43353-884 : Apriso 375 mg Oral Capsule, Extended Release


NDC: 43353-884
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Product Type: Human Prescription Drug
Drug Name:  Apriso
Dosage Form: Oral Capsule, Extended Release
Application #: NDA022301
Rev. Date: 


Appearance:


Markings: G;M
Shapes:  Capsule
Colors:  Blue / Black
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.

G M: (65649-103) Apriso 375 mg Oral Capsule, Extended Release by Aphena Pharma Solutions - Tennessee, LLC
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:

  • 43353-884-79: 2160 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (43353‑884‑79)

Active Ingredients:

  • Mesalamine

Dosage Strength:

  • 375 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Magnesium Stearate
  • Microcrystalline Cellulose
  • Hypromellose, Unspecified
  • Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)
  • Talc
  • Titanium Dioxide
  • Triethyl Citrate
  • Aspartame
  • Anhydrous Citric Acid
  • Crospovidone, Unspecified

Pharmaceutical Classes:

  • Aminosalicylate [EPC]
  • Aminosalicylic Acids [CS]

Related Products:

Based on records with the same trade name.
  • 54868-6150 Apriso 375 mg 24 Hr Extended Release Capsule by Physicians Total Care, Inc.
  • 65649-103 Apriso 375 mg 24 Hr Extended Release Capsule by Salix Pharmaceuticals, Inc.

NDC QR Code

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NDC 43353-884 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.