Zanaflex

Product NDC
73352-090
11-digit product format
733520090
Labeler code
73352
Product ID
73352-090_4007fbf6-8eb7-85e9-e063-6394a90a4013
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Zanaflex
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui2723708, 2723710

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
73352-090-60Zanaflex60 in 1 BOTTLECAPSULE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73352-090-60EA - Each73352-090d60c2844-1a9d-449b-8247-8cd92df2276312025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2723708tiZANidine 8 MG Oral CapsulePSN9833a1b8-f530-4a06-bc77-7d11b6e94c652
2723710Zanaflex 8 MG Oral CapsulePSN9833a1b8-f530-4a06-bc77-7d11b6e94c652
2723710tizanidine 8 MG Oral Capsule [Zanaflex]SBD9833a1b8-f530-4a06-bc77-7d11b6e94c652
2723708tizanidine 8 MG Oral CapsuleSCD9833a1b8-f530-4a06-bc77-7d11b6e94c652
2723708tizanidine 8 MG (tizanidine hydrochloride 9.16 MG) Oral CapsuleSY9833a1b8-f530-4a06-bc77-7d11b6e94c652
2723710Zanaflex 8 MG (tizanidine hydrochloride 9.16 MG) Oral CapsuleSY9833a1b8-f530-4a06-bc77-7d11b6e94c652
2723710Zanaflex 8 MG Oral CapsuleSY9833a1b8-f530-4a06-bc77-7d11b6e94c652

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73352-090-607335200906060 CAPSULE in 1 BOTTLE (73352-090-60) 60 capsule2025-09-16NoNoCurrent