FDA.reportPublic FDA data

Tizanidine

Product NDC
68084-775
11-digit product format
680840775
Labeler code
68084
Product ID
68084-775_35bfea02-ba73-d8c2-e063-6394a90a5c9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA076286
Marketing category
ANDA
Marketing start
2016-01-25
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
68084-775-25Tizanidine30 in 1 BOX, UNIT-DOSETABLET3012
68084-775-95Tizanidine1 in 1 BLISTER PACKTABLET112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-775-11EA - Each68084-775b63ec8d6-83d6-4262-aa14-aac1d3d9e1c312014-07-02
68084-775-21EA - Each68084-775e78caa67-2de8-41cc-beb6-5c93d60188ab12014-07-02
68084-775-25EA - Each68084-77566e763a3-7e15-4093-9576-3f7ccb5a173212016-02-04
68084-775-95EA - Each68084-775fd51feeb-3b38-4282-b652-ee594d0931b112016-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TIZANIDINE HYDROCHLORIDEACTIVE INGREDIENTB53E3NMY5CTIZANIDINE TABLET [AMERICAN HEALTH PACKAGING]4
TIZANIDINEACTIVE MOIETY6AI06C00GWTIZANIDINE TABLET [AMERICAN HEALTH PACKAGING]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTIZANIDINE TABLET [AMERICAN HEALTH PACKAGING]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTIZANIDINE TABLET [AMERICAN HEALTH PACKAGING]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TIZANIDINE TABLET [AMERICAN HEALTH PACKAGING]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTIZANIDINE TABLET [AMERICAN HEALTH PACKAGING]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-775TIZANIDINE TABLET [AMERICAN HEALTH PACKAGING]11Current NDC, Legacy NDC, 2 package rows20241025_3670f9e3-988d-48e6-9df0-d403d699e08a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSN3670f9e3-988d-48e6-9df0-d403d699e08a12
313413tiZANidine HCl 4 MG Oral TabletPSN3670f9e3-988d-48e6-9df0-d403d699e08a12
313412tizanidine 2 MG Oral TabletSCD3670f9e3-988d-48e6-9df0-d403d699e08a12
313413tizanidine 4 MG Oral TabletSCD3670f9e3-988d-48e6-9df0-d403d699e08a12
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY3670f9e3-988d-48e6-9df0-d403d699e08a12
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY3670f9e3-988d-48e6-9df0-d403d699e08a12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-775-256808407752530 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-775-25) / 1 TABLET in 1 BLISTER PACK (68084-775-95) 30 blister pack2016-01-250000-00-00NoNoCurrent
68084-775-95680840775951 in 1 BLISTER PACKHistorical