NDC 60631-040

Edarbi

Azilsartan Kamedoxomil

Edarbi is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Arbor Pharmaceuticals. The primary component is Azilsartan Kamedoxomil.

Product ID60631-040_7136bd41-8f63-4ff1-abd1-87bdae146ee8
NDC60631-040
Product TypeHuman Prescription Drug
Proprietary NameEdarbi
Generic NameAzilsartan Kamedoxomil
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2013-02-01
Marketing CategoryNDA / NDA
Application NumberNDA200796
Labeler NameArbor Pharmaceuticals
Substance NameAZILSARTAN KAMEDOXOMIL
Active Ingredient Strength40 mg/1
Pharm ClassesAngiotensin 2 Type 1 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Decreased Blood Pressure [PE]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 60631-040-30

30 TABLET in 1 BOTTLE (60631-040-30)
Marketing Start Date2013-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60631-040-90 [60631004090]

Edarbi TABLET
Marketing CategoryNDA
Application NumberNDA200796
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-02-01
Marketing End Date2014-08-13

NDC 60631-040-07 [60631004007]

Edarbi TABLET
Marketing CategoryNDA
Application NumberNDA200796
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-02-01
Marketing End Date2019-12-31

NDC 60631-040-30 [60631004030]

Edarbi TABLET
Marketing CategoryNDA
Application NumberNDA200796
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-02-01

Drug Details

Active Ingredients

IngredientStrength
AZILSARTAN KAMEDOXOMIL40 mg/1

OpenFDA Data

SPL SET ID:52b27c75-9f5a-4816-bafd-dace9d7d2063
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1091646
  • 1091650
  • 1091652
  • 1091654
  • UPC Code
  • 0364764844301
  • 0364764884307
  • Pharmacological Class

    • Angiotensin 2 Type 1 Receptor Antagonists [MoA]
    • Angiotensin 2 Receptor Blocker [EPC]
    • Decreased Blood Pressure [PE]

    Medicade Reported Pricing

    60631004030 EDARBI 40 MG TABLET

    Pricing Unit: EA | Drug Type: