FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
0591-5440
11-digit product format
005915440
Labeler code
0591
Product ID
0591-5440_1c95cff4-9b82-4f75-a16c-53606be2708f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA062031
Marketing category
ANDA
Marketing start
1990-01-01
Marketing end
2020-04-30
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-5440-05EA - Each0591-5440619165f9-79d5-4d43-9cb5-1045a820914112012-07-24
0591-5440-50EA - Each0591-544005c2c604-1ab8-469a-9b73-1d719763636a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [PHYSICIANS TOTAL CARE, INC.]2
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE CAPSULE [TYA PHARMACEUTICALS]2
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE CAPSULE [TYA PHARMACEUTICALS]2
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE CAPSULE DOXYCYCLINE HYCLATE TABLET [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE CAPSULE [TYA PHARMACEUTICALS]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 BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXYCYCLINE HYCLATE CAPSULE [TYA PHARMACEUTICALS]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 [TYA PHARMACEUTICALS]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
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE CAPSULE [TYA PHARMACEUTICALS]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
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE HYCLATE CAPSULE [TYA PHARMACEUTICALS]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXYCYCLINE HYCLATE CAPSULE [TYA PHARMACEUTICALS]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
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE CAPSULE [TYA PHARMACEUTICALS]2
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
DOXYCYCLINEACTIVE MOIETYN12000U13ODOXYCYCLINE HYCLATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXYCYCLINE HYCLATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
GELATININACTIVE INGREDIENT2G86QN327LDOXYCYCLINE HYCLATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE HYCLATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXYCYCLINE HYCLATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN19b19a55-972c-47c1-b031-cad69c624fa12
1649988doxycycline hyclate 100 MG Oral CapsulePSN1b0820a9-cded-4d1b-a56e-ed543d2156352
1650143doxycycline hyclate 100 MG Oral TabletPSN19b19a55-972c-47c1-b031-cad69c624fa12
1649405doxycycline hyclate 50 MG Oral CapsulePSN19b19a55-972c-47c1-b031-cad69c624fa12
1649988doxycycline hyclate 100 MG Oral CapsuleSCD19b19a55-972c-47c1-b031-cad69c624fa12
1649988doxycycline hyclate 100 MG Oral CapsuleSCD1b0820a9-cded-4d1b-a56e-ed543d2156352
1650143doxycycline hyclate 100 MG Oral TabletSCD19b19a55-972c-47c1-b031-cad69c624fa12
1649405doxycycline hyclate 50 MG Oral CapsuleSCD19b19a55-972c-47c1-b031-cad69c624fa12
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY19b19a55-972c-47c1-b031-cad69c624fa12
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY1b0820a9-cded-4d1b-a56e-ed543d2156352
1649988doxycycline hyclate 100 MG Oral CapsulePSN14300ca2-d99d-40c6-a771-2aeceb344dce1
1649988doxycycline hyclate 100 MG Oral CapsuleSCD14300ca2-d99d-40c6-a771-2aeceb344dce1
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY14300ca2-d99d-40c6-a771-2aeceb344dce1