NDC 53401-100

Doxycycline Hyclate

Doxycycline Hyclate

Doxycycline Hyclate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions (formerly Testpak). The primary component is Doxycycline Hyclate.

Product ID53401-100_660693fd-25d3-485a-86b6-0ef4bda647ce
NDC53401-100
Product TypeHuman Prescription Drug
Proprietary NameDoxycycline Hyclate
Generic NameDoxycycline Hyclate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2011-07-14
Marketing CategoryANDA / ANDA
Application NumberANDA062505
Labeler NameAphena Pharma Solutions (Formerly TestPak)
Substance NameDOXYCYCLINE HYCLATE
Active Ingredient Strength100 mg/1
Pharm ClassesTetracycline-class Drug [EPC],Tetracyclines [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 53401-100-99

100 TABLET in 1 BOTTLE (53401-100-99)
Marketing Start Date2011-07-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53401-100-99 [53401010099]

Doxycycline Hyclate TABLET
Marketing CategoryANDA
Application NumberANDA062505
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-07-14
Inactivation Date2019-10-29

Drug Details

Active Ingredients

IngredientStrength
DOXYCYCLINE HYCLATE100 mg/1

OpenFDA Data

SPL SET ID:08c07b97-137a-437f-b6c8-f83e301ef030
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1650143
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0143-3141Doxycycline HyclateDoxycycline Hyclate
    0143-3142Doxycycline HyclateDoxycycline Hyclate
    0143-9802Doxycycline HyclateDoxycycline Hyclate
    0143-9803Doxycycline HyclateDoxycycline Hyclate
    0378-0145doxycycline hyclatedoxycycline
    0378-0148doxycycline hyclatedoxycycline
    0378-0167doxycycline hyclatedoxycycline
    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
    68047-714Doxycycline HyclateDoxycycline Hyclate
    68071-3206doxycycline hyclatedoxycycline hyclate
    68071-3243Doxycycline HyclateDoxycycline Hyclate
    68071-3252Doxycycline HyclateDoxycycline Hyclate
    68071-3104Doxycycline HyclateDoxycycline Hyclate
    68071-3386Doxycycline HyclateDoxycycline Hyclate
    68071-4478Doxycycline HyclateDoxycycline Hyclate
    68071-4354Doxycycline HyclateDoxycycline Hyclate
    68151-2022Doxycycline HyclateDoxycycline Hyclate
    68180-654doxycycline hyclatedoxycycline hyclate
    68180-653doxycycline hyclatedoxycycline hyclate
    68382-222Doxycycline hyclateDoxycycline hyclate
    68308-716Doxycycline HyclateDoxycycline Hyclate
    68308-775Doxycycline HyclateDoxycycline Hyclate
    68382-211Doxycycline hyclateDoxycycline hyclate
    68382-221Doxycycline hyclateDoxycycline hyclate
    68308-710Doxycycline HyclateDoxycycline Hyclate
    68308-715Doxycycline HyclateDoxycycline Hyclate
    68788-2112Doxycycline HyclateDoxycycline Hyclate
    68645-020Doxycycline HyclateDoxycycline Hyclate
    68788-6441Doxycycline HyclateDoxycycline Hyclate
    68788-7371Doxycycline HyclateDoxycycline Hyclate
    68788-9292Doxycycline HyclateDoxycycline Hyclate
    68788-9037Doxycycline HyclateDoxycycline Hyclate
    68788-9767Doxycycline HyclateDoxycycline Hyclate
    69097-226Doxycycline HyclateDoxycycline Hyclate
    69097-225Doxycycline HyclateDoxycycline Hyclate
    69097-227doxycycline hyclatedoxycycline hyclate
    69235-320Doxycycline HyclateDoxycycline Hyclate
    69238-1100Doxycycline HyclateDoxycycline Hyclate
    69238-1500Doxycycline HyclateDoxycycline Hyclate
    69238-1501Doxycycline HyclateDoxycycline Hyclate
    69668-515Doxycycline HyclateDoxycycline Hyclate

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