tizanidine hydrochloride

Product NDC
71610-114
11-digit product format
716100114
Labeler code
71610
Product ID
71610-114_8826f454-0316-4981-8c28-9bf20cf956f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tizanidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076280
Marketing category
ANDA
Marketing start
2002-06-27
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-114-30EA - Each71610-1140195b31b-e0b5-42c0-b4ac-1abfee5fa1db12018-10-11
71610-114-53EA - Each71610-11439e40d50-ef27-48a1-9da3-e2c9b0ad5d6d12018-10-11
71610-114-60EA - Each71610-1147c41bf44-2c3a-4c3d-ad9f-9710dd56d6ad12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-114TIZANIDINE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20180831_2d354fee-9440-4d56-8990-fe1dcc2305fc.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-114-307161001143030 TABLET in 1 BOTTLE (71610-114-30) 30 tablet2018-08-090000-00-00NoNoCurrent
71610-114-537161001145360 TABLET in 1 BOTTLE (71610-114-53) 60 tablet2018-08-090000-00-00NoNoCurrent
71610-114-607161001146090 TABLET in 1 BOTTLE (71610-114-60) 90 tablet2018-08-090000-00-00NoNoCurrent