NDC 0121-0489

DIPHENHYDRAMINE HYDROCHLORIDE

Diphenhydramine Hydrochloride

DIPHENHYDRAMINE HYDROCHLORIDE is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Pharmaceutical Associates, Inc.. The primary component is Diphenhydramine Hydrochloride.

Product ID0121-0489_834bd7f3-8c65-a61e-e053-2a91aa0a5db5
NDC0121-0489
Product TypeHuman Prescription Drug
Proprietary NameDIPHENHYDRAMINE HYDROCHLORIDE
Generic NameDiphenhydramine Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date1982-02-10
Marketing CategoryANDA / ANDA
Application NumberANDA087513
Labeler NamePharmaceutical Associates, Inc.
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength13 mg/5mL
Pharm ClassesHistamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0121-0489-00

10 TRAY in 1 CASE (0121-0489-00) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-0489-05)
Marketing Start Date1982-02-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0121-0489-00 [00121048900]

DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION
Marketing CategoryANDA
Application NumberANDA087513
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1982-02-10

NDC 0121-0489-04 [00121048904]

DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION
Marketing CategoryANDA
Application NumberANDA087513
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-08-29

NDC 0121-0489-10 [00121048910]

DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION
Marketing CategoryANDA
Application NumberANDA087513
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1982-02-10

NDC 0121-0489-20 [00121048920]

DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION
Marketing CategoryANDA
Application NumberANDA087513
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1982-02-10
Marketing End Date2012-08-09

NDC 0121-0489-05 [00121048905]

DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION
Marketing CategoryANDA
Application NumberANDA087513
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1982-02-10

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/5mL

OpenFDA Data

SPL SET ID:6fe6fe2d-4405-4e7a-a2ed-5eb367d52842
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1049906
  • Pharmacological Class

    • Histamine H1 Receptor Antagonists [MoA]
    • Histamine-1 Receptor Antagonist [EPC]

    NDC Crossover Matching brand name "DIPHENHYDRAMINE HYDROCHLORIDE" or generic name "Diphenhydramine Hydrochloride"

    NDCBrand NameGeneric Name
    0121-0489DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE
    0121-0978DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE
    0185-0648diphenhydramine hydrochloridediphenhydramine hydrochloride
    0185-0649diphenhydramine hydrochloridediphenhydramine hydrochloride
    68016-789Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    68071-1786Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    68210-1510DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE
    68788-9698Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    68788-9697Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    69206-995Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    69367-187Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    69842-304Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    69842-825DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE
    69842-834DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE
    70000-0207Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    70385-2007Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    70518-0441Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    70518-0861Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    70518-1082Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    70518-1680Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    70692-783Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    0603-3339Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    71335-0435Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    71872-7005Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    0615-7656Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    76045-102Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    72485-102Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    76413-306Diphenhydramine hydrochlorideDiphenhydramine hydrochloride
    76457-002diphenhydramine hydrochloridediphenhydramine hydrochloride
    0641-0376Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    0904-2056Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    0904-5306Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    0904-6741Diphenhydramine hydrochlorideDiphenhydramine hydrochloride
    0904-6740Diphenhydramine hydrochlorideDiphenhydramine hydrochloride
    11822-6415Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    17714-023Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    17714-020Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    17714-135Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    17714-021Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    42254-190Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    42806-649Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    42806-648Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    46122-356Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    49483-329DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE
    50090-0046Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    50090-0045Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    50090-1841Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    50090-2764Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    50090-3787Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride
    50436-3594Diphenhydramine HydrochlorideDiphenhydramine Hydrochloride

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