FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
0143-9803
11-digit product format
001439803
Labeler code
0143
Product ID
0143-9803_bc3351b4-baf4-455a-9b12-162da800c25d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA062396
Marketing category
ANDA
Marketing start
1984-05-07
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE HYCLATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19XTS3T51U
Rxcui1649405, 1649988

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
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
6a5b4392-5ab0-af0d-e0be-47b34e9dbb84Product name520171121
01a4aa74-7e05-63bd-bc10-1b5ceb111371Product name220171115
58b1278c-6dce-49b6-a05e-ea16f389acbaProduct name120160620
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9803-05Doxycycline Hyclate500 in 1 BOTTLE, PLASTICCAPSULE50050
0143-9803-50Doxycycline Hyclate50 in 1 BOTTLE, PLASTICCAPSULE5050

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9803-05EA - Each0143-98030a9b4f32-0d60-4e04-acc0-3e2250605a3712013-03-03
0143-9803-50EA - Each0143-98030a6b2827-0023-422a-b3c1-03bbece5aedc12013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]12
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]12
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PDOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]12
ALCOHOLINACTIVE INGREDIENT3K9958V90MDOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]12
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]12
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]12
DIACETYLATED MONOGLYCERIDESINACTIVE INGREDIENT5Z17386USFDOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]12
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]12
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]12
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]12
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]12
GELATININACTIVE INGREDIENT2G86QN327LDOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]12
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]12
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]12
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]12
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [WEST-WARD PHARMACEUTICALS CORP]12
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]8
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]8
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE CAPSULE [MAJOR PHARMACEUTICALS]8
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MDOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLATE HYCLATE (DOXYCYCLINE HYCLATE) CAPSULE [LIBERTY PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9803DOXYCYCLINE HYCLATE CAPSULE [HIKMA PHARMACEUTICALS USA INC.]48Current NDC, Legacy NDC, 2 package rows20250515_4ec4c8ca-ce83-4948-8626-21eb82ae5c19.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN4ec4c8ca-ce83-4948-8626-21eb82ae5c1950
1649405doxycycline hyclate 50 MG Oral CapsulePSN4ec4c8ca-ce83-4948-8626-21eb82ae5c1950
1649988doxycycline hyclate 100 MG Oral CapsuleSCD4ec4c8ca-ce83-4948-8626-21eb82ae5c1950
1649405doxycycline hyclate 50 MG Oral CapsuleSCD4ec4c8ca-ce83-4948-8626-21eb82ae5c1950
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY4ec4c8ca-ce83-4948-8626-21eb82ae5c1950
1649988doxycycline hyclate 100 MG Oral CapsulePSN5f523294-e62b-4da5-8799-047d4bed966f48
1649988doxycycline hyclate 100 MG Oral CapsuleSCD5f523294-e62b-4da5-8799-047d4bed966f48
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY5f523294-e62b-4da5-8799-047d4bed966f48
1649988doxycycline hyclate 100 MG Oral CapsulePSNe24a3292-0d4f-4692-8cf7-a82bd19e593229
