NDC 63323-664

Diphenhydramine

Diphenhydramine Hydrochloride

Diphenhydramine is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Diphenhydramine Hydrochloride.

Product ID63323-664_5047ce2d-6241-4e8e-bb2e-5dff97314f9d
NDC63323-664
Product TypeHuman Prescription Drug
Proprietary NameDiphenhydramine
Generic NameDiphenhydramine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2002-08-01
Marketing CategoryANDA / ANDA
Application NumberANDA040466
Labeler NameFresenius Kabi USA, LLC
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength50 mg/mL
Pharm ClassesHistamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 63323-664-01

25 VIAL, SINGLE-DOSE in 1 TRAY (63323-664-01) > 1 mL in 1 VIAL, SINGLE-DOSE (63323-664-00)
Marketing Start Date2002-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-664-00 [63323066400]

Diphenhydramine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040466
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-24

NDC 63323-664-16 [63323066416]

Diphenhydramine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040466
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2002-08-01

NDC 63323-664-41 [63323066441]

Diphenhydramine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040466
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-18

NDC 63323-664-01 [63323066401]

Diphenhydramine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA040466
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2002-08-01

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/mL

OpenFDA Data

SPL SET ID:fc574e74-1fdc-4a61-a1ed-492ae43faed2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1723740

    • Pharmacological Class

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

    Medicade Reported Pricing

    63323066416 DIPHENHYDRAMINE 50 MG/ML VIAL

    Pricing Unit: ML | Drug Type:

    63323066401 DIPHENHYDRAMINE 50 MG/ML VIAL

    Pricing Unit: ML | Drug Type:

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

    NDCBrand NameGeneric Name
    68196-929diphenhydraminediphenhydramine
    76413-333DiphenhydramineDiphenhydramine
    21695-500DiphenhydramineDiphenhydramine
    21695-304DiphenhydramineDiphenhydramine
    42571-169DIPHENHYDRAMINEDIPHENHYDRAMINE
    51824-048DiphenhydramineDiphenhydramine
    52959-053DiphenhydramineDiphenhydramine
    57344-090DiphenhydramineDiphenhydramine
    57344-113DiphenhydramineDiphenhydramine
    58599-003DIPHENHYDRAMINEDIPHENHYDRAMINE
    58599-004DIPHENHYDRAMINEDIPHENHYDRAMINE
    63323-664DiphenhydramineDiphenhydramine
    42571-337DIPHENHYDRAMINEDIPHENHYDRAMINE
    61010-4409DiphenhydramineDiphenhydramine
    0363-7100Adult Allergy ReliefDiphenhydramine Hydrochloride
    0363-0100ALLERGY RELIEFDIPHENHYDRAMINE HYDROCHLORIDE
    0113-7479basic care allergy reliefDiphenhydramine Hydrochloride
    0363-0710childrens Allergy Dye Free Wal DrylDiphenhydramine hydrochloride
    0363-0004Childrens WAL-DRYLDiphenhydramine Hydrochloride
    0121-0865Diphenhydramine HCl Oral Solutiondiphenhydramine hydrochloride
    0121-1730Diphenhydramine HCl Oral Solutiondiphenhydramine hydrochloride
    0121-0489DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE
    0121-0978DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE
    0185-0648diphenhydramine hydrochloridediphenhydramine hydrochloride
    0185-0649diphenhydramine hydrochloridediphenhydramine hydrochloride
    0363-0293Dye Free Wal Dryl AllergyDiphenhydramine Hydrochloride
    0363-0753Dye Free Wal Sleep ZDIPHENHYDRAMINE HYDROCHLORIDE
    0113-0462Good Sense Allergy Reliefdiphenhydramine hydrochloride
    0113-0479good sense allergy reliefDiphenhydramine Hydrochloride
    0113-0431good sense nighttime sleep aidDiphenhydramine Hydrochloride
    0113-1909good sense sleep aiddiphenhydramine hydrochloride
    0031-9304Robitussin Direct Runny Nosediphenhydramine
    0363-0092Wal DrylDiphenhydramine Hydrochloride
    0363-0379wal dryl allergyDiphenhydramine Hydrochloride
    0363-0060Wal-Sleep ZDiphenhydramine Hydrochloride
    0363-0223Wal-SomDiphenhydramine hydrochloride
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