NDC 0093-3727

diclofenac epolamine

Diclofenac Epolamine

diclofenac epolamine is a Topical System in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa Inc.. The primary component is Diclofenac Epolamine.

Product ID0093-3727_1c20dee4-d1d6-4c98-966d-05c499bde19f
NDC0093-3727
Product TypeHuman Prescription Drug
Proprietary Namediclofenac epolamine
Generic NameDiclofenac Epolamine
Dosage FormSystem
Route of AdministrationTOPICAL
Marketing Start Date2019-02-05
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021234
Labeler NameTeva Pharmaceuticals USA Inc.
Substance NameDICLOFENAC EPOLAMINE
Active Ingredient Strength0 g/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 0093-3727-55

6 POUCH in 1 CARTON (0093-3727-55) > 5 SYSTEM in 1 POUCH (0093-3727-50)
Marketing Start Date2020-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0093-3727-55 [00093372755]

diclofenac epolamine SYSTEM
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA021234
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-05

NDC 0093-3727-50 [00093372750]

diclofenac epolamine SYSTEM
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA021234
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-05

Drug Details

Active Ingredients

IngredientStrength
DICLOFENAC EPOLAMINE.013 g/1

OpenFDA Data

SPL SET ID:d7bfe17d-e88e-4792-bfba-cea56ed96c3b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 855626

    • 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 epolamine" or generic name "Diclofenac Epolamine"

    NDCBrand NameGeneric Name
    0093-3225diclofenac epolamineDiclofenac Epolamine
    0093-3727diclofenac epolaminediclofenac epolamine
    50436-1335diclofenac epolamineDiclofenac Epolamine
    50436-3727diclofenac epolaminediclofenac epolamine
    55700-801Diclofenac EpolamineDiclofenac Epolamine
    55700-807diclofenac epolamineDiclofenac Epolamine
    55700-886diclofenac epolamineDiclofenac Epolamine
    59762-0411Diclofenac EpolamineDiclofenac Epolamine
    59762-0707diclofenac epolamineDiclofenac Epolamine
    70518-3000diclofenac epolamineDiclofenac Epolamine
    21695-707FlectorDiclofenac epolamine
    35356-077FlectorDiclofenac Epolamine
    42254-248FlectorDiclofenac Epolamine
    50090-1195FlectorDiclofenac Epolamine
    50436-1332FlectorDiclofenac Epolamine
    52959-518FlectorDiclofenac Epolamine
    60793-132FLECTORDiclofenac Epolamine
    60793-411FlectorDiclofenac Epolamine
    63629-4762FlectorDiclofenac Epolamine
    68788-6396FlectorDiclofenac Epolamine
    71858-0305LICARTdiclofenac epolamine
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