FDA.reportPublic FDA data

Doxycycline hyclate

Product NDC
71335-2086
11-digit product format
713352086
Labeler code
71335
Product ID
71335-2086_19a9909b-de48-4cb9-8b34-45b6a1b0dade
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207774
Marketing category
ANDA
Marketing start
2022-01-10
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
Rxcui1649988

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b4321c75-2e87-4d90-9726-9a28fb2293a3Product name320260112
5e99724e-0654-4aec-b7a2-0b9b10e312eeProduct name320250227
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
71335-2086-0Doxycycline hyclate6 in 1 BOTTLECAPSULE6103
71335-2086-1Doxycycline hyclate10 in 1 BOTTLECAPSULE10103
71335-2086-2Doxycycline hyclate20 in 1 BOTTLECAPSULE20103
71335-2086-3Doxycycline hyclate30 in 1 BOTTLECAPSULE30103
71335-2086-4Doxycycline hyclate40 in 1 BOTTLECAPSULE40103
71335-2086-5Doxycycline hyclate60 in 1 BOTTLECAPSULE60103
71335-2086-6Doxycycline hyclate28 in 1 BOTTLECAPSULE28103
71335-2086-7Doxycycline hyclate14 in 1 BOTTLECAPSULE14103
71335-2086-8Doxycycline hyclate90 in 1 BOTTLECAPSULE90103
71335-2086-9Doxycycline hyclate365 in 1 BOTTLECAPSULE365103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2086-1EA - Each71335-20860930c4b7-2e25-464b-ad42-754c9ba0ce4812024-02-14
71335-2086-2EA - Each71335-2086d9cc2eec-b3b7-4df6-b481-5a8980c8b09212024-02-14
71335-2086-3EA - Each71335-2086cae2aaa4-e18c-4b6f-80f5-0e431c0c6f5512024-02-14
71335-2086-5EA - Each71335-2086659e852f-0eb1-447e-9598-24ac8dcfc8a712024-02-14
71335-2086-7EA - Each71335-2086d0fd83dc-d399-4111-8851-f2cd3d8ee70312024-02-14
71335-2086-8EA - Each71335-2086ed80c7d4-7e5a-42ef-878d-6fd70ef8520812024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2086DOXYCYCLINE HYCLATE CAPSULE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 10 package rows20240824_30b041a0-8f5f-4d9f-b11b-106f7432955b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN30b041a0-8f5f-4d9f-b11b-106f7432955b103
1649988doxycycline hyclate 100 MG Oral CapsuleSCD30b041a0-8f5f-4d9f-b11b-106f7432955b103
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY30b041a0-8f5f-4d9f-b11b-106f7432955b103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2086-0713352086006 CAPSULE in 1 BOTTLE (71335-2086-0) 6 capsule2024-04-030000-00-00NoNoCurrent
71335-2086-17133520860110 CAPSULE in 1 BOTTLE (71335-2086-1) 10 capsule2022-12-080000-00-00NoNoCurrent
71335-2086-27133520860220 CAPSULE in 1 BOTTLE (71335-2086-2) 20 capsule2022-05-240000-00-00NoNoCurrent
71335-2086-37133520860330 CAPSULE in 1 BOTTLE (71335-2086-3) 30 capsule2022-08-220000-00-00NoNoCurrent
71335-2086-47133520860440 CAPSULE in 1 BOTTLE (71335-2086-4) 40 capsule2024-04-030000-00-00NoNoCurrent
71335-2086-57133520860560 CAPSULE in 1 BOTTLE (71335-2086-5) 60 capsule2022-09-090000-00-00NoNoCurrent
71335-2086-67133520860628 CAPSULE in 1 BOTTLE (71335-2086-6) 28 capsule2024-04-030000-00-00NoNoCurrent
71335-2086-77133520860714 CAPSULE in 1 BOTTLE (71335-2086-7) 14 capsule2022-09-140000-00-00NoNoCurrent
71335-2086-87133520860890 CAPSULE in 1 BOTTLE (71335-2086-8) 90 capsule2022-08-240000-00-00NoNoCurrent
71335-2086-971335208609365 CAPSULE in 1 BOTTLE (71335-2086-9) 365 capsule2024-04-030000-00-00NoNoCurrent