FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
50090-2446
11-digit product format
500902446
Labeler code
50090
Product ID
50090-2446_2fcbfb55-c1d6-4508-ab6e-5a3af473cbdf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA062505
Marketing category
ANDA
Marketing start
2016-07-19
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
50090-2446-02023-01-30C16284748780-1f386c64a-32f7-0266-e053-dadaa90a7c1aDoxycycline Hyclate Capsules, USP 50 mg and 100 mg Doxycycline Hyclate Tablets, USP 100 mg
50090-2446-12023-01-30C16284748780-1f386c64a-32f7-0266-e053-dadaa90a7c1aDoxycycline Hyclate Capsules, USP 50 mg and 100 mg Doxycycline Hyclate Tablets, USP 100 mg
50090-2446-22023-01-30C16284748780-1f386c64a-32f7-0266-e053-dadaa90a7c1aDoxycycline Hyclate Capsules, USP 50 mg and 100 mg Doxycycline Hyclate Tablets, USP 100 mg
50090-2446-32023-01-30C16284748780-1f386c64a-32f7-0266-e053-dadaa90a7c1aDoxycycline Hyclate Capsules, USP 50 mg and 100 mg Doxycycline Hyclate Tablets, USP 100 mg
50090-2446-52023-01-30C16284748780-1f386c64a-32f7-0266-e053-dadaa90a7c1aDoxycycline Hyclate Capsules, USP 50 mg and 100 mg Doxycycline Hyclate Tablets, USP 100 mg
50090-2446-62023-01-30C16284748780-1f386c64a-32f7-0266-e053-dadaa90a7c1aDoxycycline Hyclate Capsules, USP 50 mg and 100 mg Doxycycline Hyclate Tablets, USP 100 mg
50090-2446-82023-01-30C16284748780-1f386c64a-32f7-0266-e053-dadaa90a7c1aDoxycycline Hyclate Capsules, USP 50 mg and 100 mg Doxycycline Hyclate Tablets, USP 100 mg
50090-2446-92023-01-30C16284748780-1f386c64a-32f7-0266-e053-dadaa90a7c1aDoxycycline Hyclate Capsules, USP 50 mg and 100 mg Doxycycline Hyclate Tablets, USP 100 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2446-0Doxycycline Hyclate10 in 1 BOTTLETABLET, FILM COATED1030
50090-2446-1Doxycycline Hyclate14 in 1 BOTTLETABLET, FILM COATED1430
50090-2446-2Doxycycline Hyclate7 in 1 BOTTLE, PLASTICTABLET, FILM COATED730
50090-2446-3Doxycycline Hyclate20 in 1 BOTTLETABLET, FILM COATED2030
50090-2446-5Doxycycline Hyclate28 in 1 BOTTLETABLET, FILM COATED2830
50090-2446-6Doxycycline Hyclate30 in 1 BOTTLETABLET, FILM COATED3030
50090-2446-8Doxycycline Hyclate60 in 1 BOTTLETABLET, FILM COATED6030
50090-2446-9Doxycycline Hyclate100 in 1 BOTTLETABLET, FILM COATED10030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2446-0EA - Each50090-244660b1c1cd-5bf8-4580-b6c5-8f8dd0c01f6b12019-03-12
50090-2446-1EA - Each50090-2446bdd2035e-90b0-40cc-a623-36784cd64fd112018-11-06
50090-2446-3EA - Each50090-2446951e7ba4-134c-4659-a0a6-2730a92de2bb12018-11-06
50090-2446-5EA - Each50090-244659d6924f-79d4-4440-8cad-e83cd473a5f812018-11-06
50090-2446-6EA - Each50090-244680724c5e-b13f-4733-b3cd-a09cb87e09d912018-11-06
50090-2446-8EA - Each50090-2446e611d090-dfea-4866-87df-f59dbe5a2ba212018-11-06
50090-2446-9EA - Each50090-2446f0bbca4c-9e2f-4297-947c-06c7a294831212019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2446DOXYCYCLINE HYCLATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]30Legacy NDC, 8 package rows20210416_e57b06c0-d0cd-41ff-9ca5-279b11c15e1c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSNe57b06c0-d0cd-41ff-9ca5-279b11c15e1c30
1650143doxycycline hyclate 100 MG Oral TabletSCDe57b06c0-d0cd-41ff-9ca5-279b11c15e1c30

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2446-05009024460010 TABLET, FILM COATED in 1 BOTTLE (50090-2446-0) 2016-08-090000-00-00NoNoCurrent
50090-2446-15009024460114 TABLET, FILM COATED in 1 BOTTLE (50090-2446-1) 2016-09-300000-00-00NoNoCurrent
50090-2446-2500902446027 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-2446-2) 2016-07-190000-00-00NoNoCurrent
50090-2446-35009024460320 TABLET, FILM COATED in 1 BOTTLE (50090-2446-3) 2016-10-130000-00-00NoNoCurrent
50090-2446-55009024460528 TABLET, FILM COATED in 1 BOTTLE (50090-2446-5) 2017-01-110000-00-00NoNoCurrent
50090-2446-65009024460630 TABLET, FILM COATED in 1 BOTTLE (50090-2446-6) 2017-01-260000-00-00NoNoCurrent
50090-2446-85009024460860 TABLET, FILM COATED in 1 BOTTLE (50090-2446-8) 2017-05-110000-00-00NoNoCurrent
50090-2446-950090244609100 TABLET, FILM COATED in 1 BOTTLE (50090-2446-9) 2018-04-100000-00-00NoNoCurrent