FDA.reportPublic FDA data

Tizanidine

Product NDC
67877-614
11-digit product format
678770614
Labeler code
67877
Product ID
67877-614_e9f19258-b62c-471d-82c4-1e2bdc030833
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA211798
Marketing category
ANDA
Marketing start
2019-01-27
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
67877-614-05Tizanidine500 in 1 BOTTLETABLET5007
67877-614-15Tizanidine150 in 1 BOTTLETABLET1507

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-614-15EA - Each67877-61493aa994c-d137-4f31-9c0d-b2f7ff481ac612019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-614TIZANIDINE TABLET [ASCEND LABORATORIES, LLC]7Current NDC, Legacy NDC, 2 package rows20230314_72f25135-1333-4e52-83f5-7df7d90e68bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSN72f25135-1333-4e52-83f5-7df7d90e68bb7
313413tiZANidine HCl 4 MG Oral TabletPSN72f25135-1333-4e52-83f5-7df7d90e68bb7
313412tizanidine 2 MG Oral TabletSCD72f25135-1333-4e52-83f5-7df7d90e68bb7
313413tizanidine 4 MG Oral TabletSCD72f25135-1333-4e52-83f5-7df7d90e68bb7
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY72f25135-1333-4e52-83f5-7df7d90e68bb7
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY72f25135-1333-4e52-83f5-7df7d90e68bb7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-614-0567877061405500 TABLET in 1 BOTTLE (67877-614-05) 500 tablet2019-01-270000-00-00NoNoCurrent
67877-614-1567877061415150 TABLET in 1 BOTTLE (67877-614-15) 150 tablet2019-01-270000-00-00NoNoCurrent