doxycycline hyclate

Product NDC
45865-116
11-digit product format
458650116
Labeler code
45865
Product ID
45865-116_b429a1e9-5bbc-8b27-e053-2a95a90a089f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA062500
Marketing category
ANDA
Marketing start
2020-07-01
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
45865-116-142025-01-30C16284748780-12cef2736-84ec-d83d-e063-dadaa90ab31fDoxycycline Hyclate Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-116-14doxycycline hyclate14 in 1 BOTTLECAPSULE141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-116DOXYCYCLINE HYCLATE CAPSULE [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 1 package rows20201117_b429a1e9-5bbb-8b27-e053-2a95a90a089f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSNb429a1e9-5bbb-8b27-e053-2a95a90a089f1
1649988doxycycline hyclate 100 MG Oral CapsuleSCDb429a1e9-5bbb-8b27-e053-2a95a90a089f1
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYb429a1e9-5bbb-8b27-e053-2a95a90a089f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-116-144586501161414 CAPSULE in 1 BOTTLE (45865-116-14) 14 capsule2020-07-010000-00-00NoNoCurrent