NDC 60631-412

Edarbyclor

Azilsartan Kamedoxomil And Chlorthalidone

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

Product ID60631-412_04d4ae5d-27d1-43e6-876b-0037e6f174c0
NDC60631-412
Product TypeHuman Prescription Drug
Proprietary NameEdarbyclor
Generic NameAzilsartan Kamedoxomil And Chlorthalidone
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2013-02-01
Marketing CategoryNDA / NDA
Application NumberNDA202331
Labeler NameArbor Pharmaceuticals
Substance NameAZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE
Active Ingredient Strength40 mg/1; mg/1
Pharm ClassesAngiotensin 2 Type 1 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Decreased Blood Pressure [PE],Thiazide-like Diuretic [EPC],Increased Diuresis [PE]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 60631-412-30

30 TABLET in 1 BOTTLE (60631-412-30)
Marketing Start Date2013-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60631-412-90 [60631041290]

Edarbyclor TABLET
Marketing CategoryNDA
Application NumberNDA202331
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-02-01
Marketing End Date2014-08-13

NDC 60631-412-07 [60631041207]

Edarbyclor TABLET
Marketing CategoryNDA
Application NumberNDA202331
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-02-01
Marketing End Date2017-05-31

NDC 60631-412-30 [60631041230]

Edarbyclor TABLET
Marketing CategoryNDA
Application NumberNDA202331
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:e60f795b-fce3-4361-aa03-f143451689d1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1235144
  • 1235150
  • 1235151
  • 1235157
  • UPC Code
  • 0360631425307
  • 0364764944308
  • Pharmacological Class

    • Angiotensin 2 Type 1 Receptor Antagonists [MoA]
    • Angiotensin 2 Receptor Blocker [EPC]
    • Decreased Blood Pressure [PE]
    • Thiazide-like Diuretic [EPC]
    • Increased Diuresis [PE]

    Medicade Reported Pricing

    60631041230 EDARBYCLOR 40-12.5 MG TABLET

    Pricing Unit: EA | Drug Type: