Home NDC 71205-404-30 Irbesartan
Product NDC 71205-404
Requested package NDC 71205-404-30
11-digit product format 712050404
Labeler code 71205
Product ID 71205-404_26b07048-78ca-46f4-bc10-b78fe387321a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name irbesartan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Proficient Rx LP
Application NDA020757
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2019-09-03
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 2021-12-31
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71205-404 71205-404-30 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71205-404 71205-404-30 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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Approval date N020757-001 AVAPRO IRBESARTAN 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-09-30 N020757-002 AVAPRO IRBESARTAN 150MG TABLET / ORAL AB RLD 1997-09-30 N020757-003 AVAPRO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.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71205-404 IRBESARTAN TABLET, FILM COATED [PROFICIENT RX LP] 2 Legacy NDC 20200702_909f7937-3790-4aa4-addd-166040193eca.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 · 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 71205-404-30 71205040430 30 TABLET, FILM COATED in 1 BOTTLE (71205-404-30) 2020-02-17 0000-00-00 No No Current