FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
50090-0026
11-digit product format
500900026
Labeler code
50090
Product ID
50090-0026_0da03c0d-fb18-4449-9dd8-eae68749d9ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA062396
Marketing category
ANDA
Marketing start
1984-11-07
Marketing end
0000-00-00
Substance
DOXYCYCLINE HYCLATE
Active strength
50 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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
50090-0026-02023-01-30C16284748780-1f386c649-c7a7-0266-e053-dadaa90a7c1aDOXYCYCLINE HYCLATE CAPSULES, USP Rx Only
50090-0026-22023-01-30C16284748780-1f386c649-c7a7-0266-e053-dadaa90a7c1aDOXYCYCLINE HYCLATE CAPSULES, USP Rx Only
50090-0026-42023-01-30C16284748780-1f386c649-c7a7-0266-e053-dadaa90a7c1aDOXYCYCLINE HYCLATE CAPSULES, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0026-0Doxycycline Hyclate14 in 1 BOTTLECAPSULE, GELATIN COATED1422
50090-0026-2Doxycycline Hyclate20 in 1 BOTTLECAPSULE, GELATIN COATED2022
50090-0026-4Doxycycline Hyclate30 in 1 BOTTLECAPSULE, GELATIN COATED3022

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0026DOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [A-S MEDICATION SOLUTIONS]22Legacy NDC, 3 package rows20210820_3501481c-5984-4671-91cc-ae78eaa39c27.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN3501481c-5984-4671-91cc-ae78eaa39c2722
1649405doxycycline hyclate 50 MG Oral CapsulePSN3501481c-5984-4671-91cc-ae78eaa39c2722
1649988doxycycline hyclate 100 MG Oral CapsuleSCD3501481c-5984-4671-91cc-ae78eaa39c2722
1649405doxycycline hyclate 50 MG Oral CapsuleSCD3501481c-5984-4671-91cc-ae78eaa39c2722
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY3501481c-5984-4671-91cc-ae78eaa39c2722

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0026-05009000260014 CAPSULE, GELATIN COATED in 1 BOTTLE (50090-0026-0) 2018-10-150000-00-00NoNoCurrent
50090-0026-25009000260220 in 1 BOTTLEHistorical
50090-0026-45009000260430 CAPSULE, GELATIN COATED in 1 BOTTLE (50090-0026-4) 2016-09-230000-00-00NoNoCurrent