Home NDC 50090-3431-2 IRBESARTAN
Product NDC 50090-3431
Requested package NDC 50090-3431-2
11-digit product format 500903431
Labeler code 50090
Product ID 50090-3431_19fd3d89-3d07-4b91-aba7-4c2d67b4fc0d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name IRBESARTAN
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA091236
Marketing category ANDA
Marketing start 2016-07-01
Marketing end 0000-00-00
Substance IRBESARTAN
Active strength 300 mg/1
Pharmacologic classes Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
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 · 15 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 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 A091236-001 IRBESARTAN IRBESARTAN 75MG TABLET / ORAL AB 2012-10-15 A091236-002 IRBESARTAN IRBESARTAN 150MG TABLET / ORAL AB 2012-10-15 A091236-003 IRBESARTAN IRBESARTAN 300MG TABLET / ORAL AB 2012-10-15
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 A091236-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-10-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091236-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-10-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091236-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-10-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091236-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-10-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091236-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-10-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091236-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-10-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091236-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-10-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091236-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-10-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091236-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-10-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091236-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-10-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091236-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-10-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091236-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-10-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091236-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-10-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091236-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-10-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091236-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-10-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091236-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-10-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091236-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-10-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091236-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-10-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091236-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-10-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091236-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-10-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091236-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-10-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091236-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-10-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091236-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-10-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091236-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-10-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091236-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-10-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091236-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-10-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091236-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-10-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091236-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-10-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091236-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-10-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091236-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-10-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091236-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-10-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091236-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-10-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091236-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-10-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091236-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-10-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091236-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-10-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091236-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-10-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091236-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-10-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091236-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-10-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091236-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-10-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091236-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-10-15 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-3431-1 IRBESARTAN 90 in 1 BOTTLE TABLET 90 5 50090-3431-2 IRBESARTAN 90 in 1 BOTTLE, PLASTIC TABLET 90 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-3431 IRBESARTAN TABLET [A-S MEDICATION SOLUTIONS] 5 Legacy NDC, 2 package rows 20190430_19db26af-5de5-4280-b743-194c61b1cb01.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 · 2 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 50090-3431-2 50090343102 90 TABLET in 1 BOTTLE, PLASTIC (50090-3431-2) 90 tablet 2016-07-01 0000-00-00 No No Current