Home NDC 59762-1720 Eplerenone
Product NDC 59762-1720
11-digit product format 597621720
Labeler code 59762
Product ID 59762-1720_f63a6d5f-f6ee-4cab-a796-d86aa1b6bf12
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 2002-09-27
Marketing end 2026-08-31
Substance EPLERENONE
Active strength 50 mg/1
Pharmacologic classes Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag No
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 · 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 · 123 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 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…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021437-002 INSPRA 50MG TABLET / ORAL AB RLD, RS 2002-09-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021437-003 INSPRA 100MG TABLET / ORAL 2002-09-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021437-001 INSPRA 25MG TABLET / ORAL AB RLD 2002-09-27 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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 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 59762-1720-1 Eplerenone 30 in 1 BOTTLE TABLET, FILM COATED 30 25 59762-1720-2 Eplerenone 90 in 1 BOTTLE TABLET, FILM COATED 90 25
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded EPLERENONE ACTIVE INGREDIENT 6995V82D0B EPLERENONE TABLET, FILM COATED [GREENSTONE LLC] 10 EPLERENONE ACTIVE MOIETY 6995V82D0B EPLERENONE TABLET, FILM COATED [GREENSTONE LLC] 10 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U EPLERENONE TABLET, FILM COATED [GREENSTONE LLC] 10 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 EPLERENONE TABLET, FILM COATED [GREENSTONE LLC] 10 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 EPLERENONE TABLET, FILM COATED [GREENSTONE LLC] 10 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT EPLERENONE TABLET, FILM COATED [GREENSTONE LLC] 10 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO EPLERENONE TABLET, FILM COATED [GREENSTONE LLC] 10 LACTOSE INACTIVE INGREDIENT J2B2A4N98G EPLERENONE TABLET, FILM COATED [GREENSTONE LLC] 10 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 EPLERENONE TABLET, FILM COATED [GREENSTONE LLC] 10 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A EPLERENONE TABLET, FILM COATED [GREENSTONE LLC] 10 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H EPLERENONE TABLET, FILM COATED [GREENSTONE LLC] 10 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J EPLERENONE TABLET, FILM COATED [GREENSTONE LLC] 10 TALC INACTIVE INGREDIENT 7SEV7J4R1U EPLERENONE TABLET, FILM COATED [GREENSTONE LLC] 10 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP EPLERENONE TABLET, FILM COATED [GREENSTONE LLC] 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59762-1720 EPLERENONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 23 Current NDC, Legacy NDC, 2 package rows 20250503_6d988699-95c2-46b9-8266-23fe7016f33b.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 Marketing end Sample Exclude flag Status 59762-1720-1 59762172001 30 TABLET, FILM COATED in 1 BOTTLE (59762-1720-1) 2002-09-27 2026-08-31 No No Current 59762-1720-2 59762172002 90 TABLET, FILM COATED in 1 BOTTLE (59762-1720-2) 2002-09-27 2026-08-31 No No Current