NDC 51285-538

Surmontil

Trimipramine Maleate

Surmontil is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Teva Women's Health, Inc.. The primary component is Trimipramine Maleate.

Product ID51285-538_0d4270cf-07e3-439e-b49c-92613d58ce33
NDC51285-538
Product TypeHuman Prescription Drug
Proprietary NameSurmontil
Generic NameTrimipramine Maleate
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date1990-09-30
Marketing End Date2020-03-31
Marketing CategoryNDA / NDA
Application NumberNDA016792
Labeler NameTeva Women's Health, Inc.
Substance NameTRIMIPRAMINE MALEATE
Active Ingredient Strength25 mg/1
Pharm ClassesTricyclic Antidepressant [EPC]
NDC Exclude FlagN

Packaging

NDC 51285-538-02

100 CAPSULE in 1 BOTTLE (51285-538-02)
Marketing Start Date1990-09-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51285-538-02 [51285053802]

Surmontil CAPSULE
Marketing CategoryNDA
Application NumberNDA016792
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1990-09-30
Marketing End Date2020-03-31

Drug Details

Active Ingredients

IngredientStrength
TRIMIPRAMINE MALEATE25 mg/1

OpenFDA Data

SPL SET ID:0177d783-773c-41bf-9db9-eb7e5c64474a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313496
  • 106834
  • 313498
  • 313499
  • 208646
  • 208645

    • Pharmacological Class

    • Tricyclic Antidepressant [EPC]

    NDC Crossover Matching brand name "Surmontil" or generic name "Trimipramine Maleate"

    NDCBrand NameGeneric Name
    51285-538SurmontilTrimipramine Maleate
    51285-539SurmontilTrimipramine Maleate
    51285-554SurmontilTrimipramine Maleate
    42806-802Trimipramine MaleateTrimipramine Maleate
    42806-803Trimipramine MaleateTrimipramine Maleate
    42806-804Trimipramine MaleateTrimipramine Maleate
    51991-944Trimipramine MaleateTrimipramine Maleate
    51991-945Trimipramine MaleateTrimipramine Maleate
    51991-946Trimipramine MaleateTrimipramine Maleate
    64850-850Trimipramine MaleateTrimipramine Maleate
    64850-851Trimipramine MaleateTrimipramine Maleate
    64850-852Trimipramine MaleateTrimipramine Maleate
    68462-804Trimipramine MaleateTrimipramine Maleate
    68462-805Trimipramine MaleateTrimipramine Maleate
    68462-806Trimipramine MaleateTrimipramine Maleate

    Trademark Results [Surmontil]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SURMONTIL
    SURMONTIL
    72122961 0725555 Live/Registered
    SOCIETE DES USINES CHIMIQUES RHONE-POULENC
    1961-06-27
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