Home NDC 65862-637-59 Irbesartan
Product NDC 65862-637
Requested package NDC 65862-637-59
11-digit product format 658620637
Labeler code 65862
Product ID 65862-637_9e17df53-3757-4012-a76f-d1aa0053fda0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Irbesartan
Dosage form TABLET
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA203081
Marketing category ANDA
Marketing start 2012-09-27
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 2026-12-31
Current FDA listing Yes 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 · 21 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 6db9cb8d1e19…3449e1ec5b70…2021-02-18 23:40 UTC · source 2021-02-18 8fc7167e32ce…e96bbc724034…2020-12-18 03:04 UTC · source 2020-12-17 4184dd79f89f…545327b3e20f…2020-06-10 20:45 UTC · source 2020-06-10 4bd3596a7b87…5c64c6f6865f…2019-12-08 06:16 UTC · source 2019-12-05 263afe128892…91768de4ddbe…2019-06-01 22:24 UTC · source 2019-05-30 5b2001dcd8f5…54b53d4dc9e4…
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 A203081-001 IRBESARTAN IRBESARTAN 75MG TABLET / ORAL AB 2012-09-27 A203081-002 IRBESARTAN IRBESARTAN 150MG TABLET / ORAL AB 2012-09-27 A203081-003 IRBESARTAN IRBESARTAN 300MG TABLET / ORAL AB 2012-09-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 A203081-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-09-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203081-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-09-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203081-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-09-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203081-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-09-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203081-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-09-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203081-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-09-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203081-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-09-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203081-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-09-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203081-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-09-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203081-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-09-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203081-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-09-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203081-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-09-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203081-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-09-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203081-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-09-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203081-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-09-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203081-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-09-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203081-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-09-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203081-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-09-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203081-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-09-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203081-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-09-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203081-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-09-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203081-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-09-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203081-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-09-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203081-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-09-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203081-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-09-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203081-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-09-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203081-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-09-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203081-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-09-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203081-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-09-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203081-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-09-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203081-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-09-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203081-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-09-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203081-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-09-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203081-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-09-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203081-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-09-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203081-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-09-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203081-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-09-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203081-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-09-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203081-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-09-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203081-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-09-27 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Irbesartan
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IRBESARTAN 75 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination J0E2756Z7N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200094 Internal RxNorm lookup 200095 Internal RxNorm lookup 200096 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-637 IRBESARTAN TABLET [AUROBINDO PHARMA LIMITED] 9 Current NDC, Legacy NDC, 5 package rows 20240516_2113a901-2612-4557-b86d-3afc006fb8bb.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Status 65862-637-59 65862063759 5000 TABLET in 1 BAG (65862-637-59) 5000 tablet 27-SEP-12 Current