FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
72578-001
11-digit product format
725780001
Labeler code
72578
Product ID
72578-001_6fd4ce71-429d-4bbb-a8e6-afd510319830
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET
Route
ORAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA207773
Marketing category
ANDA
Marketing start
2019-03-14
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Doxycycline Hyclate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE HYCLATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19XTS3T51U
Rxcui1650143

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
72578-001-01Doxycycline Hyclate100 in 1 BOTTLETABLET1007
72578-001-05Doxycycline Hyclate500 in 1 BOTTLETABLET5007
72578-001-10Doxycycline Hyclate1000 in 1 BOTTLETABLET10007
72578-001-18Doxycycline Hyclate50 in 1 BOTTLETABLET507
72578-001-30Doxycycline Hyclate10 in 1 BLISTER PACKTABLET107
72578-001-77Doxycycline Hyclate10 in 1 CARTONTABLET107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-001-05EA - Each72578-00189f63c6c-7909-49e8-bbb1-f9aa442f2bf412019-09-05
72578-001-18EA - Each72578-00112d4a54d-0719-4b25-9438-6b7b48b835e612019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-001DOXYCYCLINE HYCLATE TABLET [VIONA PHARMACEUTICALS INC]6Current NDC, Legacy NDC, 6 package rows20250429_763997f0-b35c-43cb-a792-3e0bae589536.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSN5b4390ed-a0ec-4ef8-864c-8a33a83653f9104
1650143doxycycline hyclate 100 MG Oral TabletSCD5b4390ed-a0ec-4ef8-864c-8a33a83653f9104
1650143doxycycline hyclate 100 MG Oral TabletPSN763997f0-b35c-43cb-a792-3e0bae5895367
1650143doxycycline hyclate 100 MG Oral TabletSCD763997f0-b35c-43cb-a792-3e0bae5895367
1650143doxycycline hyclate 100 MG Oral TabletPSNbdacaaa7-b46e-ee0c-e053-2a95a90aea3c3
1650143doxycycline hyclate 100 MG Oral TabletSCDbdacaaa7-b46e-ee0c-e053-2a95a90aea3c3
1650143doxycycline hyclate 100 MG Oral TabletPSN104cac0f-7c99-4faf-ba08-0159ed767a3e1
1650143doxycycline hyclate 100 MG Oral TabletSCD104cac0f-7c99-4faf-ba08-0159ed767a3e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72578-001-0172578000101100 TABLET in 1 BOTTLE (72578-001-01) 100 tablet2019-03-140000-00-00NoNoCurrent
72578-001-0572578000105500 TABLET in 1 BOTTLE (72578-001-05) 500 tablet2019-03-140000-00-00NoNoCurrent
72578-001-10725780001101000 TABLET in 1 BOTTLE (72578-001-10) 1000 tablet2019-03-140000-00-00NoNoCurrent
72578-001-187257800011850 TABLET in 1 BOTTLE (72578-001-18) 50 tablet2019-03-140000-00-00NoNoCurrent
72578-001-307257800013010 in 1 BLISTER PACKHistorical
72578-001-777257800017710 BLISTER PACK in 1 CARTON (72578-001-77) / 10 TABLET in 1 BLISTER PACK (72578-001-30) 10 blister pack2019-03-140000-00-00NoNoCurrent