GLYCOPYRROLATE

Product NDC
51662-1431
11-digit product format
516621431
Labeler code
51662
Product ID
51662-1431_2b382c02-1322-a447-e063-6394a90ac5c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GLYCOPYRROLATE
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA208973
Marketing category
ANDA
Marketing start
2019-12-21
Substance
GLYCOPYRROLATE
Active strength
1 mg/5mL
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
V92SO9WP2IGLYCOPYRROLATE51186-83-5GLYCOPYRROLATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51662-1431-1516621431015 mL in 1 VIAL (51662-1431-1) 5 ml2019-12-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
GLYCOPYRROLATE INJECTIONHF Acquisition Co LLC, DBA HealthFirst2025-01-08HUMAN PRESCRIPTION DRUG LABEL3