65649-103 : Apriso 375 mg 24 Hr Extended Release Capsule


NDC: 65649-103
Labeler: Salix Pharmaceuticals, Inc.
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 24 Hr Extended Release Capsule by Salix Pharmaceuticals, Inc.
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:

  • 65649-103-01: 1 BOTTLE IN 1 CARTON (65649‑103‑01) > 4 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE
  • 65649-103-02: 120 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (65649‑103‑02)

Active Ingredients:

  • Mesalamine

Dosage Strength:

  • 375 mg

Inactive Ingredients:

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

Pharmaceutical Classes:

  • Aminosalicylate [EPC]
  • Aminosalicylic Acids [CS]

Related Products:

Based on records with the same trade name.
  • 43353-884 Apriso 375 mg Oral Capsule, Extended Release by Aphena Pharma Solutions - Tennessee, LLC
  • 54868-6150 Apriso 375 mg 24 Hr Extended Release Capsule by Physicians Total Care, Inc.

NDC QR Code

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NDC 65649-103 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.