GLYCATE

Product NDC
15370-160
11-digit product format
153700160
Labeler code
15370
Product ID
15370-160_c0415d78-5541-4f94-868e-7447cae5bbfb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GLYCOPYRROLATE
Dosage form
TABLET
Route
ORAL
Labeler
Carwin Pharmaceutical Associates, LLC
Application
ANDA091522
Marketing category
ANDA
Marketing start
2018-06-10
Marketing end
0000-00-00
Substance
GLYCOPYRROLATE
Active strength
2 mg/1
Pharmacologic classes
Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
15370-160-10EA - Each15370-160c109a933-f2da-4cdd-83f5-d63da2254c2312018-07-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
15370-160-03153700160033 TABLET in 1 BOTTLE, PLASTIC (15370-160-03) 3 tablet2018-06-100000-00-00NoNoCurrent
15370-160-1015370016010100 TABLET in 1 BOTTLE, PLASTIC (15370-160-10) 100 tablet2018-06-100000-00-00NoNoCurrent