FDA.reportPublic FDA data

Tizanidne hydrochloride

Product NDC
68788-8798
11-digit product format
687888798
Labeler code
68788
Product ID
68788-8798_ff9d2f6a-8654-4dbe-ab07-4f9cacda54ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidne Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA212196
Marketing category
ANDA
Marketing start
2025-01-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tizanidne hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui485485

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
68788-8798-1Tizanidne hydrochloride100 in 1 BOTTLECAPSULE1002
68788-8798-2Tizanidne hydrochloride20 in 1 BOTTLECAPSULE202
68788-8798-3Tizanidne hydrochloride30 in 1 BOTTLECAPSULE302
68788-8798-6Tizanidne hydrochloride60 in 1 BOTTLECAPSULE602
68788-8798-8Tizanidne hydrochloride120 in 1 BOTTLECAPSULE1202
68788-8798-9Tizanidne hydrochloride90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8798-1EA - Each68788-87982698a62e-2aa5-4be4-9aab-867f837d6ccc12025-02-10
68788-8798-2EA - Each68788-8798c12a3797-37e4-404b-afd1-0d9c76d03c7012025-02-10
68788-8798-3EA - Each68788-8798cb9db06e-8552-482b-a815-428aa69c013312025-02-10
68788-8798-6EA - Each68788-87989aa947ae-9005-4af5-88d4-c0e0b274fa3b12025-02-10
68788-8798-8EA - Each68788-879870f2f573-e60a-452b-b7ad-a061f9c78a3612025-02-10
68788-8798-9EA - Each68788-87980bec1f42-6dcd-4aff-9ddb-7ab6eccdb91d12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8798TIZANIDNE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 6 package rows20250101_3f569c5a-ec9d-4356-ac04-c17714ff68d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485485tiZANidine HCl 4 MG Oral CapsulePSN3f569c5a-ec9d-4356-ac04-c17714ff68d12
485485tizanidine 4 MG Oral CapsuleSCD3f569c5a-ec9d-4356-ac04-c17714ff68d12
485485tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral CapsuleSY3f569c5a-ec9d-4356-ac04-c17714ff68d12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8798-168788879801100 CAPSULE in 1 BOTTLE (68788-8798-1) 100 capsule2025-01-01NoNoHistorical
68788-8798-26878887980220 CAPSULE in 1 BOTTLE (68788-8798-2) 20 capsule2025-01-01NoNoHistorical
68788-8798-36878887980330 CAPSULE in 1 BOTTLE (68788-8798-3) 30 capsule2025-01-01NoNoHistorical
68788-8798-66878887980660 CAPSULE in 1 BOTTLE (68788-8798-6) 60 capsule2025-01-01NoNoHistorical
68788-8798-868788879808120 CAPSULE in 1 BOTTLE (68788-8798-8) 120 capsule2025-01-01NoNoHistorical
68788-8798-96878887980990 CAPSULE in 1 BOTTLE (68788-8798-9) 90 capsule2025-01-01NoNoHistorical