FDA.reportPublic FDA data

TIZANIDINE HYDROCHLORIDE

Product NDC
75834-209
11-digit product format
758340209
Labeler code
75834
Product ID
75834-209_359eaf8b-a8f7-4493-ba61-98e106bcc3d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TIZANIDINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Nivagen Pharmaceuticals, Inc.
Application
ANDA210021
Marketing category
ANDA
Marketing start
2019-09-26
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, 485485, 485486

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
75834-209-15TIZANIDINE HYDROCHLORIDE150 in 1 BOTTLECAPSULE1502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-209-15EA - Each75834-2090ca21061-d257-4d97-8c7e-e217ff10489712019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-209TIZANIDINE HYDROCHLORIDE CAPSULE [NIVAGEN PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 1 package rows20210115_c4a5b305-4265-4f90-a9ff-c16c0b936a06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485486tiZANidine HCl 2 MG Oral CapsulePSNc4a5b305-4265-4f90-a9ff-c16c0b936a062
485485tiZANidine HCl 4 MG Oral CapsulePSNc4a5b305-4265-4f90-a9ff-c16c0b936a062
485484tiZANidine HCl 6 MG Oral CapsulePSNc4a5b305-4265-4f90-a9ff-c16c0b936a062
485486tizanidine 2 MG Oral CapsuleSCDc4a5b305-4265-4f90-a9ff-c16c0b936a062
485485tizanidine 4 MG Oral CapsuleSCDc4a5b305-4265-4f90-a9ff-c16c0b936a062
485484tizanidine 6 MG Oral CapsuleSCDc4a5b305-4265-4f90-a9ff-c16c0b936a062
485486tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral CapsuleSYc4a5b305-4265-4f90-a9ff-c16c0b936a062
485485tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral CapsuleSYc4a5b305-4265-4f90-a9ff-c16c0b936a062
485484tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral CapsuleSYc4a5b305-4265-4f90-a9ff-c16c0b936a062

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75834-209-1575834020915150 CAPSULE in 1 BOTTLE (75834-209-15) 150 capsule2019-09-260000-00-00NoNoCurrent