NDC 51862-557

Doryx

Doxycycline Hyclate

Doryx is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Mayne Pharma. The primary component is Doxycycline Hyclate.

Product ID51862-557_38948e5b-3c60-4977-8d76-d12523540a53
NDC51862-557
Product TypeHuman Prescription Drug
Proprietary NameDoryx
Generic NameDoxycycline Hyclate
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2015-05-26
Marketing CategoryNDA / NDA
Application NumberNDA050795
Labeler NameMayne Pharma
Substance NameDOXYCYCLINE HYCLATE
Active Ingredient Strength50 mg/1
Pharm ClassesTetracycline-class Drug [EPC], Tetracyclines [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 51862-557-00

6 TABLET, DELAYED RELEASE in 1 BOTTLE (51862-557-00)
Marketing Start Date2015-05-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51862-557-00 [51862055700]

Doryx TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA050795
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-05-26
Marketing End Date2020-04-03

NDC 51862-557-12 [51862055712]

Doryx TABLET, DELAYED RELEASE
Marketing CategoryNDA
Application NumberNDA050795
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-05-26

Drug Details

Active Ingredients

IngredientStrength
DOXYCYCLINE HYCLATE50 mg/1

OpenFDA Data

SPL SET ID:99cf2de6-e0a3-42f2-9929-d33e107af948
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1653433
  • 1653435
  • 1423080
  • 1423082
    • UPC Code
  • 0351862558063
  • 0351862557127

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Doryx" or generic name "Doxycycline Hyclate"

    NDCBrand NameGeneric Name
    51862-557DoryxDoryx
    51862-558DoryxDoryx
    51862-562DoryxDoryx
    0440-1481Doxycyclate HyclateDoxycycline Hyclate
    0143-2112DoxycyclineDoxycycline hyclate
    0440-7483DoxycyclineDoxycycline hyclate
    0143-3141Doxycycline HyclateDoxycycline Hyclate
    0143-3142Doxycycline HyclateDoxycycline Hyclate
    0143-9802Doxycycline HyclateDoxycycline Hyclate
    0143-9803Doxycycline HyclateDoxycycline Hyclate
    0378-3030Doxycycline HyclateDoxycycline Hyclate
    0378-4531Doxycycline Hyclatedoxycycline hyclate
    0378-4532Doxycycline Hyclatedoxycycline hyclate
    0378-4533Doxycycline Hyclatedoxycycline hyclate
    0378-4535Doxycycline Hyclatedoxycycline hyclate
    0440-7481Doxycycline HyclateDoxycycline Hyclate
    0440-7482Doxycycline HyclateDoxycycline Hyclate
    0463-2013Doxycycline HyclateDoxycycline Hyclate
    0463-6000Doxycycline HyclateDoxycycline Hyclate
    0527-1336Doxycycline HyclateDoxycycline Hyclate
    0591-4550Doxycycline HyclateDoxycycline Hyclate
    0591-4575Doxycycline HyclateDoxycycline Hyclate
    0069-0950Vibramycin Hyclatedoxycycline hyclate

    Trademark Results [Doryx]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DORYX
    DORYX
    86578233 4812939 Live/Registered
    Mayne pharma International Pty Ltd
    2015-03-26
    DORYX
    DORYX
    73365387 1259073 Live/Registered
    F. H. Faulding & Co. Ltd.
    1982-05-19
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.