Amantadine Hydrochloride

Product NDC
42799-118
11-digit product format
427990118
Labeler code
42799
Product ID
42799-118_bac5026a-a519-4abc-8041-2f4eb18ea9a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amantadine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Edenbridge Pharmaceuticals LLC.
Application
ANDA212407
Marketing category
ANDA
Marketing start
2022-09-15
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
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42799-118-0142799011801100 TABLET in 1 BOTTLE (42799-118-01) 100 tablet2022-09-150000-00-00NoNoCurrent
42799-118-0242799011802500 TABLET in 1 BOTTLE (42799-118-02) 500 tablet2022-09-150000-00-00NoNoCurrent