Galantamine

Product NDC
51079-853
11-digit product format
510790853
Labeler code
51079
Product ID
51079-853_7c5f5818-0a28-556a-e053-2991aa0a69cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
galantamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA077590
Marketing category
ANDA
Marketing start
2009-11-09
Marketing end
0000-00-00
Substance
GALANTAMINE HYDROBROMIDE
Active strength
8 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-853-01EA - Each51079-8534459b78b-41e1-41b3-b398-987ab491f00f12012-07-24
51079-853-03EA - Each51079-85339157f11-5624-456a-bd9c-b26fdb1213a912012-07-24