Home NDC 51991-877 EPLERENONE
Product NDC 51991-877
11-digit product format 519910877
Labeler code 51991
Product ID 51991-877_546c0ded-8c22-4840-b369-a3029dedc299
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name EPLERENONE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Breckenridge Pharmaceutical, Inc.
Application ANDA208283
Marketing category ANDA
Marketing start 2018-09-18
Substance EPLERENONE
Active strength 25 mg/1
Pharmacologic classes Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208283-001 EPLERENONE EPLERENONE 25MG TABLET / ORAL AB 2018-09-14 A208283-002 EPLERENONE EPLERENONE 50MG TABLET / ORAL AB 2018-09-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A208283-001 EPLERENONE 25MG TABLET / ORAL AB 2018-09-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208283-002 EPLERENONE 50MG TABLET / ORAL AB 2018-09-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208283-001 EPLERENONE 25MG TABLET / ORAL AB 2018-09-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208283-002 EPLERENONE 50MG TABLET / ORAL AB 2018-09-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208283-001 EPLERENONE 25MG TABLET / ORAL AB 2018-09-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208283-002 EPLERENONE 50MG TABLET / ORAL AB 2018-09-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208283-001 EPLERENONE 25MG TABLET / ORAL AB 2018-09-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208283-002 EPLERENONE 50MG TABLET / ORAL AB 2018-09-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208283-001 EPLERENONE 25MG TABLET / ORAL AB 2018-09-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208283-002 EPLERENONE 50MG TABLET / ORAL AB 2018-09-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208283-001 EPLERENONE 25MG TABLET / ORAL AB 2018-09-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208283-002 EPLERENONE 50MG TABLET / ORAL AB 2018-09-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208283-001 EPLERENONE 25MG TABLET / ORAL AB 2018-09-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208283-002 EPLERENONE 50MG TABLET / ORAL AB 2018-09-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208283-001 EPLERENONE 25MG TABLET / ORAL AB 2018-09-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208283-002 EPLERENONE 50MG TABLET / ORAL AB 2018-09-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208283-001 EPLERENONE 25MG TABLET / ORAL AB 2018-09-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208283-002 EPLERENONE 50MG TABLET / ORAL AB 2018-09-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208283-001 EPLERENONE 25MG TABLET / ORAL AB 2018-09-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208283-002 EPLERENONE 50MG TABLET / ORAL AB 2018-09-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208283-001 EPLERENONE 25MG TABLET / ORAL AB 2018-09-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208283-002 EPLERENONE 50MG TABLET / ORAL AB 2018-09-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208283-001 EPLERENONE 25MG TABLET / ORAL AB 2018-09-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208283-002 EPLERENONE 50MG TABLET / ORAL AB 2018-09-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208283-001 EPLERENONE 25MG TABLET / ORAL AB 2018-09-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208283-002 EPLERENONE 50MG TABLET / ORAL AB 2018-09-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208283-001 EPLERENONE 25MG TABLET / ORAL AB 2018-09-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208283-002 EPLERENONE 50MG TABLET / ORAL AB 2018-09-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208283-001 EPLERENONE 25MG TABLET / ORAL AB 2018-09-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208283-002 EPLERENONE 50MG TABLET / ORAL AB 2018-09-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208283-001 EPLERENONE 25MG TABLET / ORAL AB 2018-09-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A208283-002 EPLERENONE 50MG TABLET / ORAL AB 2018-09-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208283-001 EPLERENONE 25MG TABLET / ORAL AB 2018-09-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A208283-002 EPLERENONE 50MG TABLET / ORAL AB 2018-09-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208283-001 EPLERENONE 25MG TABLET / ORAL AB 2018-09-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A208283-002 EPLERENONE 50MG TABLET / ORAL AB 2018-09-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208283-001 EPLERENONE 25MG TABLET / ORAL AB 2018-09-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A208283-002 EPLERENONE 50MG TABLET / ORAL AB 2018-09-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208283-001 EPLERENONE 25MG TABLET / ORAL AB 2018-09-14 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A208283-002 EPLERENONE 50MG TABLET / ORAL AB 2018-09-14 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base EPLERENONE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EPLERENONE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6995V82D0B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 351256 Internal RxNorm lookup 351257 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51991-877-11 EPLERENONE 10 in 1 CARTON TABLET, FILM COATED 10 8 51991-877-33 EPLERENONE 30 in 1 BOTTLE TABLET, FILM COATED 30 8 51991-877-90 EPLERENONE 90 in 1 BOTTLE TABLET, FILM COATED 90 8 51991-877-99 EPLERENONE 10 in 1 BLISTER PACK TABLET, FILM COATED 10 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51991-877 EPLERENONE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.] 6 Current NDC, Legacy NDC, 4 package rows 20240327_e2a51c12-bdc2-4b3b-8e9e-bf363c2817ed.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51991-877-11 51991087711 10 BLISTER PACK in 1 CARTON (51991-877-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK (51991-877-99) 10 blister pack 2018-09-18 0000-00-00 No No Current 51991-877-33 51991087733 30 TABLET, FILM COATED in 1 BOTTLE (51991-877-33) 2018-09-18 0000-00-00 No No Current 51991-877-90 51991087790 90 TABLET, FILM COATED in 1 BOTTLE (51991-877-90) 2018-09-18 0000-00-00 No No Current 51991-877-99 51991087799 10 in 1 BLISTER PACK Historical