NDC 0121-4788

CYPROHEPTADINE

Cyproheptadine

CYPROHEPTADINE is a Oral Syrup in the Human Prescription Drug category. It is labeled and distributed by Pharmaceutical Associates, Inc.. The primary component is Cyproheptadine.

Product ID0121-4788_fc72c9e4-1bc6-4d5c-b4e9-ca85e11dc8ba
NDC0121-4788
Product TypeHuman Prescription Drug
Proprietary NameCYPROHEPTADINE
Generic NameCyproheptadine
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2013-07-29
Marketing CategoryANDA / ANDA
Application NumberANDA091295
Labeler NamePharmaceutical Associates, Inc.
Substance NameCYPROHEPTADINE
Active Ingredient Strength2 mg/5mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0121-4788-05

4 TRAY in 1 CASE (0121-4788-05) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE
Marketing Start Date2013-07-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0121-4788-10 [00121478810]

CYPROHEPTADINE SYRUP
Marketing CategoryANDA
Application NumberANDA091295
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-07-29
Inactivation Date2020-01-31

NDC 0121-4788-05 [00121478805]

CYPROHEPTADINE SYRUP
Marketing CategoryANDA
Application NumberANDA091295
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-07-29
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CYPROHEPTADINE2 mg/5mL

OpenFDA Data

SPL SET ID:e3b94a78-0d41-4618-aca5-b1770f945559
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 866021
  • UPC Code
  • 0301210788161
  • NDC Crossover Matching brand name "CYPROHEPTADINE" or generic name "Cyproheptadine"

    NDCBrand NameGeneric Name
    0121-0788CYPROHEPTADINECYPROHEPTADINE
    0121-4788CYPROHEPTADINECYPROHEPTADINE
    62135-949CYPROHEPTADINECYPROHEPTADINE HYDROCHLORIDE

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.