FDA.reportPublic FDA data

Doxycycline Monohydrate

Product NDC
0591-0411
11-digit product format
005910411
Labeler code
0591
Product ID
0591-0411_87ec24be-f5bb-46ef-90fa-d818e0969f07
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
NDA050641
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2005-02-07
Marketing end
2020-01-31
Substance
DOXYCYCLINE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-0411-50EA - Each0591-0411c62b1224-e9f7-44b3-bd13-11097ac6d6c812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINEACTIVE INGREDIENTN12000U13ODOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE MONOHYDRATE (DOXYCYCLINE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649990doxycycline monohydrate 100 MG Oral CapsulePSN6a0e5b78-bc00-0766-e053-2a91aa0a094d2
1649990doxycycline monohydrate 100 MG Oral CapsulePSN96424d21-3fa4-4a32-8b98-fd593748f2362
1649990doxycycline monohydrate 100 MG Oral CapsuleSCD6a0e5b78-bc00-0766-e053-2a91aa0a094d2
1649990doxycycline monohydrate 100 MG Oral CapsuleSCD96424d21-3fa4-4a32-8b98-fd593748f2362
1649990doxycycline monohydrate 100 MG Oral CapsulePSN8ced6ac0-22f2-42d2-bced-4a97da5507a01
1649990doxycycline monohydrate 100 MG Oral CapsuleSCD8ced6ac0-22f2-42d2-bced-4a97da5507a01