FDA.reportPublic FDA data

TIZANIDINE HYDROCHLORIDE

Product NDC
71335-9743
11-digit product format
713359743
Labeler code
71335
Product ID
71335-9743_ff7a82ea-c03c-44f6-9b15-468cb8d15a9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tizanidine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210267
Marketing category
ANDA
Marketing start
2019-03-20
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
71335-9743-1TIZANIDINE HYDROCHLORIDE30 in 1 BOTTLE, PLASTICCAPSULE30101
71335-9743-2TIZANIDINE HYDROCHLORIDE60 in 1 BOTTLE, PLASTICCAPSULE60101
71335-9743-3TIZANIDINE HYDROCHLORIDE90 in 1 BOTTLE, PLASTICCAPSULE90101
71335-9743-4TIZANIDINE HYDROCHLORIDE120 in 1 BOTTLE, PLASTICCAPSULE120101
71335-9743-5TIZANIDINE HYDROCHLORIDE28 in 1 BOTTLE, PLASTICCAPSULE28101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9743TIZANIDINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]101Current NDC, 5 package rows20240410_ff7a82ea-c03c-44f6-9b15-468cb8d15a9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485484tiZANidine HCl 6 MG Oral CapsulePSNff7a82ea-c03c-44f6-9b15-468cb8d15a9c101
485484tizanidine 6 MG Oral CapsuleSCDff7a82ea-c03c-44f6-9b15-468cb8d15a9c101
485484tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral CapsuleSYff7a82ea-c03c-44f6-9b15-468cb8d15a9c101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9743-17133597430130 CAPSULE in 1 BOTTLE, PLASTIC (71335-9743-1) 30 capsule2024-04-05NoNoHistorical
71335-9743-27133597430260 CAPSULE in 1 BOTTLE, PLASTIC (71335-9743-2) 60 capsule2023-06-26NoNoHistorical
71335-9743-37133597430390 CAPSULE in 1 BOTTLE, PLASTIC (71335-9743-3) 90 capsule2024-04-05NoNoHistorical
71335-9743-471335974304120 CAPSULE in 1 BOTTLE, PLASTIC (71335-9743-4) 120 capsule2024-04-05NoNoHistorical
71335-9743-57133597430528 CAPSULE in 1 BOTTLE, PLASTIC (71335-9743-5) 28 capsule2024-04-05NoNoHistorical