Glycopyrrolate

Product NDC
16714-536
11-digit product format
167140536
Labeler code
16714
Product ID
16714-536_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
2022-08-10
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
16714-536-01ML - Milliliter16714-5366922d3e5-b806-46d5-83a3-24396204e89012022-06-06
16714-536-25ML - Milliliter16714-53634e53507-9fec-4561-a5ee-f0445880585a12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-536GLYCOPYRROLATE 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
16714-536-01167140536011 VIAL in 1 CARTON (16714-536-01) > 1 mL in 1 VIAL1 vial2022-08-100000-00-00NoNoCurrent
16714-536-251671405362525 VIAL in 1 CARTON (16714-536-25) > 1 mL in 1 VIAL25 vial2022-08-100000-00-00NoNoCurrent