FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
42806-310
11-digit product format
428060310
Labeler code
42806
Product ID
42806-310_108c5769-3b01-40dd-b493-1f38df313b4c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA062269
Marketing category
ANDA
Marketing start
2025-03-07
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
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
42806-310-01Doxycycline Hyclate100 in 1 BOTTLETABLET, FILM COATED1002
42806-310-05Doxycycline Hyclate500 in 1 BOTTLETABLET, FILM COATED5002
42806-310-50Doxycycline Hyclate50 in 1 BOTTLETABLET, FILM COATED502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-310-05EA - Each42806-3104659622b-7a4f-48d8-b255-17f5a5f67dc312025-05-14
42806-310-50EA - Each42806-3100a0c76bf-17f0-46e2-a1cd-6e1a81a882c212025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-310DOXYCYCLINE HYCLATE TABLET, FILM COATED [EPIC PHARMA, LLC]2Current NDC, 3 package rows20250403_2b402587-8ecc-4fea-83ad-8071345b6356.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSNf39365f9-eb64-00cb-e053-2995a90a8d804
1650143doxycycline hyclate 100 MG Oral TabletPSNf39365f9-eb64-00cb-e053-2995a90a8d804
1649988doxycycline hyclate 100 MG Oral CapsuleSCDf39365f9-eb64-00cb-e053-2995a90a8d804
1650143doxycycline hyclate 100 MG Oral TabletSCDf39365f9-eb64-00cb-e053-2995a90a8d804
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYf39365f9-eb64-00cb-e053-2995a90a8d804
1650143doxycycline hyclate 100 MG Oral TabletPSN9cbd8699-e2c2-40d4-8797-e676f2a10eb23
1650143doxycycline hyclate 100 MG Oral TabletSCD9cbd8699-e2c2-40d4-8797-e676f2a10eb23
1650143doxycycline hyclate 100 MG Oral TabletPSN2b402587-8ecc-4fea-83ad-8071345b63562
1650143doxycycline hyclate 100 MG Oral TabletPSN44f2fdde-cf84-6f42-e063-6394a90af94e2
1650143doxycycline hyclate 100 MG Oral TabletSCD2b402587-8ecc-4fea-83ad-8071345b63562
1650143doxycycline hyclate 100 MG Oral TabletSCD44f2fdde-cf84-6f42-e063-6394a90af94e2
1650143doxycycline hyclate 100 MG Oral TabletPSN61195fc6-3fa7-4203-b526-477b483958561
1650143doxycycline hyclate 100 MG Oral TabletPSNca63aa91-519d-429f-adfc-a4ec453672941
1650143doxycycline hyclate 100 MG Oral TabletSCD61195fc6-3fa7-4203-b526-477b483958561
1650143doxycycline hyclate 100 MG Oral TabletSCDca63aa91-519d-429f-adfc-a4ec453672941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42806-310-0142806031001100 TABLET, FILM COATED in 1 BOTTLE (42806-310-01) 2025-03-07NoNoCurrent
42806-310-0542806031005500 TABLET, FILM COATED in 1 BOTTLE (42806-310-05) 2025-03-07NoNoCurrent
42806-310-504280603105050 TABLET, FILM COATED in 1 BOTTLE (42806-310-50) 2025-03-07NoNoCurrent