Home NDC 29300-214 Irbesartan
Product NDC 29300-214
11-digit product format 293000214
Labeler code 29300
Product ID 29300-214_90c9face-5ead-4f4e-81f3-026124b50ba8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Irbesartan
Dosage form TABLET
Route ORAL
Labeler Unichem Pharmaceuticals (USA), Inc.
Application ANDA203020
Marketing category ANDA
Marketing start 2015-12-07
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 A203020-001 IRBESARTAN IRBESARTAN 75MG TABLET / ORAL AB 2015-12-07 A203020-002 IRBESARTAN IRBESARTAN 150MG TABLET / ORAL AB 2015-12-07 A203020-003 IRBESARTAN IRBESARTAN 300MG TABLET / ORAL AB 2015-12-07
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 A203020-001 IRBESARTAN 75MG TABLET / ORAL AB 2015-12-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203020-002 IRBESARTAN 150MG TABLET / ORAL AB 2015-12-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203020-003 IRBESARTAN 300MG TABLET / ORAL AB 2015-12-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203020-001 IRBESARTAN 75MG TABLET / ORAL AB 2015-12-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203020-002 IRBESARTAN 150MG TABLET / ORAL AB 2015-12-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203020-003 IRBESARTAN 300MG TABLET / ORAL AB 2015-12-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203020-001 IRBESARTAN 75MG TABLET / ORAL AB 2015-12-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203020-002 IRBESARTAN 150MG TABLET / ORAL AB 2015-12-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203020-003 IRBESARTAN 300MG TABLET / ORAL AB 2015-12-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203020-001 IRBESARTAN 75MG TABLET / ORAL AB 2015-12-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203020-002 IRBESARTAN 150MG TABLET / ORAL AB 2015-12-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203020-003 IRBESARTAN 300MG TABLET / ORAL AB 2015-12-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203020-001 IRBESARTAN 75MG TABLET / ORAL AB 2015-12-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203020-002 IRBESARTAN 150MG TABLET / ORAL AB 2015-12-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203020-003 IRBESARTAN 300MG TABLET / ORAL AB 2015-12-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203020-001 IRBESARTAN 75MG TABLET / ORAL AB 2015-12-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203020-002 IRBESARTAN 150MG TABLET / ORAL AB 2015-12-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203020-003 IRBESARTAN 300MG TABLET / ORAL AB 2015-12-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203020-001 IRBESARTAN 75MG TABLET / ORAL AB 2015-12-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203020-002 IRBESARTAN 150MG TABLET / ORAL AB 2015-12-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203020-003 IRBESARTAN 300MG TABLET / ORAL AB 2015-12-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203020-001 IRBESARTAN 75MG TABLET / ORAL AB 2015-12-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203020-002 IRBESARTAN 150MG TABLET / ORAL AB 2015-12-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203020-003 IRBESARTAN 300MG TABLET / ORAL AB 2015-12-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203020-001 IRBESARTAN 75MG TABLET / ORAL AB 2015-12-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203020-002 IRBESARTAN 150MG TABLET / ORAL AB 2015-12-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203020-003 IRBESARTAN 300MG TABLET / ORAL AB 2015-12-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203020-001 IRBESARTAN 75MG TABLET / ORAL AB 2015-12-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203020-002 IRBESARTAN 150MG TABLET / ORAL AB 2015-12-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203020-003 IRBESARTAN 300MG TABLET / ORAL AB 2015-12-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203020-001 IRBESARTAN 75MG TABLET / ORAL AB 2015-12-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203020-002 IRBESARTAN 150MG TABLET / ORAL AB 2015-12-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203020-003 IRBESARTAN 300MG TABLET / ORAL AB 2015-12-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203020-001 IRBESARTAN 75MG TABLET / ORAL AB 2015-12-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203020-002 IRBESARTAN 150MG TABLET / ORAL AB 2015-12-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203020-003 IRBESARTAN 300MG TABLET / ORAL AB 2015-12-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203020-001 IRBESARTAN 75MG TABLET / ORAL AB 2015-12-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203020-002 IRBESARTAN 150MG TABLET / ORAL AB 2015-12-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203020-003 IRBESARTAN 300MG TABLET / ORAL AB 2015-12-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203020-001 IRBESARTAN 75MG TABLET / ORAL AB 2015-12-07 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 105 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 29300-214-05 Irbesartan 500 in 1 BOTTLE, PLASTIC TABLET 500 13 29300-214-13 Irbesartan 30 in 1 BOTTLE, PLASTIC TABLET 30 13 29300-214-19 Irbesartan 90 in 1 BOTTLE, PLASTIC TABLET 90 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 29300-214 IRBESARTAN TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] 12 Current NDC, Legacy NDC, 3 package rows 20220120_fdf196d5-e933-49de-9c4c-bde50149c7d4.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Irbesartan IRBESARTAN Unichem Pharmaceuticals (USA), Inc. fdf196d5-e933-49de-9c4c-bde50149c7d4 2025-08-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 203020 application number: ANDA203020 ndc (product): 29300-214
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 29300-214-05 29300021405 500 TABLET in 1 BOTTLE, PLASTIC (29300-214-05) 500 tablet 2018-02-28 0000-00-00 No No Current 29300-214-13 29300021413 30 TABLET in 1 BOTTLE, PLASTIC (29300-214-13) 30 tablet 2018-02-28 0000-00-00 No No Current 29300-214-19 29300021419 90 TABLET in 1 BOTTLE, PLASTIC (29300-214-19) 90 tablet 2018-02-28 0000-00-00 No No Current