FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
71335-1464
11-digit product format
713351464
Labeler code
71335
Product ID
71335-1464_b0842e69-7e68-4c2f-a7c2-094ce9fae4f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA062396
Marketing category
ANDA
Marketing start
1984-05-07
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
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
71335-1464-0Doxycycline Hyclate6 in 1 BOTTLECAPSULE69
71335-1464-1Doxycycline Hyclate10 in 1 BOTTLECAPSULE109
71335-1464-2Doxycycline Hyclate20 in 1 BOTTLECAPSULE209
71335-1464-3Doxycycline Hyclate30 in 1 BOTTLECAPSULE309
71335-1464-4Doxycycline Hyclate40 in 1 BOTTLECAPSULE409
71335-1464-5Doxycycline Hyclate60 in 1 BOTTLECAPSULE609
71335-1464-6Doxycycline Hyclate28 in 1 BOTTLECAPSULE289
71335-1464-7Doxycycline Hyclate14 in 1 BOTTLECAPSULE149
71335-1464-8Doxycycline Hyclate90 in 1 BOTTLECAPSULE909
71335-1464-9Doxycycline Hyclate365 in 1 BOTTLECAPSULE3659

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1464-1EA - Each71335-14643acea215-e0d7-4dfe-99cb-d366b22a259a12024-02-14
71335-1464-2EA - Each71335-146453ddcabe-b2af-4480-b126-43bf4eb014d412024-02-14
71335-1464-3EA - Each71335-1464a637fbc9-cbad-4c0c-9749-12578bcc071f12024-02-14
71335-1464-4EA - Each71335-14640012c3d6-11fd-44f9-b520-18ba4cd349fc12024-02-14
71335-1464-5EA - Each71335-146452c0a271-f00e-432b-9b75-ec99e9b9ec3a12024-02-14
71335-1464-6EA - Each71335-146419ff12e4-2eba-4117-985d-87eaa609def612024-02-14
71335-1464-7EA - Each71335-1464220bb85c-420c-46c0-830f-8c15d3ae4dab12024-02-14
71335-1464-8EA - Each71335-146430be405b-20d1-4e1c-978e-5227238a501f12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1464DOXYCYCLINE HYCLATE CAPSULE [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 10 package rows20240809_214e5a5c-7f3e-478b-93d3-1713de9e7672.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN214e5a5c-7f3e-478b-93d3-1713de9e76729
1649988doxycycline hyclate 100 MG Oral CapsuleSCD214e5a5c-7f3e-478b-93d3-1713de9e76729
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY214e5a5c-7f3e-478b-93d3-1713de9e76729

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1464-0713351464006 CAPSULE in 1 BOTTLE (71335-1464-0) 6 capsule2024-04-030000-00-00NoNoCurrent
71335-1464-17133514640110 CAPSULE in 1 BOTTLE (71335-1464-1) 10 capsule2020-02-240000-00-00NoNoCurrent
71335-1464-27133514640220 CAPSULE in 1 BOTTLE (71335-1464-2) 20 capsule2020-01-130000-00-00NoNoCurrent
71335-1464-37133514640330 CAPSULE in 1 BOTTLE (71335-1464-3) 30 capsule2020-02-030000-00-00NoNoCurrent
71335-1464-47133514640440 CAPSULE in 1 BOTTLE (71335-1464-4) 40 capsule2020-03-170000-00-00NoNoCurrent
71335-1464-57133514640560 CAPSULE in 1 BOTTLE (71335-1464-5) 60 capsule2020-01-090000-00-00NoNoCurrent
71335-1464-67133514640628 CAPSULE in 1 BOTTLE (71335-1464-6) 28 capsule2020-01-090000-00-00NoNoCurrent
71335-1464-77133514640714 CAPSULE in 1 BOTTLE (71335-1464-7) 14 capsule2020-01-130000-00-00NoNoCurrent
71335-1464-87133514640890 CAPSULE in 1 BOTTLE (71335-1464-8) 90 capsule2020-01-090000-00-00NoNoCurrent
71335-1464-971335146409365 CAPSULE in 1 BOTTLE (71335-1464-9) 365 capsule2024-04-030000-00-00NoNoCurrent