FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
71335-1686
11-digit product format
713351686
Labeler code
71335
Product ID
71335-1686_b6e24c58-c6cb-4722-8824-c879f564b7d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA062505
Marketing category
ANDA
Marketing start
1984-09-11
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Doxycycline Hyclate
Listing expiration
2027-12-31

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
71335-1686-1Doxycycline Hyclate20 in 1 BOTTLETABLET, FILM COATED2012
71335-1686-2Doxycycline Hyclate30 in 1 BOTTLETABLET, FILM COATED3012
71335-1686-3Doxycycline Hyclate50 in 1 BOTTLETABLET, FILM COATED5012
71335-1686-4Doxycycline Hyclate14 in 1 BOTTLETABLET, FILM COATED1412
71335-1686-5Doxycycline Hyclate40 in 1 BOTTLETABLET, FILM COATED4012
71335-1686-6Doxycycline Hyclate60 in 1 BOTTLETABLET, FILM COATED6012
71335-1686-7Doxycycline Hyclate28 in 1 BOTTLETABLET, FILM COATED2812
71335-1686-8Doxycycline Hyclate10 in 1 BOTTLETABLET, FILM COATED1012
71335-1686-9Doxycycline Hyclate6 in 1 BOTTLETABLET, FILM COATED612

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1686DOXYCYCLINE HYCLATE TABLET, FILM COATED [BRYANT RANCH PREPACK]11Current NDC, Legacy NDC, 9 package rows20240824_b70a3a12-76a2-4558-bf2c-eaa38a9ba0a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSNb70a3a12-76a2-4558-bf2c-eaa38a9ba0a012
1650143doxycycline hyclate 100 MG Oral TabletSCDb70a3a12-76a2-4558-bf2c-eaa38a9ba0a012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1686-17133516860120 TABLET, FILM COATED in 1 BOTTLE (71335-1686-1) 2026-01-270000-00-00NoNoCurrent
71335-1686-27133516860230 TABLET, FILM COATED in 1 BOTTLE (71335-1686-2) 2026-01-270000-00-00NoNoCurrent
71335-1686-37133516860350 TABLET, FILM COATED in 1 BOTTLE (71335-1686-3) 2026-01-270000-00-00NoNoCurrent
71335-1686-47133516860414 TABLET, FILM COATED in 1 BOTTLE (71335-1686-4) 2026-01-270000-00-00NoNoCurrent
71335-1686-57133516860540 TABLET, FILM COATED in 1 BOTTLE (71335-1686-5) 2026-01-270000-00-00NoNoCurrent
71335-1686-67133516860660 TABLET, FILM COATED in 1 BOTTLE (71335-1686-6) 2026-01-27NoNoHistorical
71335-1686-77133516860728 TABLET, FILM COATED in 1 BOTTLE (71335-1686-7) 2026-01-27NoNoHistorical
71335-1686-87133516860810 TABLET, FILM COATED in 1 BOTTLE (71335-1686-8) 2026-01-27NoNoHistorical
71335-1686-9713351686096 TABLET, FILM COATED in 1 BOTTLE (71335-1686-9) 2026-01-27NoNoHistorical