FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
50090-4981
11-digit product format
500904981
Labeler code
50090
Product ID
50090-4981_6f99616c-200e-4da8-84fa-b1471655ef0c
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
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4981-02023-02-06C16284748780-1f386c64a-3555-0266-e053-dadaa90a7c1aDoxycycline Hyclate Capsules, USP Doxycycline for Oral Suspension, USP Doxycycline Hyclate Tablets, USP
50090-4981-12023-02-06C16284748780-1f386c64a-3555-0266-e053-dadaa90a7c1aDoxycycline Hyclate Capsules, USP Doxycycline for Oral Suspension, USP Doxycycline Hyclate Tablets, USP
50090-4981-32023-02-06C16284748780-1f386c64a-3555-0266-e053-dadaa90a7c1aDoxycycline Hyclate Capsules, USP Doxycycline for Oral Suspension, USP Doxycycline Hyclate Tablets, USP
50090-4981-52023-02-06C16284748780-1f386c64a-3555-0266-e053-dadaa90a7c1aDoxycycline Hyclate Capsules, USP Doxycycline for Oral Suspension, USP Doxycycline Hyclate Tablets, USP
50090-4981-62023-02-06C16284748780-1f386c64a-3555-0266-e053-dadaa90a7c1aDoxycycline Hyclate Capsules, USP Doxycycline for Oral Suspension, USP Doxycycline Hyclate Tablets, USP
50090-4981-82023-02-06C16284748780-1f386c64a-3555-0266-e053-dadaa90a7c1aDoxycycline Hyclate Capsules, USP Doxycycline for Oral Suspension, USP Doxycycline Hyclate Tablets, USP
50090-4981-02023-01-30C16284748780-1f386c64a-3555-0266-e053-dadaa90a7c1aDoxycycline Hyclate Capsules, USP Doxycycline for Oral Suspension, USP Doxycycline Hyclate Tablets, USP
50090-4981-12023-01-30C16284748780-1f386c64a-3555-0266-e053-dadaa90a7c1aDoxycycline Hyclate Capsules, USP Doxycycline for Oral Suspension, USP Doxycycline Hyclate Tablets, USP
50090-4981-32023-01-30C16284748780-1f386c64a-3555-0266-e053-dadaa90a7c1aDoxycycline Hyclate Capsules, USP Doxycycline for Oral Suspension, USP Doxycycline Hyclate Tablets, USP
50090-4981-52023-01-30C16284748780-1f386c64a-3555-0266-e053-dadaa90a7c1aDoxycycline Hyclate Capsules, USP Doxycycline for Oral Suspension, USP Doxycycline Hyclate Tablets, USP
50090-4981-62023-01-30C16284748780-1f386c64a-3555-0266-e053-dadaa90a7c1aDoxycycline Hyclate Capsules, USP Doxycycline for Oral Suspension, USP Doxycycline Hyclate Tablets, USP
50090-4981-82023-01-30C16284748780-1f386c64a-3555-0266-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
50090-4981-0Doxycycline Hyclate10 in 1 BOTTLETABLET, FILM COATED1011
50090-4981-1Doxycycline Hyclate14 in 1 BOTTLETABLET, FILM COATED1411
50090-4981-3Doxycycline Hyclate20 in 1 BOTTLETABLET, FILM COATED2011
50090-4981-5Doxycycline Hyclate28 in 1 BOTTLETABLET, FILM COATED2811
50090-4981-6Doxycycline Hyclate30 in 1 BOTTLETABLET, FILM COATED3011
50090-4981-8Doxycycline Hyclate60 in 1 BOTTLETABLET, FILM COATED6011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4981-0EA - Each50090-4981e80cdb2f-fb76-4389-9609-a1b09b208d4b12024-06-10
50090-4981-1EA - Each50090-4981c63cc8ae-0d18-4b5b-8dcf-c34bfc8a818612022-03-09
50090-4981-3EA - Each50090-4981a3945a73-54ce-4cb9-99d1-ea8e0e37db1712022-03-09
50090-4981-5EA - Each50090-4981ba4f7d88-1d1c-476b-b21d-33936b69dd5312022-03-09
50090-4981-6EA - Each50090-498132a059e3-fe36-4e5e-8396-df8b204a363112022-03-09
50090-4981-8EA - Each50090-498127192eef-2616-419c-a82f-22e01374eccb12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4981DOXYCYCLINE HYCLATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 6 package rows20240426_a84d7562-08bf-417f-a599-ba0d17c55232.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSNa84d7562-08bf-417f-a599-ba0d17c5523211
1650143doxycycline hyclate 100 MG Oral TabletSCDa84d7562-08bf-417f-a599-ba0d17c5523211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4981-05009049810010 TABLET, FILM COATED in 1 BOTTLE (50090-4981-0) 2020-04-010000-00-00NoNoCurrent
50090-4981-15009049810114 TABLET, FILM COATED in 1 BOTTLE (50090-4981-1) 2020-04-010000-00-00NoNoCurrent
50090-4981-35009049810320 TABLET, FILM COATED in 1 BOTTLE (50090-4981-3) 2020-04-010000-00-00NoNoCurrent
50090-4981-55009049810528 TABLET, FILM COATED in 1 BOTTLE (50090-4981-5) 2020-04-010000-00-00NoNoCurrent
50090-4981-65009049810630 TABLET, FILM COATED in 1 BOTTLE (50090-4981-6) 2020-04-010000-00-00NoNoCurrent
50090-4981-85009049810860 TABLET, FILM COATED in 1 BOTTLE (50090-4981-8) 2020-04-010000-00-00NoNoCurrent