Home NDC 72205-328 Irbesartan
Product NDC 72205-328
11-digit product format 722050328
Labeler code 72205
Product ID 72205-328_1f98fd95-e564-45b3-947f-45eba77f2af5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Irbesartan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Novadoz Pharmaceuticals LLC
Application ANDA219539
Marketing category ANDA
Marketing start 2025-11-04
Substance IRBESARTAN
Active strength 150 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 A219539-001 IRBESARTAN IRBESARTAN 75MG TABLET / ORAL AB 2025-11-04 A219539-002 IRBESARTAN IRBESARTAN 150MG TABLET / ORAL AB 2025-11-04 A219539-003 IRBESARTAN IRBESARTAN 300MG TABLET / ORAL AB 2025-11-04
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.
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 A219539-001 IRBESARTAN 75MG TABLET / ORAL AB 2025-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219539-002 IRBESARTAN 150MG TABLET / ORAL AB 2025-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219539-003 IRBESARTAN 300MG TABLET / ORAL AB 2025-11-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219539-001 IRBESARTAN 75MG TABLET / ORAL AB 2025-11-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219539-002 IRBESARTAN 150MG TABLET / ORAL AB 2025-11-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219539-003 IRBESARTAN 300MG TABLET / ORAL AB 2025-11-04 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219539-001 IRBESARTAN 75MG TABLET / ORAL AB 2025-11-04 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219539-002 IRBESARTAN 150MG TABLET / ORAL AB 2025-11-04 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219539-003 IRBESARTAN 300MG TABLET / ORAL AB 2025-11-04 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Irbesartan
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IRBESARTAN 150 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 72205-328-05 Irbesartan 500 in 1 BOTTLE TABLET, FILM COATED 500 1 72205-328-06 Irbesartan 10 in 1 BLISTER PACK TABLET, FILM COATED 10 1 72205-328-06 Irbesartan 10 in 1 CARTON TABLET, FILM COATED 10 1 72205-328-10 Irbesartan 10 in 1 BOTTLE TABLET, FILM COATED 10 1 72205-328-30 Irbesartan 30 in 1 BOTTLE TABLET, FILM COATED 30 1 72205-328-90 Irbesartan 90 in 1 BOTTLE TABLET, FILM COATED 90 1 72205-328-99 Irbesartan 1000 in 1 BOTTLE TABLET, FILM COATED 1000 1
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 Sample Exclude flag Status 72205-328-05 72205032805 500 TABLET, FILM COATED in 1 BOTTLE (72205-328-05) 2025-11-07 No No Current 72205-328-06 72205032806 10 BLISTER PACK in 1 CARTON (72205-328-06) / 10 TABLET, FILM COATED in 1 BLISTER PACK 10 blister pack 2025-11-07 No No Current 72205-328-10 72205032810 10 TABLET, FILM COATED in 1 BOTTLE (72205-328-10) 2025-11-07 No No Current 72205-328-30 72205032830 30 TABLET, FILM COATED in 1 BOTTLE (72205-328-30) 2025-11-07 No No Current 72205-328-90 72205032890 90 TABLET, FILM COATED in 1 BOTTLE (72205-328-90) 2025-11-07 No No Current 72205-328-99 72205032899 1000 TABLET, FILM COATED in 1 BOTTLE (72205-328-99) 2025-11-07 No No Current