0378-1261 : Propafenone Hydrochloride 425 mg Oral Capsule, Extended Release


NDC: 0378-1261
Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Propafenone Hydrochloride
Dosage Form: Oral Capsule, Extended Release
Application #: ANDA203803
Rev. Date: 


Appearance:


Markings: MYLAN;1261
Shapes:  Capsule
Colors:  Red / Orange
Size (mm): 23
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:

  • 0378-1261-05: 500 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (0378‑1261‑05)
  • 0378-1261-91: 60 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (0378‑1261‑91)

Active Ingredients:

  • Propafenone Hydrochloride

Dosage Strength:

  • 425 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Ethylcellulose, Unspecified
  • Gelatin, Unspecified
  • Hypromellose, Unspecified
  • Magnesium Stearate
  • Ferric Oxide Red
  • Sodium Lauryl Sulfate
  • Titanium Dioxide
  • Ammonia
  • Ferrosoferric Oxide
  • Polyethylene Glycol, Unspecified
  • Shellac
  • Ferric Oxide Yellow

Pharmaceutical Classes:

  • Antiarrhythmic [EPC]

Related Products:

Based on records with the same trade name.
  • 0378-1258 Propafenone Hydrochloride 225 mg Oral Capsule, Extended Release by Mylan Pharmaceuticals Inc.
  • 0378-1259 Propafenone Hydrochloride 325 mg Oral Capsule, Extended Release by Mylan Pharmaceuticals Inc.
  • 0591-2285 Propafenone Hydrochloride 225 mg Oral Capsule, Extended Release by Actavis Pharma, Inc.
  • 0591-2286 Propafenone Hydrochloride 325 mg Oral Capsule, Extended Release by Actavis Pharma, Inc.
  • 0591-2287 Propafenone Hydrochloride 425 mg Oral Capsule, Extended Release by Actavis Pharma, Inc.
  • 0603-5448 Propafenone Hydrochloride 150 mg Oral Tablet by Qualitest Pharmaceuticals
  • 0603-5449 Propafenone Hydrochloride 225 mg Oral Tablet by Qualitest Pharmaceuticals
  • 0603-5450 Propafenone Hydrochloride 300 mg Oral Tablet by Qualitest Pharmaceuticals
  • 0615-7574 Propafenone Hydrochloride 150 mg Oral Tablet by Ncs Healthcare of Ky, Inc Dba Vangard Labs
  • 0832-0740 Propafenone Hydrochloride 225 mg Oral Capsule, Extended Release by Upsher-smith Laboratories, LLC
  • 0832-0741 Propafenone Hydrochloride 325 mg Oral Capsule, Extended Release by Upsher-smith Laboratories, LLC
  • 0832-0742 Propafenone Hydrochloride 425 mg Oral Capsule, Extended Release by Upsher-smith Laboratories, LLC
  • 16571-736 Propafenone Hydrochloride 225 mg Oral Capsule, Extended Release by Rising Pharma Holdings, Inc.
  • 16571-737 Propafenone Hydrochloride 325 mg Oral Capsule, Extended Release by Rising Pharma Holdings, Inc.
  • 16571-738 Propafenone Hydrochloride 425 mg Oral Capsule, Extended Release by Rising Pharma Holdings, Inc.
  • 16714-825 Propafenone Hydrochloride 225 mg Oral Capsule, Extended Release by Northstar Rx LLC
  • 16714-826 Propafenone Hydrochloride 325 mg Oral Capsule, Extended Release by Northstar Rx LLC
  • 16714-827 Propafenone Hydrochloride 425 mg Oral Capsule, Extended Release by Northstar Rx LLC
  • 24979-085 Propafenone Hydrochloride 225 mg Oral Capsule, Extended Release by Twi Pharmaceuticals, Inc.
  • 24979-086 Propafenone Hydrochloride 325 mg Oral Capsule, Extended Release by Twi Pharmaceuticals, Inc.
  • More related products ...

NDC QR Code

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NDC 0378-1261 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.