NDC 16110-075

Monodox

Doxycycline

Monodox is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Aqua Pharmaceuticals, Llc. The primary component is Doxycycline.

Product ID16110-075_a6d054f6-c27d-4641-ae0e-a6f59a196f54
NDC16110-075
Product TypeHuman Prescription Drug
Proprietary NameMonodox
Generic NameDoxycycline
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2007-01-31
Marketing CategoryNDA / NDA
Application NumberNDA050641
Labeler NameAqua Pharmaceuticals, LLC
Substance NameDOXYCYCLINE
Active Ingredient Strength75 mg/1
Pharm ClassesTetracycline-class Drug [EPC],Tetracyclines [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 16110-075-01

100 CAPSULE in 1 BOTTLE (16110-075-01)
Marketing Start Date2007-01-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16110-075-01 [16110007501]

Monodox CAPSULE
Marketing CategoryNDA
Application NumberNDA050641
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-01-31

Drug Details

Active Ingredients

IngredientStrength
DOXYCYCLINE75 mg/1

OpenFDA Data

SPL SET ID:a65325a7-ae0a-4704-99c4-a3a2e4e1dcf2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 205621
  • 1649401
  • 700408
  • 205619
  • 700410
  • 1649990
  • PHarm Class EPC
  • Tetracycline-class Drug [EPC]
  • UPC Code
  • 0316110259048
  • 0316110075013
  • 0316110260068
  • NUI Code
  • N0000007948
  • N0000175882
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Monodox" or generic name "Doxycycline"

    NDCBrand NameGeneric Name
    16110-259MonodoxMonodox
    16110-075MonodoxMonodox
    16110-260MonodoxMonodox
    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 [Monodox]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MONODOX
    MONODOX
    74050983 1678972 Live/Registered
    Oclassen Pharmaceuticals, Inc.
    1990-04-20

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