FDA.reportPublic FDA data

tizanidine hydrochloride

Product NDC
72888-161
11-digit product format
728880161
Labeler code
72888
Product ID
72888-161_3f9bf106-484a-1c3c-e063-6394a90ac8a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tizanidine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Advagen Pharma Limited
Application
ANDA213798
Marketing category
ANDA
Marketing start
2025-08-28
Substance
TIZANIDINE HYDROCHLORIDE
Active strength
8 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 HYDROCHLORIDE8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui485484, 485485, 485486, 2723708

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
72888-161-15tizanidine hydrochloride150 in 1 BOTTLECAPSULE1505

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2723708tiZANidine 8 MG Oral CapsulePSN7f39499a-98cf-4d13-9b07-ccb5c22e43c85
485486tiZANidine HCl 2 MG Oral CapsulePSN7f39499a-98cf-4d13-9b07-ccb5c22e43c85
485485tiZANidine HCl 4 MG Oral CapsulePSN7f39499a-98cf-4d13-9b07-ccb5c22e43c85
485484tiZANidine HCl 6 MG Oral CapsulePSN7f39499a-98cf-4d13-9b07-ccb5c22e43c85
485486tizanidine 2 MG Oral CapsuleSCD7f39499a-98cf-4d13-9b07-ccb5c22e43c85
485485tizanidine 4 MG Oral CapsuleSCD7f39499a-98cf-4d13-9b07-ccb5c22e43c85
485484tizanidine 6 MG Oral CapsuleSCD7f39499a-98cf-4d13-9b07-ccb5c22e43c85
2723708tizanidine 8 MG Oral CapsuleSCD7f39499a-98cf-4d13-9b07-ccb5c22e43c85
485486tizanidine 2 MG (as tizanidine HCl 2.288 MG) Oral CapsuleSY7f39499a-98cf-4d13-9b07-ccb5c22e43c85
485485tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral CapsuleSY7f39499a-98cf-4d13-9b07-ccb5c22e43c85
485484tizanidine 6 MG (as tizanidine HCl 6.87 MG) Oral CapsuleSY7f39499a-98cf-4d13-9b07-ccb5c22e43c85
2723708tizanidine 8 MG (tizanidine hydrochloride 9.16 MG) Oral CapsuleSY7f39499a-98cf-4d13-9b07-ccb5c22e43c85

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72888-161-1572888016115150 CAPSULE in 1 BOTTLE (72888-161-15) 150 capsule2025-08-28NoNoCurrent