Doxycycline Hyclate

Product NDC
42582-215
11-digit product format
425820215
Labeler code
42582
Product ID
42582-215_fc04d0bc-e56a-464a-9e69-17dd48d392f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Bi-Coastal Pharma International, LLC
Application
ANDA211343
Marketing category
ANDA
Marketing start
2020-05-28
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
42582-215-052023-01-30C16284748780-1f386c64a-0f79-0266-e053-dadaa90a7c1aDOXYCYCLINE HYCLATE TABLETS, USP
42582-215-182023-01-30C16284748780-1f386c64a-0f79-0266-e053-dadaa90a7c1aDOXYCYCLINE HYCLATE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42582-215-05Doxycycline Hyclate50 in 1 BOTTLETABLET, COATED503
42582-215-18Doxycycline Hyclate500 in 1 BOTTLETABLET, COATED5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42582-215DOXYCYCLINE HYCLATE TABLET, COATED [BI-COASTAL PHARMA INTERNATIONAL, LLC]3Legacy NDC, 2 package rows20210327_4ee17bbb-29ba-49ce-8f81-748879831314.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSN4ee17bbb-29ba-49ce-8f81-7488798313143
1650143doxycycline hyclate 100 MG Oral TabletSCD4ee17bbb-29ba-49ce-8f81-7488798313143

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42582-215-054258202150550 TABLET, COATED in 1 BOTTLE (42582-215-05) 2020-05-280000-00-00NoNoCurrent
42582-215-1842582021518100 TABLET, COATED in 1 BOTTLE (42582-215-18) 2020-05-280000-00-00NoNoCurrent