FDA.reportPublic FDA data

doxycycline hyclate

Product NDC
71335-1549
11-digit product format
713351549
Labeler code
71335
Product ID
71335-1549_ba41e410-24fb-4f51-99e6-8e378914663d
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
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
Rxcui1649988

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
71335-1549-0doxycycline hyclate6 in 1 BOTTLECAPSULE67
71335-1549-1doxycycline hyclate10 in 1 BOTTLECAPSULE107
71335-1549-2doxycycline hyclate20 in 1 BOTTLECAPSULE207
71335-1549-3doxycycline hyclate30 in 1 BOTTLECAPSULE307
71335-1549-4doxycycline hyclate40 in 1 BOTTLECAPSULE407
71335-1549-5doxycycline hyclate60 in 1 BOTTLECAPSULE607
71335-1549-6doxycycline hyclate28 in 1 BOTTLECAPSULE287
71335-1549-7doxycycline hyclate14 in 1 BOTTLECAPSULE147
71335-1549-8doxycycline hyclate90 in 1 BOTTLECAPSULE907
71335-1549-9doxycycline hyclate365 in 1 BOTTLECAPSULE3657

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1549-0EA - Each71335-15492089e022-0593-42d7-b7b0-50974d3b182812024-02-14
71335-1549-1EA - Each71335-1549e18b33ce-cd4a-4729-b0b2-e3620b433e6612024-02-14
71335-1549-2EA - Each71335-1549b69568fe-ee7a-41c7-8ec2-33984d631c4e12024-02-14
71335-1549-3EA - Each71335-1549f9fbfcc6-6a15-41d7-8c61-5a59dcdceb8112024-02-14
71335-1549-5EA - Each71335-1549b64fab57-df2a-4244-98f3-55d383a4ed5312024-02-14
71335-1549-6EA - Each71335-15496954509f-c224-4847-8bf5-711ac78538a912024-02-14
71335-1549-7EA - Each71335-15499d945f46-ca6c-49a2-b8f5-bc799499b38712024-02-14
71335-1549-8EA - Each71335-1549c3b9f422-5efa-4f71-a687-175d9a487be212024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1549DOXYCYCLINE HYCLATE CAPSULE [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 10 package rows20240410_6f530f28-8c10-41dc-818f-1aef2306bde5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN6f530f28-8c10-41dc-818f-1aef2306bde57
1649988doxycycline hyclate 100 MG Oral CapsuleSCD6f530f28-8c10-41dc-818f-1aef2306bde57
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY6f530f28-8c10-41dc-818f-1aef2306bde57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1549-0713351549006 CAPSULE in 1 BOTTLE (71335-1549-0) 6 capsule2024-04-030000-00-00NoNoCurrent
71335-1549-17133515490110 CAPSULE in 1 BOTTLE (71335-1549-1) 10 capsule2020-12-300000-00-00NoNoCurrent
71335-1549-27133515490220 CAPSULE in 1 BOTTLE (71335-1549-2) 20 capsule2020-04-210000-00-00NoNoCurrent
71335-1549-37133515490330 CAPSULE in 1 BOTTLE (71335-1549-3) 30 capsule2020-03-230000-00-00NoNoCurrent
71335-1549-47133515490440 CAPSULE in 1 BOTTLE (71335-1549-4) 40 capsule2024-04-030000-00-00NoNoCurrent
71335-1549-57133515490560 CAPSULE in 1 BOTTLE (71335-1549-5) 60 capsule2020-11-230000-00-00NoNoCurrent
71335-1549-67133515490628 CAPSULE in 1 BOTTLE (71335-1549-6) 28 capsule2020-03-250000-00-00NoNoCurrent
71335-1549-77133515490714 CAPSULE in 1 BOTTLE (71335-1549-7) 14 capsule2020-05-270000-00-00NoNoCurrent
71335-1549-87133515490890 CAPSULE in 1 BOTTLE (71335-1549-8) 90 capsule2021-01-110000-00-00NoNoCurrent
71335-1549-971335154909365 CAPSULE in 1 BOTTLE (71335-1549-9) 365 capsule2024-04-030000-00-00NoNoCurrent