Glycopyrrolate

Product NDC
16714-620
11-digit product format
167140620
Labeler code
16714
Product ID
16714-620_2ea12faa-b458-1f8a-a030-90dbacf97b00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glycopyrrolate
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
NORTHSTAR RX LLC
Application
ANDA210246
Marketing category
ANDA
Marketing start
2022-11-18
Marketing end
0000-00-00
Substance
GLYCOPYRROLATE
Active strength
0 mg/mL
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-620-01ML - Milliliter16714-620cd58e372-dc74-43c3-bdb3-b460098ebd3012022-06-06
16714-620-25ML - Milliliter16714-62066e8320f-6349-4901-9c2e-08f31a4a603112022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-620GLYCOPYRROLATE INJECTION [NORTHSTAR RX LLC]5Legacy NDC20250523_47393ff2-7ef5-a49b-4970-fc1d866e43b7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-620-01167140620011 VIAL in 1 CARTON (16714-620-01) > 2 mL in 1 VIAL1 vial2022-11-180000-00-00NoNoCurrent
16714-620-251671406202525 VIAL in 1 CARTON (16714-620-25) > 2 mL in 1 VIAL25 vial2022-11-180000-00-00NoNoCurrent