Home NDC 62135-978-30 IRBESARTAN
Product NDC 62135-978
Requested package NDC 62135-978-30
11-digit product format 621350978
Labeler code 62135
Product ID 62135-978_352d8ab7-2e21-869d-e063-6294a90ab91f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name IRBESARTAN
Dosage form TABLET
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA077205
Marketing category ANDA
Marketing start 2012-11-14
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 A077205-001 IRBESARTAN IRBESARTAN 75MG TABLET / ORAL AB 2012-11-14 A077205-002 IRBESARTAN IRBESARTAN 150MG TABLET / ORAL AB 2012-11-14 A077205-003 IRBESARTAN IRBESARTAN 300MG TABLET / ORAL AB 2012-11-14
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.
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 2026-08-01 22:54:32 2026-06 A077205-001 IRBESARTAN 75MG TABLET / ORAL AB 2012-11-14 a50c72e98297…2026-08-01 22:54:32 2026-06 A077205-002 IRBESARTAN 150MG TABLET / ORAL AB 2012-11-14 a50c72e98297…2026-08-01 22:54:32 2026-06 A077205-003 IRBESARTAN 300MG TABLET / ORAL AB 2012-11-14 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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 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 62135-978-30 IRBESARTAN 30 in 1 BOTTLE TABLET 30 3 62135-978-90 IRBESARTAN 90 in 1 BOTTLE TABLET 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-978 IRBESARTAN TABLET [CHARTWELL RX, LLC] 3 Current NDC, 2 package rows 20250516_6eb0cb56-2e51-45ef-9fd5-5646cf9f78a3.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 62135-978-30 62135097830 30 TABLET in 1 BOTTLE (62135-978-30) 30 tablet 2025-05-06 No No Current