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 ID: 60631-412_04d4ae5d-27d1-43e6-876b-0037e6f174c0
• NDC: 60631-412
• Product Type: Human Prescription Drug
• Proprietary Name: Edarbyclor
• Generic Name: Azilsartan Kamedoxomil And Chlorthalidone
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2013-02-01
• Marketing Category: NDA / NDA
• Application Number: NDA202331
• Labeler Name: Arbor Pharmaceuticals
• Substance Name: AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE
• Active Ingredient Strength: 40 mg/1; mg/1
• Pharm Classes: Angiotensin 2 Type 1 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Decreased Blood Pressure [PE],Thiazide-like Diuretic [EPC],Increased Diuresis [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 60631-412-30

30 TABLET in 1 BOTTLE (60631-412-30)

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

NDC SPL Data Element Entries

NDC 60631-412-90 [60631041290]

Edarbyclor TABLET

• Marketing Category: NDA
• Application Number: NDA202331
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-02-01
• Marketing End Date: 2014-08-13

NDC 60631-412-07 [60631041207]

Edarbyclor TABLET

• Marketing Category: NDA
• Application Number: NDA202331
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-02-01
• Marketing End Date: 2017-05-31

NDC 60631-412-30 [60631041230]

Edarbyclor TABLET

• Marketing Category: NDA
• Application Number: NDA202331
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-02-01

Drug Details

Active Ingredients

Ingredient	Strength
AZILSARTAN KAMEDOXOMIL	40 mg/1

OpenFDA Data

• SPL SET ID: e60f795b-fce3-4361-aa03-f143451689d1
• Manufacturer:
  • Arbor Pharmaceuticals
• UNII:
  • Q0MQD1073Q
  • WEC6I2K1FC
• 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:

NDC Crossover Matching brand name "Edarbyclor" or generic name "Azilsartan Kamedoxomil And Chlorthalidone"

NDC	Brand Name	Generic Name
60631-412	Edarbyclor	Azilsartan kamedoxomil and chlorthalidone
60631-425	Edarbyclor	Azilsartan kamedoxomil and chlorthalidone