Glycopyrrolate

Product NDC
0404-9775
11-digit product format
004049775
Labeler code
0404
Product ID
0404-9775_6b90d651-b13c-441c-ab12-8f866f0bfcbb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glycopyrrolate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Henry Schein, Inc.
Application
ANDA210083
Marketing category
ANDA
Marketing start
2025-10-16
Substance
GLYCOPYRROLATE
Active strength
.2 mg/mL
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
0404-9775-01004049775011 VIAL in 1 BAG (0404-9775-01) / 1 mL in 1 VIAL1 vial2025-10-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
GlycopyrrolateHenry Schein, Inc.2025-10-16HUMAN PRESCRIPTION DRUG LABEL1