GLYRX-PF

Product NDC
51754-6013
11-digit product format
517546013
Labeler code
51754
Product ID
51754-6013_442634f7-9858-421d-91db-5bfdb21dcf13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glycopyrrolate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Exela Pharma Sciences, LLC
Application
NDA210997
Marketing category
NDA
Marketing start
2020-06-01
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
51754-6013-35175460130310 SYRINGE, PLASTIC in 1 CARTON (51754-6013-3) / 3 mL in 1 SYRINGE, PLASTIC2020-12-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
GLYRX-PFExela Pharma Sciences, LLC2025-07-23HUMAN PRESCRIPTION DRUG LABEL5