NDC 0781-3458

Phenylephrine Hydrochloride

Phenylephrine Hydrochloride

Phenylephrine Hydrochloride is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Phenylephrine Hydrochloride.

Product ID0781-3458_2a3480c8-f8ff-46a8-b23e-df017db41936
NDC0781-3458
Product TypeHuman Prescription Drug
Proprietary NamePhenylephrine Hydrochloride
Generic NamePhenylephrine Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2020-01-15
Marketing CategoryANDA / ANDA
Application NumberANDA208905
Labeler NameSandoz Inc
Substance NamePHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength10 mg/mL
Pharm Classesalpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0781-3458-95

10 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0781-3458-95) > 5 mL in 1 VIAL, PHARMACY BULK PACKAGE (0781-3458-75)
Marketing Start Date2020-01-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-3458-95 [00781345895]

Phenylephrine Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA208905
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2020-01-15

NDC 0781-3458-75 [00781345875]

Phenylephrine Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA208905
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-15

Drug Details

Active Ingredients

IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE10 mg/mL

OpenFDA Data

SPL SET ID:6feb2da2-05ef-47bb-9d8d-01b81ad69059
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1232651
  • 1666372

    • Pharmacological Class

    • alpha-1 Adrenergic Agonist [EPC]
    • Adrenergic alpha1-Agonists [MoA]

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

    NDCBrand NameGeneric Name
    0363-0394phenylephrine hydrochloridephenylephrine hydrochloride
    0404-9931Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0641-6142Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0641-6188Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0641-6189Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0641-6229Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0781-3422Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0781-3458Phenylephrine HydrochloridePhenylephrine Hydrochloride
    69097-534PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE
    69097-535Phenylephrine hydrochloridePhenylephrine hydrochloride
    69097-614Phenylephrine hydrochloridePhenylephrine hydrochloride
    70121-1579Phenylephrine hydrochloridePhenylephrine hydrochloride
    70121-1578Phenylephrine hydrochloridePhenylephrine hydrochloride
    70121-1577Phenylephrine hydrochloridePhenylephrine hydrochloride
    70518-1038Phenylephrine HydrochloridePhenylephrine Hydrochloride
    11673-394phenylephrine hydrochloridephenylephrine hydrochloride
    17478-201Phenylephrine HydrochloridePhenylephrine Hydrochloride
    17478-206Phenylephrine HydrochloridePhenylephrine Hydrochloride
    42023-213Phenylephrine hydrochloridePhenylephrine hydrochloride
    42023-214Phenylephrine hydrochloridePhenylephrine hydrochloride
    42023-215Phenylephrine hydrochloridePhenylephrine hydrochloride
    42702-102Phenylephrine HydrochloridePhenylephrine Hydrochloride
    42702-103Phenylephrine HydrochloridePhenylephrine Hydrochloride
    50730-4812phenylephrine hydrochloridephenylephrine hydrochloride
    52584-142PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE
    55154-5129Phenylephrine HydrochloridePhenylephrine Hydrochloride
    57344-131Phenylephrine HydrochloridePhenylephrine Hydrochloride
    71872-7159Phenylephrine hydrochloridePhenylephrine hydrochloride
    63323-751Phenylephrine HydrochloridePhenylephrine Hydrochloride
    52584-577Phenylephrine HydrochloridePhenylephrine Hydrochloride
    55154-8226Phenylephrine hydrochloridePhenylephrine hydrochloride
    50090-4514Phenylephrine HydrochloridePhenylephrine Hydrochloride
    50090-4515Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0781-3466Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0067-20864 WayPhenylephrine hydrochloride
    0113-7094basic care sinus pePhenylephrine Hydrochloride
    0363-0390ephrine nosePhenylephrine hydrochloride
    0363-2023Ephrine Nose DropsPhenylephrine hydrochloride
    0113-0094Good Sense Nasal Decongestant PEPhenylephrine Hydrochloride
    0113-0648Good Sense Nasal FourPhenylephrine hydrochloride
    0295-1217Little Remedies Decongestant Nose DropsPhenylephrine Hydrochloride
    0363-0717nasalPhenylephrine hydrochloride
    0295-1117Neo-SynephrinePhenylephrine hydrochloride
    0295-1118Neo-SynephrinePhenylephrine hydrochloride
    0295-1119Neo-SynephrinePhenylephrine hydrochloride
    0225-0800Neo-Synephrine MildPHENYLEPHRINE HYDROCHLORIDE
    0225-0805Neo-Synephrine RegularPHENYLEPHRINE HYDROCHLORIDE
    0225-0810Neo-Synephrine RegularPHENYLEPHRINE HYDROCHLORIDE
    0113-2004sinus PEPhenylephrine Hydrochloride
    0363-0648Wal FourPhenylephrine hydrochloride
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