FDA.reportPublic FDA data

doxycycline hyclate

Product NDC
50090-5588
11-digit product format
500905588
Labeler code
50090
Product ID
50090-5588_5dd673c7-ed2a-43b6-9ad9-e7884756dfc8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA062500
Marketing category
ANDA
Marketing start
1984-09-11
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
Rxcui1649988

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5588-02023-02-07C16284748780-1f386c64a-231c-0266-e053-dadaa90a7c1aDoxycycline Hyclate Capsules, USP Doxycycline for Oral Suspension, USP Doxycycline Hyclate Tablets, USP
50090-5588-02023-01-30C16284748780-1f386c64a-231c-0266-e053-dadaa90a7c1aDoxycycline Hyclate Capsules, USP Doxycycline for Oral Suspension, USP Doxycycline Hyclate Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5588-0doxycycline hyclate20 in 1 BOTTLECAPSULE207
50090-5588-1doxycycline hyclate14 in 1 BOTTLECAPSULE147

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5588-0EA - Each50090-5588198c210b-7a3e-4ba9-80a2-636e8da464cb12024-02-14
50090-5588-1EA - Each50090-5588ff0e61ae-1521-46c6-a06c-0aae1f4d54cb12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5588DOXYCYCLINE HYCLATE CAPSULE [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 2 package rows20240430_4164f6b7-5ebd-4f5f-a536-9a37b2e0562c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN4164f6b7-5ebd-4f5f-a536-9a37b2e0562c7
1649988doxycycline hyclate 100 MG Oral CapsuleSCD4164f6b7-5ebd-4f5f-a536-9a37b2e0562c7
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY4164f6b7-5ebd-4f5f-a536-9a37b2e0562c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5588-05009055880020 CAPSULE in 1 BOTTLE (50090-5588-0) 20 capsule2021-07-120000-00-00NoNoCurrent
50090-5588-15009055880114 CAPSULE in 1 BOTTLE (50090-5588-1) 14 capsule2023-12-27NoNoCurrent