FDA.reportPublic FDA data

Doxycycline

Product NDC
82804-028
11-digit product format
828040028
Labeler code
82804
Product ID
82804-028_b83c4c4b-2885-43e7-b1c9-0b3bbf75528d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA209582
Marketing category
ANDA
Marketing start
2018-01-11
Substance
DOXYCYCLINE
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN12000U13O
Rxcui1650142

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
82804-028-06Doxycycline6 in 1 BOTTLETABLET, FILM COATED61
82804-028-14Doxycycline14 in 1 BOTTLETABLET, FILM COATED141
82804-028-20Doxycycline20 in 1 BOTTLETABLET, FILM COATED201
82804-028-30Doxycycline30 in 1 BOTTLETABLET, FILM COATED301
82804-028-60Doxycycline60 in 1 BOTTLETABLET, FILM COATED601
82804-028-90Doxycycline90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-028-14EA - Each82804-028218338d4-fe66-4ed4-badb-07ceea8b2b9412023-12-05
82804-028-20EA - Each82804-028ca5fe203-ab9d-4fc9-ac2a-cb30a83bcfb112023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-028DOXYCYCLINE TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, 6 package rows20231019_b83c4c4b-2885-43e7-b1c9-0b3bbf75528d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650142doxycycline monohydrate 100 MG Oral TabletPSNb83c4c4b-2885-43e7-b1c9-0b3bbf75528d1
1650142doxycycline monohydrate 100 MG Oral TabletSCDb83c4c4b-2885-43e7-b1c9-0b3bbf75528d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82804-028-06828040028066 TABLET, FILM COATED in 1 BOTTLE (82804-028-06) 2023-10-17NoNoCurrent
82804-028-148280400281414 TABLET, FILM COATED in 1 BOTTLE (82804-028-14) 2023-10-17NoNoCurrent
82804-028-208280400282020 TABLET, FILM COATED in 1 BOTTLE (82804-028-20) 2023-10-17NoNoCurrent
82804-028-308280400283030 TABLET, FILM COATED in 1 BOTTLE (82804-028-30) 2023-10-17NoNoCurrent
82804-028-608280400286060 TABLET, FILM COATED in 1 BOTTLE (82804-028-60) 2023-10-17NoNoCurrent
82804-028-908280400289090 TABLET, FILM COATED in 1 BOTTLE (82804-028-90) 2023-10-17NoNoCurrent