1649988doxycycline hyclate 100 MG Oral CapsuleSCDe24a3292-0d4f-4692-8cf7-a82bd19e593229
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYe24a3292-0d4f-4692-8cf7-a82bd19e593229
1649988doxycycline hyclate 100 MG Oral CapsulePSN4dc319c1-b7ef-40e4-9e66-fb24cfdefea825
1649988doxycycline hyclate 100 MG Oral CapsuleSCD4dc319c1-b7ef-40e4-9e66-fb24cfdefea825
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY4dc319c1-b7ef-40e4-9e66-fb24cfdefea825
1649988doxycycline hyclate 100 MG Oral CapsulePSNc4aae81f-0219-450f-aa60-953964f7417217
1649988doxycycline hyclate 100 MG Oral CapsuleSCDc4aae81f-0219-450f-aa60-953964f7417217
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYc4aae81f-0219-450f-aa60-953964f7417217
1649988doxycycline hyclate 100 MG Oral CapsulePSN214e5a5c-7f3e-478b-93d3-1713de9e76729
1649988doxycycline hyclate 100 MG Oral CapsuleSCD214e5a5c-7f3e-478b-93d3-1713de9e76729
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY214e5a5c-7f3e-478b-93d3-1713de9e76729
1649988doxycycline hyclate 100 MG Oral CapsulePSN8c525e4e-6e1b-4579-e053-2a95a90a43da6
1649988doxycycline hyclate 100 MG Oral CapsuleSCD8c525e4e-6e1b-4579-e053-2a95a90a43da6
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY8c525e4e-6e1b-4579-e053-2a95a90a43da6
1649988doxycycline hyclate 100 MG Oral CapsulePSNe98d11b0-535f-4e57-9639-6358835c04bc5
1649988doxycycline hyclate 100 MG Oral CapsuleSCDe98d11b0-535f-4e57-9639-6358835c04bc5
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYe98d11b0-535f-4e57-9639-6358835c04bc5
1649988doxycycline hyclate 100 MG Oral CapsulePSN8c273efa-62ec-16b2-e053-2995a90ac41d4
1649988doxycycline hyclate 100 MG Oral CapsulePSNb336f235-5b57-7d6a-e053-2a95a90a0b884
1649988doxycycline hyclate 100 MG Oral CapsulePSN88012cf8-509b-84cf-e053-2a95a90af3bc4
1649988doxycycline hyclate 100 MG Oral CapsuleSCD8c273efa-62ec-16b2-e053-2995a90ac41d4
1649988doxycycline hyclate 100 MG Oral CapsuleSCD88012cf8-509b-84cf-e053-2a95a90af3bc4
1649988doxycycline hyclate 100 MG Oral CapsuleSCDb336f235-5b57-7d6a-e053-2a95a90a0b884
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY8c273efa-62ec-16b2-e053-2995a90ac41d4
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYb336f235-5b57-7d6a-e053-2a95a90a0b884
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY88012cf8-509b-84cf-e053-2a95a90af3bc4
1649988doxycycline hyclate 100 MG Oral CapsulePSNf309ccbb-b68a-3190-e053-2995a90a0ad43
1649988doxycycline hyclate 100 MG Oral CapsuleSCDf309ccbb-b68a-3190-e053-2995a90a0ad43
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYf309ccbb-b68a-3190-e053-2995a90a0ad43
1649988doxycycline hyclate 100 MG Oral CapsulePSN52ba329a-8cb3-cf30-e063-6394a90aa0dc1
1649988doxycycline hyclate 100 MG Oral CapsulePSN3a85933f-bd73-4ad7-968d-c90cb7c7a60c1
1649988doxycycline hyclate 100 MG Oral CapsulePSNea66360f-6ab0-47ff-9b15-37e54395ff2f1
1649988doxycycline hyclate 100 MG Oral CapsuleSCD52ba329a-8cb3-cf30-e063-6394a90aa0dc1
1649988doxycycline hyclate 100 MG Oral CapsuleSCD3a85933f-bd73-4ad7-968d-c90cb7c7a60c1
1649988doxycycline hyclate 100 MG Oral CapsuleSCDea66360f-6ab0-47ff-9b15-37e54395ff2f1
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY52ba329a-8cb3-cf30-e063-6394a90aa0dc1
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY3a85933f-bd73-4ad7-968d-c90cb7c7a60c1
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYea66360f-6ab0-47ff-9b15-37e54395ff2f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9803-0500143980305500 CAPSULE in 1 BOTTLE, PLASTIC (0143-9803-05) 500 capsule2010-05-150000-00-00NoNoCurrent
0143-9803-500014398035050 CAPSULE in 1 BOTTLE, PLASTIC (0143-9803-50) 50 capsule2010-05-150000-00-00NoNoCurrent