NDC 42211-204

Zorvolex

Diclofenac

Zorvolex is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Iroko Pharmaceuticals Llc. The primary component is Diclofenac.

Product ID42211-204_73b05aef-df1b-4b6c-8409-021f697deae1
NDC42211-204
Product TypeHuman Prescription Drug
Proprietary NameZorvolex
Generic NameDiclofenac
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2013-10-31
Marketing CategoryNDA / NDA
Application NumberNDA204592
Labeler NameIroko Pharmaceuticals LLC
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 Through2020-12-31

Packaging

NDC 42211-204-43

1 BLISTER PACK in 1 CARTON (42211-204-43) > 3 CAPSULE in 1 BLISTER PACK
Marketing Start Date2013-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42211-204-41 [42211020441]

Zorvolex CAPSULE
Marketing CategoryNDA
Application NumberNDA204592
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-10-31
Marketing End Date2013-12-17

NDC 42211-204-29 [42211020429]

Zorvolex CAPSULE
Marketing CategoryNDA
Application NumberNDA204592
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-10-31

NDC 42211-204-43 [42211020443]

Zorvolex CAPSULE
Marketing CategoryNDA
Application NumberNDA204592
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-10-31

NDC 42211-204-23 [42211020423]

Zorvolex CAPSULE
Marketing CategoryNDA
Application NumberNDA204592
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-10-31

Drug Details

Active Ingredients

IngredientStrength
DICLOFENAC35 mg/1

Pharmacological Class

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

Medicade Reported Pricing

42211020429 ZORVOLEX 35 MG CAPSULE

Pricing Unit: EA | Drug Type:

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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