NDC 68001-331

Vazculep

Phenylephrine Hydrochloride

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

Product ID68001-331_35b03246-570d-4384-921b-bcba8a64255d
NDC68001-331
Product TypeHuman Prescription Drug
Proprietary NameVazculep
Generic NamePhenylephrine Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-06-30
Marketing CategoryNDA / NDA
Application NumberNDA204300
Labeler NameBluePoint Laboratories
Substance NamePHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength10 mg/mL
Pharm Classesalpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68001-331-65

1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (68001-331-65) > 10 mL in 1 VIAL, PHARMACY BULK PACKAGE
Marketing Start Date2017-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68001-331-65 [68001033165]

Vazculep INJECTION
Marketing CategoryNDA
Application NumberNDA204300
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-06-30

Drug Details

Active Ingredients

IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE10 mg/mL

OpenFDA Data

SPL SET ID:35b03246-570d-4384-921b-bcba8a64255d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1232651
  • 1542385
    • UPC Code
  • 0368001331654

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    68001-331VazculepVazculep
    71872-7042VazculepVazculep
    76014-004VazculepVazculep
    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
    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
    0113-2004sinus PEPhenylephrine Hydrochloride
    0363-0648Wal FourPhenylephrine hydrochloride

    Trademark Results [Vazculep]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    VAZCULEP
    VAZCULEP
    85679127 4704141 Live/Registered
    Éclat Pharmaceuticals, LLC
    2012-07-17
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.