FDA.reportPublic FDA data

Tizanidine

Product NDC
71610-864
11-digit product format
716100864
Labeler code
71610
Product ID
71610-864_390c9dff-6c5c-7bfa-e063-6294a90ad843
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076416
Marketing category
ANDA
Marketing start
2003-12-11
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIZANIDINE HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB53E3NMY5C
Rxcui313413

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
71610-864-16Tizanidine6000 in 1 BOTTLETABLET60004
71610-864-30Tizanidine30 in 1 BOTTLETABLET304
71610-864-53Tizanidine60 in 1 BOTTLETABLET604
71610-864-60Tizanidine90 in 1 BOTTLETABLET904
71610-864-80Tizanidine180 in 1 BOTTLETABLET1804

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-864-16EA - Each71610-864a9052ef2-101a-4593-b2ae-805ac5d610d312024-12-10
71610-864-30EA - Each71610-864829101a7-ddaa-416c-9048-6000eaf8d63d12025-08-11
71610-864-53EA - Each71610-864302fcf66-a03a-4499-b843-5d96ae412a1712025-03-04
71610-864-60EA - Each71610-864d6e7ffce-e399-4827-90cf-55289574fe0412025-03-04
71610-864-80EA - Each71610-8649860a93a-4399-4acd-8cce-70369931516a12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-864TIZANIDINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]3Current NDC, 5 package rows20250207_25db7cc0-604c-3d6b-e063-6394a90a337f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSN25db7cc0-604c-3d6b-e063-6394a90a337f4
313413tizanidine 4 MG Oral TabletSCD25db7cc0-604c-3d6b-e063-6394a90a337f4
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSY25db7cc0-604c-3d6b-e063-6394a90a337f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-864-16716100864166000 TABLET in 1 BOTTLE (71610-864-16) 6000 tablet2024-10-29NoNoCurrent
71610-864-307161008643030 TABLET in 1 BOTTLE (71610-864-30) 30 tablet2025-07-02NoNoCurrent
71610-864-537161008645360 TABLET in 1 BOTTLE (71610-864-53) 60 tablet2025-01-24NoNoCurrent
71610-864-607161008646090 TABLET in 1 BOTTLE (71610-864-60) 90 tablet2025-01-24NoNoCurrent
71610-864-8071610086480180 TABLET in 1 BOTTLE (71610-864-80) 180 tablet2025-01-31NoNoCurrent