Glycopyrrolate

Product NDC
71288-408
11-digit product format
712880408
Labeler code
71288
Product ID
71288-408_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
71288-408-05ML - Milliliter71288-40871e3fc5d-118d-4f09-ad87-48e441f2d80b12019-07-02
71288-408-06ML - Milliliter71288-408832ae135-3360-45e1-9546-fe7d44f4529e12019-07-02
71288-408-20ML - Milliliter71288-408b367171c-ad81-4009-b20e-cc0e7f9b202b12019-07-02
71288-408-21ML - Milliliter71288-408c84655cb-a920-4742-a456-4c9f7fbf886112019-07-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71288-408-067128804080625 VIAL, MULTI-DOSE in 1 CARTON (71288-408-06) > 5 mL in 1 VIAL, MULTI-DOSE (71288-408-05) 2019-05-150000-00-00NoNoCurrent
71288-408-217128804082110 VIAL, MULTI-DOSE in 1 CARTON (71288-408-21) > 20 mL in 1 VIAL, MULTI-DOSE (71288-408-20) 2019-05-150000-00-00NoNoCurrent