Doxycycline

Product NDC
83008-031
11-digit product format
830080031
Labeler code
83008
Product ID
83008-031_7ab88902-6dfb-45ad-962c-77992458d032
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA209582
Marketing category
ANDA
Marketing start
2023-06-16
Marketing end
2026-07-31
Substance
DOXYCYCLINE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Doxycycline

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
83008-031-20Doxycycline20 in 1 BOTTLETABLET, FILM COATED203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83008-031DOXYCYCLINE TABLET, FILM COATED [QUALITY CARE PRODUCTS, LLC]3Current NDC, 1 package rows20241208_4a9d9656-c8d6-4b3e-881a-1001e5a0a48f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650142doxycycline monohydrate 100 MG Oral TabletPSN4a9d9656-c8d6-4b3e-881a-1001e5a0a48f3
1650142doxycycline monohydrate 100 MG Oral TabletSCD4a9d9656-c8d6-4b3e-881a-1001e5a0a48f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
83008-031-208300800312020 TABLET, FILM COATED in 1 BOTTLE (83008-031-20) 2023-06-162026-07-31NoNoHistorical