FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
71205-653
11-digit product format
712050653
Labeler code
71205
Product ID
71205-653_86c1f165-af79-4f01-ab61-3bdbce24cd0d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA062676
Marketing category
ANDA
Marketing start
1986-07-10
Substance
DOXYCYCLINE HYCLATE
Active strength
50 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 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
71205-653-10Doxycycline Hyclate10 in 1 BOTTLE, PLASTICCAPSULE101
71205-653-14Doxycycline Hyclate14 in 1 BOTTLE, PLASTICCAPSULE141
71205-653-20Doxycycline Hyclate20 in 1 BOTTLE, PLASTICCAPSULE201
71205-653-30Doxycycline Hyclate30 in 1 BOTTLE, PLASTICCAPSULE301
71205-653-60Doxycycline Hyclate60 in 1 BOTTLE, PLASTICCAPSULE601
71205-653-90Doxycycline Hyclate90 in 1 BOTTLE, PLASTICCAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-653-20EA - Each71205-65333643abe-3deb-4066-b32a-782ffbfd475712022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-653DOXYCYCLINE HYCLATE CAPSULE [PROFICIENT RX LP]1Current NDC, Legacy NDC, 6 package rows20220414_86c1f165-af79-4f01-ab61-3bdbce24cd0d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649405doxycycline hyclate 50 MG Oral CapsulePSN86c1f165-af79-4f01-ab61-3bdbce24cd0d1
1649405doxycycline hyclate 50 MG Oral CapsuleSCD86c1f165-af79-4f01-ab61-3bdbce24cd0d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-653-107120506531010 CAPSULE in 1 BOTTLE, PLASTIC (71205-653-10) 10 capsule2022-04-120000-00-00NoNoCurrent
71205-653-147120506531414 CAPSULE in 1 BOTTLE, PLASTIC (71205-653-14) 14 capsule2022-04-120000-00-00NoNoCurrent
71205-653-207120506532020 CAPSULE in 1 BOTTLE, PLASTIC (71205-653-20) 20 capsule2022-04-120000-00-00NoNoCurrent
71205-653-307120506533030 CAPSULE in 1 BOTTLE, PLASTIC (71205-653-30) 30 capsule2022-04-120000-00-00NoNoCurrent
71205-653-607120506536060 CAPSULE in 1 BOTTLE, PLASTIC (71205-653-60) 60 capsule2022-04-120000-00-00NoNoCurrent
71205-653-907120506539090 CAPSULE in 1 BOTTLE, PLASTIC (71205-653-90) 90 capsule2022-04-120000-00-00NoNoCurrent