FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
61748-111
11-digit product format
617480111
Labeler code
61748
Product ID
61748-111_bd7113f1-cbc8-43f9-9cb1-e6bb9b5588bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
VersaPharm Incorporated
Application
ANDA062396
Marketing category
ANDA
Marketing start
1998-04-01
Marketing end
0000-00-00
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
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
61748-111-142020-01-31C16284748780-19d75b9cf-d6c1-f424-e053-dadaa90a57ceDOXYCYCLINE HYCLATE CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61748-111-14Doxycycline Hyclate14 in 1 BOTTLE, PLASTICCAPSULE, GELATIN COATED142

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61748-111-14EA - Each61748-111d031d222-1999-499d-a5ec-750cf6fff8ad12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [VERSAPHARM INCORPORATED]2
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [VERSAPHARM INCORPORATED]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MDOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [VERSAPHARM INCORPORATED]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3DOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [VERSAPHARM INCORPORATED]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [VERSAPHARM INCORPORATED]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [VERSAPHARM INCORPORATED]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [VERSAPHARM INCORPORATED]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [VERSAPHARM INCORPORATED]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [VERSAPHARM INCORPORATED]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [VERSAPHARM INCORPORATED]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [VERSAPHARM INCORPORATED]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [VERSAPHARM INCORPORATED]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [VERSAPHARM INCORPORATED]2
SHELLACINACTIVE INGREDIENT46N107B71ODOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [VERSAPHARM INCORPORATED]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [VERSAPHARM INCORPORATED]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [VERSAPHARM INCORPORATED]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [VERSAPHARM INCORPORATED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61748-111DOXYCYCLINE HYCLATE CAPSULE, GELATIN COATED [VERSAPHARM INCORPORATED]2Legacy NDC, 1 package rows20150217_41fd9969-059c-47a6-a424-4382804407c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN41fd9969-059c-47a6-a424-4382804407c02
1649988doxycycline hyclate 100 MG Oral CapsuleSCD41fd9969-059c-47a6-a424-4382804407c02
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY41fd9969-059c-47a6-a424-4382804407c02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61748-111-146174801111414 in 1 BOTTLE, PLASTICHistorical