Home NDC 42658-123 IRBESARTAN
Product NDC 42658-123
11-digit product format 426580123
Labeler code 42658
Product ID 42658-123_422e87bf-8271-64d5-e063-6294a90a63ce
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name IRBESARTAN
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Hisun Pharmaceuticals USA Inc.
Application ANDA206194
Marketing category ANDA
Marketing start 2017-04-15
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 A206194-001 IRBESARTAN IRBESARTAN 75MG TABLET / ORAL AB 2016-06-14 A206194-002 IRBESARTAN IRBESARTAN 150MG TABLET / ORAL AB 2016-06-14 A206194-003 IRBESARTAN IRBESARTAN 300MG TABLET / ORAL AB 2016-06-14
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 A206194-001 IRBESARTAN 75MG TABLET / ORAL AB 2016-06-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206194-002 IRBESARTAN 150MG TABLET / ORAL AB 2016-06-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206194-003 IRBESARTAN 300MG TABLET / ORAL AB 2016-06-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206194-001 IRBESARTAN 75MG TABLET / ORAL AB 2016-06-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206194-002 IRBESARTAN 150MG TABLET / ORAL AB 2016-06-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206194-003 IRBESARTAN 300MG TABLET / ORAL AB 2016-06-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206194-001 IRBESARTAN 75MG TABLET / ORAL AB 2016-06-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206194-002 IRBESARTAN 150MG TABLET / ORAL AB 2016-06-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206194-003 IRBESARTAN 300MG TABLET / ORAL AB 2016-06-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206194-001 IRBESARTAN 75MG TABLET / ORAL AB 2016-06-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206194-002 IRBESARTAN 150MG TABLET / ORAL AB 2016-06-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206194-003 IRBESARTAN 300MG TABLET / ORAL AB 2016-06-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206194-001 IRBESARTAN 75MG TABLET / ORAL AB 2016-06-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206194-002 IRBESARTAN 150MG TABLET / ORAL AB 2016-06-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206194-003 IRBESARTAN 300MG TABLET / ORAL AB 2016-06-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206194-001 IRBESARTAN 75MG TABLET / ORAL AB 2016-06-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206194-002 IRBESARTAN 150MG TABLET / ORAL AB 2016-06-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206194-003 IRBESARTAN 300MG TABLET / ORAL AB 2016-06-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206194-001 IRBESARTAN 75MG TABLET / ORAL AB 2016-06-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206194-002 IRBESARTAN 150MG TABLET / ORAL AB 2016-06-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206194-003 IRBESARTAN 300MG TABLET / ORAL AB 2016-06-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206194-001 IRBESARTAN 75MG TABLET / ORAL AB 2016-06-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206194-002 IRBESARTAN 150MG TABLET / ORAL AB 2016-06-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206194-003 IRBESARTAN 300MG TABLET / ORAL AB 2016-06-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206194-001 IRBESARTAN 75MG TABLET / ORAL AB 2016-06-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206194-002 IRBESARTAN 150MG TABLET / ORAL AB 2016-06-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206194-003 IRBESARTAN 300MG TABLET / ORAL AB 2016-06-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206194-001 IRBESARTAN 75MG TABLET / ORAL AB 2016-06-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206194-002 IRBESARTAN 150MG TABLET / ORAL AB 2016-06-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206194-003 IRBESARTAN 300MG TABLET / ORAL AB 2016-06-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206194-001 IRBESARTAN 75MG TABLET / ORAL AB 2016-06-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206194-002 IRBESARTAN 150MG TABLET / ORAL AB 2016-06-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206194-003 IRBESARTAN 300MG TABLET / ORAL AB 2016-06-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206194-001 IRBESARTAN 75MG TABLET / ORAL AB 2016-06-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206194-002 IRBESARTAN 150MG TABLET / ORAL AB 2016-06-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206194-003 IRBESARTAN 300MG TABLET / ORAL AB 2016-06-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206194-001 IRBESARTAN 75MG TABLET / ORAL AB 2016-06-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206194-002 IRBESARTAN 150MG TABLET / ORAL AB 2016-06-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206194-003 IRBESARTAN 300MG TABLET / ORAL AB 2016-06-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206194-001 IRBESARTAN 75MG TABLET / ORAL AB 2016-06-14 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 2027-12-31 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 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 42658-123-01 IRBESARTAN 30 in 1 BOTTLE TABLET, FILM COATED 30 11 42658-123-04 IRBESARTAN 90 in 1 BOTTLE TABLET, FILM COATED 90 11 42658-123-07 IRBESARTAN 500 in 1 BOTTLE TABLET, FILM COATED 500 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42658-123 IRBESARTAN TABLET, FILM COATED [HISUN PHARMACEUTICALS USA INC.] 8 Current NDC, Legacy NDC, 3 package rows 20211110_61ab1b6e-c849-49ca-a3f0-150774db649d.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 Marketing start Marketing end Sample Exclude flag Status 42658-123-01 42658012301 30 TABLET, FILM COATED in 1 BOTTLE (42658-123-01) 2017-04-15 0000-00-00 No No Current 42658-123-04 42658012304 90 TABLET, FILM COATED in 1 BOTTLE (42658-123-04) 2017-04-15 0000-00-00 No No Current 42658-123-07 42658012307 500 TABLET, FILM COATED in 1 BOTTLE (42658-123-07) 2017-04-15 0000-00-00 No No Current