0378-1031 : Eplerenone 50 mg Oral Tablet, Film Coated


NDC: 0378-1031
Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Eplerenone
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA203896
Rev. Date: 


Appearance:


Markings: M;EP2
Shapes:  Round
Colors:  Yellow
Size (mm): 8
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.

NDC Package Codes:

  • 0378-1031-77: 90 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (0378‑1031‑77)
  • 0378-1031-93: 30 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (0378‑1031‑93)

Active Ingredients:

  • Eplerenone

Dosage Strength:

  • 50 mg

Inactive Ingredients:

  • Croscarmellose Sodium
  • Hypromellose, Unspecified
  • Lactose Monohydrate
  • Magnesium Stearate
  • Microcrystalline Cellulose
  • Polyethylene Glycol, Unspecified
  • Polysorbate 80
  • Ferric Oxide Red
  • Sodium Lauryl Sulfate
  • Talc
  • Titanium Dioxide
  • Ferric Oxide Yellow

Pharmaceutical Classes:

  • Aldosterone Antagonist [EPC]
  • Aldosterone Antagonists [MoA]

Related Products:

Based on records with the same trade name.
  • 0378-1030 Eplerenone 25 mg Oral Tablet, Film Coated by Mylan Pharmaceuticals Inc.
  • 0185-5368 Eplerenone 25 mg Oral Tablet by Eon Labs, Inc.
  • 0185-5369 Eplerenone 50 mg Oral Tablet by Eon Labs, Inc.
  • 0832-0480 Eplerenone 25 mg Oral Tablet by Upsher-smith Laboratories, Inc.
  • 0832-0481 Eplerenone 50 mg Oral Tablet by Upsher-smith Laboratories, Inc.
  • 16729-293 Eplerenone 25 mg Oral Tablet, Film Coated by Accord Healthcare, Inc.
  • 16729-294 Eplerenone 50 mg Oral Tablet, Film Coated by Accord Healthcare, Inc.
  • 31722-049 Eplerenone 25 mg Oral Tablet, Film Coated by Camber Pharmaceuticals, Inc.
  • 31722-050 Eplerenone 50 mg Oral Tablet, Film Coated by Camber Pharmaceuticals, Inc.
  • 42254-011 Eplerenone 50 mg Oral Tablet by Rebel Distributors Corp.
  • 42291-454 Eplerenone 25 mg Oral Tablet, Coated by Avkare
  • 42291-455 Eplerenone 50 mg Oral Tablet, Coated by Avkare
  • 51991-877 Eplerenone 25 mg Oral Tablet, Film Coated by Breckenridge Pharmaceutical, Inc.
  • 51991-878 Eplerenone 50 mg Oral Tablet, Film Coated by Breckenridge Pharmaceutical, Inc.
  • 54868-6065 Eplerenone 25 mg Oral Tablet by Physicians Total Care, Inc.
  • 59762-1710 Eplerenone 25 mg Oral Tablet by Greenstone LLC
  • 59762-1720 Eplerenone 50 mg Oral Tablet by Greenstone LLC
  • 60505-2651 Eplerenone 25 mg Oral Tablet by Apotex Corp
  • 60505-2652 Eplerenone 50 mg Oral Tablet by Apotex Corp
  • 60687-451 Eplerenone 25 mg Oral Tablet, Film Coated by American Health Packaging
  • More related products ...

NDC QR Code

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NDC 0378-1031 QR Code

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Note: The RxChat 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.