Amantadine HCL

Product NDC
72189-535
11-digit product format
721890535
Labeler code
72189
Product ID
72189-535_12894d87-0c1f-831b-e063-6294a90af11d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amantadine HCL
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA209035
Marketing category
ANDA
Marketing start
2024-02-23
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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-535-307218905353030 TABLET in 1 BOTTLE (72189-535-30) 30 tablet2024-02-23NoNoHistorical
72189-535-907218905359090 TABLET in 1 BOTTLE (72189-535-90) 90 tablet2024-02-23NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amantadine HCLDirect_Rx2024-02-29HUMAN PRESCRIPTION DRUG LABEL4