FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
71205-385
11-digit product format
712050385
Labeler code
71205
Product ID
71205-385_cb3fa2b9-be07-42c8-b617-d1ada36ca132
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA207289
Marketing category
ANDA
Marketing start
2016-06-28
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
71205-385-14Doxycycline Hyclate14 in 1 BOTTLECAPSULE144
71205-385-20Doxycycline Hyclate20 in 1 BOTTLECAPSULE204
71205-385-30Doxycycline Hyclate30 in 1 BOTTLECAPSULE304
71205-385-42Doxycycline Hyclate42 in 1 BOTTLECAPSULE424
71205-385-60Doxycycline Hyclate60 in 1 BOTTLECAPSULE604
71205-385-90Doxycycline Hyclate90 in 1 BOTTLECAPSULE904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-385DOXYCYCLINE HYCLATE (DOXYCYCLINE) CAPSULE [PROFICIENT RX LP]4Current NDC, Legacy NDC, 6 package rows20220702_e2151005-fb4a-485d-88ad-b44c4594d579.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSNe2151005-fb4a-485d-88ad-b44c4594d5794
1649988doxycycline hyclate 100 MG Oral CapsuleSCDe2151005-fb4a-485d-88ad-b44c4594d5794
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYe2151005-fb4a-485d-88ad-b44c4594d5794

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-385-147120503851414 CAPSULE in 1 BOTTLE (71205-385-14) 14 capsule2020-01-150000-00-00NoNoCurrent
71205-385-207120503852020 CAPSULE in 1 BOTTLE (71205-385-20) 20 capsule2020-01-150000-00-00NoNoCurrent
71205-385-307120503853030 CAPSULE in 1 BOTTLE (71205-385-30) 30 capsule2020-01-150000-00-00NoNoCurrent
71205-385-427120503854242 CAPSULE in 1 BOTTLE (71205-385-42) 42 capsule2020-05-080000-00-00NoNoCurrent
71205-385-607120503856060 CAPSULE in 1 BOTTLE (71205-385-60) 60 capsule2020-01-150000-00-00NoNoCurrent
71205-385-907120503859090 CAPSULE in 1 BOTTLE (71205-385-90) 90 capsule2020-01-150000-00-00NoNoCurrent