69344-204 : Zorvolex 35 mg Oral Capsule

NDC:	69344-204
Labeler:	Egalet Us Inc.
Product Type:	Human Prescription Drug
Drug Name:	Zorvolex
Dosage Form:	Oral Capsule
Application #:	NDA204592
Rev. Date:	Feb 4, 2019

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]

NDC QR Code

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NDC 69344-204 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.