Doxycycline Hyclate

Product NDC
11819-305
11-digit product format
118190305
Labeler code
11819
Product ID
11819-305_99c94f94-7630-4942-9c78-ea6b740e5d2b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
HHS/Program Support Center/Supply Service Center
Application
ANDA062505
Marketing category
ANDA
Marketing start
2011-06-17
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
11819-305-302019-11-13C16284748780-197449f38-c0f8-f6ea-e053-dbdaa90aa703DOXYCYCLINE HYCLATE TABLETS USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11819-305-30Doxycycline Hyclate30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Doxycycline HyclateACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDOXYCYCLINE HYCLATE TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOXYCYCLINE HYCLATE TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOXYCYCLINE HYCLATE TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODOXYCYCLINE HYCLATE TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
METHYLCELLULOSE (400 MPA.S)INACTIVE INGREDIENTO0GN6F9B2YDOXYCYCLINE HYCLATE TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOXYCYCLINE HYCLATE TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE HYCLATE TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DOXYCYCLINE HYCLATE TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDOXYCYCLINE HYCLATE TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11819-305DOXYCYCLINE HYCLATE TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1Legacy NDC, 1 package rows20120306_e563fe71-0316-4caf-9b50-59e2c5e2596e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSNe563fe71-0316-4caf-9b50-59e2c5e2596e1
1650143doxycycline hyclate 100 MG Oral TabletSCDe563fe71-0316-4caf-9b50-59e2c5e2596e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
11819-305-301181903053030 in 1 BOTTLEHistorical