Doxycycline Hyclate

Product NDC
0143-9802
11-digit product format
001439802
Labeler code
0143
Product ID
0143-9802_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
50 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 HYCLATE50 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
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
0143-9802-50Doxycycline Hyclate50 in 1 BOTTLE, PLASTICCAPSULE5050

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9802DOXYCYCLINE HYCLATE CAPSULE [HIKMA PHARMACEUTICALS USA INC.]48Current NDC, Legacy NDC, 1 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
1649405doxycycline hyclate 50 MG Oral CapsulePSN325d5331-d48e-1bc4-e063-6394a90a65b91
1649405doxycycline hyclate 50 MG Oral CapsuleSCD325d5331-d48e-1bc4-e063-6394a90a65b91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9802-500014398025050 CAPSULE in 1 BOTTLE, PLASTIC (0143-9802-50) 50 capsule2020-05-270000-00-00NoNoCurrent