FDA.reportPublic FDA data

Tizanidine

Product NDC
33261-104
11-digit product format
332610104
Labeler code
33261
Product ID
33261-104_9b79e6bb-62f1-473c-ac30-3dba1a23384d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA076286
Marketing category
ANDA
Marketing start
2002-07-03
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-104-022020-01-31C16284748780-19d75b9d0-beed-f424-e053-dadaa90a57ceTizanidine Tablets USP
33261-104-102020-01-31C16284748780-19d75b9d0-beed-f424-e053-dadaa90a57ceTizanidine Tablets USP
33261-104-202020-01-31C16284748780-19d75b9d0-beed-f424-e053-dadaa90a57ceTizanidine Tablets USP
33261-104-302020-01-31C16284748780-19d75b9d0-beed-f424-e053-dadaa90a57ceTizanidine Tablets USP
33261-104-602020-01-31C16284748780-19d75b9d0-beed-f424-e053-dadaa90a57ceTizanidine Tablets USP
33261-104-902020-01-31C16284748780-19d75b9d0-beed-f424-e053-dadaa90a57ceTizanidine Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-104-02Tizanidine120 in 1 BOTTLETABLET1202
33261-104-10Tizanidine10 in 1 BOTTLETABLET102
33261-104-20Tizanidine20 in 1 BOTTLETABLET202
33261-104-30Tizanidine30 in 1 BOTTLETABLET302
33261-104-60Tizanidine60 in 1 BOTTLETABLET602
33261-104-90Tizanidine90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-104-02EA - Each33261-1043f2a3964-fdca-43b1-9c47-b7de3dff6eaf12015-10-02
33261-104-10EA - Each33261-1043da25819-b005-46c0-90ba-9b12c8e4516812015-10-02
33261-104-20EA - Each33261-10464628934-44a2-4502-8f4e-072e35eee91412015-10-02
33261-104-30EA - Each33261-104c02bef3a-8e0a-4cd7-8f04-b9079c8d1a8612015-10-02
33261-104-60EA - Each33261-104c1bca3da-722e-47a6-b5dd-72193217c65612015-10-02
33261-104-90EA - Each33261-104a6ed2c9d-e957-4d74-ab7a-6e35813931ab12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TIZANIDINE HYDROCHLORIDEACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [AIDAREX PHARMACEUTICALS LLC]2
TIZANIDINEACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [AIDAREX PHARMACEUTICALS LLC]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [AIDAREX PHARMACEUTICALS LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [AIDAREX PHARMACEUTICALS LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [AIDAREX PHARMACEUTICALS LLC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE TABLET [AIDAREX PHARMACEUTICALS LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-104TIZANIDINE TABLET [AIDAREX PHARMACEUTICALS LLC]2Legacy NDC, 6 package rows20121017_9852284f-0101-4167-81d5-e74732b95e8f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSN9852284f-0101-4167-81d5-e74732b95e8f2
313413tiZANidine HCl 4 MG Oral TabletPSN9852284f-0101-4167-81d5-e74732b95e8f2
313412tizanidine 2 MG Oral TabletSCD9852284f-0101-4167-81d5-e74732b95e8f2
313413tizanidine 4 MG Oral TabletSCD9852284f-0101-4167-81d5-e74732b95e8f2
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY9852284f-0101-4167-81d5-e74732b95e8f2
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY9852284f-0101-4167-81d5-e74732b95e8f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-104-0233261010402120 in 1 BOTTLEHistorical
33261-104-103326101041010 in 1 BOTTLEHistorical
33261-104-203326101042020 in 1 BOTTLEHistorical
33261-104-303326101043030 in 1 BOTTLEHistorical
33261-104-603326101046060 in 1 BOTTLEHistorical
33261-104-903326101049090 in 1 BOTTLEHistorical