Doxycycline

Product NDC
40032-791
11-digit product format
400320791
Labeler code
40032
Product ID
40032-791_69d6f881-5c24-44c9-ae77-de969367ede4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
Novel Laboratories, Inc.
Application
ANDA204446
Marketing category
ANDA
Marketing start
2015-05-28
Marketing end
0000-00-00
Substance
DOXYCYCLINE
Active strength
75 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40032-791-01Doxycycline100 in 1 BOTTLECAPSULE1005
40032-791-10Doxycycline1000 in 1 BOTTLECAPSULE10005
40032-791-11Doxycycline50 in 1 BOTTLECAPSULE505

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINEACTIVE INGREDIENTN12000U13ODOXYCYCLINE CAPSULE [NOVEL LABORATORIES, INC.]3
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE CAPSULE [NOVEL LABORATORIES, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE CAPSULE [NOVEL LABORATORIES, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDOXYCYCLINE CAPSULE [NOVEL LABORATORIES, INC.]3
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYDOXYCYCLINE CAPSULE [NOVEL LABORATORIES, INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DOXYCYCLINE CAPSULE [NOVEL LABORATORIES, INC.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDOXYCYCLINE CAPSULE [NOVEL LABORATORIES, INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DOXYCYCLINE CAPSULE [NOVEL LABORATORIES, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LDOXYCYCLINE CAPSULE [NOVEL LABORATORIES, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE CAPSULE [NOVEL LABORATORIES, INC.]3
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TDOXYCYCLINE CAPSULE [NOVEL LABORATORIES, INC.]3
SHELLACINACTIVE INGREDIENT46N107B71ODOXYCYCLINE CAPSULE [NOVEL LABORATORIES, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE CAPSULE [NOVEL LABORATORIES, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXYCYCLINE CAPSULE [NOVEL LABORATORIES, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DOXYCYCLINE CAPSULE [NOVEL LABORATORIES, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE CAPSULE [NOVEL LABORATORIES, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40032-791DOXYCYCLINE CAPSULE [NOVEL LABORATORIES, INC.]5Legacy NDC, 3 package rows20191221_3d07e4d0-fe80-4eb1-8369-0a995a638713.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649990doxycycline monohydrate 100 MG Oral CapsulePSN3d07e4d0-fe80-4eb1-8369-0a995a6387135
1649401doxycycline monohydrate 50 MG Oral CapsulePSN3d07e4d0-fe80-4eb1-8369-0a995a6387135
700408doxycycline monohydrate 75 MG Oral CapsulePSN3d07e4d0-fe80-4eb1-8369-0a995a6387135
1649990doxycycline monohydrate 100 MG Oral CapsuleSCD3d07e4d0-fe80-4eb1-8369-0a995a6387135
1649401doxycycline monohydrate 50 MG Oral CapsuleSCD3d07e4d0-fe80-4eb1-8369-0a995a6387135
700408doxycycline monohydrate 75 MG Oral CapsuleSCD3d07e4d0-fe80-4eb1-8369-0a995a6387135

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
40032-791-0140032079101100 CAPSULE in 1 BOTTLE (40032-791-01) 100 capsule2015-05-280000-00-00NoNoCurrent
40032-791-10400320791101000 CAPSULE in 1 BOTTLE (40032-791-10) 1000 capsule2015-05-280000-00-00NoNoCurrent
40032-791-114003207911150 CAPSULE in 1 BOTTLE (40032-791-11) 50 capsule2015-05-280000-00-00NoNoCurrent