FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
72789-319
11-digit product format
727890319
Labeler code
72789
Product ID
72789-319_38058bd8-226e-5aca-e063-6294a90a32f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA062677
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
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
72789-319-06Doxycycline Hyclate6 in 1 BOTTLE, PLASTICTABLET, FILM COATED630
72789-319-07Doxycycline Hyclate7 in 1 BOTTLE, PLASTICTABLET, FILM COATED730
72789-319-10Doxycycline Hyclate10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1030
72789-319-14Doxycycline Hyclate14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1430
72789-319-28Doxycycline Hyclate28 in 1 BOTTLE, PLASTICTABLET, FILM COATED2830
72789-319-30Doxycycline Hyclate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3030
72789-319-60Doxycycline Hyclate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6030

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-319DOXYCYCLINE HYCLATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]29Current NDC, 7 package rows20250406_3af9348c-a98b-4059-a5ef-4229e2b33af0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSN3af9348c-a98b-4059-a5ef-4229e2b33af030
1650143doxycycline hyclate 100 MG Oral TabletSCD3af9348c-a98b-4059-a5ef-4229e2b33af030

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-319-06727890319066 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-319-06) 2023-12-18NoNoCurrent
72789-319-07727890319077 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-319-07) 2023-12-06NoNoCurrent
72789-319-107278903191010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-319-10) 2023-03-29NoNoCurrent
72789-319-147278903191414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-319-14) 2025-04-04NoNoCurrent
72789-319-287278903192828 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-319-28) 2023-04-26NoNoCurrent
72789-319-307278903193030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-319-30) 2023-08-08NoNoCurrent
72789-319-607278903196060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-319-60) 2023-06-06NoNoCurrent