Amantadine Hydrochloride

Product NDC
70518-3381
11-digit product format
705183381
Labeler code
70518
Product ID
70518-3381_d9de7287-0dd8-643a-e053-2995a90a9c4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amantadine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076186
Marketing category
ANDA
Marketing start
2022-03-10
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-3381-0EA - Each70518-338169ba29e9-6672-4e21-9d21-0dcb79603f7c12023-01-09
70518-3381-1EA - Each70518-3381268add20-09e5-4305-ad13-179c4ac61d0612023-01-09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3381-070518338100100 POUCH in 1 BOX (70518-3381-0) > 1 TABLET in 1 POUCH (70518-3381-1) 100 pouch2022-03-100000-00-00NoNoCurrent