NDC 69543-413

FENDIQUE ER

Phendimetrazine Tartrate

FENDIQUE ER is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Virtus Pharmaceuticals, Llc. The primary component is Phendimetrazine Tartrate.

Product ID69543-413_1dd8c9bd-e4c2-40f4-879f-f55fc03e3fde
NDC69543-413
Product TypeHuman Prescription Drug
Proprietary NameFENDIQUE ER
Generic NamePhendimetrazine Tartrate
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2020-03-18
Marketing CategoryNDA / NDA
Application NumberNDA018074
Labeler NameVirtus Pharmaceuticals, LLC
Substance NamePHENDIMETRAZINE TARTRATE
Active Ingredient Strength105 mg/1
Pharm ClassesAppetite Suppression [PE],Increased Sympathetic Activity [PE],Sympathomimetic Amine Anorectic [EPC]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 69543-413-10

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69543-413-10)
Marketing Start Date2020-03-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69543-413-11 [69543041311]

FENDIQUE ER CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA018074
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-18

NDC 69543-413-10 [69543041310]

FENDIQUE ER CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA018074
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-18

Drug Details

Active Ingredients

IngredientStrength
PHENDIMETRAZINE TARTRATE105 mg/1

OpenFDA Data

SPL SET ID:1dd8c9bd-e4c2-40f4-879f-f55fc03e3fde
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 979543
  • 2284301
  • UPC Code
  • 0369543413105
  • Pharmacological Class

    • Appetite Suppression [PE]
    • Increased Sympathetic Activity [PE]
    • Sympathomimetic Amine Anorectic [EPC]

    NDC Crossover Matching brand name "FENDIQUE ER" or generic name "Phendimetrazine Tartrate"

    NDCBrand NameGeneric Name
    69543-413FENDIQUE ERFENDIQUE ER
    0185-4057Phendimetrazine TartratePhendimetrazine Tartrate
    0185-5254Phendimetrazine TartratePhendimetrazine Tartrate
    0463-8000phendimetrazine tartratephendimetrazine tartrate
    0463-8500phendimetrazine tartratephendimetrazine tartrate
    10544-041Phendimetrazine TartratePhendimetrazine Tartrate
    10702-045Phendimetrazine TartratePhendimetrazine Tartrate
    10702-077Phendimetrazine TartratePhendimetrazine Tartrate
    10702-078Phendimetrazine TartratePhendimetrazine Tartrate
    12634-028phendimetrazine tartratephendimetrazine tartrate
    12634-539phendimetrazine tartratephendimetrazine tartrate
    12634-910Phendimetrazine TartratePhendimetrazine Tartrate
    17224-500Phendimetrazine TartratePhendimetrazine Tartrate
    17224-501PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATE
    17224-831PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATE
    21695-597Phendimetrazine TartratePhendimetrazine Tartrate
    33261-341Phendimetrazine TartratePhendimetrazine Tartrate
    33261-390Phendimetrazine TartratePhendimetrazine Tartrate
    43063-510Phendimetrazine TartratePhendimetrazine Tartrate
    43063-892PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATE
    43547-264phendimetrazine tartratephendimetrazine tartrate
    46672-138phendimetrazine tartratephendimetrazine tartrate
    50090-0338Phendimetrazine TartratePhendimetrazine Tartrate
    50090-0715Phendimetrazine TartratePhendimetrazine Tartrate
    50090-2235Phendimetrazine TartratePhendimetrazine Tartrate
    50090-2592Phendimetrazine TartratePhendimetrazine Tartrate
    50090-3976Phendimetrazine TartratePhendimetrazine Tartrate
    50090-3988PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATE

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