Benztropine Mesylate

Product NDC
0603-2439
11-digit product format
006032439
Labeler code
0603
Product ID
0603-2439_7d977221-80bc-44cc-8210-c69e9bd3e368
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benztropine mesylate
Dosage form
TABLET
Route
ORAL
Labeler
Par Pharmaceutical, Inc.
Application
ANDA204713
Marketing category
ANDA
Marketing start
2017-05-15
Marketing end
0000-00-00
Substance
BENZTROPINE MESYLATE
Active strength
2 mg/1
Pharmacologic classes
Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-2439-21EA - Each0603-24398c1750b6-8907-4e62-9c25-8811fa0c876312017-08-11
0603-2439-32EA - Each0603-243967fd8676-d5fa-4a40-9936-29a3d10d870412017-08-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0603-2439-2100603243921100 TABLET in 1 BOTTLE, PLASTIC (0603-2439-21) 100 tablet2017-05-150000-00-00NoNoCurrent
0603-2439-32006032439321000 TABLET in 1 BOTTLE, PLASTIC (0603-2439-32) 1000 tablet2017-05-150000-00-00NoNoCurrent