Glycopyrrolate

Product NDC
0404-9776
11-digit product format
004049776
Labeler code
0404
Product ID
0404-9776_25fc7503-41ff-49f5-87d5-476fa9f279dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glycopyrrolate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Henry Schein, Inc.
Application
ANDA210842
Marketing category
ANDA
Marketing start
2025-11-05
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 formatDescriptionMarketing startSampleExclude flagStatus
0404-9776-05004049776051 VIAL, GLASS in 1 BAG (0404-9776-05) / 1 mL in 1 VIAL, GLASS2025-11-05NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
GLYCOPYRROLATE INJECTION, USP Rx ONLY NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOLHenry Schein, Inc.2025-11-05HUMAN PRESCRIPTION DRUG LABEL1