NDC 0378-3030

Doxycycline Hyclate

Doxycycline Hyclate

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

Product ID0378-3030_0a0172c0-c2f1-410f-a951-1e5b8738be37
NDC0378-3030
Product TypeHuman Prescription Drug
Proprietary NameDoxycycline Hyclate
Generic NameDoxycycline Hyclate
Dosage FormTablet, Delayed Release
Route of AdministrationORAL
Marketing Start Date2012-04-30
Marketing End Date2019-08-31
Marketing CategoryANDA / ANDA
Application NumberANDA091052
Labeler NameMylan Pharmaceuticals Inc.
Substance NameDOXYCYCLINE HYCLATE
Active Ingredient Strength150 mg/1
Pharm ClassesTetracycline-class Drug [EPC],Tetracyclines [CS]
NDC Exclude FlagN

Packaging

NDC 0378-3030-01

100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-3030-01)
Marketing Start Date2012-04-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-3030-93 [00378303093]

Doxycycline Hyclate TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA091052
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-30
Marketing End Date2017-11-27

NDC 0378-3030-05 [00378303005]

Doxycycline Hyclate TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA091052
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-30
Marketing End Date2014-11-24

NDC 0378-3030-91 [00378303091]

Doxycycline Hyclate TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA091052
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-04-30
Marketing End Date2017-11-27

NDC 0378-3030-01 [00378303001]

Doxycycline Hyclate TABLET, DELAYED RELEASE
Marketing CategoryANDA
Application NumberANDA091052
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-04-30
Marketing End Date2019-08-31

Drug Details

Active Ingredients

IngredientStrength
DOXYCYCLINE HYCLATE150 mg/1

OpenFDA Data

SPL SET ID:9f6c6dff-befc-4e1c-8a62-7c783c23fb3a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 799048

    • 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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