42211-203 : Zorvolex (Diclofenac 18 mg)

Labeler: Iroko Pharmaceuticals LLC
Product Type: Human Prescription Drug
Drug Name:  Zorvolex
Dosage Form: Oral Capsule
Application #: NDA204592
Rev. Date: 


Markings: IP;203;18;mg
Shapes:  Capsule
Colors:  Blue / Green
Size (mm): 18
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:

  • 42211-203-23: 30 CAPSULE IN 1 BOTTLE (42211‑203‑23)
  • 42211-203-29: 90 CAPSULE IN 1 BOTTLE (42211‑203‑29)
  • 42211-203-43: 1 BLISTER PACK IN 1 CARTON (42211‑203‑43) > 3 CAPSULE IN 1 BLISTER PACK

Active Ingredients:

  • Diclofenac

Dosage Strength:

  • 18 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
  • Ferrosoferric Oxide

Pharmaceutical Classes:

  • Cyclooxygenase Inhibitors [MoA]
  • Decreased Prostaglandin Production [PE]
  • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
  • Nonsteroidal Anti-inflammatory Drug [EPC]

Related Products:

Based on records with the same trade name.
  • 42211-204 Zorvolex (Diclofenac 35 mg) by Iroko Pharmaceuticals LLC
  • 69344-203 Zorvolex 18 mg Oral Capsule by Egalet Us Inc.
  • 69344-204 Zorvolex 35 mg Oral Capsule by Egalet Us Inc.


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