FDA.reportPublic FDA data

TIZANIDINE HYDROCHLORIDE

Product NDC
68788-8747
11-digit product format
687888747
Labeler code
68788
Product ID
68788-8747_6f6e730a-5ef2-4a87-9b1d-8cc2b6aa9989
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tizanidine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA210267
Marketing category
ANDA
Marketing start
2024-09-26
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 HYDROCHLORIDE
Listing expiration
2026-12-31

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
68788-8747-1TIZANIDINE HYDROCHLORIDE100 in 1 BOTTLE, PLASTICCAPSULE1002
68788-8747-2TIZANIDINE HYDROCHLORIDE20 in 1 BOTTLE, PLASTICCAPSULE202
68788-8747-3TIZANIDINE HYDROCHLORIDE30 in 1 BOTTLE, PLASTICCAPSULE302
68788-8747-6TIZANIDINE HYDROCHLORIDE60 in 1 BOTTLE, PLASTICCAPSULE602
68788-8747-8TIZANIDINE HYDROCHLORIDE120 in 1 BOTTLE, PLASTICCAPSULE1202
68788-8747-9TIZANIDINE HYDROCHLORIDE90 in 1 BOTTLE, PLASTICCAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8747-1EA - Each68788-8747d019caca-67f3-47ba-b397-3886f740963712024-12-10
68788-8747-2EA - Each68788-8747e9c69917-e260-48c2-ad2e-945c79ea393212024-12-10
68788-8747-3EA - Each68788-8747ab2f6e50-4d22-4fb2-9748-3e2821f5899b12024-12-10
68788-8747-6EA - Each68788-87478a2ca624-a22c-4d7a-841c-e802ef33072312024-12-10
68788-8747-8EA - Each68788-874767af3ac7-1980-4229-a38f-10e6ea67360f12024-12-10
68788-8747-9EA - Each68788-874734b79798-98b7-4811-b4c2-0aabe1c9932a12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8747TIZANIDINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 6 package rows20240927_6439a7ef-1b22-4fa1-9be3-eedd3cd24191.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485485tiZANidine HCl 4 MG Oral CapsulePSN6439a7ef-1b22-4fa1-9be3-eedd3cd241912
485485tizanidine 4 MG Oral CapsuleSCD6439a7ef-1b22-4fa1-9be3-eedd3cd241912
485485tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral CapsuleSY6439a7ef-1b22-4fa1-9be3-eedd3cd241912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8747-168788874701100 CAPSULE in 1 BOTTLE, PLASTIC (68788-8747-1) 100 capsule2024-09-26NoNoHistorical
68788-8747-26878887470220 CAPSULE in 1 BOTTLE, PLASTIC (68788-8747-2) 20 capsule2024-09-26NoNoHistorical
68788-8747-36878887470330 CAPSULE in 1 BOTTLE, PLASTIC (68788-8747-3) 30 capsule2024-09-26NoNoHistorical
68788-8747-66878887470660 CAPSULE in 1 BOTTLE, PLASTIC (68788-8747-6) 60 capsule2024-09-26NoNoHistorical
68788-8747-868788874708120 CAPSULE in 1 BOTTLE, PLASTIC (68788-8747-8) 120 capsule2024-09-26NoNoHistorical
68788-8747-96878887470990 CAPSULE in 1 BOTTLE, PLASTIC (68788-8747-9) 90 capsule2024-09-26NoNoHistorical