FDA.reportPublic FDA data

Tizanidine

Product NDC
50268-760
11-digit product format
502680760
Labeler code
50268
Product ID
50268-760_4823baf7-5542-f52e-e063-6394a90abeee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA076286
Marketing category
ANDA
Marketing start
2017-08-24
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tizanidine
Listing expiration
2027-12-31

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
50268-760-11Tizanidine1 in 1 BLISTER PACKTABLET16
50268-760-15Tizanidine50 in 1 BOX, UNIT-DOSETABLET506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-760-11EA - Each50268-760da2d867e-61d1-4b49-b970-8b1ec5564b1d12018-01-12
50268-760-15EA - Each50268-7603408be9e-4695-473d-b3a3-a11a2467803912018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-760TIZANIDINE TABLET [AVPAK]4Current NDC, Legacy NDC, 2 package rows20240110_b694225c-1fa9-4726-89a6-fd3f87084248.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSNb694225c-1fa9-4726-89a6-fd3f870842486
313413tiZANidine HCl 4 MG Oral TabletPSNb694225c-1fa9-4726-89a6-fd3f870842486
313412tizanidine 2 MG Oral TabletSCDb694225c-1fa9-4726-89a6-fd3f870842486
313413tizanidine 4 MG Oral TabletSCDb694225c-1fa9-4726-89a6-fd3f870842486
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSYb694225c-1fa9-4726-89a6-fd3f870842486
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYb694225c-1fa9-4726-89a6-fd3f870842486

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-760-11502680760111 in 1 BLISTER PACKHistorical
50268-760-155026807601550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-760-15) / 1 TABLET in 1 BLISTER PACK (50268-760-11) 50 blister pack2017-08-240000-00-00NoNoCurrent