FDA.reportPublic FDA data

Tizanidine

Product NDC
57664-503
11-digit product format
576640503
Labeler code
57664
Product ID
57664-503_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
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

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 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
57664-503-18Tizanidine1000 in 1 BOTTLETABLET10009
57664-503-89Tizanidine150 in 1 BOTTLETABLET1509

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-503-13EA - Each57664-50359c52ed5-491e-40c4-ac95-b8ece7f27eb112012-07-24
57664-503-18EA - Each57664-503a018f0c4-88ae-4fd7-b1ba-40f719e56f0212012-07-24
57664-503-83EA - Each57664-503a478ffde-beef-44f3-ac09-bcc953752dc112012-07-24
57664-503-88EA - Each57664-503bf01783f-a12a-4fc3-a1d2-0e8f21c7f2ef12012-07-24
57664-503-89EA - Each57664-5036ad6f4c9-2594-4909-b656-38d0eaf517b612012-07-24

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
57664-503TIZANIDINE 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
313413tiZANidine HCl 4 MG Oral TabletPSNdd3bf952-50b1-4d50-9073-57fd6888053b103
313413tizanidine 4 MG Oral TabletSCDdd3bf952-50b1-4d50-9073-57fd6888053b103
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYdd3bf952-50b1-4d50-9073-57fd6888053b103
313413tiZANidine HCl 4 MG Oral TabletPSN51da17a0-63d2-44fb-a79d-a3bee862e028101
313413tizanidine 4 MG Oral TabletSCD51da17a0-63d2-44fb-a79d-a3bee862e028101
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY51da17a0-63d2-44fb-a79d-a3bee862e028101
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
313413tiZANidine HCl 4 MG Oral TabletPSNcf0dca9d-37ff-4c21-a5cc-56d4839d4d3516
313413tizanidine 4 MG Oral TabletSCDcf0dca9d-37ff-4c21-a5cc-56d4839d4d3516
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYcf0dca9d-37ff-4c21-a5cc-56d4839d4d3516
313413tiZANidine HCl 4 MG Oral TabletPSNfdf4f09d-4537-a438-e053-6394a90a573d12
313413tizanidine 4 MG Oral TabletSCDfdf4f09d-4537-a438-e053-6394a90a573d12
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYfdf4f09d-4537-a438-e053-6394a90a573d12
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
313413tiZANidine HCl 4 MG Oral TabletPSNaf73c6ab-6c1c-94d1-e053-2a95a90a4e3c6
313413tizanidine 4 MG Oral TabletSCDaf73c6ab-6c1c-94d1-e053-2a95a90a4e3c6
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYaf73c6ab-6c1c-94d1-e053-2a95a90a4e3c6
313413tiZANidine HCl 4 MG Oral TabletPSN76dc85bd-3cde-4940-a99b-663b70bf9f545
313413tiZANidine HCl 4 MG Oral TabletPSN03fa03a6-fd05-4f17-872a-3c123330935d5
313413tizanidine 4 MG Oral TabletSCD76dc85bd-3cde-4940-a99b-663b70bf9f545
313413tizanidine 4 MG Oral TabletSCD03fa03a6-fd05-4f17-872a-3c123330935d5
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY03fa03a6-fd05-4f17-872a-3c123330935d5
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY76dc85bd-3cde-4940-a99b-663b70bf9f545
313413tiZANidine HCl 4 MG Oral TabletPSN2a91884a-39c3-f7ac-e063-6394a90ade143
313413tizanidine 4 MG Oral TabletSCD2a91884a-39c3-f7ac-e063-6394a90ade143
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY2a91884a-39c3-f7ac-e063-6394a90ade143
313413tiZANidine HCl 4 MG Oral TabletPSNf32f399f-42af-f0ba-e053-2a95a90a8c2e2
313413tizanidine 4 MG Oral TabletSCDf32f399f-42af-f0ba-e053-2a95a90a8c2e2
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYf32f399f-42af-f0ba-e053-2a95a90a8c2e2
313412tiZANidine HCl 2 MG Oral TabletPSN2f460275-565f-4737-a3df-bf80b9acc2681
313413tiZANidine HCl 4 MG Oral TabletPSNd646e3e1-d611-4c23-9ded-b327e4acfe4f1
313413tiZANidine HCl 4 MG Oral TabletPSNfefe8332-32eb-4b81-978f-b23b334d7d571
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
313413tizanidine 4 MG Oral TabletSCDd646e3e1-d611-4c23-9ded-b327e4acfe4f1
313413tizanidine 4 MG Oral TabletSCDfefe8332-32eb-4b81-978f-b23b334d7d571
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
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYfefe8332-32eb-4b81-978f-b23b334d7d571
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYd646e3e1-d611-4c23-9ded-b327e4acfe4f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57664-503-18576640503181000 TABLET in 1 BOTTLE (57664-503-18) 1000 tablet2003-12-110000-00-00NoNoCurrent
57664-503-8957664050389150 TABLET in 1 BOTTLE (57664-503-89) 150 tablet2003-12-110000-00-00NoNoCurrent