FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
50090-4592
11-digit product format
500904592
Labeler code
50090
Product ID
50090-4592_7f4b9f1b-fff7-4708-a503-3a427fc21f0c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA207289
Marketing category
ANDA
Marketing start
2016-06-28
Marketing end
0000-00-00
Substance
DOXYCYCLINE HYCLATE
Active strength
100 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
50090-4592-02023-01-30C16284748780-1f386c649-f859-0266-e053-dadaa90a7c1aDoxycycline Hyclate Capsules, USP (100 mg) Rx Only
50090-4592-12023-01-30C16284748780-1f386c649-f859-0266-e053-dadaa90a7c1aDoxycycline Hyclate Capsules, USP (100 mg) Rx Only
50090-4592-22023-01-30C16284748780-1f386c649-f859-0266-e053-dadaa90a7c1aDoxycycline Hyclate Capsules, USP (100 mg) Rx Only
50090-4592-32023-01-30C16284748780-1f386c649-f859-0266-e053-dadaa90a7c1aDoxycycline Hyclate Capsules, USP (100 mg) Rx Only
50090-4592-42023-01-30C16284748780-1f386c649-f859-0266-e053-dadaa90a7c1aDoxycycline Hyclate Capsules, USP (100 mg) Rx Only
50090-4592-52023-01-30C16284748780-1f386c649-f859-0266-e053-dadaa90a7c1aDoxycycline Hyclate Capsules, USP (100 mg) Rx Only
50090-4592-62023-01-30C16284748780-1f386c649-f859-0266-e053-dadaa90a7c1aDoxycycline Hyclate Capsules, USP (100 mg) Rx Only
50090-4592-72023-01-30C16284748780-1f386c649-f859-0266-e053-dadaa90a7c1aDoxycycline Hyclate Capsules, USP (100 mg) Rx Only
50090-4592-82023-01-30C16284748780-1f386c649-f859-0266-e053-dadaa90a7c1aDoxycycline Hyclate Capsules, USP (100 mg) Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4592-0Doxycycline Hyclate40 in 1 BOTTLECAPSULE405
50090-4592-1Doxycycline Hyclate20 in 1 BOTTLECAPSULE205
50090-4592-2Doxycycline Hyclate10 in 1 BOTTLECAPSULE105
50090-4592-3Doxycycline Hyclate12 in 1 BOTTLECAPSULE125
50090-4592-4Doxycycline Hyclate4 in 1 BOTTLECAPSULE45
50090-4592-5Doxycycline Hyclate5 in 1 BOTTLECAPSULE55
50090-4592-6Doxycycline Hyclate14 in 1 BOTTLECAPSULE145
50090-4592-7Doxycycline Hyclate11 in 1 BOTTLECAPSULE115
50090-4592-8Doxycycline Hyclate500 in 1 BOTTLECAPSULE5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4592-1EA - Each50090-4592a976444b-787b-4d6b-8c61-b3dd109ee90712022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4592DOXYCYCLINE HYCLATE (DOXYCYCLINE) CAPSULE [A-S MEDICATION SOLUTIONS]5Legacy NDC, 9 package rows20210417_34907713-088d-4434-b2cb-cb6c448092ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN34907713-088d-4434-b2cb-cb6c448092ef5
1649988doxycycline hyclate 100 MG Oral CapsuleSCD34907713-088d-4434-b2cb-cb6c448092ef5
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY34907713-088d-4434-b2cb-cb6c448092ef5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4592-05009045920040 CAPSULE in 1 BOTTLE (50090-4592-0) 40 capsule2019-10-090000-00-00NoNoCurrent
50090-4592-15009045920120 CAPSULE in 1 BOTTLE (50090-4592-1) 20 capsule2019-10-090000-00-00NoNoCurrent
50090-4592-25009045920210 CAPSULE in 1 BOTTLE (50090-4592-2) 10 capsule2019-10-090000-00-00NoNoCurrent
50090-4592-35009045920312 CAPSULE in 1 BOTTLE (50090-4592-3) 12 capsule2019-10-090000-00-00NoNoCurrent
50090-4592-4500904592044 CAPSULE in 1 BOTTLE (50090-4592-4) 4 capsule2019-10-090000-00-00NoNoCurrent
50090-4592-5500904592055 CAPSULE in 1 BOTTLE (50090-4592-5) 5 capsule2019-10-090000-00-00NoNoCurrent
50090-4592-65009045920614 CAPSULE in 1 BOTTLE (50090-4592-6) 14 capsule2019-10-090000-00-00NoNoCurrent
50090-4592-75009045920711 CAPSULE in 1 BOTTLE (50090-4592-7) 11 capsule2019-10-090000-00-00NoNoCurrent
50090-4592-850090459208500 CAPSULE in 1 BOTTLE (50090-4592-8) 500 capsule2019-10-090000-00-00NoNoCurrent