NDC 59390-149

Diclofenac

Diclofenac Sodium

Diclofenac is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Altaire Pharmaceuticals Inc.. The primary component is Diclofenac Sodium.

Product ID59390-149_0561ff06-43b4-493e-93f7-b778fc829036
NDC59390-149
Product TypeHuman Prescription Drug
Proprietary NameDiclofenac
Generic NameDiclofenac Sodium
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2015-11-16
Marketing CategoryANDA / ANDA
Application NumberANDA203383
Labeler NameAltaire Pharmaceuticals Inc.
Substance NameDICLOFENAC SODIUM
Active Ingredient Strength1 mg/mL
Pharm ClassesAnti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 59390-149-02

1 BOTTLE, DROPPER in 1 CARTON (59390-149-02) > 2.5 mL in 1 BOTTLE, DROPPER
Marketing Start Date2015-11-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59390-149-02 [59390014902]

Diclofenac SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA203383
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-11-16
Inactivation Date2020-01-31

NDC 59390-149-05 [59390014905]

Diclofenac SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA203383
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-11-16
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DICLOFENAC SODIUM1 mg/mL

OpenFDA Data

SPL SET ID:5372866a-dab3-45c8-8c2a-755ca36c1791
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 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 "Diclofenac" or generic name "Diclofenac Sodium"

    NDCBrand NameGeneric Name
    17478-892DiclofenacDiclofenac
    35356-554DiclofenacDiclofenac
    50090-0641DiclofenacDiclofenac
    59390-149DiclofenacDiclofenac
    73480-242DICLOFENACDICLOFENAC
    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
    0067-8152Voltarendiclofenac sodium
    0067-8153Voltarendiclofenac sodium
    0078-0478VOLTARENdiclofenac sodium

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