amantadine hydrochloride

Product NDC
0904-6630
11-digit product format
009046630
Labeler code
0904
Product ID
0904-6630_8d103602-84fd-445f-8885-4c7ab1836863
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amantadine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA208278
Marketing category
ANDA
Marketing start
2016-08-04
Marketing end
0000-00-00
Substance
AMANTADINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6630-06EA - Each0904-66302415c210-b93e-4c5f-9b87-227c177f325f12019-04-11
0904-6630-61EA - Each0904-6630e3a7b7a6-3e95-4224-bc63-b537d06f8dad12017-04-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6630-060090466300650 BLISTER PACK in 1 CARTON (0904-6630-06) > 1 CAPSULE in 1 BLISTER PACK50 blister pack2016-08-040000-00-00NoNoCurrent
0904-6630-6100904663061100 BLISTER PACK in 1 CARTON (0904-6630-61) > 1 CAPSULE in 1 BLISTER PACK100 blister pack2016-08-040000-00-00NoNoCurrent