NDC 52565-002

Diclofenac Sodium

Diclofenac Sodium

Diclofenac Sodium is a Topical Solution in the Human Prescription Drug category. It is labeled and distributed by Teligent Pharma, Inc.. The primary component is Diclofenac Sodium.

Product ID52565-002_7a098a07-3765-4613-8350-7c9f59c4cb18
NDC52565-002
Product TypeHuman Prescription Drug
Proprietary NameDiclofenac Sodium
Generic NameDiclofenac Sodium
Dosage FormSolution
Route of AdministrationTOPICAL
Marketing Start Date2018-07-31
Marketing CategoryANDA / ANDA
Application NumberANDA202769
Labeler NameTeligent Pharma, Inc.
Substance NameDICLOFENAC SODIUM
Active Ingredient Strength16 mg/mL
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 52565-002-05

1 BOTTLE in 1 CARTON (52565-002-05) > 150 mL in 1 BOTTLE
Marketing Start Date2018-07-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52565-002-05 [52565000205]

Diclofenac Sodium SOLUTION
Marketing CategoryANDA
Application NumberANDA202769
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-07-31

Drug Details

Active Ingredients

IngredientStrength
DICLOFENAC SODIUM16.05 mg/mL

OpenFDA Data

SPL SET ID:5960adae-9ed2-469a-b092-ac977d260222
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 857700

    • 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]

    Medicade Reported Pricing

    52565002759 ERYTHROMYCIN 2% SOLUTION

    Pricing Unit: ML | Drug Type:

    52565002359 BETAMETHASONE DP AUG 0.05% LOT

    Pricing Unit: ML | Drug Type:

    52565002329 BETAMETHASONE DP AUG 0.05% LOT

    Pricing Unit: ML | Drug Type:

    52565002285 ECONAZOLE NITRATE 1% CREAM

    Pricing Unit: GM | Drug Type:

    52565002230 ECONAZOLE NITRATE 1% CREAM

    Pricing Unit: GM | Drug Type:

    52565002215 ECONAZOLE NITRATE 1% CREAM

    Pricing Unit: GM | Drug Type:

    52565002060 FLUOCINOLONE 0.025% CREAM

    Pricing Unit: GM | Drug Type:

    52565002015 FLUOCINOLONE 0.025% CREAM

    Pricing Unit: GM | Drug Type:

    52565000205 DICLOFENAC 1.5% TOPICAL SOLN

    Pricing Unit: ML | Drug Type:

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

    NDCBrand NameGeneric Name
    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
    67544-899Diclofenac SodiumDiclofenac Sodium
    68001-200Diclofenac SodiumDiclofenac Sodium
    68001-201Diclofenac SodiumDiclofenac Sodium
    68001-202Diclofenac SodiumDiclofenac Sodium
    68001-279Diclofenac SodiumDiclofenac Sodium
    68001-280Diclofenac SodiumDiclofenac Sodium
    68001-281Diclofenac SodiumDiclofenac Sodium
    68071-2045Diclofenac SodiumDiclofenac Sodium
    68071-3159Diclofenac sodiumDiclofenac sodium
    68071-3325Diclofenac SodiumDiclofenac Sodium
    68071-3132Diclofenac SodiumDiclofenac Sodium
    68071-4158Diclofenac SodiumDiclofenac Sodium
    68071-4382Diclofenac SodiumDiclofenac Sodium
    68071-4246Diclofenac sodiumDiclofenac sodium
    68084-333Diclofenac SodiumDiclofenac Sodium
    68151-0849Diclofenac SodiumDiclofenac Sodium
    68151-2481Diclofenac SodiumDiclofenac Sodium
    68180-538Diclofenac SodiumDiclofenac Sodium
    0472-1783Diclofenac SodiumDiclofenac Sodium
    68387-260Diclofenac SodiumDiclofenac Sodium
    68382-999Diclofenac sodiumDiclofenac sodium
    68462-355DICLOFENAC SODIUMDICLOFENAC SODIUM
    68682-103Diclofenac SodiumDiclofenac Sodium
    68788-7270Diclofenac SodiumDiclofenac Sodium
    68788-6368Diclofenac SodiumDiclofenac Sodium
    68788-6388Diclofenac SodiumDiclofenac Sodium
    68788-6831Diclofenac sodiumDiclofenac sodium
    68788-7225Diclofenac sodiumDiclofenac sodium
    68788-7097Diclofenac SodiumDiclofenac Sodium
    68788-6952Diclofenac SodiumDiclofenac Sodium
    68788-9231Diclofenac SodiumDiclofenac Sodium
    68788-9389Diclofenac SodiumDiclofenac Sodium
    68788-9523Diclofenac SodiumDiclofenac Sodium
    68788-9175Diclofenac SodiumDiclofenac Sodium
    68788-9185Diclofenac SodiumDiclofenac Sodium
    68788-9435DICLOFENAC SODIUMDICLOFENAC SODIUM
    69097-524Diclofenac SodiumDiclofenac Sodium
    0527-2170Diclofenac SodiumDiclofenac Sodium
    69621-300Diclofenac SodiumDiclofenac Sodium
    69837-399DICLOFENAC SODIUMDICLOFENAC SODIUM
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