NDC 60687-451

EPLERENONE

Eplerenone

EPLERENONE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by American Health Packaging. The primary component is Eplerenone.

Product ID60687-451_87afd65d-5873-ca56-e053-2a95a90afb70
NDC60687-451
Product TypeHuman Prescription Drug
Proprietary NameEPLERENONE
Generic NameEplerenone
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-05-01
Marketing CategoryANDA / ANDA
Application NumberANDA208283
Labeler NameAmerican Health Packaging
Substance NameEPLERENONE
Active Ingredient Strength25 mg/1
Pharm ClassesAldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 60687-451-21

30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-451-21) > 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-451-11)
Marketing Start Date2019-05-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60687-451-21 [60687045121]

EPLERENONE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA208283
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-01

NDC 60687-451-11 [60687045111]

EPLERENONE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA208283
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-01

Drug Details

Active Ingredients

IngredientStrength
EPLERENONE25 mg/1

Pharmacological Class

  • Aldosterone Antagonist [EPC]
  • Aldosterone Antagonists [MoA]
  • Aldosterone Antagonist [EPC]
  • Aldosterone Antagonists [MoA]

NDC Crossover Matching brand name "EPLERENONE" or generic name "Eplerenone"

NDCBrand NameGeneric Name
0185-5368EplerenoneEplerenone
0185-5369EplerenoneEplerenone
0378-1030Eplerenoneeplerenone
0378-1031Eplerenoneeplerenone
0832-0480EplerenoneEplerenone
0832-0481EplerenoneEplerenone
16729-293EplerenoneEplerenone
16729-294EplerenoneEplerenone
42254-011EplerenoneEplerenone
42291-454EplerenoneEplerenone
42291-455EplerenoneEplerenone
51991-877EPLERENONEEPLERENONE
51991-878EPLERENONEEPLERENONE
59762-1710Eplerenoneeplerenone
68084-948EplerenoneEplerenone
59762-1720EplerenoneEplerenone
60505-2652EplerenoneEplerenone
60505-2651EplerenoneEplerenone
60687-451EPLERENONEEPLERENONE
70436-098eplerenoneeplerenone
70436-099eplerenoneeplerenone
0025-1710Inspraeplerenone
0025-1720Inspraeplerenone
21695-797Inspraeplerenone

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