Home NDC 46708-441 IRBESARTAN
Product NDC 46708-441
11-digit product format 467080441
Labeler code 46708
Product ID 46708-441_2efa4733-b806-42ee-b587-cae816493fa7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name IRBESARTAN
Dosage form TABLET
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA091236
Marketing category ANDA
Marketing start 2016-07-01
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 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.
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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 46708-441-30 2023-02-01 These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 46708-441-31 2023-02-01 These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 46708-441-71 2023-02-01 These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 46708-441-90 2023-02-01 These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 46708-441-91 2023-02-01 These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 46708-441-30 2023-01-30 These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 46708-441-31 2023-01-30 These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 46708-441-71 2023-01-30 These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 46708-441-90 2023-01-30 These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997 46708-441-91 2023-01-30 These highlights do not include all the information needed to use IRBESARTAN TABLETS safely and effectively. See full prescribing information for IRBESARTAN TABLETS. IRBESARTAN tablets, for oral use Initial U.S. Approval: 1997
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 46708-441-30 IRBESARTAN 30 in 1 BOTTLE TABLET 30 3 46708-441-31 IRBESARTAN 100 in 1 BOTTLE TABLET 100 3 46708-441-71 IRBESARTAN 500 in 1 BOTTLE TABLET 500 3 46708-441-90 IRBESARTAN 90 in 1 BOTTLE TABLET 90 3 46708-441-91 IRBESARTAN 1000 in 1 BOTTLE TABLET 1000 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-441 IRBESARTAN TABLET [ALEMBIC PHARMACEUTICALS LIMITED] 3 Current NDC, Legacy NDC, 5 package rows 20230202_0898f423-0aa9-409c-8d4e-1349b59141d1.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 46708-441-30 46708044130 30 TABLET in 1 BOTTLE (46708-441-30) 30 tablet 2016-07-01 0000-00-00 No No Current 46708-441-31 46708044131 100 TABLET in 1 BOTTLE (46708-441-31) 100 tablet 2016-07-01 0000-00-00 No No Current 46708-441-71 46708044171 500 TABLET in 1 BOTTLE (46708-441-71) 500 tablet 2016-07-01 0000-00-00 No No Current 46708-441-90 46708044190 90 TABLET in 1 BOTTLE (46708-441-90) 90 tablet 2016-07-01 0000-00-00 No No Current 46708-441-91 46708044191 1000 TABLET in 1 BOTTLE (46708-441-91) 1000 tablet 2016-07-01 0000-00-00 No No Current