FDA.reportPublic FDA data

doxycycline hyclate

Product NDC
71335-1768
11-digit product format
713351768
Labeler code
71335
Product ID
71335-1768_94b694b8-aeaf-4405-a7e4-772f392ec509
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA062500
Marketing category
ANDA
Marketing start
1984-09-11
Substance
DOXYCYCLINE HYCLATE
Active strength
50 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 HYCLATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19XTS3T51U
Rxcui1649405

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
71335-1768-1doxycycline hyclate30 in 1 BOTTLECAPSULE30106
71335-1768-2doxycycline hyclate90 in 1 BOTTLECAPSULE90106
71335-1768-3doxycycline hyclate28 in 1 BOTTLECAPSULE28106
71335-1768-4doxycycline hyclate20 in 1 BOTTLECAPSULE20106
71335-1768-5doxycycline hyclate60 in 1 BOTTLECAPSULE60106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1768DOXYCYCLINE HYCLATE CAPSULE [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 5 package rows20240502_6e06e73c-b777-4a2d-988f-b009f2fc34d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649405doxycycline hyclate 50 MG Oral CapsulePSN6e06e73c-b777-4a2d-988f-b009f2fc34d1106
1649405doxycycline hyclate 50 MG Oral CapsuleSCD6e06e73c-b777-4a2d-988f-b009f2fc34d1106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1768-17133517680130 CAPSULE in 1 BOTTLE (71335-1768-1) 30 capsule2021-01-130000-00-00NoNoCurrent
71335-1768-27133517680290 CAPSULE in 1 BOTTLE (71335-1768-2) 90 capsule2022-03-100000-00-00NoNoCurrent
71335-1768-37133517680328 CAPSULE in 1 BOTTLE (71335-1768-3) 28 capsule2022-03-100000-00-00NoNoCurrent
71335-1768-47133517680420 CAPSULE in 1 BOTTLE (71335-1768-4) 20 capsule2022-03-100000-00-00NoNoCurrent
71335-1768-57133517680560 CAPSULE in 1 BOTTLE (71335-1768-5) 60 capsule2022-03-100000-00-00NoNoCurrent