FDA.reportPublic FDA data

Mondoxyne

Product NDC
69668-431
11-digit product format
696680431
Labeler code
69668
Product ID
69668-431_1ec7dd0d-c02d-33db-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
Oculus Innovative Sciences
Application
ANDA204446
Marketing category
ANDA
Marketing start
2015-05-28
Marketing end
0000-00-00
Substance
DOXYCYCLINE
Active strength
50 mg/50mg
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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
69668-431-012020-01-31C16284748780-19d75b9d0-7948-f424-e053-dadaa90a57ceMondoxyne NL 50mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69668-431-01Mondoxyne50 mg in 1 BOTTLECAPSULE502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69668-431-01EA - Each69668-431461b2350-b6bb-4511-b6c9-14b9f01f10df12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINEACTIVE INGREDIENTN12000U13OMONDOXYNE (DOXYCYCLINE) CAPSULE [OCULUS INNOVATIVE SCIENCES]2
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862MONDOXYNE (DOXYCYCLINE) CAPSULE [OCULUS INNOVATIVE SCIENCES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69668-431MONDOXYNE (DOXYCYCLINE) CAPSULE [OCULUS INNOVATIVE SCIENCES]2Legacy NDC, 1 package rows20150911_1ef34e6d-2505-74fb-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649401doxycycline monohydrate 50 MG Oral CapsulePSN1ef34e6d-2505-74fb-e054-00144ff8d46c2
1666098Mondoxyne NL 50 MG Oral CapsulePSN1ef34e6d-2505-74fb-e054-00144ff8d46c2
1666098doxycycline monohydrate 50 MG Oral Capsule [Mondoxyne]SBD1ef34e6d-2505-74fb-e054-00144ff8d46c2
1649401doxycycline monohydrate 50 MG Oral CapsuleSCD1ef34e6d-2505-74fb-e054-00144ff8d46c2
1666098Mondoxyne 50 MG Oral CapsuleSY1ef34e6d-2505-74fb-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
69668-431-016966804310150 mg in 1 BOTTLE50 mgHistorical