FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
71335-2526
11-digit product format
713352526
Labeler code
71335
Product ID
71335-2526_cb44d5e4-1ae5-4bab-8388-2dac2063d766
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA065182
Marketing category
ANDA
Marketing start
2019-08-30
Substance
DOXYCYCLINE HYCLATE
Active strength
20 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 HYCLATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19XTS3T51U
Rxcui283535

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
71335-2526-1Doxycycline Hyclate20 in 1 BOTTLETABLET202
71335-2526-2Doxycycline Hyclate60 in 1 BOTTLETABLET602
71335-2526-3Doxycycline Hyclate30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2526DOXYCYCLINE HYCLATE TABLET [BRYANT RANCH PREPACK]2Current NDC, 3 package rows20250303_942ab6dd-e355-41da-b139-72cc8b7a2667.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283535doxycycline hyclate 20 MG Oral TabletPSN942ab6dd-e355-41da-b139-72cc8b7a26672
283535doxycycline hyclate 20 MG Oral TabletSCD942ab6dd-e355-41da-b139-72cc8b7a26672

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2526-17133525260120 TABLET in 1 BOTTLE (71335-2526-1) 20 tablet2025-02-03NoNoCurrent
71335-2526-27133525260260 TABLET in 1 BOTTLE (71335-2526-2) 60 tablet2025-02-03NoNoCurrent
71335-2526-37133525260330 TABLET in 1 BOTTLE (71335-2526-3) 30 tablet2024-11-04NoNoCurrent