irbesartan

Generic: irbesartan

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name irbesartan
Generic Name irbesartan
Labeler chartwell rx, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

irbesartan 300 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-978
Product ID 62135-978_352d8ab7-2e21-869d-e063-6294a90ab91f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077205
Listing Expiration 2026-12-31
Marketing Start 2012-11-14

Pharmacologic Class

Established (EPC)
angiotensin 2 receptor blocker [epc]
Mechanism of Action
angiotensin 2 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135978
Hyphenated Format 62135-978

Supplemental Identifiers

RxCUI
200094 200095 200096
UPC
0362135977900 0362135976903 0362135977306 0362135978303 0362135978907 0362135976309
UNII
J0E2756Z7N
NUI
N0000000070 N0000175561

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name irbesartan (source: ndc)
Generic Name irbesartan (source: ndc)
Application Number ANDA077205 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (62135-978-30)
  • 90 TABLET in 1 BOTTLE (62135-978-90)
source: ndc

Packages (2)

62135-978-30 30 TABLET in 1 BOTTLE (62135-978-30) 62135-978-90 90 TABLET in 1 BOTTLE (62135-978-90)

Ingredients (1)

irbesartan (300 mg/1)

Linked Drug Pages (1)

IRBESARTAN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "352d8ab7-2e21-869d-e063-6294a90ab91f", "openfda": {"nui": ["N0000000070", "N0000175561"], "upc": ["0362135977900", "0362135976903", "0362135977306", "0362135978303", "0362135978907", "0362135976309"], "unii": ["J0E2756Z7N"], "rxcui": ["200094", "200095", "200096"], "spl_set_id": ["6eb0cb56-2e51-45ef-9fd5-5646cf9f78a3"], "pharm_class_epc": ["Angiotensin 2 Receptor Blocker [EPC]"], "pharm_class_moa": ["Angiotensin 2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (62135-978-30)", "package_ndc": "62135-978-30", "marketing_start_date": "20250506"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (62135-978-90)", "package_ndc": "62135-978-90", "marketing_start_date": "20250501"}], "brand_name": "IRBESARTAN", "product_id": "62135-978_352d8ab7-2e21-869d-e063-6294a90ab91f", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "62135-978", "generic_name": "IRBESARTAN", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "IRBESARTAN", "active_ingredients": [{"name": "IRBESARTAN", "strength": "300 mg/1"}], "application_number": "ANDA077205", "marketing_category": "ANDA", "marketing_start_date": "20121114", "listing_expiration_date": "20261231"}