10544-189 : Diclofenac Sodium 75 mg/1 Oral Tablet, Delayed Release


NDC10544-189
Labeler: Blenheim Pharmacal, Inc.
Product Type: Human Prescription Drug
Drug Name:  Diclofenac Sodium Delayed Release
Dosage Form: Oral Tablet, Delayed Release
Application #: ANDA075185
Rev. Date: 


Appearance:


Markings: CTI;103;
Shapes:  Round
Colors:  White
Size (mm): 10
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.

CTI 103 : (60429-058) Diclofenac Sodium 75 mg/1 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:

  • 10544-189-01: 1000 TABLET, DELAYED RELEASE IN 1 BOTTLE, PLASTIC (10544‑189‑01)
  • 10544-189-14: 14 TABLET, DELAYED RELEASE IN 1 BOTTLE, PLASTIC (10544‑189‑14)
  • 10544-189-20: 20 TABLET, DELAYED RELEASE IN 1 BOTTLE, PLASTIC (10544‑189‑20)
  • 10544-189-30: 30 TABLET, DELAYED RELEASE IN 1 BOTTLE, PLASTIC (10544‑189‑30)
  • 10544-189-60: 60 TABLET, DELAYED RELEASE IN 1 BOTTLE, PLASTIC (10544‑189‑60)
  • 10544-189-90: 90 TABLET, DELAYED RELEASE IN 1 BOTTLE, PLASTIC (10544‑189‑90)

Active Ingredients:

  • Diclofenac Sodium

Dosage Strength:

  • 75 mg

Inactive Ingredients:

  • Ferrosoferric Oxide
  • Hypromelloses
  • Lactose Monohydrate
  • Magnesium Stearate
  • Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)
  • Cellulose, Microcrystalline
  • Shellac
  • Polyethylene Glycol 2000
  • Povidones
  • Sodium Starch Glycolate Type a Potato
  • Talc
  • Titanium Dioxide

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
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  • 0440-6396 Diclofenac Sodium Delayed Release 75 mg Oral Tablet, Delayed Release by Liberty Pharmaceuticals, Inc.
  • 43063-693 Diclofenac Sodium Delayed Release 50 mg Oral Tablet, Delayed Release by Pd-rx Pharmaceuticals, Inc.
  • 43063-694 Diclofenac Sodium Delayed Release 75 mg Oral Tablet, Delayed Release by Pd-rx Pharmaceuticals, Inc.
  • 45865-999 Diclofenac Sodium Delayed Release 50 mg Oral Tablet, Delayed Release by Medsource Pharmaceuticals
  • 50090-0542 Diclofenac Sodium Delayed Release 50 mg Oral Tablet, Delayed Release by A-s Medication Solutions
  • 50090-0543 Diclofenac Sodium Delayed Release Delayed Release 50 mg Oral Tablet, Delayed Release by A-s Medication Solutions
  • 50090-0545 Diclofenac Sodium Delayed Release 75 mg Oral Tablet, Delayed Release by A-s Medication Solutions
  • 50436-1003 Diclofenac Sodium Delayed Release 75 mg Oral Tablet, Delayed Release by Unit Dose Services
  • 50436-1022 Diclofenac Sodium Delayed Release 50 mg Oral Tablet, Delayed Release by Unit Dose Services
  • 51655-176 Diclofenac Sodium Delayed Release 75 mg Oral Tablet, Delayed Release by Northwind Pharmaceuticals
  • 51655-280 Diclofenac Sodium Delayed Release 50 mg Oral Tablet, Delayed Release by Northwind Pharmaceuticals, LLC
  • 52125-297 Diclofenac Sodium 75 mg Delayed Release Tablet by Remedyrepack Inc.
  • 52125-372 Diclofenac Sodium Delayed Release 50 mg Oral Tablet, Delayed Release by Remedyrepack Inc.
  • 52125-505 Diclofenac Sodium 75 mg Delayed Release Tablet by Remedyrepack Inc.
  • 53002-5360 Diclofenac Sodium Delayed Release 75 mg Oral Tablet, Delayed Release by Rpk Pharmaceuticals, Inc.
  • 53002-5370 Diclofenac Sodium Delayed Release 50 mg Oral Tablet, Delayed Release by Rpk Pharmaceuticals, Inc.
  • 55700-834 Diclofenac Sodium Delayed Release 75 mg Oral Tablet, Delayed Release by Quality Care Products, LLC
  • 57315-015 Diclofenac Sodium 50 mg Delayed Release Tablet by Alphapharm Pty Ltd
  • 57315-016 Diclofenac Sodium 75 mg Delayed Release Tablet by Alphapharm Pty Ltd
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NDC 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.