Glycopyrrolate

Product NDC
76045-206
11-digit product format
760450206
Labeler code
76045
Product ID
76045-206_d8f5e3e4-34e3-4e52-b76d-69e210e649d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glycopyrrolate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA209024
Marketing category
ANDA
Marketing start
2020-10-30
Substance
GLYCOPYRROLATE
Active strength
.2 mg/mL
Pharmacologic classes
Anticholinergic [EPC], Cholinergic 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
76045-206-107604502061024 BLISTER PACK in 1 CARTON (76045-206-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-206-01) / 1 mL in 1 SYRINGE, GLASS24 blister pack2020-10-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Glycopyrrolate Injection, USPFresenius Kabi USA, LLC | Fresenius Kabi, USA LLC2023-08-16HUMAN PRESCRIPTION DRUG LABEL8