Glycopyrrolate

Product NDC
71288-407
11-digit product format
712880407
Labeler code
71288
Product ID
71288-407_69319d90-2a3e-4514-9959-b75779280e89
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glycopyrrolate
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA211705
Marketing category
ANDA
Marketing start
2019-05-15
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
71288-407-01ML - Milliliter71288-4074c47a772-d779-4d47-9d19-f726deb5fdbe12019-07-02
71288-407-02ML - Milliliter71288-407edda245a-7edf-4440-b044-4ba8a025597c12019-07-02
71288-407-03ML - Milliliter71288-407b7c17347-971c-4828-a67b-167383a2395512019-07-02
71288-407-04ML - Milliliter71288-4072784112e-0136-4112-a2e9-1c104c314f9512019-07-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71288-407-037128804070325 VIAL, SINGLE-DOSE in 1 CARTON (71288-407-03) > 1 mL in 1 VIAL, SINGLE-DOSE (71288-407-01) 2019-05-150000-00-00NoNoCurrent
71288-407-047128804070425 VIAL, SINGLE-DOSE in 1 CARTON (71288-407-04) > 2 mL in 1 VIAL, SINGLE-DOSE (71288-407-02) 2019-05-150000-00-00NoNoCurrent