NDC 60631-080

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 ID: 60631-080_7136bd41-8f63-4ff1-abd1-87bdae146ee8
• NDC: 60631-080
• Product Type: Human Prescription Drug
• Proprietary Name: Edarbi
• Generic Name: Azilsartan Kamedoxomil
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2013-02-01
• Marketing Category: NDA / NDA
• Application Number: NDA200796
• Labeler Name: Arbor Pharmaceuticals
• Substance Name: AZILSARTAN KAMEDOXOMIL
• Active Ingredient Strength: 80 mg/1
• Pharm Classes: Angiotensin 2 Type 1 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Decreased Blood Pressure [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 60631-080-30

30 TABLET in 1 BOTTLE (60631-080-30)

• Marketing Start Date: 2013-02-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 60631-080-07 [60631008007]

Edarbi TABLET

• Marketing Category: NDA
• Application Number: NDA200796
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-02-01
• Marketing End Date: 2019-05-31

NDC 60631-080-30 [60631008030]

Edarbi TABLET

• Marketing Category: NDA
• Application Number: NDA200796
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-02-01

NDC 60631-080-90 [60631008090]

Edarbi TABLET

• Marketing Category: NDA
• Application Number: NDA200796
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-02-01
• Marketing End Date: 2014-08-13

Drug Details

Active Ingredients

Ingredient	Strength
AZILSARTAN KAMEDOXOMIL	80 mg/1

OpenFDA Data

• SPL SET ID: 52b27c75-9f5a-4816-bafd-dace9d7d2063
• Manufacturer:
  • Arbor Pharmaceuticals
• UNII:
  • WEC6I2K1FC
• 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

60631008030 EDARBI 80 MG TABLET

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Edarbi" or generic name "Azilsartan Kamedoxomil"

NDC	Brand Name	Generic Name
60631-040	Edarbi	Azilsartan kamedoxomil
60631-080	Edarbi	Azilsartan kamedoxomil