68382-649 : Mesalamine 800 mg Oral Tablet, Delayed Release


NDC: 68382-649
Labeler: Zydus Pharmaceuticals (Usa) Inc.
Product Type: Human Prescription Drug
Drug Name:  Mesalamine
Dosage Form: Oral Tablet, Delayed Release
Application #: NDA021830
Rev. Date: 


Appearance:


Markings: WC;800
Shapes:  Capsule
Colors:  Brown
Size (mm): 19
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.

WC 800: (60687-347) Mesalamine 800 mg Oral Tablet, Delayed Release by Zydus Pharmaceuticals (Usa) 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:

  • 68382-649-28: 180 TABLET, DELAYED RELEASE IN 1 BOTTLE (68382‑649‑28)

Active Ingredients:

  • Mesalamine

Dosage Strength:

  • 800 mg

Inactive Ingredients:

  • Dibutyl Sebacate
  • Ferric Oxide Red
  • Ferric Oxide Yellow
  • Lactose Monohydrate
  • Magnesium Stearate
  • Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)
  • Methacrylic Acid - Methyl Methacrylate Copolymer (1:2)
  • Polyethylene Glycols
  • Povidone
  • Silicon Dioxide
  • Sodium Starch Glycolate Type a Potato
  • Talc

Pharmaceutical Classes:

  • Aminosalicylate [EPC]
  • Aminosalicylic Acids [CS]

Related Products:

Based on records with the same trade name.
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NDC QR Code

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NDC 68382-649 QR Code

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