FDA.reportPublic FDA data

tizanidine

Product NDC
64980-659
11-digit product format
649800659
Labeler code
64980
Product ID
64980-659_356b3e79-d47b-467a-af62-2adca35f1a2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA218920
Marketing category
ANDA
Marketing start
2024-12-15
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
64980-659-03tizanidine30 in 1 BOTTLETABLET303
64980-659-10tizanidine1000 in 1 BOTTLETABLET10003
64980-659-15tizanidine150 in 1 BOTTLETABLET1503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-659-10EA - Each64980-6598d0a36b3-5a1d-454c-b441-8ec11e785acc12025-01-14
64980-659-15EA - Each64980-659237d6bd3-3f9c-4b7f-9aa1-270f9917b2cb12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-659TIZANIDINE TABLET [RISING PHARMA HOLDINGS, INC.]2Current NDC, 3 package rows20250515_433ac98f-ac22-44ad-a8b4-5db5560b9d0f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSN433ac98f-ac22-44ad-a8b4-5db5560b9d0f3
313413tiZANidine HCl 4 MG Oral TabletPSN433ac98f-ac22-44ad-a8b4-5db5560b9d0f3
313412tizanidine 2 MG Oral TabletSCD433ac98f-ac22-44ad-a8b4-5db5560b9d0f3
313413tizanidine 4 MG Oral TabletSCD433ac98f-ac22-44ad-a8b4-5db5560b9d0f3
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY433ac98f-ac22-44ad-a8b4-5db5560b9d0f3
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY433ac98f-ac22-44ad-a8b4-5db5560b9d0f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64980-659-036498006590330 TABLET in 1 BOTTLE (64980-659-03) 30 tablet2024-12-15NoNoHistorical
64980-659-10649800659101000 TABLET in 1 BOTTLE (64980-659-10) 1000 tablet2024-12-15NoNoHistorical
64980-659-1564980065915150 TABLET in 1 BOTTLE (64980-659-15) 150 tablet2024-12-15NoNoHistorical