NDC 50383-959

Protriptyline hydrochloride

Protriptyline Hydrochloride

Protriptyline hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Hi-tech Pharmacal Co., Inc.. The primary component is Protriptyline Hydrochloride.

Product ID50383-959_7f966124-2b93-191b-e053-2991aa0a0849
NDC50383-959
Product TypeHuman Prescription Drug
Proprietary NameProtriptyline hydrochloride
Generic NameProtriptyline Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2013-10-28
Marketing CategoryANDA / ANDA
Application NumberANDA202220
Labeler NameHi-Tech Pharmacal Co., Inc.
Substance NamePROTRIPTYLINE HYDROCHLORIDE
Active Ingredient Strength5 mg/1
Pharm ClassesTricyclic Antidepressant [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50383-959-10

100 TABLET, FILM COATED in 1 BOTTLE (50383-959-10)
Marketing Start Date2013-10-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50383-959-10 [50383095910]

Protriptyline hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202220
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-10-28

Drug Details

Active Ingredients

IngredientStrength
PROTRIPTYLINE HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:9a773f26-2d86-4b5e-abfa-ef5718c8184b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 905172
  • 905168
    • UPC Code
  • 0350383959106

    • Pharmacological Class

    • Tricyclic Antidepressant [EPC]
    • Tricyclic Antidepressant [EPC]

    Medicade Reported Pricing

    50383095910 PROTRIPTYLINE HCL 5 MG TABLET

    Pricing Unit: EA | Drug Type:

    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.