FDA.reportPublic FDA data

Monodox

Product NDC
16110-260
11-digit product format
161100260
Labeler code
16110
Product ID
16110-260_a6d054f6-c27d-4641-ae0e-a6f59a196f54
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
Aqua Pharmaceuticals, LLC
Application
NDA050641
Marketing category
NDA
Marketing start
1992-02-10
Marketing end
0000-00-00
Substance
DOXYCYCLINE
Active strength
50 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
16110-260-062021-01-29C16284748780-1ba0f9c33-4b23-a910-e053-dadaa90a0b85MONODOX ® Doxycycline Monohydrate Capsules Aqua Pharmaceuticals, LLC Revised: March 2017 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16110-260-06Monodox100 in 1 BOTTLECAPSULE10018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16110-260-06EA - Each16110-26052dcd59a-e8be-49fc-8677-eec4958f22a512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINEACTIVE INGREDIENTN12000U13OMONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC]17
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC]17
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC]17
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC]17
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC]17
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC]17
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC]17
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC]17
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC]17
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC]17
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC]17
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC]17
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC]17
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC]17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16110-260MONODOX (DOXYCYCLINE) CAPSULE [AQUA PHARMACEUTICALS, LLC]18Legacy NDC, 1 package rows20170503_a65325a7-ae0a-4704-99c4-a3a2e4e1dcf2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649990doxycycline monohydrate 100 MG Oral CapsulePSNa65325a7-ae0a-4704-99c4-a3a2e4e1dcf218
1649401doxycycline monohydrate 50 MG Oral CapsulePSNa65325a7-ae0a-4704-99c4-a3a2e4e1dcf218
700408doxycycline monohydrate 75 MG Oral CapsulePSNa65325a7-ae0a-4704-99c4-a3a2e4e1dcf218
205621Monodox 100 MG Oral CapsulePSNa65325a7-ae0a-4704-99c4-a3a2e4e1dcf218
205619Monodox 50 MG Oral CapsulePSNa65325a7-ae0a-4704-99c4-a3a2e4e1dcf218
700410Monodox 75 MG Oral CapsulePSNa65325a7-ae0a-4704-99c4-a3a2e4e1dcf218
205621doxycycline monohydrate 100 MG Oral Capsule [Monodox]SBDa65325a7-ae0a-4704-99c4-a3a2e4e1dcf218
205619doxycycline monohydrate 50 MG Oral Capsule [Monodox]SBDa65325a7-ae0a-4704-99c4-a3a2e4e1dcf218
700410doxycycline monohydrate 75 MG Oral Capsule [Monodox]SBDa65325a7-ae0a-4704-99c4-a3a2e4e1dcf218
1649990doxycycline monohydrate 100 MG Oral CapsuleSCDa65325a7-ae0a-4704-99c4-a3a2e4e1dcf218
1649401doxycycline monohydrate 50 MG Oral CapsuleSCDa65325a7-ae0a-4704-99c4-a3a2e4e1dcf218
700408doxycycline monohydrate 75 MG Oral CapsuleSCDa65325a7-ae0a-4704-99c4-a3a2e4e1dcf218
205621Monodox (as doxycycline monohydrate) 100 MG Oral CapsuleSYa65325a7-ae0a-4704-99c4-a3a2e4e1dcf218
205621Monodox 100 MG Oral CapsuleSYa65325a7-ae0a-4704-99c4-a3a2e4e1dcf218
205619Monodox 50 MG Oral CapsuleSYa65325a7-ae0a-4704-99c4-a3a2e4e1dcf218
700410Monodox 75 MG Oral CapsuleSYa65325a7-ae0a-4704-99c4-a3a2e4e1dcf218

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
16110-260-0616110026006100 in 1 BOTTLEHistorical