FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
50090-7546
11-digit product format
500907546
Labeler code
50090
Product ID
50090-7546_ce1b3144-4e87-4dae-8895-e86da7938394
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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
50090-7546-0Doxycycline Hyclate10 in 1 BOTTLETABLET, FILM COATED101
50090-7546-1Doxycycline Hyclate14 in 1 BOTTLETABLET, FILM COATED141
50090-7546-3Doxycycline Hyclate20 in 1 BOTTLETABLET, FILM COATED201
50090-7546-5Doxycycline Hyclate28 in 1 BOTTLETABLET, FILM COATED281
50090-7546-6Doxycycline Hyclate30 in 1 BOTTLETABLET, FILM COATED301
50090-7546-8Doxycycline Hyclate60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7546-0EA - Each50090-75467e34ef7a-be39-48b2-b7a4-b0dbf2c037cf12025-06-13
50090-7546-1EA - Each50090-7546edd06cf9-2e66-45d7-8b77-f26499a1c12112025-06-13
50090-7546-3EA - Each50090-754618b2d2d5-5189-4551-b774-c43bc734d90612025-06-13
50090-7546-5EA - Each50090-754666475b29-aa66-4ec7-815f-83380c99edc212025-06-13
50090-7546-6EA - Each50090-754659ce77a9-697b-470f-ac7f-5fbff07a9c5112025-06-13
50090-7546-8EA - Each50090-7546962bb44d-1b22-4240-8083-203a5dcda69012025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7546DOXYCYCLINE HYCLATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 6 package rows20250519_61195fc6-3fa7-4203-b526-477b48395856.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSN61195fc6-3fa7-4203-b526-477b483958561
1650143doxycycline hyclate 100 MG Oral TabletSCD61195fc6-3fa7-4203-b526-477b483958561

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7546-05009075460010 TABLET, FILM COATED in 1 BOTTLE (50090-7546-0) 2025-05-14NoNoCurrent
50090-7546-15009075460114 TABLET, FILM COATED in 1 BOTTLE (50090-7546-1) 2025-05-14NoNoCurrent
50090-7546-35009075460320 TABLET, FILM COATED in 1 BOTTLE (50090-7546-3) 2025-05-14NoNoCurrent
50090-7546-55009075460528 TABLET, FILM COATED in 1 BOTTLE (50090-7546-5) 2025-05-14NoNoCurrent
50090-7546-65009075460630 TABLET, FILM COATED in 1 BOTTLE (50090-7546-6) 2025-05-14NoNoCurrent
50090-7546-85009075460860 TABLET, FILM COATED in 1 BOTTLE (50090-7546-8) 2025-05-14NoNoCurrent