Benztropine Mesylate

Product NDC
43353-707
11-digit product format
433530707
Labeler code
43353
Product ID
43353-707_1d70ed3f-5d35-4983-8502-0f8ef144d462
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benztropine mesylate
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennnessee, LLC
Application
ANDA204713
Marketing category
ANDA
Marketing start
2017-05-15
Marketing end
0000-00-00
Substance
BENZTROPINE MESYLATE
Active strength
1 mg/1
Pharmacologic classes
Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]
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
43353-707-09EA - Each43353-7070280b6df-4327-4546-8ac0-01cc3d2d422812017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-707BENZTROPINE MESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNNESSEE, LLC]2Legacy NDC20221221_262711f1-3ac4-4b85-a550-f16d1db3fba9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-707-09433530707099000 TABLET in 1 BOTTLE, PLASTIC (43353-707-09) 9000 tablet2017-07-250000-00-00NoNoCurrent