69344-204 : Zorvolex 35 mg Oral Capsule


NDC69344-204
Labeler: Egalet Us Inc.
Product Type: Human Prescription Drug
Drug Name:  Zorvolex
Dosage Form: Oral Capsule
Application #: NDA204592
Rev. Date: 


Appearance:


Markings: IP;204;35;mg
Shapes:  Capsule
Colors:  Blue / Green
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.

NDC Package Codes:

  • 69344-204-29: 90 CAPSULE IN 1 BOTTLE (69344‑204‑29)

Active Ingredients:

  • Diclofenac

Dosage Strength:

  • 35 mg

Inactive Ingredients:

  • Lactose Monohydrate
  • Sodium Lauryl Sulfate
  • Cellulose, Microcrystalline
  • Croscarmellose Sodium
  • Sodium Stearyl Fumarate
  • Gelatin
  • Titanium Dioxide
  • Fd&c Blue No. 1
  • Fd&c Blue No. 2
  • Ferric Oxide Yellow /

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.
  • 69344-203 Zorvolex 18 mg Oral Capsule by Egalet Us Inc.
  • 42211-203 Zorvolex (Diclofenac 18 mg) by Iroko Pharmaceuticals LLC
  • 42211-204 Zorvolex (Diclofenac 35 mg) by Iroko Pharmaceuticals LLC

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.