FDA.reportPublic FDA data

Doxycycline

Product NDC
62584-693
11-digit product format
625840693
Labeler code
62584
Product ID
62584-693_1d7291e1-b616-d4f6-e063-6394a90ab01a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA065095
Marketing category
ANDA
Marketing start
2013-03-08
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Doxycycline
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE HYCLATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19XTS3T51U
Rxcui1650143

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
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
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
58b1278c-6dce-49b6-a05e-ea16f389acbaProduct name120160620

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62584-693-11Doxycycline1 in 1 BLISTER PACKTABLET, COATED111
62584-693-21Doxycycline30 in 1 BOX, UNIT-DOSETABLET, COATED3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62584-693-01EA - Each62584-69324443e7a-64a8-4a21-a491-4528d3ea270312012-07-24
62584-693-11EA - Each62584-69360dc7e89-5ccc-437a-9bf4-4b366b22f52a12012-07-24
62584-693-21EA - Each62584-693b3a0c401-b803-4cd5-9e3a-5e6ac46f571412013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [CARDINAL HEALTH]3
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [CARDINAL HEALTH]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [CARDINAL HEALTH]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [CARDINAL HEALTH]3
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [CARDINAL HEALTH]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [CARDINAL HEALTH]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [CARDINAL HEALTH]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [CARDINAL HEALTH]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [CARDINAL HEALTH]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [CARDINAL HEALTH]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [CARDINAL HEALTH]3
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [AMERICAN HEALTH PACKAGING]2
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [AMERICAN HEALTH PACKAGING]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [AMERICAN HEALTH PACKAGING]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [AMERICAN HEALTH PACKAGING]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [AMERICAN HEALTH PACKAGING]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [AMERICAN HEALTH PACKAGING]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [AMERICAN HEALTH PACKAGING]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [AMERICAN HEALTH PACKAGING]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [AMERICAN HEALTH PACKAGING]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [AMERICAN HEALTH PACKAGING]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [AMERICAN HEALTH PACKAGING]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [AMERICAN HEALTH PACKAGING]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [AMERICAN HEALTH PACKAGING]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62584-693DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [AMERICAN HEALTH PACKAGING]11Current NDC, Legacy NDC, 2 package rows20240718_10988250-b267-4f10-b264-5f127cc1ae18.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSN53deb73a-c828-46e8-994e-d84e3bf8dc9814
1650143doxycycline hyclate 100 MG Oral TabletSCD53deb73a-c828-46e8-994e-d84e3bf8dc9814
1650143doxycycline hyclate 100 MG Oral TabletPSN10988250-b267-4f10-b264-5f127cc1ae1811
1650143doxycycline hyclate 100 MG Oral TabletSCD10988250-b267-4f10-b264-5f127cc1ae1811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62584-693-11625840693111 in 1 BLISTER PACKHistorical
62584-693-216258406932130 BLISTER PACK in 1 BOX, UNIT-DOSE (62584-693-21) / 1 TABLET, COATED in 1 BLISTER PACK (62584-693-11) 30 blister pack2013-03-080000-00-00NoNoCurrent