Home NDC 59762-1107 Eplerenone
Product NDC 59762-1107
11-digit product format 597621107
Labeler code 59762
Product ID 59762-1107_b4bf45ee-6524-4a9d-9d7d-91886e32ee72
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name eplerenone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application NDA021437
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2024-12-13
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021437-001 INSPRA EPLERENONE 25MG TABLET / ORAL AB RLD 2002-09-27 N021437-002 INSPRA EPLERENONE 50MG TABLET / ORAL AB RLD, RS 2002-09-27 N021437-003 INSPRA EPLERENONE 100MG TABLET / ORAL 2002-09-27
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 4 · 126 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 N021437-001 INSPRA 25MG TABLET / ORAL AB RLD 2002-09-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021437-002 INSPRA 50MG TABLET / ORAL AB RLD, RS 2002-09-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021437-003 INSPRA 100MG TABLET / ORAL 2002-09-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021437-001 INSPRA 25MG TABLET / ORAL AB RLD 2002-09-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021437-002 INSPRA 50MG TABLET / ORAL AB RLD, RS 2002-09-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021437-003 INSPRA 100MG TABLET / ORAL 2002-09-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021437-001 INSPRA 25MG TABLET / ORAL AB RLD 2002-09-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021437-002 INSPRA 50MG TABLET / ORAL AB RLD, RS 2002-09-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021437-003 INSPRA 100MG TABLET / ORAL 2002-09-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021437-001 INSPRA 25MG TABLET / ORAL AB RLD 2002-09-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021437-002 INSPRA 50MG TABLET / ORAL AB RLD, RS 2002-09-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021437-003 INSPRA 100MG TABLET / ORAL 2002-09-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021437-001 INSPRA 25MG TABLET / ORAL AB RLD 2002-09-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021437-002 INSPRA 50MG TABLET / ORAL AB RLD, RS 2002-09-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021437-003 INSPRA 100MG TABLET / ORAL 2002-09-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021437-001 INSPRA 25MG TABLET / ORAL AB RLD 2002-09-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021437-002 INSPRA 50MG TABLET / ORAL AB RLD, RS 2002-09-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021437-003 INSPRA 100MG TABLET / ORAL 2002-09-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021437-001 INSPRA 25MG TABLET / ORAL AB RLD 2002-09-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021437-002 INSPRA 50MG TABLET / ORAL AB RLD, RS 2002-09-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021437-003 INSPRA 100MG TABLET / ORAL 2002-09-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021437-001 INSPRA 25MG TABLET / ORAL AB RLD 2002-09-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021437-002 INSPRA 50MG TABLET / ORAL AB RLD, RS 2002-09-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021437-003 INSPRA 100MG TABLET / ORAL 2002-09-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021437-001 INSPRA 25MG TABLET / ORAL AB RLD 2002-09-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021437-002 INSPRA 50MG TABLET / ORAL AB RLD, RS 2002-09-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021437-003 INSPRA 100MG TABLET / ORAL 2002-09-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021437-001 INSPRA 25MG TABLET / ORAL AB RLD 2002-09-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021437-002 INSPRA 50MG TABLET / ORAL AB RLD, RS 2002-09-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021437-003 INSPRA 100MG TABLET / ORAL 2002-09-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021437-001 INSPRA 25MG TABLET / ORAL AB RLD 2002-09-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021437-002 INSPRA 50MG TABLET / ORAL AB RLD, RS 2002-09-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021437-003 INSPRA 100MG TABLET / ORAL 2002-09-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021437-001 INSPRA 25MG TABLET / ORAL AB RLD 2002-09-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021437-002 INSPRA 50MG TABLET / ORAL AB RLD, RS 2002-09-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021437-003 INSPRA 100MG TABLET / ORAL 2002-09-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021437-001 INSPRA 25MG TABLET / ORAL AB RLD 2002-09-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021437-002 INSPRA 50MG TABLET / ORAL AB RLD, RS 2002-09-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021437-003 INSPRA 100MG TABLET / ORAL 2002-09-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021437-001 INSPRA 25MG TABLET / ORAL AB RLD 2002-09-27 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Observed Orange Book patent history# Patent history page 1 of 7 · 246 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 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 59762-1107-2 Eplerenone 30 in 1 BOTTLE TABLET, FILM COATED 30 46 59762-1107-3 Eplerenone 90 in 1 BOTTLE TABLET, FILM COATED 90 46
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59762-1107 EPLERENONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 3 Current NDC, 2 package rows 20250503_4286699b-2320-4d3d-831c-32085f36fb67.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 · 3 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 59762-1107-2 59762110702 30 TABLET, FILM COATED in 1 BOTTLE (59762-1107-2) 2024-12-13 No No Current 59762-1107-3 59762110703 90 TABLET, FILM COATED in 1 BOTTLE (59762-1107-3) 2025-10-24 No No Current