FDA.reportPublic FDA data

Doxycycline

Product NDC
0115-1327
11-digit product format
001151327
Labeler code
0115
Product ID
0115-1327_25e3946b-93e0-40f2-9ca6-d96b9b1c1476
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA200065
Marketing category
ANDA
Marketing start
2011-02-17
Marketing end
0000-00-00
Substance
DOXYCYCLINE
Active strength
150 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
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
0115-1327-012023-01-30C16284748780-1f386c649-e6b7-0266-e053-dadaa90a7c1aDoxycycline Capsules, USP
0115-1327-032023-01-30C16284748780-1f386c649-e6b7-0266-e053-dadaa90a7c1aDoxycycline Capsules, USP
0115-1327-082023-01-30C16284748780-1f386c649-e6b7-0266-e053-dadaa90a7c1aDoxycycline Capsules, USP
0115-1327-102023-01-30C16284748780-1f386c649-e6b7-0266-e053-dadaa90a7c1aDoxycycline Capsules, USP
0115-1327-132023-01-30C16284748780-1f386c649-e6b7-0266-e053-dadaa90a7c1aDoxycycline Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0115-1327-01Doxycycline100 in 1 BOTTLECAPSULE10013
0115-1327-03Doxycycline1000 in 1 BOTTLECAPSULE100013
0115-1327-08Doxycycline30 in 1 BOTTLECAPSULE3013
0115-1327-10Doxycycline90 in 1 BOTTLECAPSULE9013
0115-1327-13Doxycycline60 in 1 BOTTLECAPSULE6013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1327-13EA - Each0115-13272a5ed75f-91b8-43ad-8ba0-22439cdbc7d712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINEACTIVE INGREDIENTN12000U13ODOXYCYCLINE CAPSULE [IMPAX GENERICS]7
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE CAPSULE [IMPAX GENERICS]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE CAPSULE [IMPAX GENERICS]7
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOXYCYCLINE CAPSULE [IMPAX GENERICS]7
GELATININACTIVE INGREDIENT2G86QN327LDOXYCYCLINE CAPSULE [IMPAX GENERICS]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDOXYCYCLINE CAPSULE [IMPAX GENERICS]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE CAPSULE [IMPAX GENERICS]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE CAPSULE [IMPAX GENERICS]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DOXYCYCLINE CAPSULE [IMPAX GENERICS]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE CAPSULE [IMPAX GENERICS]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1327DOXYCYCLINE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]13Legacy NDC, 5 package rows20200131_5878bfaf-66b2-4a78-b6b0-f6405d44ebef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728207doxycycline monohydrate 150 MG Oral CapsulePSN5878bfaf-66b2-4a78-b6b0-f6405d44ebef13
728207doxycycline monohydrate 150 MG Oral CapsuleSCD5878bfaf-66b2-4a78-b6b0-f6405d44ebef13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0115-1327-0100115132701100 CAPSULE in 1 BOTTLE (0115-1327-01) 100 capsule2011-02-170000-00-00NoNoCurrent
0115-1327-03001151327031000 CAPSULE in 1 BOTTLE (0115-1327-03) 1000 capsule2011-02-170000-00-00NoNoCurrent
0115-1327-080011513270830 CAPSULE in 1 BOTTLE (0115-1327-08) 30 capsule2011-02-170000-00-00NoNoCurrent
0115-1327-100011513271090 CAPSULE in 1 BOTTLE (0115-1327-10) 90 capsule2011-02-170000-00-00NoNoCurrent
0115-1327-130011513271360 CAPSULE in 1 BOTTLE (0115-1327-13) 60 capsule2011-02-170000-00-00NoNoCurrent