NDC 27437-051

SOLOSEC

Secnidazole

SOLOSEC is a Oral Granule in the Human Prescription Drug category. It is labeled and distributed by Lupin Pharmaceuticals, Inc.. The primary component is Secnidazole.

Product ID27437-051_2d4f4392-eef9-470e-83a0-6fe7a695ecd9
NDC27437-051
Product TypeHuman Prescription Drug
Proprietary NameSOLOSEC
Generic NameSecnidazole
Dosage FormGranule
Route of AdministrationORAL
Marketing Start Date2017-10-30
Marketing CategoryNDA / NDA
Application NumberNDA209363
Labeler NameLupin Pharmaceuticals, Inc.
Substance NameSECNIDAZOLE
Active Ingredient Strength2 g/4.8g
Pharm ClassesNitroimidazole Antimicrobial [EPC],Nitroimidazoles [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 27437-051-01

1 PACKET in 1 BOX, UNIT-DOSE (27437-051-01) > 2 g in 1 PACKET
Marketing Start Date2017-10-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 27437-051-02 [27437005102]

SOLOSEC GRANULE
Marketing CategoryNDA
Application NumberNDA209363
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-19

NDC 27437-051-01 [27437005101]

SOLOSEC GRANULE
Marketing CategoryNDA
Application NumberNDA209363
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-10-30

Drug Details

Active Ingredients

IngredientStrength
SECNIDAZOLE2 g/4.8g

OpenFDA Data

SPL SET ID:551e43d5-f700-4d6e-8029-026f8a8932ff
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1946692
  • 1946698
  • Pharmacological Class

    • Nitroimidazole Antimicrobial [EPC]
    • Nitroimidazoles [CS]

    Medicade Reported Pricing

    27437005101 SOLOSEC 2 GM GRANULE PACKET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "SOLOSEC" or generic name "Secnidazole"

    NDCBrand NameGeneric Name
    27437-051SOLOSECsecnidazole
    64811-401SolosecSECNIDAZOLE

    Trademark Results [SOLOSEC]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SOLOSEC
    SOLOSEC
    86696432 5498160 Live/Registered
    Symbiomix Therapeutics, LLC
    2015-07-17

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