Amantadine

Product NDC
67046-1531
11-digit product format
670461531
Labeler code
67046
Product ID
67046-1531_303c5b22-0edf-b2d7-e063-6394a90a9de6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amantadine
Dosage form
TABLET
Route
ORAL
Labeler
Coupler LLC
Application
ANDA214284
Marketing category
ANDA
Marketing start
2025-03-13
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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
M6Q1EO9TD0AMANTADINE HYDROCHLORIDE665-66-7AMANTADINE HYDROCHLORIDE
BF4C9Z1J53AMANTADINE768-94-5Amantadine

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-1531-36704615310330 TABLET in 1 BLISTER PACK (67046-1531-3) 30 tablet2025-03-13NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amantadine Hydrochloride Tablets, USP Rx onlyCoupler LLC2025-03-13HUMAN PRESCRIPTION DRUG LABEL1