NDC 67857-808

Sernivo

Betamethasone Dipropionate

Sernivo is a Topical Spray in the Human Prescription Drug category. It is labeled and distributed by Promius Pharma, Llc. The primary component is Betamethasone Dipropionate.

Product ID67857-808_87e07b91-6b99-09b8-9d58-240ec3ad06de
NDC67857-808
Product TypeHuman Prescription Drug
Proprietary NameSernivo
Generic NameBetamethasone Dipropionate
Dosage FormSpray
Route of AdministrationTOPICAL
Marketing Start Date2016-02-22
Marketing CategoryNDA / NDA
Application NumberNDA208079
Labeler NamePromius Pharma, LLC
Substance NameBETAMETHASONE DIPROPIONATE
Active Ingredient Strength1 mg/g
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 67857-808-04

1 BOTTLE in 1 CARTON (67857-808-04) > 120 g in 1 BOTTLE
Marketing Start Date2016-02-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67857-808-04 [67857080804]

Sernivo SPRAY
Marketing CategoryNDA
Application NumberNDA208079
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-02-22

Drug Details

Active Ingredients

IngredientStrength
BETAMETHASONE DIPROPIONATE.5 mg/g

OpenFDA Data

SPL SET ID:590cee5b-2712-4da6-99fe-5e14b44f2597
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1738541
  • 1738536
    • UPC Code
  • 0367857808044

    • Pharmacological Class

    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]
    • Corticosteroid [EPC]
    • Corticosteroid Hormone Receptor Agonists [MoA]

    Medicade Reported Pricing

    67857080804 SERNIVO 0.05% SPRAY

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "Sernivo" or generic name "Betamethasone Dipropionate"

    NDCBrand NameGeneric Name
    67857-808SernivoSernivo
    69482-800SernivoSernivo
    0168-0055Betamethasone DipropionateBetamethasone Dipropionate
    0168-0056Betamethasone DipropionateBetamethasone Dipropionate
    0168-0057Betamethasone DipropionateBetamethasone Dipropionate
    0168-0265Betamethasone DipropionateBetamethasone dipropionate
    0168-0266Betamethasone DipropionateBetamethasone Dipropionate
    0168-0267Betamethasone DipropionateBetamethasone Dipropionate
    0168-0268Betamethasone Dipropionatebetamethasone dipropionate
    0472-0380Betamethasone DipropionateBetamethasone Dipropionate
    0472-0381Betamethasone DipropionateBetamethasone Dipropionate
    0472-0382Betamethasone DipropionateBetamethasone Dipropionate
    0713-0659Betamethasone DipropionateBetamethasone Dipropionate
    0713-0728Betamethasone DipropionateBetamethasone Dipropionate
    0085-0575DIPROLENEbetamethasone dipropionate
    0085-0962DIPROLENEbetamethasone dipropionate
    0085-0517DIPROLENE AFbetamethasone dipropionate

    Trademark Results [Sernivo]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SERNIVO
    SERNIVO
    86441980 5096019 Live/Registered
    ENCORE DERMATOLOGY, INC.
    2014-10-31
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.