Benztropine Mesylate

Product NDC
0517-0785
11-digit product format
005170785
Labeler code
0517
Product ID
0517-0785_38afd657-1aed-43d6-aad3-9e75fc025e57
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benztropine Mesylate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
American Regent, Inc.
Application
ANDA091152
Marketing category
ANDA
Marketing start
2011-02-04
Marketing end
0000-00-00
Substance
BENZTROPINE MESYLATE
Active strength
1 mg/mL
Pharmacologic classes
Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0517-0785-052019-12-04C16284748780-1960f7f55-d8ad-8e05-e053-dbdaa90a074a633411f3-f092-4f59-84b0-6ac12a8aa013
0517-0785-052019-10-29C16284748780-1960f7f55-d8ad-8e05-e053-dbdaa90a074a633411f3-f092-4f59-84b0-6ac12a8aa013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0517-0785-05ML - Milliliter0517-07853378fb4c-9f3a-42a7-b1b0-ef6803f5355312012-07-24