FDA.reportPublic FDA data

Tizanidine

Product NDC
68788-7991
11-digit product format
687887991
Labeler code
68788
Product ID
68788-7991_3b5f067f-fbe1-4ba1-b3a9-c7c6576c1729
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA076286
Marketing category
ANDA
Marketing start
2021-08-06
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

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
68788-7991-3Tizanidine30 in 1 BOTTLETABLET305
68788-7991-6Tizanidine60 in 1 BOTTLETABLET605
68788-7991-8Tizanidine120 in 1 BOTTLETABLET1205
68788-7991-9Tizanidine90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7991-3EA - Each68788-7991b31ffa26-d10e-4260-acca-018743925e9a12021-09-07
68788-7991-6EA - Each68788-799114c80e74-c3ba-4b3c-8ae2-999ec84a628d12021-09-07
68788-7991-8EA - Each68788-7991e45ac39e-118d-4746-a890-e06888527f4512021-09-07
68788-7991-9EA - Each68788-7991c87d2f16-4dff-4320-a5ce-565edb2e273312021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7991TIZANIDINE TABLET [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 4 package rows20240821_3c993e3c-ee52-45a7-be39-60eaac7a1092.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313412tiZANidine HCl 2 MG Oral TabletPSN3c993e3c-ee52-45a7-be39-60eaac7a10925
313412tizanidine 2 MG Oral TabletSCD3c993e3c-ee52-45a7-be39-60eaac7a10925
313412tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral TabletSY3c993e3c-ee52-45a7-be39-60eaac7a10925

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7991-36878879910330 TABLET in 1 BOTTLE (68788-7991-3) 30 tablet2021-08-060000-00-00NoNoCurrent
68788-7991-66878879910660 TABLET in 1 BOTTLE (68788-7991-6) 60 tablet2021-08-060000-00-00NoNoCurrent
68788-7991-868788799108120 TABLET in 1 BOTTLE (68788-7991-8) 120 tablet2021-08-060000-00-00NoNoCurrent
68788-7991-96878879910990 TABLET in 1 BOTTLE (68788-7991-9) 90 tablet2021-08-060000-00-00NoNoCurrent