Eplerenone

Product NDC
71205-863
11-digit product format
712050863
Labeler code
71205
Product ID
71205-863_49b9759a-c1b9-4ebe-874b-81fb82a42755
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Eplerenone
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA207842
Marketing category
ANDA
Marketing start
2021-11-08
Substance
EPLERENONE
Active strength
25 mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
6995V82D0BEPLERENONE107724-20-9EPLERENONE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71205-863-0071205086300100 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-00) 2022-03-24NoNoHistorical
71205-863-11712050863111000 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-11) 2022-03-24NoNoHistorical
71205-863-307120508633030 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-30) 2022-03-24NoNoHistorical
71205-863-5571205086355500 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-55) 2022-03-24NoNoHistorical
71205-863-607120508636060 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-60) 2022-03-24NoNoHistorical
71205-863-7271205086372120 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-72) 2022-03-24NoNoHistorical
71205-863-7871205086378180 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-78) 2022-03-24NoNoHistorical
71205-863-907120508639090 TABLET, COATED in 1 BOTTLE, PLASTIC (71205-863-90) 2022-03-24NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
EplerenoneProficient Rx LP2022-03-01HUMAN PRESCRIPTION DRUG LABEL1