FDA.reportPublic FDA data

doxycycline

Product NDC
72789-496
11-digit product format
727890496
Labeler code
72789
Product ID
72789-496_4e044247-785c-7df0-e063-6394a90acab2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA205115
Marketing category
ANDA
Marketing start
2016-03-14
Substance
DOXYCYCLINE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
doxycycline
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN12000U13O
Rxcui1649990

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
72789-496-02doxycycline2 in 1 BOTTLE, PLASTICCAPSULE25
72789-496-10doxycycline10 in 1 BOTTLE, PLASTICCAPSULE105
72789-496-20doxycycline20 in 1 BOTTLE, PLASTICCAPSULE205
72789-496-60doxycycline60 in 1 BOTTLE, PLASTICCAPSULE605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-496DOXYCYCLINE CAPSULE [PD-RX PHARMACEUTICALS, INC.]1Current NDC, 4 package rows20250321_7028b7f9-21cd-4c8e-97aa-a3e7d849939b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649990doxycycline monohydrate 100 MG Oral CapsulePSN7028b7f9-21cd-4c8e-97aa-a3e7d849939b5
1649990doxycycline monohydrate 100 MG Oral CapsuleSCD7028b7f9-21cd-4c8e-97aa-a3e7d849939b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-496-02727890496022 CAPSULE in 1 BOTTLE, PLASTIC (72789-496-02) 2 capsule2025-03-06NoNoCurrent
72789-496-107278904961010 CAPSULE in 1 BOTTLE, PLASTIC (72789-496-10) 10 capsule2025-02-24NoNoCurrent
72789-496-207278904962020 CAPSULE in 1 BOTTLE, PLASTIC (72789-496-20) 20 capsule2025-03-18NoNoCurrent
72789-496-607278904966060 CAPSULE in 1 BOTTLE, PLASTIC (72789-496-60) 60 capsule2025-12-15NoNoCurrent