amantadine hydrochloride

Product NDC
71205-702
11-digit product format
712050702
Labeler code
71205
Product ID
71205-702_743d1b73-f47e-4bbf-bb52-45b1e7f17308
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amantadine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA208278
Marketing category
ANDA
Marketing start
2016-08-04
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
71205-702-207120507022020 CAPSULE in 1 BOTTLE (71205-702-20) 20 capsule2022-09-29NoNoHistorical
71205-702-307120507023030 CAPSULE in 1 BOTTLE (71205-702-30) 30 capsule2022-09-29NoNoHistorical
71205-702-607120507026060 CAPSULE in 1 BOTTLE (71205-702-60) 60 capsule2022-09-29NoNoHistorical
71205-702-907120507029090 CAPSULE in 1 BOTTLE (71205-702-90) 90 capsule2022-09-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Amantadine Hydrochloride Capsules, USP Rx onlyProficient Rx LP2022-09-01HUMAN PRESCRIPTION DRUG LABEL1