Benztropine Mesylate

Product NDC
0904-6789
11-digit product format
009046789
Labeler code
0904
Product ID
0904-6789_c00ab670-2d95-44fb-9f4c-c12441a52057
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benztropine mesylate
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6789-61EA - Each0904-67892ecd41f1-28a9-4866-a9e3-6860dbe31f9812019-09-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6789-6100904678961100 BLISTER PACK in 1 CARTON (0904-6789-61) > 1 TABLET in 1 BLISTER PACK100 blister pack2017-05-150000-00-00NoNoCurrent