FDA.reportPublic FDA data

CUPRIC CHLORIDE

Product NDC
72819-234
11-digit product format
728190234
Labeler code
72819
Product ID
72819-234_2472ecab-62ab-84e2-e063-6394a90a86c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CUPRIC CHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Archis Pharma LLC
Application
ANDA217626
Marketing category
ANDA
Marketing start
2024-07-05
Substance
CUPRIC CHLORIDE
Active strength
.4 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72819-234-06CUPRIC CHLORIDE10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1011
72819-234-16CUPRIC CHLORIDE25 in 1 PACKAGEINJECTION, SOLUTION2511
72819-234-96CUPRIC CHLORIDE10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION101
72819-234-99CUPRIC CHLORIDE25 in 1 PACKAGEINJECTION, SOLUTION251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72819-234-06ML - Milliliter72819-234e00aa240-a51b-444e-9b9d-2accf49145b112024-07-12
72819-234-16ML - Milliliter72819-2345fd9ba4f-fcca-46dc-94f5-0f630081d3b512024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72819-234CUPRIC CHLORIDE INJECTION, SOLUTION [ARCHIS PHARMA LLC]11Current NDC, 2 package rows20241016_77e9dd68-baed-4d62-9284-daecd995de2c.zip
72819-234CUPRIC CHLORIDE INJECTION, SOLUTION [ARCHIS PHARMA LLC]1Current NDC, 2 package rows20241018_45586a5f-4864-4b01-9211-002c77585249.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204536copper 4 MG in 10 ML InjectionPSN77e9dd68-baed-4d62-9284-daecd995de2c11
20453610 ML cupric chloride 1.07 MG/ML InjectionSCD77e9dd68-baed-4d62-9284-daecd995de2c11
204536copper 4 MG per 10 ML InjectionSY77e9dd68-baed-4d62-9284-daecd995de2c11
204536copper 4 MG in 10 ML InjectionPSN45586a5f-4864-4b01-9211-002c775852491
20453610 ML cupric chloride 1.07 MG/ML InjectionSCD45586a5f-4864-4b01-9211-002c775852491
204536copper 4 MG per 10 ML InjectionSY45586a5f-4864-4b01-9211-002c775852491

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72819-234-067281902340610 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
72819-234-167281902341625 VIAL, SINGLE-DOSE in 1 PACKAGE (72819-234-16) / 10 mL in 1 VIAL, SINGLE-DOSE (72819-234-06) 2024-07-05NoNoHistorical
72819-234-967281902349610 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
72819-234-997281902349925 VIAL, SINGLE-DOSE in 1 PACKAGE (72819-234-99) / 10 mL in 1 VIAL, SINGLE-DOSE (72819-234-96) 2024-10-01NoNoHistorical