Doxycycline Hyclate

Product NDC
24658-312
11-digit product format
246580312
Labeler code
24658
Product ID
24658-312_d9e26c7a-fffd-4291-9784-aa227f7003d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET
Route
ORAL
Labeler
PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS
Application
ANDA062269
Marketing category
ANDA
Marketing start
2013-11-25
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
2023-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24658-312-01Doxycycline Hyclate100 in 1 BOTTLETABLET10021
24658-312-05Doxycycline Hyclate500 in 1 BOTTLETABLET50021
24658-312-10Doxycycline Hyclate1000 in 1 BOTTLETABLET100021
24658-312-20Doxycycline Hyclate20 in 1 BOTTLETABLET2021
24658-312-50Doxycycline Hyclate50 in 1 BOTTLETABLET5021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24658-312-01EA - Each24658-31238a1c7c8-e00d-4a51-9700-3aa98af3d32512014-01-04
24658-312-05EA - Each24658-312235476a4-72ae-40f0-a74e-38e95e9ece1712014-01-04
24658-312-10EA - Each24658-3128a641d08-1824-499a-a43c-7e28d84ab9d912015-07-20
24658-312-20EA - Each24658-3120301c355-995b-4edd-a32f-15769f74f1f712014-01-04
24658-312-50EA - Each24658-31256ca802e-663e-4327-85f2-6100db7f80bb12014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE TABLET [BLU PHARMACEUTICALS, LLC]10
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE TABLET [BLU PHARMACEUTICALS, LLC]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE TABLET [BLU PHARMACEUTICALS, LLC]10
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDOXYCYCLINE HYCLATE TABLET [BLU PHARMACEUTICALS, LLC]10
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOXYCYCLINE HYCLATE TABLET [BLU PHARMACEUTICALS, LLC]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODOXYCYCLINE HYCLATE TABLET [BLU PHARMACEUTICALS, LLC]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE TABLET [BLU PHARMACEUTICALS, LLC]10
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOXYCYCLINE HYCLATE TABLET [BLU PHARMACEUTICALS, LLC]10
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDOXYCYCLINE HYCLATE TABLET [BLU PHARMACEUTICALS, LLC]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE TABLET [BLU PHARMACEUTICALS, LLC]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24658-312DOXYCYCLINE HYCLATE TABLET [PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS]21Legacy NDC, 5 package rows20231221_8a9e1d08-1665-46d2-bda6-aa11a3f18646.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSN8a9e1d08-1665-46d2-bda6-aa11a3f1864621
1652674doxycycline hyclate 50 MG Oral TabletPSN8a9e1d08-1665-46d2-bda6-aa11a3f1864621
1650143doxycycline hyclate 100 MG Oral TabletSCD8a9e1d08-1665-46d2-bda6-aa11a3f1864621
1652674doxycycline hyclate 50 MG Oral TabletSCD8a9e1d08-1665-46d2-bda6-aa11a3f1864621
1650143doxycycline hyclate 100 MG Oral TabletPSNee45d9e1-65f7-4c6e-87cd-c9afc8eb85c42
1650143doxycycline hyclate 100 MG Oral TabletSCDee45d9e1-65f7-4c6e-87cd-c9afc8eb85c42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24658-312-0124658031201100 TABLET in 1 BOTTLE (24658-312-01) 100 tablet2013-11-250000-00-00NoNoCurrent
24658-312-0524658031205500 TABLET in 1 BOTTLE (24658-312-05) 500 tablet2013-11-250000-00-00NoNoCurrent
24658-312-10246580312101000 TABLET in 1 BOTTLE (24658-312-10) 1000 tablet2013-11-250000-00-00NoNoCurrent
24658-312-202465803122020 TABLET in 1 BOTTLE (24658-312-20) 20 tablet2013-11-250000-00-00NoNoCurrent
24658-312-502465803125050 TABLET in 1 BOTTLE (24658-312-50) 50 tablet2013-11-250000-00-00NoNoCurrent