FDA.reportPublic FDA data

Tizanidine

Product NDC
68788-8802
11-digit product format
687888802
Labeler code
68788
Product ID
68788-8802_6e97c1ba-8171-4707-98ee-61afed75daac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA091283
Marketing category
ANDA
Marketing start
2025-01-02
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
Rxcui313413

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
68788-8802-1Tizanidine100 in 1 BOTTLETABLET1001
68788-8802-2Tizanidine20 in 1 BOTTLETABLET201
68788-8802-3Tizanidine30 in 1 BOTTLETABLET301
68788-8802-6Tizanidine60 in 1 BOTTLETABLET601
68788-8802-8Tizanidine120 in 1 BOTTLETABLET1201
68788-8802-9Tizanidine90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8802-1EA - Each68788-8802447cf10c-121a-4232-9ccb-514ae6723e3f12025-03-04
68788-8802-2EA - Each68788-88025e0aadef-fe6d-419e-bce2-38157342a72612025-03-04
68788-8802-3EA - Each68788-8802cd1639ec-5889-44ae-b62f-3005a352abd112025-03-04
68788-8802-6EA - Each68788-880203f83ec8-bc3b-434c-b439-4de64870e32a12025-03-04
68788-8802-8EA - Each68788-8802e2713a27-a454-4794-a74e-62c45cd819a612025-03-04
68788-8802-9EA - Each68788-8802ca20b818-8045-4ce8-822d-cfeaa3d18e3612025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8802TIZANIDINE TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 6 package rows20250105_6e97c1ba-8171-4707-98ee-61afed75daac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSN6e97c1ba-8171-4707-98ee-61afed75daac1
313413tizanidine 4 MG Oral TabletSCD6e97c1ba-8171-4707-98ee-61afed75daac1
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY6e97c1ba-8171-4707-98ee-61afed75daac1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8802-168788880201100 TABLET in 1 BOTTLE (68788-8802-1) 100 tablet2025-01-02NoNoCurrent
68788-8802-26878888020220 TABLET in 1 BOTTLE (68788-8802-2) 20 tablet2025-01-02NoNoCurrent
68788-8802-36878888020330 TABLET in 1 BOTTLE (68788-8802-3) 30 tablet2025-01-02NoNoCurrent
68788-8802-66878888020660 TABLET in 1 BOTTLE (68788-8802-6) 60 tablet2025-01-02NoNoCurrent
68788-8802-868788880208120 TABLET in 1 BOTTLE (68788-8802-8) 120 tablet2025-01-02NoNoCurrent
68788-8802-96878888020990 TABLET in 1 BOTTLE (68788-8802-9) 90 tablet2025-01-02NoNoCurrent