Legacy NDC, 2 package rows20201010_4659df31-8b89-4eff-9d86-7b7e38de416b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSN81501cb1-0a76-4bd0-8eee-dbd1e4a0b69f104
313412tizanidine 2 MG Oral TabletSCD81501cb1-0a76-4bd0-8eee-dbd1e4a0b69f104
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY81501cb1-0a76-4bd0-8eee-dbd1e4a0b69f104
313412tiZANidine HCl 2 MG Oral TabletPSN5f8a5b21-4adb-4f2c-91ae-bc33c3810752102
313412tiZANidine HCl 2 MG Oral TabletPSNe13292b0-9858-4405-8787-a2392d1b6d75102
313412tizanidine 2 MG Oral TabletSCD5f8a5b21-4adb-4f2c-91ae-bc33c3810752102
313412tizanidine 2 MG Oral TabletSCDe13292b0-9858-4405-8787-a2392d1b6d75102
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY5f8a5b21-4adb-4f2c-91ae-bc33c3810752102
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSYe13292b0-9858-4405-8787-a2392d1b6d75102
313412tiZANidine HCl 2 MG Oral TabletPSN5a5b6614-038f-4e5b-9543-0497872c7882100
313412tizanidine 2 MG Oral TabletSCD5a5b6614-038f-4e5b-9543-0497872c7882100
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY5a5b6614-038f-4e5b-9543-0497872c7882100
313412tiZANidine HCl 2 MG Oral TabletPSNfd16a25c-67b6-ae6c-e053-6394a90aeee020
313413tiZANidine HCl 4 MG Oral TabletPSNfd16a25c-67b6-ae6c-e053-6394a90aeee020
313412tizanidine 2 MG Oral TabletSCDfd16a25c-67b6-ae6c-e053-6394a90aeee020
313413tizanidine 4 MG Oral TabletSCDfd16a25c-67b6-ae6c-e053-6394a90aeee020
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSYfd16a25c-67b6-ae6c-e053-6394a90aeee020
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYfd16a25c-67b6-ae6c-e053-6394a90aeee020
313412tiZANidine HCl 2 MG Oral TabletPSN4659df31-8b89-4eff-9d86-7b7e38de416b9
313413tiZANidine HCl 4 MG Oral TabletPSN4659df31-8b89-4eff-9d86-7b7e38de416b9
313412tizanidine 2 MG Oral TabletSCD4659df31-8b89-4eff-9d86-7b7e38de416b9
313413tizanidine 4 MG Oral TabletSCD4659df31-8b89-4eff-9d86-7b7e38de416b9
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY4659df31-8b89-4eff-9d86-7b7e38de416b9
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY4659df31-8b89-4eff-9d86-7b7e38de416b9
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
313412tiZANidine HCl 2 MG Oral TabletPSN73269d77-16b5-4787-9a7d-1b86886234365
313412tizanidine 2 MG Oral TabletSCD73269d77-16b5-4787-9a7d-1b86886234365
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY73269d77-16b5-4787-9a7d-1b86886234365
313412tiZANidine HCl 2 MG Oral TabletPSN20424d92-5ca1-4114-bc51-1f07c3bed6be3
313412tizanidine 2 MG Oral TabletSCD20424d92-5ca1-4114-bc51-1f07c3bed6be3
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY20424d92-5ca1-4114-bc51-1f07c3bed6be3
313412tiZANidine HCl 2 MG Oral TabletPSN2f460275-565f-4737-a3df-bf80b9acc2681
313413tiZANidine HCl 4 MG Oral TabletPSN2f460275-565f-4737-a3df-bf80b9acc2681
313412tizanidine 2 MG Oral TabletSCD2f460275-565f-4737-a3df-bf80b9acc2681
313413tizanidine 4 MG Oral TabletSCD2f460275-565f-4737-a3df-bf80b9acc2681
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY2f460275-565f-4737-a3df-bf80b9acc2681
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY2f460275-565f-4737-a3df-bf80b9acc2681

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57664-502-18576640502181000 TABLET in 1 BOTTLE (57664-502-18) 1000 tablet2003-12-110000-00-00NoNoCurrent
57664-502-8957664050289150 TABLET in 1 BOTTLE (57664-502-89) 150 tablet2003-12-110000-00-00NoNoCurrent