Tizanidine

Product NDC
50436-6756
11-digit product format
504366756
Labeler code
50436
Product ID
50436-6756_69857599-9207-41e9-862c-78b55db14609
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-6756-1Tizanidine30 in 1 BOTTLETABLET3010
50436-6756-2Tizanidine60 in 1 BOTTLETABLET6010
50436-6756-3Tizanidine90 in 1 BOTTLETABLET9010
50436-6756-4Tizanidine120 in 1 BOTTLETABLET12010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-6756-1EA - Each50436-6756268b5252-1f36-46aa-976d-f09e05ea218612012-07-24
50436-6756-2EA - Each50436-6756d175cc01-3c03-478d-8843-cf20a20c19b612012-07-24
50436-6756-3EA - Each50436-67561e68c87a-cb7f-42c5-b94e-2ad2507cbefe12013-02-13
50436-6756-4EA - Each50436-6756e3b64089-f3d9-4478-9bd1-83ada4a8ee9812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Tizanidine HydrochlorideACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [UNIT DOSE SERVICES]3
TizanidineACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [UNIT DOSE SERVICES]3
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [UNIT DOSE SERVICES]3
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [UNIT DOSE SERVICES]3
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [UNIT DOSE SERVICES]3
stearic acidINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE TABLET [UNIT DOSE SERVICES]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-6756TIZANIDINE TABLET [UNIT DOSE SERVICES]10Legacy NDC, 4 package rows20171207_204984ed-771c-4249-bba5-50d51c60e901.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSN204984ed-771c-4249-bba5-50d51c60e90110
313413tizanidine 4 MG Oral TabletSCD204984ed-771c-4249-bba5-50d51c60e90110
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY204984ed-771c-4249-bba5-50d51c60e90110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-6756-15043667560130 in 1 BOTTLEHistorical
50436-6756-25043667560260 in 1 BOTTLEHistorical
50436-6756-35043667560390 in 1 BOTTLEHistorical
50436-6756-450436675604120 in 1 BOTTLEHistorical