Home NDC 31722-050 EPLERENONE
Product NDC 31722-050
11-digit product format 317220050
Labeler code 31722
Product ID 31722-050_fe285cf1-1e78-943b-e053-6394a90a760d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name EPLERENONE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA213812
Marketing category ANDA
Marketing start 2023-06-02
Substance EPLERENONE
Active strength 50 mg/1
Pharmacologic classes Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A213812-001 EPLERENONE EPLERENONE 25MG TABLET / ORAL AB 2023-06-02 A213812-002 EPLERENONE EPLERENONE 50MG TABLET / ORAL AB 2023-06-02
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 2 · 46 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 2026-08-18 06:07:40 2026-07 A213812-001 EPLERENONE 25MG TABLET / ORAL AB 2023-06-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213812-002 EPLERENONE 50MG TABLET / ORAL AB 2023-06-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213812-001 EPLERENONE 25MG TABLET / ORAL AB 2023-06-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213812-002 EPLERENONE 50MG TABLET / ORAL AB 2023-06-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213812-001 EPLERENONE 25MG TABLET / ORAL AB 2023-06-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213812-002 EPLERENONE 50MG TABLET / ORAL AB 2023-06-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213812-001 EPLERENONE 25MG TABLET / ORAL AB 2023-06-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213812-002 EPLERENONE 50MG TABLET / ORAL AB 2023-06-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213812-001 EPLERENONE 25MG TABLET / ORAL AB 2023-06-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213812-002 EPLERENONE 50MG TABLET / ORAL AB 2023-06-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213812-001 EPLERENONE 25MG TABLET / ORAL AB 2023-06-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213812-002 EPLERENONE 50MG TABLET / ORAL AB 2023-06-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213812-001 EPLERENONE 25MG TABLET / ORAL AB 2023-06-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213812-002 EPLERENONE 50MG TABLET / ORAL AB 2023-06-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213812-001 EPLERENONE 25MG TABLET / ORAL AB 2023-06-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213812-002 EPLERENONE 50MG TABLET / ORAL AB 2023-06-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213812-001 EPLERENONE 25MG TABLET / ORAL AB 2023-06-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213812-002 EPLERENONE 50MG TABLET / ORAL AB 2023-06-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213812-001 EPLERENONE 25MG TABLET / ORAL AB 2023-06-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213812-002 EPLERENONE 50MG TABLET / ORAL AB 2023-06-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213812-001 EPLERENONE 25MG TABLET / ORAL AB 2023-06-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213812-002 EPLERENONE 50MG TABLET / ORAL AB 2023-06-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213812-001 EPLERENONE 25MG TABLET / ORAL AB 2023-06-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213812-002 EPLERENONE 50MG TABLET / ORAL AB 2023-06-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213812-001 EPLERENONE 25MG TABLET / ORAL AB 2023-06-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213812-002 EPLERENONE 50MG TABLET / ORAL AB 2023-06-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213812-001 EPLERENONE 25MG TABLET / ORAL AB 2023-06-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213812-002 EPLERENONE 50MG TABLET / ORAL AB 2023-06-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213812-001 EPLERENONE 25MG TABLET / ORAL AB 2023-06-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A213812-002 EPLERENONE 50MG TABLET / ORAL AB 2023-06-02 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213812-001 EPLERENONE 25MG TABLET / ORAL AB 2023-06-02 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213812-002 EPLERENONE 50MG TABLET / ORAL AB 2023-06-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213812-001 EPLERENONE 25MG TABLET / ORAL AB 2023-06-02 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A213812-002 EPLERENONE 50MG TABLET / ORAL AB 2023-06-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213812-001 EPLERENONE 25MG TABLET / ORAL AB 2023-06-02 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A213812-002 EPLERENONE 50MG TABLET / ORAL AB 2023-06-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213812-001 EPLERENONE 25MG TABLET / ORAL AB 2023-06-02 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213812-002 EPLERENONE 50MG TABLET / ORAL AB 2023-06-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213812-001 EPLERENONE 25MG TABLET / ORAL AB 2023-06-02 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213812-002 EPLERENONE 50MG TABLET / ORAL AB 2023-06-02 9b2671bbb829…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 46 observed states.
Additional Listing Data#
Finished product Yes
Brand name base EPLERENONE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EPLERENONE 50 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 31722-050-30 EPLERENONE 30 in 1 BOTTLE TABLET, FILM COATED 30 1 31722-050-90 EPLERENONE 90 in 1 BOTTLE TABLET, FILM COATED 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-050 EPLERENONE (EPLERENONE) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 1 Current NDC, 2 package rows 20230616_25a1c77c-7008-4b07-af14-5522a282783a.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 31722-050-30 31722005030 30 TABLET, FILM COATED in 1 BOTTLE (31722-050-30) 2023-06-02 No No Current 31722-050-90 31722005090 90 TABLET, FILM COATED in 1 BOTTLE (31722-050-90) 2023-06-02 No No Current