FDA.reportPublic FDA data

Doxycycline hyclate

Product NDC
72578-055
11-digit product format
725780055
Labeler code
72578
Product ID
72578-055_ebe90bc1-d956-4813-9d89-16212c08966b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA207774
Marketing category
ANDA
Marketing start
2022-01-10
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
Rxcui1649405, 1649988

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b4321c75-2e87-4d90-9726-9a28fb2293a3Product name320260112
5e99724e-0654-4aec-b7a2-0b9b10e312eeProduct name320250227
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
72578-055-01Doxycycline hyclate100 in 1 BOTTLECAPSULE1006
72578-055-05Doxycycline hyclate500 in 1 BOTTLECAPSULE5006
72578-055-10Doxycycline hyclate1000 in 1 BOTTLECAPSULE10006
72578-055-18Doxycycline hyclate50 in 1 BOTTLECAPSULE506
72578-055-30Doxycycline hyclate10 in 1 BLISTER PACKCAPSULE106
72578-055-77Doxycycline hyclate10 in 1 CARTONCAPSULE106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-055-05EA - Each72578-055e81f82d7-f271-4ecb-8ca2-47dfad031d1c12022-04-06
72578-055-18EA - Each72578-055807d6257-6bba-41eb-87f7-720107e973d712022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-055DOXYCYCLINE HYCLATE CAPSULE [VIONA PHARMACEUTICALS INC]4Current NDC, Legacy NDC, 6 package rows20250529_51d245a3-ef51-474a-bc91-377d5f42dde3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN30b041a0-8f5f-4d9f-b11b-106f7432955b103
1649988doxycycline hyclate 100 MG Oral CapsuleSCD30b041a0-8f5f-4d9f-b11b-106f7432955b103
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY30b041a0-8f5f-4d9f-b11b-106f7432955b103
1649988doxycycline hyclate 100 MG Oral CapsulePSN51d245a3-ef51-474a-bc91-377d5f42dde36
1649405doxycycline hyclate 50 MG Oral CapsulePSN51d245a3-ef51-474a-bc91-377d5f42dde36
1649988doxycycline hyclate 100 MG Oral CapsuleSCD51d245a3-ef51-474a-bc91-377d5f42dde36
1649405doxycycline hyclate 50 MG Oral CapsuleSCD51d245a3-ef51-474a-bc91-377d5f42dde36
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY51d245a3-ef51-474a-bc91-377d5f42dde36
1649988doxycycline hyclate 100 MG Oral CapsulePSNbed39bae-64c2-44b4-9c95-682ead4e67384
1649988doxycycline hyclate 100 MG Oral CapsulePSNdf44c686-de34-487a-8741-a0a12993cab24
1649405doxycycline hyclate 50 MG Oral CapsulePSNbed39bae-64c2-44b4-9c95-682ead4e67384
1649988doxycycline hyclate 100 MG Oral CapsuleSCDbed39bae-64c2-44b4-9c95-682ead4e67384
1649988doxycycline hyclate 100 MG Oral CapsuleSCDdf44c686-de34-487a-8741-a0a12993cab24
1649405doxycycline hyclate 50 MG Oral CapsuleSCDbed39bae-64c2-44b4-9c95-682ead4e67384
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYdf44c686-de34-487a-8741-a0a12993cab24
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYbed39bae-64c2-44b4-9c95-682ead4e67384
1649988doxycycline hyclate 100 MG Oral CapsulePSN65b3a0e2-32a5-436a-b805-854fbffcb6112
1649988doxycycline hyclate 100 MG Oral CapsulePSNe38dc17a-ee2a-8fc8-e053-2995a90a2a472
1649988doxycycline hyclate 100 MG Oral CapsulePSNe2ad6736-c532-1197-e053-2a95a90ae1f62
1649988doxycycline hyclate 100 MG Oral CapsulePSN45c4b584-b7e2-4e91-a93d-aff14feb606f2
1649988doxycycline hyclate 100 MG Oral CapsuleSCD65b3a0e2-32a5-436a-b805-854fbffcb6112
1649988doxycycline hyclate 100 MG Oral CapsuleSCDe2ad6736-c532-1197-e053-2a95a90ae1f62
1649988doxycycline hyclate 100 MG Oral CapsuleSCD45c4b584-b7e2-4e91-a93d-aff14feb606f2
1649988doxycycline hyclate 100 MG Oral CapsuleSCDe38dc17a-ee2a-8fc8-e053-2995a90a2a472
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY45c4b584-b7e2-4e91-a93d-aff14feb606f2
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY65b3a0e2-32a5-436a-b805-854fbffcb6112
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYe2ad6736-c532-1197-e053-2a95a90ae1f62
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYe38dc17a-ee2a-8fc8-e053-2995a90a2a472

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72578-055-0172578005501100 CAPSULE in 1 BOTTLE (72578-055-01) 100 capsule2022-01-100000-00-00NoNoCurrent
72578-055-0572578005505500 CAPSULE in 1 BOTTLE (72578-055-05) 500 capsule2022-01-100000-00-00NoNoCurrent
72578-055-10725780055101000 CAPSULE in 1 BOTTLE (72578-055-10) 1000 capsule2022-01-100000-00-00NoNoCurrent
72578-055-187257800551850 CAPSULE in 1 BOTTLE (72578-055-18) 50 capsule2022-01-100000-00-00NoNoCurrent
72578-055-307257800553010 in 1 BLISTER PACKHistorical
72578-055-777257800557710 BLISTER PACK in 1 CARTON (72578-055-77) / 10 CAPSULE in 1 BLISTER PACK (72578-055-30) 10 blister pack2022-01-100000-00-00NoNoCurrent