Home NDC 0025-1710 Inspra
Product NDC 0025-1710
11-digit product format 000251710
Labeler code 0025
Product ID 0025-1710_b3853cca-756f-411a-b3d5-58d1152d9875
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name eplerenone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Pfizer Laboratories Div Pfizer Inc
Application NDA021437
Marketing category NDA
Marketing start 2002-09-27
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 · 26 matching rows.
View current auxiliary records. · View the auxiliary file history.
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.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded EPLERENONE ACTIVE INGREDIENT 6995V82D0B INSPRA (EPLERENONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10 EPLERENONE ACTIVE MOIETY 6995V82D0B INSPRA (EPLERENONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U INSPRA (EPLERENONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 INSPRA (EPLERENONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 INSPRA (EPLERENONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT INSPRA (EPLERENONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO INSPRA (EPLERENONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10 LACTOSE INACTIVE INGREDIENT J2B2A4N98G INSPRA (EPLERENONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 INSPRA (EPLERENONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A INSPRA (EPLERENONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H INSPRA (EPLERENONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J INSPRA (EPLERENONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10 TALC INACTIVE INGREDIENT 7SEV7J4R1U INSPRA (EPLERENONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP INSPRA (EPLERENONE) TABLET, FILM COATED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 10 eplerenone ACTIVE INGREDIENT 6995V82D0B INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP] 1 eplerenone ACTIVE MOIETY 6995V82D0B INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP] 1 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP] 1 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP] 1 ferric oxide red INACTIVE INGREDIENT 1K09F3G675 INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP] 1 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP] 1 lactose INACTIVE INGREDIENT J2B2A4N98G INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP] 1 polyethylene glycol INACTIVE INGREDIENT 3WJQ0SDW1A INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP] 1 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP] 1 sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP] 1 talc INACTIVE INGREDIENT 7SEV7J4R1U INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP INSPRA (EPLERENONE) TABLET [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0025-1710 INSPRA (EPLERENONE) TABLET, FILM COATED [PFIZER LABORATORIES DIV PFIZER INC] 22 Legacy NDC 20240919_a55a39ff-1bd5-428b-a64f-c44262e2f3ed.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 Units Marketing start Marketing end Sample Exclude flag Status 0025-1710-01 00025171001 30 TABLET, FILM COATED in 1 BOTTLE (0025-1710-01) 2002-09-27 0000-00-00 No No Current 0025-1710-02 00025171002 90 TABLET, FILM COATED in 1 BOTTLE (0025-1710-02) 2002-09-27 0000-00-00 No No Current 0025-1710-03 00025171003 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0025-1710-03) > 1 TABLET, FILM COATED in 1 BLISTER PACK 100 blister pack 2002-09-27 0000-00-00 No No Current