Home NDC 68180-412-09 Irbesartan
Product NDC 68180-412
Requested package NDC 68180-412-09
11-digit product format 681800412
Labeler code 68180
Product ID 68180-412_22c8bdba-6c34-485a-af89-3aafd7fd8605
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Irbesartan
Dosage form TABLET
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA201531
Marketing category ANDA
Marketing start 2012-10-23
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 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 · 12 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…
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 A201531-001 IRBESARTAN IRBESARTAN 75MG TABLET / ORAL 2012-10-15 A201531-002 IRBESARTAN IRBESARTAN 150MG TABLET / ORAL 2012-10-15 A201531-003 IRBESARTAN IRBESARTAN 300MG TABLET / ORAL 2012-10-15
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 A201531-001 IRBESARTAN 75MG TABLET / ORAL 2012-10-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201531-002 IRBESARTAN 150MG TABLET / ORAL 2012-10-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201531-003 IRBESARTAN 300MG TABLET / ORAL 2012-10-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201531-001 IRBESARTAN 75MG TABLET / ORAL 2012-10-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201531-002 IRBESARTAN 150MG TABLET / ORAL 2012-10-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201531-003 IRBESARTAN 300MG TABLET / ORAL 2012-10-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201531-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-10-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201531-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-10-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201531-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-10-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201531-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-10-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201531-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-10-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201531-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-10-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201531-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-10-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201531-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-10-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201531-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-10-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201531-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-10-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201531-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-10-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201531-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-10-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201531-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-10-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201531-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-10-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201531-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-10-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201531-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-10-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201531-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-10-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201531-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-10-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201531-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-10-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201531-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-10-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201531-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-10-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201531-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-10-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201531-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-10-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201531-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-10-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201531-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-10-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201531-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-10-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201531-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-10-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201531-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-10-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201531-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-10-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201531-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-10-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201531-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-10-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201531-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-10-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201531-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-10-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201531-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-10-15 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 114 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 300 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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68180-412-02 Irbesartan 500 in 1 BOTTLE TABLET 500 17 68180-412-06 Irbesartan 30 in 1 BOTTLE TABLET 30 17 68180-412-09 Irbesartan 90 in 1 BOTTLE TABLET 90 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IRBESARTAN ACTIVE INGREDIENT J0E2756Z7N IRBESARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] 6 IRBESARTAN ACTIVE MOIETY J0E2756Z7N IRBESARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] 6 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK IRBESARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 IRBESARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] 6 MANNITOL INACTIVE INGREDIENT 3OWL53L36A IRBESARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] 6 POVIDONE INACTIVE INGREDIENT FZ989GH94E IRBESARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 IRBESARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] 6 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J IRBESARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-412 IRBESARTAN TABLET [LUPIN PHARMACEUTICALS, INC.] 17 Current NDC, Legacy NDC, 3 package rows 20231129_a7c093c2-3eef-4956-8a14-c36aada0304f.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 Marketing end Sample Exclude flag Status 68180-412-09 68180041209 90 TABLET in 1 BOTTLE (68180-412-09) 90 tablet 2012-10-23 0000-00-00 No No Current