FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
0591-5553
11-digit product format
005915553
Labeler code
0591
Product ID
0591-5553_0fb9a3f8-9ebb-4c21-8a73-9f082b39039c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA062421
Marketing category
ANDA
Marketing start
1990-01-01
Marketing end
2027-02-28
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Doxycycline Hyclate

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
0591-5553-05Doxycycline Hyclate500 in 1 BOTTLE, PLASTICTABLET50033
0591-5553-50Doxycycline Hyclate50 in 1 BOTTLE, PLASTICTABLET5033

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-5553-05EA - Each0591-5553d2c2d32a-3eb5-4d61-ac4f-d8169e39536512012-07-24
0591-5553-50EA - Each0591-55539aaa99db-ca81-4b97-a46e-e9922d2e875c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [ACTAVIS PHARMA, INC.]16
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [ACTAVIS PHARMA, INC.]16
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [ACTAVIS PHARMA, INC.]16
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [ACTAVIS PHARMA, INC.]16
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [ACTAVIS PHARMA, INC.]16
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [ACTAVIS PHARMA, INC.]16
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [ACTAVIS PHARMA, INC.]16
GELATININACTIVE INGREDIENT2G86QN327LDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [ACTAVIS PHARMA, INC.]16
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [ACTAVIS PHARMA, INC.]16
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [ACTAVIS PHARMA, INC.]16
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [ACTAVIS PHARMA, INC.]16
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [ACTAVIS PHARMA, INC.]16
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [ACTAVIS PHARMA, INC.]16
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [ACTAVIS PHARMA, INC.]16
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [PHYSICIANS TOTAL CARE, INC.]2
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [PHYSICIANS TOTAL CARE, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [PHYSICIANS TOTAL CARE, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [PHYSICIANS TOTAL CARE, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [PHYSICIANS TOTAL CARE, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [PHYSICIANS TOTAL CARE, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [PHYSICIANS TOTAL CARE, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [PHYSICIANS TOTAL CARE, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [PHYSICIANS TOTAL CARE, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-5553DOXYCYCLINE HYCLATE TABLET [ACTAVIS PHARMA, INC.]32Current NDC, Legacy NDC, 2 package rows20250508_a569ba80-ffea-40b2-9fbe-a42810b1fccb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSNa569ba80-ffea-40b2-9fbe-a42810b1fccb33
1650143doxycycline hyclate 100 MG Oral TabletSCDa569ba80-ffea-40b2-9fbe-a42810b1fccb33
1649988doxycycline hyclate 100 MG Oral CapsulePSN19b19a55-972c-47c1-b031-cad69c624fa12
1650143doxycycline hyclate 100 MG Oral TabletPSN19b19a55-972c-47c1-b031-cad69c624fa12
1650143doxycycline hyclate 100 MG Oral TabletPSN19d93cd3-6ac6-4e5d-8e7e-1a48799df3cf2
1649405doxycycline hyclate 50 MG Oral CapsulePSN19b19a55-972c-47c1-b031-cad69c624fa12
1649988doxycycline hyclate 100 MG Oral CapsuleSCD19b19a55-972c-47c1-b031-cad69c624fa12
1650143doxycycline hyclate 100 MG Oral TabletSCD19b19a55-972c-47c1-b031-cad69c624fa12
1650143doxycycline hyclate 100 MG Oral TabletSCD19d93cd3-6ac6-4e5d-8e7e-1a48799df3cf2
1649405doxycycline hyclate 50 MG Oral CapsuleSCD19b19a55-972c-47c1-b031-cad69c624fa12
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY19b19a55-972c-47c1-b031-cad69c624fa12
1650143doxycycline hyclate 100 MG Oral TabletPSN4dbf2821-c502-4dcd-a0a1-603ae95a43351
1650143doxycycline hyclate 100 MG Oral TabletSCD4dbf2821-c502-4dcd-a0a1-603ae95a43351

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-5553-000059155530044444 TABLET in 1 BOX (0591-5553-00)44444 tablet02-FEB-83Current
0591-5553-0500591555305500 TABLET in 1 BOTTLE, PLASTIC (0591-5553-05) 500 tablet1990-01-012027-02-28NoNoCurrent
0591-5553-500059155535050 TABLET in 1 BOTTLE, PLASTIC (0591-5553-50) 50 tablet1990-01-012027-02-28NoNoCurrent
0591-5553-770059155537753340 TABLET in 1 CONTAINER (0591-5553-77)53340 tablet19-SEP-24Current