NDC 50546-550-01 - DORYX

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
50546-550
Requested NDC
50546-550-01
Package NDCs from labels
50546-550-01
Manufacturer
Warner Chilcott (US), Inc.
Effective date
2007-08-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DORYX ® (doxycycline hyclate) Delayed-Release Capsules, 75 mg and 100 mgWarner Chilcott (US), Inc.2007-08-02Human prescription drug label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50546-550-01DORYX60000 in 1 BAGCAPSULE, DELAYED RELEASE PELLETS600001
50546-550-01DORYX1 in 1 DRUMCAPSULE, DELAYED RELEASE PELLETS11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50546-550DORYX (DOXYCYCLINE HYCLATE) CAPSULE, DELAYED RELEASE PELLETS [WARNER CHILCOTT (US), INC.]12 package rows20070815_33C9CD03-A005-476A-9A57-50BFE913674A.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
doxycycline hyclateACTIVE INGREDIENT19XTS3T51UDORYX (DOXYCYCLINE HYCLATE) CAPSULE, DELAYED RELEASE PELLETS [WARNER CHILCOTT (US), INC.]1
doxycyclineACTIVE MOIETYN12000U13ODORYX (DOXYCYCLINE HYCLATE) CAPSULE, DELAYED RELEASE PELLETS [WARNER CHILCOTT (US), INC.]1
CELLULOSIC POLYMER COATINGINACTIVE INGREDIENTDORYX (DOXYCYCLINE HYCLATE) CAPSULE, DELAYED RELEASE PELLETS [WARNER CHILCOTT (US), INC.]1
D & C YELLOW NO. 10INACTIVE INGREDIENTDORYX (DOXYCYCLINE HYCLATE) CAPSULE, DELAYED RELEASE PELLETS [WARNER CHILCOTT (US), INC.]1
FD & C BLUE NO. 1INACTIVE INGREDIENTDORYX (DOXYCYCLINE HYCLATE) CAPSULE, DELAYED RELEASE PELLETS [WARNER CHILCOTT (US), INC.]1
FD & C YELLOW NO. 6INACTIVE INGREDIENTDORYX (DOXYCYCLINE HYCLATE) CAPSULE, DELAYED RELEASE PELLETS [WARNER CHILCOTT (US), INC.]1
GELATININACTIVE INGREDIENT2G86QN327LDORYX (DOXYCYCLINE HYCLATE) CAPSULE, DELAYED RELEASE PELLETS [WARNER CHILCOTT (US), INC.]1
LACTOSEINACTIVE INGREDIENTDORYX (DOXYCYCLINE HYCLATE) CAPSULE, DELAYED RELEASE PELLETS [WARNER CHILCOTT (US), INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DORYX (DOXYCYCLINE HYCLATE) CAPSULE, DELAYED RELEASE PELLETS [WARNER CHILCOTT (US), INC.]1
MICROCRYSTALINE CELLULOSEINACTIVE INGREDIENTDORYX (DOXYCYCLINE HYCLATE) CAPSULE, DELAYED RELEASE PELLETS [WARNER CHILCOTT (US), INC.]1
POVIDONEINACTIVE INGREDIENTDORYX (DOXYCYCLINE HYCLATE) CAPSULE, DELAYED RELEASE PELLETS [WARNER CHILCOTT (US), INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DORYX (DOXYCYCLINE HYCLATE) CAPSULE, DELAYED RELEASE PELLETS [WARNER CHILCOTT (US), INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDORYX (DOXYCYCLINE HYCLATE) CAPSULE, DELAYED RELEASE PELLETS [WARNER CHILCOTT (US), INC.]1
STARCH WHEATINACTIVE INGREDIENTDORYX (DOXYCYCLINE HYCLATE) CAPSULE, DELAYED RELEASE PELLETS [WARNER CHILCOTT (US), INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDORYX (DOXYCYCLINE HYCLATE) CAPSULE, DELAYED RELEASE PELLETS [WARNER CHILCOTT (US), INC.]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AF9B7747-099C-FD1C-BBA9-ACE476770C1E33C9CD03-A005-476A-9A57-50BFE913674A2007-08-02Warnings, Adverse reactionsExact identifier
spl id: AF9B7747-099C-FD1C-BBA9-ACE476770C1E
spl set id: 33C9CD03-A005-476A-9A57-50BFE913674A

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.