Galantamine hydrobromide

Product NDC
43353-984
11-digit product format
433530984
Labeler code
43353
Product ID
43353-984_ee9210aa-aedf-4658-bd12-0710ee2e54b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Galantamine hydrobromide
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA079028
Marketing category
ANDA
Marketing start
2009-12-15
Marketing end
0000-00-00
Substance
GALANTAMINE HYDROBROMIDE
Active strength
16 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-984-05EA - Each43353-984f5daccaf-9e9b-4bfb-b164-1689860997bd12016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-984GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20160715_9a04069a-02e2-4428-a73f-51e58b51af89.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-984-05433530984054200 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43353-984-05) 2015-11-150000-00-00NoNoCurrent