NDC 65628-208

FIRVANQ

Vancomycin Hydrochloride

FIRVANQ is a Oral Kit in the Human Prescription Drug category. It is labeled and distributed by Azurity Pharmaceuticals, Inc. The primary component is .

Product ID65628-208_3a951c17-24fc-4da7-b573-c08cdd92c4fc
NDC65628-208
Product TypeHuman Prescription Drug
Proprietary NameFIRVANQ
Generic NameVancomycin Hydrochloride
Dosage FormKit
Route of AdministrationORAL
Marketing Start Date2018-01-26
Marketing CategoryNDA / NDA
Application NumberNDA208910
Labeler NameAzurity Pharmaceuticals, Inc
Active Ingredient Strength0
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 65628-208-10

1 KIT in 1 CARTON (65628-208-10) * 15 g in 1 BOTTLE * 289 mL in 1 BOTTLE
Marketing Start Date2018-01-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65628-208-10 [65628020810]

FIRVANQ KIT
Marketing CategoryNDA
Application NumberNDA208910
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-01-26

Drug Details

OpenFDA Data

SPL SET ID:5aca5508-b577-446c-9980-ab4c7582b4b9
Manufacturer
RxNorm Concept Unique ID - RxCUI
  • 2000127
  • 2000133
  • 2000134
  • 2000136

    • NDC Crossover Matching brand name "FIRVANQ" or generic name "Vancomycin Hydrochloride"

    NDCBrand NameGeneric Name
    65628-208FIRVANQFIRVANQ
    65628-204FIRVANQFIRVANQ
    65628-205FIRVANQFIRVANQ
    65628-206FIRVANQFIRVANQ
    65628-015FIRVANQFIRVANQ
    65628-016FIRVANQFIRVANQ
    0121-0867VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDE
    0121-0890VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDE
    0143-9355Vancomycin HydrochlorideVancomycin Hydrochloride
    0143-9356Vancomycin HydrochlorideVancomycin Hydrochloride
    0143-9357Vancomycin HydrochlorideVancomycin Hydrochloride
    0143-9358Vancomycin HydrochlorideVancomycin Hydrochloride
    0143-9359Vancomycin HydrochlorideVancomycin Hydrochloride
    0338-3551VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDE
    0338-3552VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDE
    0338-3580VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDE

    Trademark Results [FIRVANQ]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    FIRVANQ
    FIRVANQ
    87715534 5651067 Live/Registered
    CutisPharma, Inc.
    2017-12-11
    FIRVANQ
    FIRVANQ
    87451656 5525903 Live/Registered
    CutisPharma, Inc.
    2017-05-16
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.