edarbi

Generic: azilsartan kamedoxomil

Labeler: azurity pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name edarbi
Generic Name azilsartan kamedoxomil
Labeler azurity pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

azilsartan kamedoxomil 40 mg/1

Manufacturer
Azurity Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 60631-040
Product ID 60631-040_2f63b0e8-977a-4d22-9550-29ad1926a9de
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA200796
Listing Expiration 2026-12-31
Marketing Start 2013-02-01

Pharmacologic Class

Classes
angiotensin 2 receptor blocker [epc] angiotensin 2 type 1 receptor antagonists [moa] decreased blood pressure [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60631040
Hyphenated Format 60631-040

Supplemental Identifiers

RxCUI
1091646 1091650 1091652 1091654
UPC
0360631080308 0360631040302

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 edarbi (source: ndc)
Generic Name azilsartan kamedoxomil (source: ndc)
Application Number NDA200796 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (60631-040-30)
  • 7 TABLET in 1 BOTTLE (60631-040-77)
source: ndc

Packages (2)

60631-040-30 30 TABLET in 1 BOTTLE (60631-040-30) 60631-040-77 7 TABLET in 1 BOTTLE (60631-040-77)

Ingredients (1)

azilsartan kamedoxomil (40 mg/1)

Linked Drug Pages (1)

Edarbi ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2f63b0e8-977a-4d22-9550-29ad1926a9de", "openfda": {"upc": ["0360631080308", "0360631040302"], "rxcui": ["1091646", "1091650", "1091652", "1091654"], "spl_set_id": ["52b27c75-9f5a-4816-bafd-dace9d7d2063"], "manufacturer_name": ["Azurity Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (60631-040-30)", "package_ndc": "60631-040-30", "marketing_start_date": "20130201"}, {"sample": false, "description": "7 TABLET in 1 BOTTLE (60631-040-77)", "package_ndc": "60631-040-77", "marketing_start_date": "20170201"}], "brand_name": "Edarbi", "product_id": "60631-040_2f63b0e8-977a-4d22-9550-29ad1926a9de", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Blocker [EPC]", "Angiotensin 2 Type 1 Receptor Antagonists [MoA]", "Decreased Blood Pressure [PE]"], "product_ndc": "60631-040", "generic_name": "Azilsartan kamedoxomil", "labeler_name": "Azurity Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Edarbi", "active_ingredients": [{"name": "AZILSARTAN KAMEDOXOMIL", "strength": "40 mg/1"}], "application_number": "NDA200796", "marketing_category": "NDA", "marketing_start_date": "20130201", "listing_expiration_date": "20261231"}