FDA.reportPublic FDA data

Tizanidine

Product NDC
33261-103
11-digit product format
332610103
Labeler code
33261
Product ID
33261-103_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
2 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
33261-103-022020-01-31C16284748780-19d75b9d0-beed-f424-e053-dadaa90a57ceTizanidine Tablets USP
33261-103-102020-01-31C16284748780-19d75b9d0-beed-f424-e053-dadaa90a57ceTizanidine Tablets USP
33261-103-202020-01-31C16284748780-19d75b9d0-beed-f424-e053-dadaa90a57ceTizanidine Tablets USP
33261-103-302020-01-31C16284748780-19d75b9d0-beed-f424-e053-dadaa90a57ceTizanidine Tablets USP
33261-103-602020-01-31C16284748780-19d75b9d0-beed-f424-e053-dadaa90a57ceTizanidine Tablets USP
33261-103-902020-01-31C16284748780-19d75b9d0-beed-f424-e053-dadaa90a57ceTizanidine Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-103-02Tizanidine120 in 1 BOTTLETABLET1202
33261-103-10Tizanidine10 in 1 BOTTLETABLET102
33261-103-20Tizanidine20 in 1 BOTTLETABLET202
33261-103-30Tizanidine30 in 1 BOTTLETABLET302
33261-103-60Tizanidine60 in 1 BOTTLETABLET602
33261-103-90Tizanidine90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-103-02EA - Each33261-103d106b7bd-eaa4-400d-aa94-e3f7273273a212015-10-02
33261-103-10EA - Each33261-10351ff7b40-a222-4802-8a74-dcc9b215bc1a12015-10-02
33261-103-20EA - Each33261-1037d9ca2bb-474c-4a1c-9ebf-6b7d93d8ac5b12015-10-02
33261-103-30EA - Each33261-1030453cb68-aad4-4345-a0c6-1fb02d5fc1d012015-10-02
33261-103-60EA - Each33261-103235ec4ef-9609-4e8d-83d1-914c5684567f12015-10-02
33261-103-90EA - Each33261-10316e2eb00-086f-45b1-b2cb-6a4abc283a3312015-10-02

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
33261-103TIZANIDINE 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
33261-103-0233261010302120 in 1 BOTTLEHistorical
33261-103-103326101031010 in 1 BOTTLEHistorical
33261-103-203326101032020 in 1 BOTTLEHistorical
33261-103-303326101033030 in 1 BOTTLEHistorical
33261-103-603326101036060 in 1 BOTTLEHistorical
33261-103-903326101039090 in 1 BOTTLEHistorical