galantamine

Product NDC
68382-178
11-digit product format
683820178
Labeler code
68382
Product ID
68382-178_ca872164-fc8d-4d1e-aee1-9626e8480cbc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
galantamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA078898
Marketing category
ANDA
Marketing start
2011-10-10
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
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
68382-178-14EA - Each68382-17867d87e9c-d301-4814-9e30-ce46235ce67512013-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-178-0168382017801100 TABLET, FILM COATED in 1 BOTTLE (68382-178-01) 2011-10-100000-00-00NoNoCurrent
68382-178-10683820178101000 TABLET, FILM COATED in 1 BOTTLE (68382-178-10) 2011-10-100000-00-00NoNoCurrent
68382-178-146838201781460 TABLET, FILM COATED in 1 BOTTLE (68382-178-14) 2011-10-100000-00-00NoNoCurrent
68382-178-7768382017877100 BLISTER PACK in 1 CARTON (68382-178-77) > 1 TABLET, FILM COATED in 1 BLISTER PACK (68382-178-30) 100 blister pack2011-10-100000-00-00NoNoCurrent