FDA.reportPublic FDA data

Doxycycline

Product NDC
55289-866
11-digit product format
552890866
Labeler code
55289
Product ID
55289-866_4d536efb-27b1-2589-e063-6394a90ad3e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA065095
Marketing category
ANDA
Marketing start
2003-07-02
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Doxycycline
Listing expiration
2027-12-31

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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55289-866-01Doxycycline100 in 1 BOTTLE, PLASTICTABLET, COATED10032
55289-866-02Doxycycline2 in 1 BOTTLE, PLASTICTABLET, COATED232
55289-866-04Doxycycline4 in 1 BOTTLE, PLASTICTABLET, COATED432
55289-866-06Doxycycline6 in 1 BOTTLE, PLASTICTABLET, COATED632
55289-866-07Doxycycline7 in 1 BOTTLE, PLASTICTABLET, COATED732
55289-866-10Doxycycline10 in 1 BOTTLE, PLASTICTABLET, COATED1032
55289-866-20Doxycycline20 in 1 BOTTLE, PLASTICTABLET, COATED2032
55289-866-28Doxycycline28 in 1 BOTTLE, PLASTICTABLET, COATED2832
55289-866-30Doxycycline30 in 1 BOTTLE, PLASTICTABLET, COATED3032
55289-866-50Doxycycline50 in 1 BOTTLE, PLASTICTABLET, COATED5032
55289-866-60Doxycycline60 in 1 BOTTLE, PLASTICTABLET, COATED6032
55289-866-71Doxycycline210 in 1 BOTTLE, PLASTICTABLET, COATED21032
55289-866-74Doxycycline400 in 1 BOTTLE, PLASTICTABLET, COATED40032
55289-866-82Doxycycline500 in 1 BOTTLE, PLASTICTABLET, COATED50032
55289-866-85Doxycycline330 in 1 BOTTLE, PLASTICTABLET, COATED33032
55289-866-86Doxycycline360 in 1 BOTTLE, PLASTICTABLET, COATED36032
55289-866-87Doxycycline300 in 1 BOTTLE, PLASTICTABLET, COATED30032
55289-866-90Doxycycline90 in 1 BOTTLE, PLASTICTABLET, COATED9032
55289-866-93Doxycycline180 in 1 BOTTLE, PLASTICTABLET, COATED18032
55289-866-95Doxycycline1000 in 1 BOTTLE, PLASTICTABLET, COATED100032
55289-866-98Doxycycline120 in 1 BOTTLE, PLASTICTABLET, COATED12032

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-866-01EA - Each55289-86690743e2a-3c73-4f2d-9567-5d16c7b9ebbf12012-07-24
55289-866-02EA - Each55289-866cf91906d-ee21-4b7f-8aa2-d70de380772c12012-07-24
55289-866-04EA - Each55289-866d5365061-4f32-4e76-be18-838c300a035e12012-07-24
55289-866-06EA - Each55289-866ceb5a2be-402f-409d-92ad-e3f7adea4ad512012-07-24
55289-866-07EA - Each55289-866528be083-44f0-4d3d-9421-a24bd26c0f0712016-10-06
55289-866-10EA - Each55289-866b8b42050-b9ee-4136-bb0e-9adc4858096012012-07-24
55289-866-14EA - Each55289-8668348cbc6-a75b-420d-9291-76b9b2aaaf5412012-07-24
55289-866-20EA - Each55289-866c21ea079-10a7-46de-b01c-dda0ab092ef712012-07-24
55289-866-28EA - Each55289-8660e46af55-ef2a-4f2a-a840-197a6fc20e4a12012-07-24
55289-866-30EA - Each55289-866aad12231-a0a8-4a19-b6a2-021ad9dff69212012-07-24
55289-866-50EA - Each55289-8666c63a6f3-2054-4ab1-822c-1ecd1f3479e612025-02-10
55289-866-60EA - Each55289-86668d8e272-b7ea-4a53-aa4b-6eb08d3a9e6212012-07-24
55289-866-71EA - Each55289-8666c87a3a8-a536-45e0-8542-bbb0209e0a7712015-01-05
55289-866-74EA - Each55289-866102006d5-a933-4eab-bee5-9a7a7794d44512012-07-24
55289-866-82EA - Each55289-866d219cfad-cca5-4ad8-af21-f926f37fafe312025-02-10
55289-866-85EA - Each55289-866d8c4cd70-a87b-449d-bee5-5be8735205c712014-08-01
55289-866-86EA - Each55289-866786a2c1d-c164-46a9-b9f7-913e273d9ebe12012-07-24
55289-866-87EA - Each55289-8665346778f-fb1e-468f-9cbe-cb447021d43812012-07-24
55289-866-90EA - Each55289-86668ebcfc0-a4c9-49c7-9654-faeebdb7a91412012-07-24
55289-866-93EA - Each55289-866ae97f53b-9317-49fe-8c71-970551f7a97912012-07-24
55289-866-95EA - Each55289-8664ba23965-27da-4124-9384-81fed18cde2712025-02-10
55289-866-98EA - Each55289-866b896f1cb-48a0-4c7f-a4c6-a3bacf6d825312014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]11
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]11
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]11
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]11
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]11
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]11
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-866DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]31Current NDC, Legacy NDC, 21 package rows20250524_c96d3986-9d92-4ec4-a319-a50aeb2f4fe7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSNc96d3986-9d92-4ec4-a319-a50aeb2f4fe732
1650143doxycycline hyclate 100 MG Oral TabletSCDc96d3986-9d92-4ec4-a319-a50aeb2f4fe732

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55289-866-0155289086601100 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-01) 2014-07-170000-00-00NoNoCurrent
55289-866-02552890866022 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-02) 2015-07-020000-00-00NoNoCurrent
55289-866-04552890866044 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-04) 2004-03-030000-00-00NoNoCurrent
55289-866-06552890866066 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-06) 2008-12-020000-00-00NoNoCurrent
55289-866-07552890866077 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-07) 2016-09-070000-00-00NoNoCurrent
55289-866-105528908661010 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-10) 2008-12-020000-00-00NoNoCurrent
55289-866-145528908661414 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-14) 2008-12-020000-00-00NoNoCurrent
55289-866-205528908662020 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-20) 2007-07-240000-00-00NoNoCurrent
55289-866-285528908662828 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-28) 2008-12-020000-00-00NoNoCurrent
55289-866-305528908663030 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-30) 2008-12-290000-00-00NoNoCurrent
55289-866-505528908665050 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-50) 2024-12-26NoNoHistorical
55289-866-605528908666060 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-60) 2008-12-020000-00-00NoNoCurrent
55289-866-7155289086671210 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-71) 2008-12-220000-00-00NoNoCurrent
55289-866-7455289086674400 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-74) 2008-12-020000-00-00NoNoCurrent
55289-866-8255289086682500 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-82) 2024-12-26NoNoHistorical
55289-866-8555289086685330 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-85) 2008-12-020000-00-00NoNoCurrent
55289-866-8655289086686360 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-86) 2008-12-020000-00-00NoNoCurrent
55289-866-8755289086687300 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-87) 2008-12-020000-00-00NoNoCurrent
55289-866-905528908669090 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-90) 2008-12-290000-00-00NoNoCurrent
55289-866-9355289086693180 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-93) 2008-12-290000-00-00NoNoCurrent
55289-866-95552890866951000 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-95) 2024-12-26NoNoHistorical
55289-866-9855289086698120 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-98) 2014-07-170000-00-00NoNoCurrent