NDC 42794-007

Protriptyline Hydrochloride

Protriptyline Hydrochloride

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

Product ID42794-007_a023bb0c-8a8b-7e5d-e053-2a95a90a6c2e
NDC42794-007
Product TypeHuman Prescription Drug
Proprietary NameProtriptyline Hydrochloride
Generic NameProtriptyline Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2020-03-02
Marketing CategoryANDA / ANDA
Application NumberANDA090462
Labeler NameSigmapharm Laboratories, LLC
Substance NamePROTRIPTYLINE HYDROCHLORIDE
Active Ingredient Strength10 mg/1
Pharm ClassesTricyclic Antidepressant [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 42794-007-02

100 TABLET, FILM COATED in 1 BOTTLE (42794-007-02)
Marketing Start Date2020-03-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42794-007-02 [42794000702]

Protriptyline Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA090462
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-03-02

Drug Details

Active Ingredients

IngredientStrength
PROTRIPTYLINE HYDROCHLORIDE10 mg/1

OpenFDA Data

SPL SET ID:a023e637-bee9-8c86-e053-2a95a90aa488
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 905172
  • 905168
    • UPC Code
  • 0342794004025
  • 0342794007026

    • 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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.