0378-7401 : Mesalamine 1.2 g/1 Oral Tablet, Delayed Release


NDC: 0378-7401
Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Mesalamine
Dosage Form: Oral Tablet, Delayed Release
Application #: ANDA203574
Rev. Date: 


Appearance:


Markings: M1200
Shapes:  Oval
Colors:  Brown
Size (mm): 21
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:

  • 0378-7401-78: 120 TABLET, DELAYED RELEASE IN 1 BOTTLE, PLASTIC (0378‑7401‑78)

Active Ingredients:

  • Mesalamine

Dosage Strength:

  • 1.2 g/1

Inactive Ingredients:

  • Ferrosoferric Oxide
  • Carboxymethylcellulose
  • Silicon Dioxide
  • Hypromellose, Unspecified
  • Lactose Monohydrate
  • Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)
  • Methacrylic Acid - Methyl Methacrylate Copolymer (1:2)
  • Polyethylene Glycol, Unspecified
  • Propylene Glycol
  • Ferric Oxide Red
  • Shellac
  • Sodium Starch Glycolate Type a Potato
  • Stearic Acid
  • Talc
  • Titanium Dioxide
  • Triacetin
  • Triethyl Citrate
  • Ferric Oxide Yellow
  • Ammonia /

Pharmaceutical Classes:

  • Aminosalicylate [EPC]
  • Aminosalicylic Acids [CS]

Related Products:

Based on records with the same trade name.
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  • 0378-9230 Mesalamine 1000 mg Rectal Suppository by Mylan Pharmaceuticals Inc.
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  • 0472-1915 Mesalamine 1000 mg Rectal Suppository by Actavis Pharma, Inc.
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  • 0781-7088 Mesalamine 1000 mg Rectal Suppository by Sandoz Inc
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  • 0904-6832 Mesalamine 800 mg Oral Tablet, Delayed Release by Major Pharmaceuticals
  • 16714-245 Mesalamine 1000 mg Rectal Suppository by Northstar Rx LLC.
  • 16714-830 Mesalamine 1.2 g/1 Oral Tablet, Delayed Release by Northstar Rx LLC.
  • 21922-045 Mesalamine 4 g/60ml Rectal Suspension by Encube Ethicals Private Limited
  • 31722-005 Mesalamine 1000 mg Rectal Suppository by Camber Pharmaceuticals, Inc.
  • 31722-043 Mesalamine 1.2 g/1 Oral Tablet, Delayed Release by Camber Pharmaceuticals, Inc.
  • 42291-563 Mesalamine 400 mg Oral Capsule, Delayed Release by Avkare, Inc
  • 42291-564 Mesalamine 1.2 g/1 Oral Tablet, Delayed Release by Avkare, Inc
  • 43386-510 Mesalamine 4 g/60ml Rectal Enema by Gavis Pharmaceuticals, LLC
  • 45802-098 Mesalamine 4 g/60ml Rectal Enema by Perrigo New York Inc
  • 45802-923 Mesalamine Kit by Perrigo New York Inc
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NDC QR Code

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NDC 0378-7401 QR Code

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