FDA.reportPublic FDA data

tizanidine

Product NDC
71610-776
11-digit product format
716100776
Labeler code
71610
Product ID
71610-776_2cee3817-e6f6-9db6-e063-6294a90a6ea1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tizanidine
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076533
Marketing category
ANDA
Marketing start
2004-01-16
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
71610-776-16tizanidine6000 in 1 BOTTLETABLET60004
71610-776-30tizanidine30 in 1 BOTTLETABLET304
71610-776-53tizanidine60 in 1 BOTTLETABLET604
71610-776-60tizanidine90 in 1 BOTTLETABLET904
71610-776-70tizanidine120 in 1 BOTTLETABLET1204
71610-776-75tizanidine7500 in 1 BOTTLETABLET75004
71610-776-80tizanidine180 in 1 BOTTLETABLET1804

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-776-16EA - Each71610-776a64c1457-f1e9-4dea-822c-04d74c2df47612024-03-12
71610-776-30EA - Each71610-7768c027ccd-98dd-459e-af1f-e38f2e5b8ca112024-03-12
71610-776-53EA - Each71610-776c35550a1-beb8-435f-aebf-e3d6cccc6b2e12024-03-12
71610-776-60EA - Each71610-776710ce53a-88ce-47a2-beda-ae10d4e94f8c12024-03-12
71610-776-70EA - Each71610-77610848438-4e14-4986-96ab-5af8602189bb12025-03-04
71610-776-75EA - Each71610-776d7c53390-72ba-4aa8-9b20-22da2c8ecf9c12024-05-16
71610-776-80EA - Each71610-776dc1dc188-6eee-4aa3-98b4-36383cceadd212025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-776TIZANIDINE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4Current NDC, 7 package rows20250205_ef7673f4-e0c1-4d79-af36-2f2ed2cc28f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313413tiZANidine HCl 4 MG Oral TabletPSNef7673f4-e0c1-4d79-af36-2f2ed2cc28f74
313413tizanidine 4 MG Oral TabletSCDef7673f4-e0c1-4d79-af36-2f2ed2cc28f74
313413tizanidine 4 MG (as tizanidine HCl 4.576 MG) Oral TabletSYef7673f4-e0c1-4d79-af36-2f2ed2cc28f74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-776-16716100776166000 TABLET in 1 BOTTLE (71610-776-16) 6000 tablet2024-01-25NoNoCurrent
71610-776-307161007763030 TABLET in 1 BOTTLE (71610-776-30) 30 tablet2024-01-22NoNoCurrent
71610-776-537161007765360 TABLET in 1 BOTTLE (71610-776-53) 60 tablet2024-01-25NoNoCurrent
71610-776-607161007766090 TABLET in 1 BOTTLE (71610-776-60) 90 tablet2024-01-25NoNoCurrent
71610-776-7071610077670120 TABLET in 1 BOTTLE (71610-776-70) 120 tablet2025-01-24NoNoCurrent
71610-776-75716100776757500 TABLET in 1 BOTTLE (71610-776-75) 7500 tablet2024-04-01NoNoCurrent
71610-776-8071610077680180 TABLET in 1 BOTTLE (71610-776-80) 180 tablet2025-01-24NoNoCurrent