Home NDC 0185-5368 Eplerenone
Product NDC 0185-5368
11-digit product format 001855368
Labeler code 0185
Product ID 0185-5368_697e0d84-e7d2-400e-baab-2ca055e4c6a4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Eplerenone
Dosage form TABLET
Route ORAL
Labeler Eon Labs, Inc.
Application ANDA078510
Marketing category ANDA
Marketing start 2008-08-01
Marketing end 0000-00-00
Substance EPLERENONE
Active strength 25 mg/1
Pharmacologic classes Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 33 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A078510-001 EPLERENONE EPLERENONE 25MG TABLET / ORAL AB 2008-08-01 A078510-002 EPLERENONE EPLERENONE 50MG TABLET / ORAL AB 2008-08-01
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 · 84 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 A078510-001 EPLERENONE 25MG TABLET / ORAL AB 2008-08-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078510-002 EPLERENONE 50MG TABLET / ORAL AB 2008-08-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078510-001 EPLERENONE 25MG TABLET / ORAL AB 2008-08-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078510-002 EPLERENONE 50MG TABLET / ORAL AB 2008-08-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078510-001 EPLERENONE 25MG TABLET / ORAL AB 2008-08-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078510-002 EPLERENONE 50MG TABLET / ORAL AB 2008-08-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078510-001 EPLERENONE 25MG TABLET / ORAL AB 2008-08-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078510-002 EPLERENONE 50MG TABLET / ORAL AB 2008-08-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078510-001 EPLERENONE 25MG TABLET / ORAL AB 2008-08-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078510-002 EPLERENONE 50MG TABLET / ORAL AB 2008-08-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078510-001 EPLERENONE 25MG TABLET / ORAL AB 2008-08-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078510-002 EPLERENONE 50MG TABLET / ORAL AB 2008-08-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078510-001 EPLERENONE 25MG TABLET / ORAL AB 2008-08-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078510-002 EPLERENONE 50MG TABLET / ORAL AB 2008-08-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078510-001 EPLERENONE 25MG TABLET / ORAL AB 2008-08-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078510-002 EPLERENONE 50MG TABLET / ORAL AB 2008-08-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078510-001 EPLERENONE 25MG TABLET / ORAL AB 2008-08-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078510-002 EPLERENONE 50MG TABLET / ORAL AB 2008-08-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078510-001 EPLERENONE 25MG TABLET / ORAL AB 2008-08-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078510-002 EPLERENONE 50MG TABLET / ORAL AB 2008-08-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078510-001 EPLERENONE 25MG TABLET / ORAL AB 2008-08-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078510-002 EPLERENONE 50MG TABLET / ORAL AB 2008-08-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078510-001 EPLERENONE 25MG TABLET / ORAL AB 2008-08-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078510-002 EPLERENONE 50MG TABLET / ORAL AB 2008-08-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078510-001 EPLERENONE 25MG TABLET / ORAL AB 2008-08-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078510-002 EPLERENONE 50MG TABLET / ORAL AB 2008-08-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078510-001 EPLERENONE 25MG TABLET / ORAL AB 2008-08-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078510-002 EPLERENONE 50MG TABLET / ORAL AB 2008-08-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078510-001 EPLERENONE 25MG TABLET / ORAL AB 2008-08-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078510-002 EPLERENONE 50MG TABLET / ORAL AB 2008-08-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078510-001 EPLERENONE 25MG TABLET / ORAL AB 2008-08-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078510-002 EPLERENONE 50MG TABLET / ORAL AB 2008-08-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078510-001 EPLERENONE 25MG TABLET / ORAL AB 2008-08-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078510-002 EPLERENONE 50MG TABLET / ORAL AB 2008-08-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078510-001 EPLERENONE 25MG TABLET / ORAL AB 2008-08-01 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078510-002 EPLERENONE 50MG TABLET / ORAL AB 2008-08-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078510-001 EPLERENONE 25MG TABLET / ORAL AB 2008-08-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078510-002 EPLERENONE 50MG TABLET / ORAL AB 2008-08-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078510-001 EPLERENONE 25MG TABLET / ORAL AB 2008-08-01 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A078510-002 EPLERENONE 50MG TABLET / ORAL AB 2008-08-01 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded EPLERENONE ACTIVE INGREDIENT 6995V82D0B EPLERENONE TABLET [EON LABS, INC.] 13 EPLERENONE ACTIVE MOIETY 6995V82D0B EPLERENONE TABLET [EON LABS, INC.] 13 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 EPLERENONE TABLET [EON LABS, INC.] 13 FD&C YELLOW NO. 5 INACTIVE INGREDIENT I753WB2F1M EPLERENONE TABLET [EON LABS, INC.] 13 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 EPLERENONE TABLET [EON LABS, INC.] 13 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO EPLERENONE TABLET [EON LABS, INC.] 13 LACTOSE INACTIVE INGREDIENT J2B2A4N98G EPLERENONE TABLET [EON LABS, INC.] 13 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X EPLERENONE TABLET [EON LABS, INC.] 13 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 EPLERENONE TABLET [EON LABS, INC.] 13 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE EPLERENONE TABLET [EON LABS, INC.] 13 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A EPLERENONE TABLET [EON LABS, INC.] 13 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H EPLERENONE TABLET [EON LABS, INC.] 13 TALC INACTIVE INGREDIENT 7SEV7J4R1U EPLERENONE TABLET [EON LABS, INC.] 13 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP EPLERENONE TABLET [EON LABS, INC.] 13 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 EPLERENONE TABLET [EON LABS, INC.] 13 EPLERENONE ACTIVE INGREDIENT 6995V82D0B EPLERENONE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 EPLERENONE ACTIVE MOIETY 6995V82D0B EPLERENONE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 EPLERENONE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO EPLERENONE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X EPLERENONE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 EPLERENONE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A EPLERENONE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H EPLERENONE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U EPLERENONE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP EPLERENONE TABLET [PHYSICIANS TOTAL CARE, INC.] 2 EPLERENONE ACTIVE INGREDIENT 6995V82D0B EPLERENONE TABLET [AMERICAN HEALTH PACKAGING] 1 EPLERENONE ACTIVE MOIETY 6995V82D0B EPLERENONE TABLET [AMERICAN HEALTH PACKAGING] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U EPLERENONE TABLET [AMERICAN HEALTH PACKAGING] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 EPLERENONE TABLET [AMERICAN HEALTH PACKAGING] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO EPLERENONE TABLET [AMERICAN HEALTH PACKAGING] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X EPLERENONE TABLET [AMERICAN HEALTH PACKAGING] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 EPLERENONE TABLET [AMERICAN HEALTH PACKAGING] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A EPLERENONE TABLET [AMERICAN HEALTH PACKAGING] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H EPLERENONE TABLET [AMERICAN HEALTH PACKAGING] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U EPLERENONE TABLET [AMERICAN HEALTH PACKAGING] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP EPLERENONE TABLET [AMERICAN HEALTH PACKAGING] 1
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 0185-5368-09 00185536809 90 TABLET in 1 BOTTLE (0185-5368-09) 90 tablet 2008-08-01 0000-00-00 No No Current 0185-5368-30 00185536830 30 TABLET in 1 BOTTLE (0185-5368-30) 30 tablet 2008-08-01 0000-00-00 No No Current