NDC 69344-204

Zorvolex

Diclofenac

Zorvolex is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Zyla Life Sciences Us Inc.. The primary component is Diclofenac.

Product ID69344-204_1b02d941-ab34-449c-89a5-126112eb2304
NDC69344-204
Product TypeHuman Prescription Drug
Proprietary NameZorvolex
Generic NameDiclofenac
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2019-02-04
Marketing CategoryNDA / NDA
Application NumberNDA204592
Labeler NameZyla Life Sciences US Inc.
Substance NameDICLOFENAC
Active Ingredient Strength35 mg/1
Pharm ClassesCyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 69344-204-29

90 CAPSULE in 1 BOTTLE (69344-204-29)
Marketing Start Date2019-02-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69344-204-29 [69344020429]

Zorvolex CAPSULE
Marketing CategoryNDA
Application NumberNDA204592
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-02-04

Drug Details

Active Ingredients

IngredientStrength
DICLOFENAC35 mg/1

OpenFDA Data

SPL SET ID:f83d5c03-8094-4216-8969-a1102da68f15
Manufacturer
UNII
UPC Code
  • 0369344203295
  • 0369344204292

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Zorvolex" or generic name "Diclofenac"

    NDCBrand NameGeneric Name
    42211-203Zorvolexdiclofenac
    42211-204Zorvolexdiclofenac
    69344-204ZorvolexZorvolex
    69344-203ZorvolexZorvolex
    0378-8750Diclofenac Sodiumdiclofenac
    17856-0833Diclofenac sodiumDiclofenac
    42291-256Diclofenac sodiumDiclofenac
    45865-986Diclofenac SodiumDiclofenac
    46122-711Diclofenac SodiumDiclofenac
    50090-2787Diclofenac sodiumDiclofenac
    50090-3316Diclofenac SodiumDiclofenac
    50090-4621Diclofenac sodiumDiclofenac
    50268-237Diclofenac sodiumDiclofenac
    50436-0833Diclofenac sodiumDiclofenac
    53149-4902Diclofenac SodiumDiclofenac
    55700-675Diclofenac sodiumDiclofenac
    55700-735Diclofenac SodiumDiclofenac
    57896-142Diclofenac SodiumDiclofenac
    58602-601Diclofenac SodiumDiclofenac
    58602-602Diclofenac SodiumDiclofenac
    58602-603Diclofenac SodiumDiclofenac
    63187-762Diclofenac sodiumDiclofenac
    65162-683Diclofenac SodiumDiclofenac
    65162-833Diclofenac sodiumDiclofenac
    65162-911Diclofenac SodiumDiclofenac
    68071-3159Diclofenac sodiumDiclofenac
    68071-4246Diclofenac sodiumDiclofenac
    68788-6831Diclofenac sodiumDiclofenac

    Trademark Results [Zorvolex]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ZORVOLEX
    ZORVOLEX
    85413540 4505759 Live/Registered
    ZYLA LIFE SCIENCES US INC.
    2011-09-01
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