Doxycycline Hyclate

Product NDC
68645-020
11-digit product format
686450020
Labeler code
68645
Product ID
68645-020_f1102345-7a13-47d3-b7bc-8686b7ef5729
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Legacy Pharmaceutical Packaging
Application
ANDA062505
Marketing category
ANDA
Marketing start
2011-02-09
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
68645-020-102020-01-31C16284748780-19d75b9d1-2601-f424-e053-dadaa90a57ceDOXYCYCLINE HYCLATE TABLETS USP Rx only
68645-020-202020-01-31C16284748780-19d75b9d1-2601-f424-e053-dadaa90a57ceDOXYCYCLINE HYCLATE TABLETS USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68645-020-10Doxycycline Hyclate20 in 1 BOTTLETABLET, FILM COATED204
68645-020-20Doxycycline Hyclate100 in 1 BOTTLETABLET, FILM COATED1004

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDOXYCYCLINE HYCLATE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOXYCYCLINE HYCLATE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOXYCYCLINE HYCLATE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODOXYCYCLINE HYCLATE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
METHYLCELLULOSE (400 CPS)INACTIVE INGREDIENTO0GN6F9B2YDOXYCYCLINE HYCLATE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ADOXYCYCLINE HYCLATE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE HYCLATE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DOXYCYCLINE HYCLATE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDOXYCYCLINE HYCLATE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68645-020DOXYCYCLINE HYCLATE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]4Legacy NDC, 2 package rows20110411_369cc496-f093-4745-b4dc-c38ef0b9da5c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSN369cc496-f093-4745-b4dc-c38ef0b9da5c4
1650143doxycycline hyclate 100 MG Oral TabletSCD369cc496-f093-4745-b4dc-c38ef0b9da5c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68645-020-106864500201020 in 1 BOTTLEHistorical
68645-020-2068645002020100 in 1 BOTTLEHistorical