Cogentin

Product NDC
76478-611
11-digit product format
764780611
Labeler code
76478
Product ID
76478-611_9f21b8d1-371b-472c-9e88-c6a8ee56d051
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benztropine mesylate
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.)
Application
NDA012015
Marketing category
NDA
Marketing start
1959-08-05
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
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76478-611-02ML - Milliliter76478-61175ea9be5-bd1e-41dd-bf3e-40f0bb57a3dc12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76478-611-02764780611025 AMPULE in 1 CARTON (76478-611-02) > 2 mL in 1 AMPULE5 ampule1959-08-050000-00-00NoNoCurrent