NDC 69668-453

Mondoxyne NL

Doxycycline

Mondoxyne NL is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Sonoma Pharmaceuticals, Inc.. The primary component is Doxycycline.

Product ID69668-453_7aca563c-68ca-7426-e053-2991aa0ad824
NDC69668-453
Product TypeHuman Prescription Drug
Proprietary NameMondoxyne NL
Generic NameDoxycycline
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2015-05-28
Marketing CategoryANDA / ANDA
Application NumberANDA204446
Labeler NameSonoma Pharmaceuticals, Inc.
Substance NameDOXYCYCLINE
Active Ingredient Strength100 mg/1
Pharm ClassesTetracycline-class Drug [EPC],Tetracyclines [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 69668-453-01

60 CAPSULE in 1 BOTTLE, PLASTIC (69668-453-01)
Marketing Start Date2018-10-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69668-453-04 [69668045304]

Mondoxyne NL CAPSULE
Marketing CategoryANDA
Application NumberANDA204446
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-16
Marketing End Date2019-11-07

NDC 69668-453-01 [69668045301]

Mondoxyne NL CAPSULE
Marketing CategoryANDA
Application NumberANDA204446
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-10-04

Drug Details

Active Ingredients

IngredientStrength
DOXYCYCLINE100 mg/1

OpenFDA Data

SPL SET ID:816b110f-36e5-4b1e-9db4-f82c87191bc6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1649990
  • 1666542
    • PHarm Class EPC
  • Tetracycline-class Drug [EPC]
    • NUI Code
  • N0000007948
  • N0000175882

    • Pharmacological Class

    • Tetracycline-class Drug [EPC]
    • Tetracyclines [CS]

    NDC Crossover Matching brand name "Mondoxyne NL" or generic name "Doxycycline"

    NDCBrand NameGeneric Name
    69668-453Mondoxyne NLMondoxyne NL
    69668-452Mondoxyne NLMondoxyne NL
    0115-1327DoxycyclineDoxycycline
    0143-9381DoxycyclineDoxycycline
    0179-0129DoxycyclineDoxycycline
    0378-5475Doxycyclinedoxycycline
    0378-6021DoxycyclineDoxycycline
    0378-6022DoxycyclineDoxycycline
    0378-6023DoxycyclineDoxycycline
    0378-6124DoxycyclineDoxycycline
    0404-9855DOXYCYCLINEdoxycycline
    0527-1335DoxycyclineDoxycycline
    0527-1338DoxycyclineDoxycycline
    0527-1535DoxycyclineDoxycycline
    0527-1537DoxycyclineDoxycycline
    0378-0145doxycycline hyclatedoxycycline
    0378-0148doxycycline hyclatedoxycycline
    0378-0167doxycycline hyclatedoxycycline
    0299-3822ORACEADOXYCYCLINE
    0069-0970Vibramycin Monohydratedoxycycline

    Trademark Results [Mondoxyne NL]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MONDOXYNE NL
    MONDOXYNE NL
    86712855 5115417 Live/Registered
    SONOMA PHARMACEUTICALS, INC.
    2015-08-03
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.