FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
42806-312
11-digit product format
428060312
Labeler code
42806
Product ID
42806-312_5a80562b-6db7-45b3-9285-d27e2353ba8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Epic Pharma, LLC
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
2022-12-31
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
42806-312-012025-07-29C16284748780-13b156c62-28e8-fb37-e063-e6dba90a4e07Doxycycline Hyclate Tablets, USP 100 mg
42806-312-052025-07-29C16284748780-13b156c62-28e8-fb37-e063-e6dba90a4e07Doxycycline Hyclate Tablets, USP 100 mg
42806-312-502025-07-29C16284748780-13b156c62-28e8-fb37-e063-e6dba90a4e07Doxycycline Hyclate Tablets, USP 100 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42806-312-01Doxycycline Hyclate100 in 1 BOTTLETABLET, FILM COATED1006
42806-312-05Doxycycline Hyclate500 in 1 BOTTLETABLET, FILM COATED5006
42806-312-50Doxycycline Hyclate50 in 1 BOTTLETABLET, FILM COATED506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-312-05EA - Each42806-312d415d37a-3425-4ad7-b2c9-466dbb21ccf412016-11-08
42806-312-50EA - Each42806-3121e0a50f3-8249-409b-89bf-63ba89349bf712016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-312DOXYCYCLINE HYCLATE TABLET, FILM COATED [EPIC PHARMA, LLC]6Legacy NDC, 3 package rows20211109_faa1c3f1-1161-4a74-8e2e-59367baba622.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSN2305ab4a-7d08-41f6-9c39-c9b6835be38911
1650143doxycycline hyclate 100 MG Oral TabletSCD2305ab4a-7d08-41f6-9c39-c9b6835be38911
1650143doxycycline hyclate 100 MG Oral TabletPSNfaa1c3f1-1161-4a74-8e2e-59367baba6226
1650143doxycycline hyclate 100 MG Oral TabletSCDfaa1c3f1-1161-4a74-8e2e-59367baba6226
1650143doxycycline hyclate 100 MG Oral TabletPSN08d1f32c-ea25-437b-a340-90c7a66e38865
1650143doxycycline hyclate 100 MG Oral TabletPSN860a1566-5857-ed88-e053-2991aa0ae2a45
1650143doxycycline hyclate 100 MG Oral TabletSCD08d1f32c-ea25-437b-a340-90c7a66e38865
1650143doxycycline hyclate 100 MG Oral TabletSCD860a1566-5857-ed88-e053-2991aa0ae2a45
1649988doxycycline hyclate 100 MG Oral CapsulePSNf39365f9-eb64-00cb-e053-2995a90a8d804
1650143doxycycline hyclate 100 MG Oral TabletPSNb2e9cf0d-0b66-0e5d-e053-2a95a90a78744
1650143doxycycline hyclate 100 MG Oral TabletPSNf39365f9-eb64-00cb-e053-2995a90a8d804
1649988doxycycline hyclate 100 MG Oral CapsuleSCDf39365f9-eb64-00cb-e053-2995a90a8d804
1650143doxycycline hyclate 100 MG Oral TabletSCDb2e9cf0d-0b66-0e5d-e053-2a95a90a78744
1650143doxycycline hyclate 100 MG Oral TabletSCDf39365f9-eb64-00cb-e053-2995a90a8d804
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYf39365f9-eb64-00cb-e053-2995a90a8d804
1650143doxycycline hyclate 100 MG Oral TabletPSNd70ae360-b2fb-44ba-a968-aba12e9c44693
1650143doxycycline hyclate 100 MG Oral TabletPSN3d00be59-a7b4-4222-84cb-13196f83b5193
1650143doxycycline hyclate 100 MG Oral TabletSCDd70ae360-b2fb-44ba-a968-aba12e9c44693
1650143doxycycline hyclate 100 MG Oral TabletSCD3d00be59-a7b4-4222-84cb-13196f83b5193

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42806-312-0142806031201100 TABLET, FILM COATED in 1 BOTTLE (42806-312-01) 2016-10-010000-00-00NoNoCurrent
42806-312-0542806031205500 TABLET, FILM COATED in 1 BOTTLE (42806-312-05) 2016-10-010000-00-00NoNoCurrent
42806-312-504280603125050 TABLET, FILM COATED in 1 BOTTLE (42806-312-50) 2016-10-010000-00-00NoNoCurrent