edarbyclor

Generic: azilsartan kamedoxomil and chlorthalidone

Labeler: azurity pharmaceuticals, inc. (formerly arbor pharmaceuticals)
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name edarbyclor
Generic Name azilsartan kamedoxomil and chlorthalidone
Labeler azurity pharmaceuticals, inc. (formerly arbor pharmaceuticals)
Dosage Form TABLET
Routes
ORAL
Active Ingredients

azilsartan kamedoxomil 40 mg/1, chlorthalidone 25 mg/1

Manufacturer
Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)

Identifiers & Regulatory

Product NDC 60631-425
Product ID 60631-425_26b92714-c5ea-943d-e063-6394a90a8341
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA202331
Listing Expiration 2026-12-31
Marketing Start 2013-02-01

Pharmacologic Class

Established (EPC)
thiazide-like diuretic [epc]
Physiologic Effect
increased diuresis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60631425
Hyphenated Format 60631-425

Supplemental Identifiers

RxCUI
1235144 1235150 1235151 1235157
UNII
Q0MQD1073Q
NUI
N0000175359 N0000175420

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 edarbyclor (source: ndc)
Generic Name azilsartan kamedoxomil and chlorthalidone (source: ndc)
Application Number NDA202331 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (60631-425-30)
source: ndc

Packages (1)

60631-425-30 30 TABLET in 1 BOTTLE (60631-425-30)

Ingredients (2)

azilsartan kamedoxomil (40 mg/1) chlorthalidone (25 mg/1)

Linked Drug Pages (1)

Edarbyclor ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "26b92714-c5ea-943d-e063-6394a90a8341", "openfda": {"nui": ["N0000175359", "N0000175420"], "unii": ["Q0MQD1073Q"], "rxcui": ["1235144", "1235150", "1235151", "1235157"], "spl_set_id": ["e60f795b-fce3-4361-aa03-f143451689d1"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide-like Diuretic [EPC]"], "manufacturer_name": ["Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (60631-425-30)", "package_ndc": "60631-425-30", "marketing_start_date": "20130201"}], "brand_name": "Edarbyclor", "product_id": "60631-425_26b92714-c5ea-943d-e063-6394a90a8341", "dosage_form": "TABLET", "pharm_class": ["Angiotensin 2 Receptor Blocker [EPC]", "Angiotensin 2 Type 1 Receptor Antagonists [MoA]", "Decreased Blood Pressure [PE]", "Increased Diuresis [PE]", "Thiazide-like Diuretic [EPC]"], "product_ndc": "60631-425", "generic_name": "Azilsartan kamedoxomil and chlorthalidone", "labeler_name": "Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Edarbyclor", "active_ingredients": [{"name": "AZILSARTAN KAMEDOXOMIL", "strength": "40 mg/1"}, {"name": "CHLORTHALIDONE", "strength": "25 mg/1"}], "application_number": "NDA202331", "marketing_category": "NDA", "marketing_start_date": "20130201", "listing_expiration_date": "20261231"}