FDA.reportPublic FDA data

Doxycycline

Product NDC
68645-021
11-digit product format
686450021
Labeler code
68645
Product ID
68645-021_af206cfa-2d91-49e2-b60d-90a7348fb706
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline hyclate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Legacy Pharmaceutical Packaging
Application
ANDA065095
Marketing category
ANDA
Marketing start
2010-05-01
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
2018-12-31
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
68645-021-102020-01-31C16284748780-19d75b9d0-76ff-f424-e053-dadaa90a57ceDOXYCYCLINE HYCLATE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68645-021-10Doxycycline20 in 1 BOTTLETABLET, COATED201

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [LEGACY PHARMACEUTICAL PACKAGING]1
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [LEGACY PHARMACEUTICAL PACKAGING]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [LEGACY PHARMACEUTICAL PACKAGING]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [LEGACY PHARMACEUTICAL PACKAGING]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [LEGACY PHARMACEUTICAL PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [LEGACY PHARMACEUTICAL PACKAGING]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68645-021DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [LEGACY PHARMACEUTICAL PACKAGING]1Legacy NDC, 1 package rows20110505_6adc5bb0-69a5-4c9f-b569-1eee446afcd2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSN6adc5bb0-69a5-4c9f-b569-1eee446afcd21
1650143doxycycline hyclate 100 MG Oral TabletSCD6adc5bb0-69a5-4c9f-b569-1eee446afcd21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68645-021-106864500211020 in 1 BOTTLEHistorical