60631-412 : Edarbyclor Oral Tablet

Labeler: Arbor Pharmaceuticals Ireland Limited
Product Type: Human Prescription Drug
Drug Name:  Edarbyclor
Dosage Form: Oral Tablet
Application #: NDA202331
Rev. Date: 


Markings: AC;40;12;5
Shapes:  Round
Colors:  Red
Size (mm): 10
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

AC 40 12 5: (64764-944) Edarbyclor Oral Tablet by Arbor Pharmaceuticals Ireland Limited
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

  • 60631-412-07: 5 BLISTER PACK IN 1 TRAY (60631‑412‑07) > 7 TABLET IN 1 BLISTER PACK
  • 60631-412-30: 30 TABLET IN 1 BOTTLE (60631‑412‑30)

Active Ingredients:

  • Azilsartan Kamedoxomil
  • Chlorthalidone

Dosage Strength:

  • 40 mg
  • 12.5 mg

Inactive Ingredients:

  • Mannitol
  • Cellulose, Microcrystalline
  • Talc
  • Titanium Dioxide
  • Ferric Oxide Red
  • Polyethylene Glycol 8000
  • Butyl Alcohol
  • Crospovidone
  • Water
  • Fumaric Acid
  • Sodium Hydroxide
  • Hydroxypropyl Cellulose (Type H)
  • Magnesium Stearate
  • Hypromelloses
  • Shellac
  • Ferrosoferric Oxide
  • Alcohol

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 60631-425 Edarbyclor Oral Tablet by Arbor Pharmaceuticals Ireland Limited
  • 64764-944 Edarbyclor 40/12.5 (Azilsartan Medoxomil (Azilsartan Kamedoxomil 42.68 mg) / Chlorthalidone) Oral Tablet by Takeda Pharmaceuticals America, Inc.
  • 64764-994 Edarbyclor 40/25 Oral Tablet by Takeda Pharmaceuticals America, Inc.


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NDC 60631-412 QR Code

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Note: The MedsChat® NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.