NDC 42806-097

Protriptyline Hydrochloride

Protriptyline Hydrochloride

Protriptyline Hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Epic Pharma, Llc. The primary component is Protriptyline Hydrochloride.

Product ID42806-097_76267b13-20ce-40fb-8d47-ce0b06ab8186
NDC42806-097
Product TypeHuman Prescription Drug
Proprietary NameProtriptyline Hydrochloride
Generic NameProtriptyline Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2013-01-09
Marketing CategoryANDA / ANDA
Application NumberANDA202220
Labeler NameEpic Pharma, LLC
Substance NamePROTRIPTYLINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesTricyclic Antidepressant [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 42806-097-01

100 TABLET, FILM COATED in 1 BOTTLE (42806-097-01)
Marketing Start Date2013-01-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42806-097-10 [42806009710]

Protriptyline Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202220
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-01-09

NDC 42806-097-01 [42806009701]

Protriptyline Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202220
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-01-09

Drug Details

Active Ingredients

IngredientStrength
PROTRIPTYLINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:c6c7c39e-e510-4f4a-bf7a-926f0e075d3a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 905172
  • 905168
    • UPC Code
  • 0342806096017

    • Pharmacological Class

    • Tricyclic Antidepressant [EPC]

    NDC Crossover Matching brand name "Protriptyline Hydrochloride" or generic name "Protriptyline Hydrochloride"

    NDCBrand NameGeneric Name
    0054-0210Protriptyline HydrochlorideProtriptyline Hydrochloride
    0054-0211Protriptyline HydrochlorideProtriptyline Hydrochloride
    42794-004Protriptyline HydrochlorideProtriptyline Hydrochloride
    42794-007Protriptyline HydrochlorideProtriptyline Hydrochloride
    42806-096Protriptyline HydrochlorideProtriptyline Hydrochloride
    42806-097Protriptyline HydrochlorideProtriptyline Hydrochloride
    50383-959Protriptyline hydrochlorideProtriptyline hydrochloride
    50383-960Protriptyline hydrochlorideProtriptyline hydrochloride
    63629-8346Protriptyline HydrochlorideProtriptyline Hydrochloride
    64980-158Protriptyline HydrochlorideProtriptyline Hydrochloride
    64980-159Protriptyline HydrochlorideProtriptyline Hydrochloride
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