DORYX MPC

Product NDC
51862-560
11-digit product format
518620560
Labeler code
51862
Product ID
51862-560_4af31df5-71da-3b6f-e063-6294a90a3906
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline hyclate
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Mayne Pharma Commercial LLC
Application
NDA050795
Marketing category
NDA
Marketing start
2023-01-02
Substance
DOXYCYCLINE HYCLATE
Active strength
60 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DORYX MPC
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE HYCLATE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19XTS3T51U
Rxcui1801138, 1801140, 1801142, 1801144

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51862-560-00DORYX MPC6 in 1 BOTTLETABLET, DELAYED RELEASE615
51862-560-00DORYX MPC1 in 1 CARTONTABLET, DELAYED RELEASE115
51862-560-12DORYX MPC120 in 1 BOTTLETABLET, DELAYED RELEASE12015
51862-560-60DORYX MPC60 in 1 BOTTLETABLET, DELAYED RELEASE6015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51862-560DORYX MPC (DOXYCYCLINE HYCLATE) TABLET, DELAYED RELEASE DORYX MPC (DOXYCYCLINE HYCLATE) TABLET, DELAYED RELEASE [MAYNE PHARMA COMMERCIAL LLC]14Current NDC, Legacy NDC, 4 package rows20250410_f9277bb8-982d-444d-9325-35d5c53a2d35.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1801140Doryx 120 MG Delayed Release Oral TabletPSNf9277bb8-982d-444d-9325-35d5c53a2d3515
1801144Doryx 60 MG Delayed Release Oral TabletPSNf9277bb8-982d-444d-9325-35d5c53a2d3515
1801138doxycycline hyclate 120 MG Delayed Release Oral TabletPSNf9277bb8-982d-444d-9325-35d5c53a2d3515
1801142doxycycline hyclate 60 MG Delayed Release Oral TabletPSNf9277bb8-982d-444d-9325-35d5c53a2d3515
1801140doxycycline hyclate 120 MG Delayed Release Oral Tablet [Doryx]SBDf9277bb8-982d-444d-9325-35d5c53a2d3515
1801144doxycycline hyclate 60 MG Delayed Release Oral Tablet [Doryx]SBDf9277bb8-982d-444d-9325-35d5c53a2d3515
1801138doxycycline hyclate 120 MG Delayed Release Oral TabletSCDf9277bb8-982d-444d-9325-35d5c53a2d3515
1801142doxycycline hyclate 60 MG Delayed Release Oral TabletSCDf9277bb8-982d-444d-9325-35d5c53a2d3515
1801140Doryx 120 MG Delayed Release Oral TabletSYf9277bb8-982d-444d-9325-35d5c53a2d3515
1801144Doryx 60 MG Delayed Release Oral TabletSYf9277bb8-982d-444d-9325-35d5c53a2d3515

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51862-560-00518620560001 BOTTLE in 1 CARTON (51862-560-00) / 6 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2023-01-020000-00-00NoNoCurrent
51862-560-1251862056012120 TABLET, DELAYED RELEASE in 1 BOTTLE (51862-560-12) 2023-01-020000-00-00NoNoCurrent
51862-560-605186205606060 TABLET, DELAYED RELEASE in 1 BOTTLE (51862-560-60) 2024-05-13NoNoCurrent