FDA.reportPublic FDA data

Doxycycline

Product NDC
42783-601
11-digit product format
427830601
Labeler code
42783
Product ID
42783-601_881b762a-b1e5-436c-800a-0f058967d0a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Elorac, Inc.
Application
ANDA065285
Marketing category
ANDA
Marketing start
2005-12-08
Marketing end
0000-00-00
Substance
DOXYCYCLINE
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
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
5e99724e-0654-4aec-b7a2-0b9b10e312eeProduct name320250227
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
d2d36660-68ce-7e7d-0630-ec4b0d859fadProduct name620220921
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
a239f4dd-cf93-4660-b190-f97d000f249fProduct name720210607
a9d03566-caeb-4466-8021-74599b048880Product name320210604
12750814-20f7-4f35-b5fa-dbc8811ba858Product name920201007
00a5dbaa-1b7d-4e56-be0c-fedc7bbf5adeProduct name120200706
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
7b4b06ac-8c50-45f0-9556-293ea558a294Product name120180808
6a5b4392-5ab0-af0d-e0be-47b34e9dbb84Product name520171121
01a4aa74-7e05-63bd-bc10-1b5ceb111371Product name220171115
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
58b1278c-6dce-49b6-a05e-ea16f389acbaProduct name120160620

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42783-601-302020-01-31C16284748780-19d75b9d0-4ed0-f424-e053-dadaa90a57ceDoxycycline Tablets, USP
42783-601-602020-01-31C16284748780-19d75b9d0-4e9a-f424-e053-dadaa90a57ceDoxycycline Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42783-601-60Doxycycline60 in 1 BOTTLETABLET, FILM COATED6011
42783-601-30Doxycycline30 in 1 BOTTLETABLET, FILM COATED307

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINEACTIVE INGREDIENTN12000U13ODOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]11
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]11
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933DOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]11
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]11
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]11
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]11
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]11
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990DOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]11
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]11
TALCINACTIVE INGREDIENT7SEV7J4R1UDOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]11
DOXYCYCLINEACTIVE INGREDIENTN12000U13ODOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]7
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]7
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933DOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]7
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]7
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]7
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990DOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]7
TALCINACTIVE INGREDIENT7SEV7J4R1UDOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]7
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GMBENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
DOXYCYCLINEACTIVE INGREDIENTN12000U13OBENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GMBENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862BENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933BENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE70BENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX19BENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXBENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PBENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDEINACTIVE INGREDIENT9CO8OUL4THBENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
LAURETH-7INACTIVE INGREDIENTZ95S6G8201BENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TBENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990BENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YBENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UBENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RBENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GMBENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
DOXYCYCLINEACTIVE INGREDIENTN12000U13OBENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GMBENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862BENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933BENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE70BENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX19BENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXBENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PBENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDEINACTIVE INGREDIENT9CO8OUL4THBENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
LAURETH-7INACTIVE INGREDIENTZ95S6G8201BENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TBENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990BENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YBENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UBENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RBENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42783-601DOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]11Legacy NDC, 1 package rows20151015_3e526226-0ac6-4357-af89-23639e23ef58.zip
42783-601DOXYCYCLINE TABLET, FILM COATED [ELORAC, INC.]7Legacy NDC, 1 package rows20151015_d9229004-5d44-4d36-a3ba-4d8826b143f1.zip
42783-601BENZODOX 30 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]4Legacy NDC20151030_ddd9a47e-7d7c-4d0c-aaa6-32702570f696.zip
42783-601BENZODOX 60 KIT (DOXYCYCLINE TABLETS AND ADVANCED ACNE WASH) KIT [ELORAC, INC.]2Legacy NDC20151017_92ab3004-f719-4861-ba6a-c93ec9ab94f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650142doxycycline monohydrate 100 MG Oral TabletPSN3e526226-0ac6-4357-af89-23639e23ef5811
1650142doxycycline monohydrate 100 MG Oral TabletSCD3e526226-0ac6-4357-af89-23639e23ef5811
1650142doxycycline monohydrate 100 MG Oral TabletPSNd9229004-5d44-4d36-a3ba-4d8826b143f17
1650142doxycycline monohydrate 100 MG Oral TabletSCDd9229004-5d44-4d36-a3ba-4d8826b143f17
1543390benzoyl peroxide 4.4 % Medicated Liquid SoapPSNddd9a47e-7d7c-4d0c-aaa6-32702570f6964
1650142doxycycline monohydrate 100 MG Oral TabletPSNddd9a47e-7d7c-4d0c-aaa6-32702570f6964
1543390benzoyl peroxide 44 MG/ML Medicated Liquid SoapSCDddd9a47e-7d7c-4d0c-aaa6-32702570f6964
1650142doxycycline monohydrate 100 MG Oral TabletSCDddd9a47e-7d7c-4d0c-aaa6-32702570f6964
1543390benzoyl peroxide 4.4 % Medicated Liquid SoapSYddd9a47e-7d7c-4d0c-aaa6-32702570f6964
1543390benzoyl peroxide 4.4 % Medicated Liquid SoapPSN92ab3004-f719-4861-ba6a-c93ec9ab94f42
1650142doxycycline monohydrate 100 MG Oral TabletPSN92ab3004-f719-4861-ba6a-c93ec9ab94f42
1543390benzoyl peroxide 44 MG/ML Medicated Liquid SoapSCD92ab3004-f719-4861-ba6a-c93ec9ab94f42
1650142doxycycline monohydrate 100 MG Oral TabletSCD92ab3004-f719-4861-ba6a-c93ec9ab94f42
1543390benzoyl peroxide 4.4 % Medicated Liquid SoapSY92ab3004-f719-4861-ba6a-c93ec9ab94f42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42783-601-304278306013030 in 1 BOTTLEHistorical
42783-601-604278306016060 in 1 BOTTLEHistorical