GLYCOPYRROLATE

Product NDC
52584-396
11-digit product format
525840396
Labeler code
52584
Product ID
52584-396_f988cd27-6258-4247-8c76-45408c494e6f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glycopyrrolate
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
General Injectables and Vaccines, Inc.
Application
ANDA208973
Marketing category
ANDA
Marketing start
2018-09-17
Marketing end
2023-12-31
Substance
GLYCOPYRROLATE
Active strength
1 mg/5mL
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52584-396-01525840396011 VIAL in 1 BAG (52584-396-01) > 5 mL in 1 VIAL1 vial2018-09-170000-00-00NoNoCurrent