Doxycycline Hyclate

Product NDC
53401-100
11-digit product format
534010100
Labeler code
53401
Product ID
53401-100_660693fd-25d3-485a-86b6-0ef4bda647ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions (Formerly TestPak)
Application
ANDA062505
Marketing category
ANDA
Marketing start
2011-07-14
Marketing end
0000-00-00
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b4321c75-2e87-4d90-9726-9a28fb2293a3Product name320260112
5e99724e-0654-4aec-b7a2-0b9b10e312eeProduct name320250227
d2d36660-68ce-7e7d-0630-ec4b0d859fadProduct name620220921
a239f4dd-cf93-4660-b190-f97d000f249fProduct name720210607
a9d03566-caeb-4466-8021-74599b048880Product name320210604
12750814-20f7-4f35-b5fa-dbc8811ba858Product name920201007
00a5dbaa-1b7d-4e56-be0c-fedc7bbf5adeProduct name120200706
7b4b06ac-8c50-45f0-9556-293ea558a294Product name120180808
6a5b4392-5ab0-af0d-e0be-47b34e9dbb84Product name520171121
01a4aa74-7e05-63bd-bc10-1b5ceb111371Product name220171115
58b1278c-6dce-49b6-a05e-ea16f389acbaProduct name120160620

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53401-100-992019-10-29C16284748780-1960f7f55-cbea-8e05-e053-dbdaa90a074aDoxycycline

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53401-100-99Doxycycline Hyclate100 in 1 BOTTLETABLET1001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Doxycycline HyclateACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE TABLET [APHENA PHARMA SOLUTIONS (FORMERLY TESTPAK)]1
Doxycycline AnhydrousACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE TABLET [APHENA PHARMA SOLUTIONS (FORMERLY TESTPAK)]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53401-100DOXYCYCLINE HYCLATE TABLET [APHENA PHARMA SOLUTIONS (FORMERLY TESTPAK)]1Legacy NDC, 1 package rows20110812_08c07b97-137a-437f-b6c8-f83e301ef030.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSN08c07b97-137a-437f-b6c8-f83e301ef0301
1650143doxycycline hyclate 100 MG Oral TabletSCD08c07b97-137a-437f-b6c8-f83e301ef0301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53401-100-9953401010099100 in 1 BOTTLEHistorical