FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
24658-310
11-digit product format
246580310
Labeler code
24658
Product ID
24658-310_65cac0b6-3550-48cf-bffa-cf42443c2731
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS
Application
ANDA062269
Marketing category
ANDA
Marketing start
2025-03-07
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
24658-310-01Doxycycline Hyclate100 in 1 BOTTLETABLET, FILM COATED1001
24658-310-05Doxycycline Hyclate500 in 1 BOTTLETABLET, FILM COATED5001
24658-310-07Doxycycline Hyclate300 in 1 BOTTLETABLET, FILM COATED3001
24658-310-08Doxycycline Hyclate400 in 1 BOTTLETABLET, FILM COATED4001
24658-310-10Doxycycline Hyclate1000 in 1 BOTTLETABLET, FILM COATED10001
24658-310-20Doxycycline Hyclate20 in 1 BOTTLETABLET, FILM COATED201
24658-310-21Doxycycline Hyclate210 in 1 BOTTLETABLET, FILM COATED2101
24658-310-30Doxycycline Hyclate30 in 1 BOTTLETABLET, FILM COATED301
24658-310-50Doxycycline Hyclate50 in 1 BOTTLETABLET, FILM COATED501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24658-310-01EA - Each24658-310f1af1755-352b-4da4-ba8d-e561bb9c154f12025-05-14
24658-310-05EA - Each24658-3109cbf5ac4-f021-42c0-98c0-9dfda7a59da012025-05-14
24658-310-07EA - Each24658-3102ea4c030-840f-4125-b7f4-f4c187da7be912025-09-12
24658-310-08EA - Each24658-31065edd7f8-eb3c-415f-9e6e-418c433eddca12025-09-12
24658-310-10EA - Each24658-3104b58ccfb-2560-49b0-9751-97a38cb3992712025-05-14
24658-310-20EA - Each24658-31099caa2bc-cffc-440e-951a-58022a51587112025-05-14
24658-310-21EA - Each24658-31090e699a8-595e-418b-acab-e44a2327f2fd12025-09-12
24658-310-30EA - Each24658-310c0f0e60e-cc2c-4086-bc08-bd506cff586212025-09-12
24658-310-50EA - Each24658-310c9d510e2-5e4a-49ad-b7df-767d411a006812025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24658-310DOXYCYCLINE HYCLATE TABLET, FILM COATED [PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS]1Current NDC, 9 package rows20250418_65cac0b6-3550-48cf-bffa-cf42443c2731.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSN051654c7-8ba6-44f2-842c-72f515e9b32d1
1650143doxycycline hyclate 100 MG Oral TabletPSN65cac0b6-3550-48cf-bffa-cf42443c27311
1650143doxycycline hyclate 100 MG Oral TabletSCD051654c7-8ba6-44f2-842c-72f515e9b32d1
1650143doxycycline hyclate 100 MG Oral TabletSCD65cac0b6-3550-48cf-bffa-cf42443c27311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
24658-310-0124658031001100 TABLET, FILM COATED in 1 BOTTLE (24658-310-01) 2025-03-07NoNoHistorical
24658-310-0524658031005500 TABLET, FILM COATED in 1 BOTTLE (24658-310-05) 2025-03-07NoNoHistorical
24658-310-0724658031007300 TABLET, FILM COATED in 1 BOTTLE (24658-310-07) 2025-04-14NoNoHistorical
24658-310-0824658031008400 TABLET, FILM COATED in 1 BOTTLE (24658-310-08) 2025-04-14NoNoHistorical
24658-310-10246580310101000 TABLET, FILM COATED in 1 BOTTLE (24658-310-10) 2025-03-07NoNoHistorical
24658-310-202465803102020 TABLET, FILM COATED in 1 BOTTLE (24658-310-20) 2025-03-07NoNoHistorical
24658-310-2124658031021210 TABLET, FILM COATED in 1 BOTTLE (24658-310-21) 2025-04-14NoNoHistorical
24658-310-302465803103030 TABLET, FILM COATED in 1 BOTTLE (24658-310-30) 2025-04-14NoNoHistorical
24658-310-502465803105050 TABLET, FILM COATED in 1 BOTTLE (24658-310-50) 2025-03-07NoNoHistorical