FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
72789-298
11-digit product format
727890298
Labeler code
72789
Product ID
72789-298_3803988c-26a5-d5d8-e063-6294a90a5933
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA062676
Marketing category
ANDA
Marketing start
1986-07-10
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
Rxcui1649988

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
72789-298-14Doxycycline Hyclate14 in 1 BOTTLE, PLASTICCAPSULE1424
72789-298-20Doxycycline Hyclate20 in 1 BOTTLE, PLASTICCAPSULE2024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-298-14EA - Each72789-2981e612398-fb62-44c3-a059-6a0a9ed5cbf112024-11-05
72789-298-20EA - Each72789-29895d4caaa-6e6d-4c0a-8e8c-73e3bb1f569312023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-298DOXYCYCLINE HYCLATE CAPSULE [PD-RX PHARMACEUTICALS, INC.]23Current NDC, 2 package rows20250221_35aa295e-ff1b-453b-8eeb-65bbeda3baa5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN35aa295e-ff1b-453b-8eeb-65bbeda3baa524
1649988doxycycline hyclate 100 MG Oral CapsuleSCD35aa295e-ff1b-453b-8eeb-65bbeda3baa524
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY35aa295e-ff1b-453b-8eeb-65bbeda3baa524

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-298-147278902981414 CAPSULE in 1 BOTTLE, PLASTIC (72789-298-14) 14 capsule2024-10-18NoNoHistorical
72789-298-207278902982020 CAPSULE in 1 BOTTLE, PLASTIC (72789-298-20) 20 capsule2022-02-01NoNoHistorical