Home NDC 0955-1040-90 Irbesartan
Product NDC 0955-1040
Requested package NDC 0955-1040-90
11-digit product format 009551040
Labeler code 0955
Product ID 0955-1040_5236a5fb-5969-4cc2-bcd1-400e261fbf46
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name irbesartan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Winthrop U.S.
Application NDA020757
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2019-09-30
Marketing end 0000-00-00
Substance IRBESARTAN
Active strength 75 mg/1
Pharmacologic classes Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
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 · 11 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…
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 N020757-001 AVAPRO IRBESARTAN 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-30 N020757-002 AVAPRO IRBESARTAN 150MG TABLET / ORAL AB RLD 1997-09-30 N020757-003 AVAPRO IRBESARTAN 300MG TABLET / ORAL AB RLD, RS 1997-09-30
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 N020757-001 AVAPRO 75MG TABLET / ORAL RLD 1997-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020757-001 AVAPRO 75MG TABLET / ORAL RLD 1997-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020757-001 AVAPRO 75MG TABLET / ORAL RLD 1997-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020757-001 AVAPRO 75MG TABLET / ORAL RLD 1997-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020757-001 AVAPRO 75MG TABLET / ORAL RLD 1997-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020757-001 AVAPRO 75MG TABLET / ORAL RLD 1997-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020757-001 AVAPRO 75MG TABLET / ORAL RLD 1997-09-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020757-001 AVAPRO 75MG TABLET / ORAL RLD 1997-09-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020757-001 AVAPRO 75MG TABLET / ORAL RLD 1997-09-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020757-001 AVAPRO 75MG TABLET / ORAL RLD 1997-09-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020757-001 AVAPRO 75MG TABLET / ORAL RLD 1997-09-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020757-001 AVAPRO 75MG TABLET / ORAL AB RLD 1997-09-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020757-001 AVAPRO 75MG TABLET / ORAL AB RLD 1997-09-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020757-002 AVAPRO 150MG TABLET / ORAL AB RLD 1997-09-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020757-003 AVAPRO 300MG TABLET / ORAL AB RLD, RS 1997-09-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020757-001 AVAPRO 75MG TABLET / ORAL AB RLD 1997-09-30 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 111 observed states.
FDA-Initiated Inactive NDC Indexing# 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Avapro IRBESARTAN Sanofi-Aventis U.S. LLC 7885b2a8-be4e-48ab-8113-4e6ab791eb98 2026-02-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020757 application number: NDA020757
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0955-1040-90 00955104090 90 TABLET, FILM COATED in 1 BOTTLE (0955-1040-90) 2019-09-30 0000-00-00 No No Current