Doxycycline Monohydrate

Product NDC
67296-1578
11-digit product format
672961578
Labeler code
67296
Product ID
67296-1578_9c9fd5c6-018a-3cf8-e053-2a95a90a4045
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Monohydrate
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
NDA050641
Marketing category
NDA
Marketing start
2018-01-01
Marketing end
0000-00-00
Substance
DOXYCYCLINE
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
67296-1578-12022-01-28C16284748780-1d6a99b39-51a1-a426-e053-dadaa90af4c2doxy mono 100mg
67296-1578-32022-01-28C16284748780-1d6a99b39-51a1-a426-e053-dadaa90af4c2doxy mono 100mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1578-1Doxycycline Monohydrate14 in 1 BOTTLECAPSULE142
67296-1578-3Doxycycline Monohydrate2 in 1 BOTTLECAPSULE22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1578DOXYCYCLINE MONOHYDRATE CAPSULE [REDPHARM DRUG, INC.]2Legacy NDC, 2 package rows20200121_6a0e5b78-bc00-0766-e053-2a91aa0a094d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649990doxycycline monohydrate 100 MG Oral CapsulePSN6a0e5b78-bc00-0766-e053-2a91aa0a094d2
1649990doxycycline monohydrate 100 MG Oral CapsuleSCD6a0e5b78-bc00-0766-e053-2a91aa0a094d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1578-16729615780114 CAPSULE in 1 BOTTLE (67296-1578-1) 14 capsule2018-01-010000-00-00NoNoCurrent
67296-1578-3672961578032 CAPSULE in 1 BOTTLE (67296-1578-3) 2 capsule2018-01-010000-00-00NoNoCurrent