FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
72789-276
11-digit product format
727890276
Labeler code
72789
Product ID
72789-276_3ccd8245-6963-e76b-e063-6394a90aa6b4
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
72789-276-01Doxycycline Hyclate100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10043
72789-276-07Doxycycline Hyclate7 in 1 BOTTLE, PLASTICTABLET, FILM COATED743
72789-276-10Doxycycline Hyclate10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1043
72789-276-14Doxycycline Hyclate14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1443
72789-276-20Doxycycline Hyclate20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2043
72789-276-28Doxycycline Hyclate28 in 1 BOTTLE, PLASTICTABLET, FILM COATED2843
72789-276-71Doxycycline Hyclate210 in 1 BOTTLE, PLASTICTABLET, FILM COATED21043
72789-276-74Doxycycline Hyclate400 in 1 BOTTLE, PLASTICTABLET, FILM COATED40043
72789-276-82Doxycycline Hyclate500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50043
72789-276-85Doxycycline Hyclate330 in 1 BOTTLE, PLASTICTABLET, FILM COATED33043
72789-276-87Doxycycline Hyclate300 in 1 BOTTLE, PLASTICTABLET, FILM COATED30043
72789-276-90Doxycycline Hyclate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9043
72789-276-93Doxycycline Hyclate180 in 1 BOTTLE, PLASTICTABLET, FILM COATED18043

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-276-01EA - Each72789-276bc3d9739-7b11-4475-8f4a-f8c7afd96a3212024-02-14
72789-276-07EA - Each72789-27636ddb714-6e8b-48b3-9a0f-e64a6a5aa7f912024-02-14
72789-276-10EA - Each72789-2767cb7b921-84ab-4fc8-b6aa-cf980b47cb3212023-08-08
72789-276-14EA - Each72789-2763774da5e-13f4-45e2-a88f-a8602150e88c12023-01-09
72789-276-20EA - Each72789-27670a14668-ec7d-4664-9f69-6f2260f84e3712023-01-09
72789-276-28EA - Each72789-276eaf27e93-f728-4531-94ac-f3cc14422a1012025-09-12
72789-276-71EA - Each72789-2764ad981fa-a388-44c8-9527-dde69657fee412023-02-06
72789-276-74EA - Each72789-276e574ed77-585d-4d37-b20a-a3df8e04598312023-02-06
72789-276-82EA - Each72789-27672490a10-dd52-491f-8947-4a222376e5cf12022-11-07
72789-276-85EA - Each72789-2761871fccb-6651-4887-bb3f-7035f697dc5012024-04-05
72789-276-87EA - Each72789-276a16baa97-2dcf-47f8-b467-1c3a5259a59312023-04-07
72789-276-90EA - Each72789-27629f2207e-562b-4bcb-9787-69b6282e294512023-02-06
72789-276-93EA - Each72789-276e0674a1e-23d8-48c9-83e2-d3be1661b88b12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-276DOXYCYCLINE HYCLATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]40Current NDC, Legacy NDC, 13 package rows20250223_1401d590-0967-4c6b-b52b-a83e9f6df097.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSN1401d590-0967-4c6b-b52b-a83e9f6df09743
1650143doxycycline hyclate 100 MG Oral TabletSCD1401d590-0967-4c6b-b52b-a83e9f6df09743

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-276-0172789027601100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-276-01) 2024-01-19NoNoHistorical
72789-276-07727890276077 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-276-07) 2024-01-19NoNoHistorical
72789-276-107278902761010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-276-10) 2023-07-13NoNoHistorical
72789-276-147278902761414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-276-14) 2022-11-180000-00-00NoNoCurrent
72789-276-207278902762020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-276-20) 2022-11-170000-00-00NoNoCurrent
72789-276-287278902762828 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-276-28) 2025-08-20NoNoHistorical
72789-276-7172789027671210 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-276-71) 2023-01-17NoNoHistorical
72789-276-7472789027674400 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-276-74) 2023-01-17NoNoHistorical
72789-276-8272789027682500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-276-82) 2022-10-070000-00-00NoNoCurrent
72789-276-8572789027685330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-276-85) 2024-02-20NoNoHistorical
72789-276-8772789027687300 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-276-87) 2023-03-02NoNoHistorical
72789-276-907278902769090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-276-90) 2023-01-17NoNoHistorical
72789-276-9372789027693180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-276-93) 2023-01-17NoNoHistorical