FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
53489-120
11-digit product format
534890120
Labeler code
53489
Product ID
53489-120_3309ec4b-fda9-8b52-e063-6394a90a5e18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA062677
Marketing category
ANDA
Marketing start
1986-07-10
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 Hyclate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE HYCLATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19XTS3T51U
Rxcui1649405, 1649988, 1650143

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
53489-120-01Doxycycline Hyclate100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10023
53489-120-02Doxycycline Hyclate50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5023
53489-120-05Doxycycline Hyclate500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50023
53489-120-60Doxycycline Hyclate20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53489-120-01EA - Each53489-120bab822de-e534-483d-bf69-0926a4fd193d12024-01-04
53489-120-02EA - Each53489-120800bf49f-6b77-444b-90d3-e0860edf452812012-07-24
53489-120-05EA - Each53489-12057e34457-2cab-4ca4-b1c7-35e9c8984ccb12012-07-24
53489-120-60EA - Each53489-120ae552f93-9598-4a53-905b-62fc9e1ae5bf12024-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Doxycycline HyclateACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
Doxycycline AnhydrousACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
carnauba waxINACTIVE INGREDIENTR12CBM0EIZDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
D&C Red No. 28INACTIVE INGREDIENT767IP0Y5NHDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOADOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
gelatinINACTIVE INGREDIENT2G86QN327LDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
hypromellosesINACTIVE INGREDIENT3NXW29V3WODOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
magnesium stearateINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ADOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC.]10
Doxycycline HyclateACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]3
Doxycycline AnhydrousACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]3
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKDOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]3
carnauba waxINACTIVE INGREDIENTR12CBM0EIZDOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]3
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]3
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48DOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]3
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GDOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]3
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOADOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]3
hypromellosesINACTIVE INGREDIENT3NXW29V3WODOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]3
magnesium stearateINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]3
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ADOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]3
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HDOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]3
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - NEW JERSEY, LLC]3
Doxycycline HyclateACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
Doxycycline HyclateACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
Doxycycline AnhydrousACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
Doxycycline AnhydrousACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKDOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKDOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
carnauba waxINACTIVE INGREDIENTR12CBM0EIZDOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
carnauba waxINACTIVE INGREDIENTR12CBM0EIZDOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48DOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
D&C Red No. 28INACTIVE INGREDIENT767IP0Y5NHDOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GDOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GDOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDDOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOADOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOADOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
gelatinINACTIVE INGREDIENT2G86QN327LDOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WODOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WODOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
magnesium stearateINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
magnesium stearateINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ADOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ADOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HDOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HDOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE) TABLET, FILM COATED [AVPAK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53489-120DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]23Current NDC, Legacy NDC, 4 package rows20250427_214a9cfe-a522-4022-81d4-e59f447401fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSN1401d590-0967-4c6b-b52b-a83e9f6df09743
1650143doxycycline hyclate 100 MG Oral TabletSCD1401d590-0967-4c6b-b52b-a83e9f6df09743
1650143doxycycline hyclate 100 MG Oral TabletPSN3af9348c-a98b-4059-a5ef-4229e2b33af030
1650143doxycycline hyclate 100 MG Oral TabletSCD3af9348c-a98b-4059-a5ef-4229e2b33af030
1650143doxycycline hyclate 100 MG Oral TabletPSNcf95b2ca-2cf8-49a8-8e3a-f9b0f5b2072c24
1650143doxycycline hyclate 100 MG Oral TabletSCDcf95b2ca-2cf8-49a8-8e3a-f9b0f5b2072c24
1650143doxycycline hyclate 100 MG Oral TabletPSNc8194d6e-c407-465e-a342-4d2d9756dfc416
1650143doxycycline hyclate 100 MG Oral TabletSCDc8194d6e-c407-465e-a342-4d2d9756dfc416
1649988doxycycline hyclate 100 MG Oral CapsulePSN53ff9f7e-0db0-c841-d334-4cf31f6588288
1650143doxycycline hyclate 100 MG Oral TabletPSN53ff9f7e-0db0-c841-d334-4cf31f6588288
1649405doxycycline hyclate 50 MG Oral CapsulePSN53ff9f7e-0db0-c841-d334-4cf31f6588288
1649988doxycycline hyclate 100 MG Oral CapsuleSCD53ff9f7e-0db0-c841-d334-4cf31f6588288
1650143doxycycline hyclate 100 MG Oral TabletSCD53ff9f7e-0db0-c841-d334-4cf31f6588288
1649405doxycycline hyclate 50 MG Oral CapsuleSCD53ff9f7e-0db0-c841-d334-4cf31f6588288
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY53ff9f7e-0db0-c841-d334-4cf31f6588288
1650143doxycycline hyclate 100 MG Oral TabletPSN465c5c54-d9b2-4ad5-a3f3-dbee6acfb9853
1650143doxycycline hyclate 100 MG Oral TabletSCD465c5c54-d9b2-4ad5-a3f3-dbee6acfb9853
1650143doxycycline hyclate 100 MG Oral TabletPSNbdaeb1eb-2f7b-3072-e053-2995a90acbd82
1650143doxycycline hyclate 100 MG Oral TabletPSNccfe4e5e-b77c-42eb-9c77-f3bd2115d36c2
1650143doxycycline hyclate 100 MG Oral TabletSCDbdaeb1eb-2f7b-3072-e053-2995a90acbd82
1650143doxycycline hyclate 100 MG Oral TabletSCDccfe4e5e-b77c-42eb-9c77-f3bd2115d36c2
1650143doxycycline hyclate 100 MG Oral TabletPSN2b5a2794-49cd-6a30-e054-00144ff88e881
1650143doxycycline hyclate 100 MG Oral TabletSCD2b5a2794-49cd-6a30-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53489-120-0153489012001100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-120-01) 2023-12-05NoNoCurrent
53489-120-025348901200250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-120-02) 1986-07-100000-00-00NoNoCurrent
53489-120-0553489012005500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-120-05) 1986-07-100000-00-00NoNoCurrent
53489-120-605348901206020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-120-60) 1986-07-100000-00-00NoNoCurrent