FDA.reportPublic FDA data

tizanidine hydrochloride

Product NDC
71335-2559
11-digit product format
713352559
Labeler code
71335
Product ID
71335-2559_d71b4bad-4314-4b31-b4f1-dbdf2c28785d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tizanidine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA213798
Marketing category
ANDA
Marketing start
2020-05-27
Substance
TIZANIDINE HYDROCHLORIDE
Active strength
4 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 HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui485485

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
71335-2559-1tizanidine hydrochloride1 in 1 BOTTLECAPSULE11
71335-2559-2tizanidine hydrochloride30 in 1 BOTTLECAPSULE301
71335-2559-3tizanidine hydrochloride60 in 1 BOTTLECAPSULE601
71335-2559-4tizanidine hydrochloride90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2559-2EA - Each71335-2559c97a1cb3-645a-49b9-b7f3-ce6afc0833d912025-10-14
71335-2559-3EA - Each71335-2559e281b61f-3d35-4921-bbcb-2b5955552b7912025-10-14
71335-2559-4EA - Each71335-2559633803ed-8be9-4626-b79a-656bedc8e05612025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2559TIZANIDINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1Current NDC, 4 package rows20250126_58c10b87-004e-4d2d-b5c1-b353c2cd071f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485485tiZANidine HCl 4 MG Oral CapsulePSN58c10b87-004e-4d2d-b5c1-b353c2cd071f1
485485tizanidine 4 MG Oral CapsuleSCD58c10b87-004e-4d2d-b5c1-b353c2cd071f1
485485tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral CapsuleSY58c10b87-004e-4d2d-b5c1-b353c2cd071f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2559-1713352559011 CAPSULE in 1 BOTTLE (71335-2559-1) 1 capsule2025-01-24NoNoHistorical
71335-2559-27133525590230 CAPSULE in 1 BOTTLE (71335-2559-2) 30 capsule2025-01-24NoNoHistorical
71335-2559-37133525590360 CAPSULE in 1 BOTTLE (71335-2559-3) 60 capsule2025-01-24NoNoHistorical
71335-2559-47133525590490 CAPSULE in 1 BOTTLE (71335-2559-4) 90 capsule2025-01-24NoNoHistorical