Doxycycline

Product NDC
43386-790
11-digit product format
433860790
Labeler code
43386
Product ID
43386-790_a3ed2ee4-163c-4167-abf2-59a7e1d66a61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
Lupin Pharmaceuticals,Inc.
Application
ANDA204446
Marketing category
ANDA
Marketing start
2015-07-08
Substance
DOXYCYCLINE
Active strength
50 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Doxycycline
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN12000U13O
Rxcui700408, 1649401, 1649990

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43386-790-01Doxycycline100 in 1 BOTTLECAPSULE1004
43386-790-10Doxycycline1000 in 1 BOTTLECAPSULE10004
43386-790-11Doxycycline50 in 1 BOTTLECAPSULE504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43386-790-01EA - Each43386-790c7cac30c-2271-4f2c-9631-a4ca65ec146612015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINEACTIVE INGREDIENTN12000U13ODOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYDOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
GELATININACTIVE INGREDIENT2G86QN327LDOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TDOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
SHELLACINACTIVE INGREDIENT46N107B71ODOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE CAPSULE [GAVIS PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43386-790DOXYCYCLINE CAPSULE [LUPIN PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 3 package rows20240131_6512bf22-c211-4127-a8c8-2419656580f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649990doxycycline monohydrate 100 MG Oral CapsulePSN6512bf22-c211-4127-a8c8-2419656580f64
1649401doxycycline monohydrate 50 MG Oral CapsulePSN6512bf22-c211-4127-a8c8-2419656580f64
700408doxycycline monohydrate 75 MG Oral CapsulePSN6512bf22-c211-4127-a8c8-2419656580f64
1649990doxycycline monohydrate 100 MG Oral CapsuleSCD6512bf22-c211-4127-a8c8-2419656580f64
1649401doxycycline monohydrate 50 MG Oral CapsuleSCD6512bf22-c211-4127-a8c8-2419656580f64
700408doxycycline monohydrate 75 MG Oral CapsuleSCD6512bf22-c211-4127-a8c8-2419656580f64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43386-790-0143386079001100 CAPSULE in 1 BOTTLE (43386-790-01) 100 capsule2015-07-080000-00-00NoNoCurrent
43386-790-10433860790101000 CAPSULE in 1 BOTTLE (43386-790-10) 1000 capsule2015-07-080000-00-00NoNoCurrent
43386-790-114338607901150 CAPSULE in 1 BOTTLE (43386-790-11) 50 capsule2015-07-080000-00-00NoNoCurrent