FDA.reportPublic FDA data

TIZANIDINE HYDROCHLORIDE

Product NDC
68788-8478
11-digit product format
687888478
Labeler code
68788
Product ID
68788-8478_07bad3ac-76c5-4a87-a0e2-e3d5baefee8b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tizanidine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA210267
Marketing category
ANDA
Marketing start
2023-07-06
Substance
TIZANIDINE HYDROCHLORIDE
Active strength
6 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 HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE6 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui485484

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
68788-8478-1TIZANIDINE HYDROCHLORIDE100 in 1 BOTTLE, PLASTICCAPSULE1003
68788-8478-3TIZANIDINE HYDROCHLORIDE30 in 1 BOTTLE, PLASTICCAPSULE303
68788-8478-6TIZANIDINE HYDROCHLORIDE60 in 1 BOTTLE, PLASTICCAPSULE603
68788-8478-9TIZANIDINE HYDROCHLORIDE90 in 1 BOTTLE, PLASTICCAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8478-1EA - Each68788-8478c305d5f8-05ce-463d-8304-c9389815481d12023-08-08
68788-8478-3EA - Each68788-8478d6be56e5-ee15-4fc3-85c4-18f1553ecfb312023-08-08
68788-8478-6EA - Each68788-847823d3d5fe-2c18-4888-85a6-4fa838341d0812023-08-08
68788-8478-9EA - Each68788-847830eae7a3-bc71-4001-8a70-f999ca18a9e212023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8478TIZANIDINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 4 package rows20240822_ae9b6808-632f-4204-8581-bf146dcab69f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485484tiZANidine HCl 6 MG Oral CapsulePSNae9b6808-632f-4204-8581-bf146dcab69f3
485484tizanidine 6 MG Oral CapsuleSCDae9b6808-632f-4204-8581-bf146dcab69f3
485484tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral CapsuleSYae9b6808-632f-4204-8581-bf146dcab69f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8478-168788847801100 CAPSULE in 1 BOTTLE, PLASTIC (68788-8478-1) 100 capsule2023-07-06NoNoHistorical
68788-8478-36878884780330 CAPSULE in 1 BOTTLE, PLASTIC (68788-8478-3) 30 capsule2023-07-06NoNoHistorical
68788-8478-66878884780660 CAPSULE in 1 BOTTLE, PLASTIC (68788-8478-6) 60 capsule2023-07-06NoNoHistorical
68788-8478-96878884780990 CAPSULE in 1 BOTTLE, PLASTIC (68788-8478-9) 90 capsule2023-07-06NoNoHistorical