FDA.reportPublic FDA data

Doxycycline

Product NDC
0440-7483
11-digit product format
004407483
Labeler code
0440
Product ID
0440-7483_a4ba92ff-e219-432b-b118-aba5737ce6b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline hyclate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Liberty Pharmaceuticals, Inc.
Application
ANDA065095
Marketing category
ANDA
Marketing start
2003-07-02
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
0440-7483-142020-01-31C16284748780-19d75b9d1-16fe-f424-e053-dadaa90a57ceDOXYCYCLINE HYCLATE TABLETS, USP
0440-7483-192020-01-31C16284748780-19d75b9d1-16fe-f424-e053-dadaa90a57ceDOXYCYCLINE HYCLATE TABLETS, USP
0440-7483-202020-01-31C16284748780-19d75b9d1-16fe-f424-e053-dadaa90a57ceDOXYCYCLINE HYCLATE TABLETS, USP
0440-7483-282020-01-31C16284748780-19d75b9d1-16fe-f424-e053-dadaa90a57ceDOXYCYCLINE HYCLATE TABLETS, USP
0440-7483-712020-01-31C16284748780-19d75b9d1-16fe-f424-e053-dadaa90a57ceDOXYCYCLINE HYCLATE TABLETS, USP
0440-7483-922020-01-31C16284748780-19d75b9d1-16fe-f424-e053-dadaa90a57ceDOXYCYCLINE HYCLATE TABLETS, USP
0440-7483-952020-01-31C16284748780-19d75b9d1-16fe-f424-e053-dadaa90a57ceDOXYCYCLINE HYCLATE TABLETS, USP
0440-7483-972020-01-31C16284748780-19d75b9d1-16fe-f424-e053-dadaa90a57ceDOXYCYCLINE HYCLATE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0440-7483-14Doxycycline14 in 1 BOTTLETABLET, COATED142
0440-7483-19Doxycycline190 in 1 BOTTLETABLET, COATED1902
0440-7483-20Doxycycline20 in 1 BOTTLETABLET, COATED202
0440-7483-28Doxycycline28 in 1 BOTTLETABLET, COATED282
0440-7483-71Doxycycline210 in 1 BOTTLETABLET, COATED2102
0440-7483-92Doxycycline180 in 1 BOTTLETABLET, COATED1802
0440-7483-95Doxycycline360 in 1 BOTTLETABLET, COATED3602
0440-7483-97Doxycycline400 in 1 BOTTLETABLET, COATED4002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0440-7483-19EA - Each0440-74839422a6a7-6ee7-4d07-8251-87d6fbeea64012013-02-13
0440-7483-71EA - Each0440-7483ab218d8a-1058-4965-a856-26118e3c1fce12013-02-13
0440-7483-92EA - Each0440-7483f5fcc7d4-1911-4932-b71f-d9608ab5064712013-02-13
0440-7483-95EA - Each0440-7483f05814cc-8f9b-4850-b4f6-77c13943197412013-02-13
0440-7483-97EA - Each0440-7483afed204b-6504-4f49-ad0d-827889de498b12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [LIBERTY PHARMACEUTICALS, INC.]2
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [LIBERTY PHARMACEUTICALS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [LIBERTY PHARMACEUTICALS, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [LIBERTY PHARMACEUTICALS, INC.]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [LIBERTY PHARMACEUTICALS, INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [LIBERTY PHARMACEUTICALS, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [LIBERTY PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [LIBERTY PHARMACEUTICALS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [LIBERTY PHARMACEUTICALS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [LIBERTY PHARMACEUTICALS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [LIBERTY PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-7483DOXYCYCLINE (DOXYCYCLINE HYCLATE) TABLET, COATED [LIBERTY PHARMACEUTICALS, INC.]2Legacy NDC, 8 package rows20121025_eb253341-5e11-4297-a947-5a6ece31a87b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSNeb253341-5e11-4297-a947-5a6ece31a87b2
1650143doxycycline hyclate 100 MG Oral TabletSCDeb253341-5e11-4297-a947-5a6ece31a87b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0440-7483-140044074831414 in 1 BOTTLEHistorical
0440-7483-1900440748319190 in 1 BOTTLEHistorical
0440-7483-200044074832020 in 1 BOTTLEHistorical
0440-7483-280044074832828 in 1 BOTTLEHistorical
0440-7483-7100440748371210 in 1 BOTTLEHistorical
0440-7483-9200440748392180 in 1 BOTTLEHistorical
0440-7483-9500440748395360 in 1 BOTTLEHistorical
0440-7483-9700440748397400 in 1 BOTTLEHistorical