Tizanidine Hydrochloride

Product NDC
73352-089
11-digit product format
733520089
Labeler code
73352
Product ID
73352-089_4bd048df-b403-70b2-e063-6394a90a7a38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tizanidine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Trifluent Pharma, LLC
Application
ANDA213798
Marketing category
ANDA
Marketing start
2025-09-16
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tizanidine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui2723708

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
73352-089-60Tizanidine Hydrochloride60 in 1 BOTTLECAPSULE603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73352-089-60EA - Each73352-089de4cd498-8346-4067-b536-ea236d44d5d112026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2723708tiZANidine 8 MG Oral CapsulePSN4a2cf456-58c5-c26d-e063-6294a90a0b243
2723708tizanidine 8 MG Oral CapsuleSCD4a2cf456-58c5-c26d-e063-6294a90a0b243
2723708tizanidine 8 MG (tizanidine hydrochloride 9.16 MG) Oral CapsuleSY4a2cf456-58c5-c26d-e063-6294a90a0b243

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73352-089-607335200896060 CAPSULE in 1 BOTTLE (73352-089-60) 60 capsule2025-09-16NoNoCurrent