NDC 0078-0478

VOLTAREN

Diclofenac Sodium

VOLTAREN is a Ophthalmic Solution in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceutical Corporation. The primary component is Diclofenac Sodium.

Product ID0078-0478_6c5976d5-702b-25d9-18a2-edeffd8df30c
NDC0078-0478
Product TypeHuman Prescription Drug
Proprietary NameVOLTAREN
Generic NameDiclofenac Sodium
Dosage FormSolution
Route of AdministrationOPHTHALMIC
Marketing Start Date1991-03-28
Marketing CategoryNDA / NDA
Application NumberNDA020037
Labeler NameNovartis Pharmaceutical Corporation
Substance NameDICLOFENAC SODIUM
Active Ingredient Strength1 mg/mL
Pharm ClassesCyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 0078-0478-61

5 mL in 1 BOTTLE, DROPPER (0078-0478-61)
Marketing Start Date1991-03-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0478-61 [00078047861]

VOLTAREN SOLUTION
Marketing CategoryNDA
Application NumberNDA020037
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1991-03-28
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
DICLOFENAC SODIUM1 mg/mL

OpenFDA Data

SPL SET ID:65037222-146c-493d-aa1c-e6df89bf5b8d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 854803
  • 854801
  • Pharmacological Class

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

    NDC Crossover Matching brand name "VOLTAREN" or generic name "Diclofenac Sodium"

    NDCBrand NameGeneric Name
    0067-8152Voltarendiclofenac sodium
    0067-8153Voltarendiclofenac sodium
    0078-0478VOLTARENdiclofenac sodium
    68387-456VoltarenVoltaren
    68788-9338VoltarenVoltaren
    70518-1578VoltarenVoltaren
    21695-791VoltarenVoltaren
    35356-187VoltarenVoltaren
    50090-1099VoltarenVoltaren
    50436-3621VoltarenVoltaren
    61919-592VOLTARENVOLTAREN
    63481-684VoltarenVoltaren
    63187-582VoltarenVoltaren
    63629-4941VoltarenVoltaren
    61919-060VOLTARENVOLTAREN
    80425-0055VoltarenVoltaren
    80425-0102VoltarenVoltaren
    80425-0056VoltarenVoltaren
    0280-0039Aleve Arthritis Pain GelDiclofenac Sodium
    0115-1483Diclofenac SodiumDiclofenac Sodium
    0168-0803DICLOFENAC SODIUMdiclofenac sodium
    0168-0844DICLOFENAC SODIUMdiclofenac sodium
    0228-2550Diclofenac SodiumDiclofenac Sodium
    0228-2551Diclofenac SodiumDiclofenac Sodium
    0363-1210Diclofenac sodiumDiclofenac sodium
    0363-1871diclofenac sodiumdiclofenac sodium
    0378-0355Diclofenac SodiumDiclofenac Sodium
    0378-6280Diclofenac Sodiumdiclofenac sodium
    0378-6281Diclofenac Sodiumdiclofenac sodium
    0113-1189good sense arthritis paindiclofenac sodium

    Trademark Results [VOLTAREN]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    VOLTAREN
    VOLTAREN
    97900726 not registered Live/Pending
    Novartis AG
    2023-04-21
    VOLTAREN
    VOLTAREN
    97799814 not registered Live/Pending
    Novartis AG
    2023-02-17
    VOLTAREN
    VOLTAREN
    97733998 not registered Live/Pending
    Novartis AG
    2022-12-28
    VOLTAREN
    VOLTAREN
    87617485 5452825 Live/Registered
    Novartis Corporation
    2017-09-21
    VOLTAREN
    VOLTAREN
    79225039 5478104 Live/Registered
    NOVARTIS AG
    2017-08-31
    VOLTAREN
    VOLTAREN
    79072252 3767722 Dead/Cancelled
    Novartis AG
    2009-07-10
    VOLTAREN
    VOLTAREN
    73557006 1394620 Dead/Cancelled
    CIBA-GEIGY CORPORATION
    1985-09-05
    VOLTAREN
    VOLTAREN
    72422688 0960282 Live/Registered
    CIBA-GEIGY LIMITED
    1972-04-28

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.