Doxycycline Hyclate

Product NDC
0904-0430
11-digit product format
009040430
Labeler code
0904
Product ID
0904-0430_6f5ebbca-b3a8-4bee-a3c3-1f211b98df88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline hyclate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA065095
Marketing category
ANDA
Marketing start
2003-07-02
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
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
0904-0430-04Doxycycline Hyclate30 in 1 CARTONTABLET, COATED3015
0904-0430-04Doxycycline Hyclate1 in 1 BLISTER PACKTABLET, COATED115
0904-0430-06Doxycycline Hyclate50 in 1 CARTONTABLET, COATED5015
0904-0430-06Doxycycline Hyclate1 in 1 BLISTER PACKTABLET, COATED115
0904-0430-95Doxycycline Hyclate20 in 1 BOTTLETABLET, COATED2015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-0430DOXYCYCLINE HYCLATE TABLET, COATED [MAJOR PHARMACEUTICALS]12Current NDC, Legacy NDC, 5 package rows20250430_e7c14a8e-c713-4f03-94e8-1ec9ae077d4d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSNe7c14a8e-c713-4f03-94e8-1ec9ae077d4d15
1650143doxycycline hyclate 100 MG Oral TabletSCDe7c14a8e-c713-4f03-94e8-1ec9ae077d4d15
1650143doxycycline hyclate 100 MG Oral TabletPSNa34fbbc7-09dc-42d6-a075-f4ea8f170ba79
1650143doxycycline hyclate 100 MG Oral TabletSCDa34fbbc7-09dc-42d6-a075-f4ea8f170ba79

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-0430-040090404300430 BLISTER PACK in 1 CARTON (0904-0430-04) / 1 TABLET, COATED in 1 BLISTER PACK30 blister pack2003-07-020000-00-00NoNoCurrent
0904-0430-060090404300650 BLISTER PACK in 1 CARTON (0904-0430-06) / 1 TABLET, COATED in 1 BLISTER PACK50 blister pack2003-07-020000-00-00NoNoCurrent
0904-0430-950090404309520 TABLET, COATED in 1 BOTTLE (0904-0430-95) 2003-07-020000-00-00NoNoCurrent