FDA.reportPublic FDA data

Tizanidine

Product NDC
68084-645
11-digit product format
680840645
Labeler code
68084
Product ID
68084-645_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
2013-10-01
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
68084-645-01Tizanidine100 in 1 BOX, UNIT-DOSETABLET10012
68084-645-11Tizanidine1 in 1 BLISTER PACKTABLET112
68084-645-65Tizanidine50 in 1 CARTONTABLET5012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-645-01EA - Each68084-645a92d7c81-2f75-4d71-8488-62ab6e91297312013-11-04
68084-645-11EA - Each68084-6454e3a52e3-0795-4beb-88ce-a30a48a9821e12013-11-04
68084-645-65EA - Each68084-645311bef01-32c8-4098-80ab-f20a9090b36c12024-01-04

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
68084-645TIZANIDINE TABLET [AMERICAN HEALTH PACKAGING]11Current NDC, Legacy NDC, 3 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
68084-645-0168084064501100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-645-01) / 1 TABLET in 1 BLISTER PACK (68084-645-11) 100 blister pack2013-10-010000-00-00NoNoCurrent
68084-645-11680840645111 in 1 BLISTER PACKHistorical
68084-645-656808406456550 BLISTER PACK in 1 CARTON (68084-645-65) / 1 TABLET in 1 BLISTER PACK (68084-645-11) 50 blister pack2023-12-15NoNoHistorical