Home NDC 57297-413 Irbesartan and Hydrochlorothiazide
Product NDC 57297-413
11-digit product format 572970413
Labeler code 57297
Product ID 57297-413_ac69bbca-81f4-4896-bb7e-df0a4428fe42
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Irbesartan and Hydrochlorothiazide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler LUPIN LIMITED
Application ANDA201524
Marketing category ANDA
Marketing start 2013-04-04
Marketing end 0000-00-00
Substance HYDROCHLOROTHIAZIDE; IRBESARTAN
Active strength 13 mg/1; mg/1
Pharmacologic classes Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag E
Listing certified through 2017-12-31
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 2 · 66 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 57297-413-09 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 57297-413-06 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 57297-413-09 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 57297-413-06 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 57297-413-09 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 57297-413-06 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 57297-413-09 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 57297-413-06 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 57297-413-09 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 57297-413-06 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 57297-413-09 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 57297-413-06 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 57297-413-09 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 57297-413-06 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 57297-413-09 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 57297-413-06 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 57297-413-09 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 57297-413-06 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 57297-413-09 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 57297-413-06 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 57297-413-09 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 57297-413-06 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 57297-413-09 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 57297-413-06 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 57297-413-09 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 57297-413-06 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 57297-413-09 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 57297-413-06 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 57297-413-09 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 57297-413-06 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 57297-413-09 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 57297-413-06 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 57297-413-09 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 57297-413-06 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 57297-413-09 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 57297-413-06 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 57297-413-09 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 57297-413-06 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 57297-413-09 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 57297-413-06 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A201524-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;150MG TABLET / ORAL 2013-02-27 A201524-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;300MG TABLET / ORAL 2013-02-27
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 3 · 88 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 2026-10-15 13:18:30 2026-09 A201524-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL 2013-02-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 A201524-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL 2013-02-27 c2088c7a36db…2026-09-14 22:38:34 2026-08 A201524-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL 2013-02-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A201524-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL 2013-02-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A201524-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL 2013-02-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201524-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL 2013-02-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201524-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL 2013-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201524-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL 2013-02-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201524-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL 2013-02-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201524-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL 2013-02-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201524-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2013-02-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201524-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2013-02-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201524-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2013-02-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201524-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2013-02-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201524-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2013-02-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201524-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2013-02-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201524-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2013-02-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201524-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2013-02-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201524-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2013-02-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201524-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2013-02-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201524-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2013-02-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201524-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2013-02-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201524-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2013-02-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201524-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2013-02-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201524-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2013-02-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201524-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2013-02-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201524-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2013-02-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201524-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2013-02-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201524-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2013-02-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201524-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2013-02-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201524-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2013-02-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201524-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2013-02-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201524-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2013-02-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A201524-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2013-02-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201524-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2013-02-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201524-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2013-02-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201524-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2013-02-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A201524-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2013-02-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201524-001 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;150MG TABLET / ORAL AB 2013-02-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A201524-002 IRBESARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;300MG TABLET / ORAL AB 2013-02-27 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing#