10544-955 : Diclofenac Sodium and Misoprostol Oral Tablet, Delayed Release


NDC: 10544-955
Labeler: Blenheim Pharmacal, Inc.
Product Type: Human Prescription Drug
Drug Name:  Diclofenac Sodium and Misoprostol Delayed-release
Dosage Form: Oral Tablet, Delayed Release
Application #: ANDA200540
Rev. Date: 


Appearance:


Markings: DM1
Shapes:  Round
Colors:  White
Size (mm): 11
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.

DM1 : (42367-111) Diclofenac Sodium and Misoprostol Oral Tablet, Delayed Release by Blenheim Pharmacal, 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:

  • 10544-955-14: 14 TABLET, DELAYED RELEASE IN 1 BOTTLE (10544‑955‑14)

Active Ingredients:

  • Diclofenac Sodium
  • Misoprostol

Dosage Strength:

  • 75 mg
  • .2 mg

Inactive Ingredients:

  • Cellulose, Microcrystalline
  • Lactose Monohydrate
  • Starch, Corn
  • Povidone K30
  • Water
  • Talc
  • Magnesium Stearate
  • Hypromelloses
  • Isopropyl Alcohol
  • Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type a
  • Triethyl Citrate
  • Sodium Starch Glycolate Type a Potato
  • Hydrogenated Castor Oil

Pharmaceutical Classes:

  • Cyclooxygenase Inhibitors [MoA]
  • Decreased Prostaglandin Production [PE]
  • Anti-Inflammatory Agents
  • Non-Steroidal [CS]
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • Prostaglandin E1 Analog [EPC]
  • Prostaglandins E
  • Synthetic [CS]

Related Products:

Based on records with the same trade name.
  • 42367-110 Diclofenac Sodium and Misoprostol Oral Tablet, Delayed Release by Eagle Pharmaceuticals, Inc.
  • 42367-111 Diclofenac Sodium and Misoprostol Oral Tablet, Delayed Release by Eagle Pharmaceuticals, Inc.
  • 63126-341 Diclofenac Sodium and Misoprostol Delayed-release Oral Tablet, Delayed Release by Yung Shin Pharmaceutical Industrual Co., Ltd.
  • 63126-342 Diclofenac Sodium and Misoprostol Delayed-release Oral Tablet, Delayed Release by Yung Shin Pharmaceutical Industrual Co., Ltd.
  • 69339-123 Diclofenac Sodium and Misoprostol Oral Tablet, Delayed Release by Dash Pharmaceuticals LLC
  • 69339-124 Diclofenac Sodium and Misoprostol Oral Tablet, Delayed Release by Dash Pharmaceuticals LLC

NDC QR Code

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NDC 10544-955 QR Code

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