Glycopyrrolate

Product NDC
0404-9777
11-digit product format
004049777
Labeler code
0404
Product ID
0404-9777_99c1e8e8-011a-455b-accb-95d07bd46c17
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
0404-9777-20004049777201 VIAL, GLASS in 1 BAG (0404-9777-20) / 1 mL in 1 VIAL, GLASS2025-11-05NoNoHistorical

Related DailyMed Labels

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