FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
71205-697
11-digit product format
712050697
Labeler code
71205
Product ID
71205-697_dd7672c9-b10f-4ea1-9000-ef3e3faa10db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA062505
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
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
Rxcui1650143

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
71205-697-10Doxycycline Hyclate10 in 1 BOTTLETABLET, FILM COATED101
71205-697-14Doxycycline Hyclate14 in 1 BOTTLETABLET, FILM COATED141
71205-697-20Doxycycline Hyclate20 in 1 BOTTLETABLET, FILM COATED201
71205-697-30Doxycycline Hyclate30 in 1 BOTTLETABLET, FILM COATED301
71205-697-60Doxycycline Hyclate60 in 1 BOTTLETABLET, FILM COATED601
71205-697-90Doxycycline Hyclate90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-697-20EA - Each71205-69775327d96-7d54-4120-9ff9-7e6097e6ee0a12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-697DOXYCYCLINE HYCLATE TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, Legacy NDC, 6 package rows20220919_dd7672c9-b10f-4ea1-9000-ef3e3faa10db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSNdd7672c9-b10f-4ea1-9000-ef3e3faa10db1
1650143doxycycline hyclate 100 MG Oral TabletSCDdd7672c9-b10f-4ea1-9000-ef3e3faa10db1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-697-107120506971010 TABLET, FILM COATED in 1 BOTTLE (71205-697-10) 2022-09-140000-00-00NoNoCurrent
71205-697-147120506971414 TABLET, FILM COATED in 1 BOTTLE (71205-697-14) 2022-09-140000-00-00NoNoCurrent
71205-697-207120506972020 TABLET, FILM COATED in 1 BOTTLE (71205-697-20) 2022-09-140000-00-00NoNoCurrent
71205-697-307120506973030 TABLET, FILM COATED in 1 BOTTLE (71205-697-30) 2022-09-140000-00-00NoNoCurrent
71205-697-607120506976060 TABLET, FILM COATED in 1 BOTTLE (71205-697-60) 2022-09-140000-00-00NoNoCurrent
71205-697-907120506979090 TABLET, FILM COATED in 1 BOTTLE (71205-697-90) 2022-09-140000-00-00NoNoCurrent