FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
53002-2711
11-digit product format
530022711
Labeler code
53002
Product ID
53002-2711_f6efe634-40e8-40e3-a16e-e82ccd2849a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA062269
Marketing category
ANDA
Marketing start
2016-10-01
Marketing end
0000-00-00
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-2711-02025-01-30C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-12025-01-30C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-22025-01-30C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-32025-01-30C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-42025-01-30C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-62025-01-30C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-72025-01-30C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-92025-01-30C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-02023-06-07C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-12023-06-07C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-22023-06-07C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-32023-06-07C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-42023-06-07C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-62023-06-07C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-72023-06-07C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-92023-06-07C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-02023-01-30C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-12023-01-30C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-22023-01-30C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-32023-01-30C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-42023-01-30C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-62023-01-30C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-72023-01-30C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-92023-01-30C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-02020-12-16C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-12020-12-16C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-22020-12-16C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-32020-12-16C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-42020-12-16C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-62020-12-16C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-72020-12-16C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-92020-12-16C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-02020-01-31C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-12020-01-31C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-22020-01-31C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-32020-01-31C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-42020-01-31C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-62020-01-31C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-72020-01-31C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg
53002-2711-92020-01-31C16284748780-19d75b9d0-e890-f424-e053-dadaa90a57ceDoxycycline Hyclate Tablets, USP 100 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-2711-0Doxycycline Hyclate100 in 1 BOTTLETABLET, FILM COATED1005
53002-2711-1Doxycycline Hyclate6 in 1 BOTTLETABLET, FILM COATED65
53002-2711-2Doxycycline Hyclate10 in 1 BOTTLETABLET, FILM COATED105
53002-2711-3Doxycycline Hyclate14 in 1 BOTTLETABLET, FILM COATED145
53002-2711-4Doxycycline Hyclate20 in 1 BOTTLETABLET, FILM COATED205
53002-2711-6Doxycycline Hyclate30 in 1 BOTTLETABLET, FILM COATED305
53002-2711-7Doxycycline Hyclate40 in 1 BOTTLETABLET, FILM COATED405
53002-2711-9Doxycycline Hyclate60 in 1 BOTTLETABLET, FILM COATED605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2711DOXYCYCLINE HYCLATE TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 8 package rows20230609_08d1f32c-ea25-437b-a340-90c7a66e3886.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSN08d1f32c-ea25-437b-a340-90c7a66e38865
1650143doxycycline hyclate 100 MG Oral TabletSCD08d1f32c-ea25-437b-a340-90c7a66e38865

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-2711-053002271100100 TABLET, FILM COATED in 1 BOTTLE (53002-2711-0) 2017-10-010000-00-00NoNoCurrent
53002-2711-1530022711016 TABLET, FILM COATED in 1 BOTTLE (53002-2711-1) 2017-10-010000-00-00NoNoCurrent
53002-2711-25300227110210 TABLET, FILM COATED in 1 BOTTLE (53002-2711-2) 2017-10-010000-00-00NoNoCurrent
53002-2711-35300227110314 TABLET, FILM COATED in 1 BOTTLE (53002-2711-3) 2017-10-010000-00-00NoNoCurrent
53002-2711-45300227110420 TABLET, FILM COATED in 1 BOTTLE (53002-2711-4) 2017-10-010000-00-00NoNoCurrent
53002-2711-65300227110630 TABLET, FILM COATED in 1 BOTTLE (53002-2711-6) 2017-10-010000-00-00NoNoCurrent
53002-2711-75300227110740 TABLET, FILM COATED in 1 BOTTLE (53002-2711-7) 2017-10-010000-00-00NoNoCurrent
53002-2711-95300227110960 TABLET, FILM COATED in 1 BOTTLE (53002-2711-9) 2017-10-010000-00-00NoNoCurrent