BENZTROPINE MESYLATE

Product NDC
71610-502
11-digit product format
716100502
Labeler code
71610
Product ID
71610-502_83880a96-336b-4e03-ac29-a41e62d78f3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BENZTROPINE MESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA090168
Marketing category
ANDA
Marketing start
2012-11-28
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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
WMJ8TL7510BENZTROPINE MESYLATE132-17-2BENZTROPINE MESYLATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-502-537161005025360 TABLET in 1 BOTTLE (71610-502-53) 60 tablet2020-12-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
BENZTROPINE MESYLATE Tablets USP 0.5 mg, 1 mg and 2 mgAphena Pharma Solutions - Tennessee, LLC2021-01-21HUMAN PRESCRIPTION DRUG LABEL1