FDA.reportPublic FDA data

COPPER

Product NDC
0409-4092
11-digit product format
004094092
Labeler code
0409
Product ID
0409-4092_bb8b2056-9f89-4d03-aae9-574de2c9b74e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CUPRIC CHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA018960
Marketing category
NDA
Marketing start
2005-02-28
Substance
CUPRIC CHLORIDE
Active strength
.4 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
COPPER
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CUPRIC CHLORIDE.4 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS2QG84156O
Rxcui204536

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-4092-01COPPER25 in 1 TRAYINJECTION, SOLUTION2525
0409-4092-11COPPER10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-4092-01ML - Milliliter0409-4092ac3655da-ca12-4173-b332-8a71ca6a691612012-07-24
0409-4092-11ML - Milliliter0409-4092c8bf9088-c77d-4ab9-af57-09940753d36612019-04-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CUPRIC CHLORIDEACTIVE INGREDIENTS2QG84156OCOPPER (CUPRIC CHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]12
CUPRIC CATIONACTIVE MOIETY8CBV67279LCOPPER (CUPRIC CHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]12
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBCOPPER (CUPRIC CHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]12
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCOPPER (CUPRIC CHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]12
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICOPPER (CUPRIC CHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]12
WATERINACTIVE INGREDIENT059QF0KO0RCOPPER (CUPRIC CHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-4092COPPER (CUPRIC CHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]23Current NDC, Legacy NDC, 2 package rows20241130_a84d61a4-8e7f-4be1-aba6-f633b334aafc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204536copper 4 MG in 10 ML InjectionPSNa84d61a4-8e7f-4be1-aba6-f633b334aafc25
20453610 ML cupric chloride 1.07 MG/ML InjectionSCDa84d61a4-8e7f-4be1-aba6-f633b334aafc25
204536copper 4 MG per 10 ML InjectionSYa84d61a4-8e7f-4be1-aba6-f633b334aafc25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-4092-010040940920125 VIAL, SINGLE-DOSE in 1 TRAY (0409-4092-01) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-4092-11) 2005-02-280000-00-00NoNoCurrent
0409-4092-110040940921110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical