FDA.reportPublic FDA data

CUPRIC CHLORIDE

Product NDC
51754-0103
11-digit product format
517540103
Labeler code
51754
Product ID
51754-0103_18dc9e1c-b9db-4160-96f7-8c4391bcf8c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cupric chloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Exela Pharma Sciences, LLC
Application
ANDA212071
Marketing category
ANDA
Marketing start
2023-02-01
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
51754-0103-3CUPRIC CHLORIDE10 in 1 CARTONINJECTION, SOLUTION101
51754-0103-3CUPRIC CHLORIDE10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION101
51754-0103-4CUPRIC CHLORIDE10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION101
51754-0103-4CUPRIC CHLORIDE25 in 1 CARTONINJECTION, SOLUTION251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51754-0103-4ML - Milliliter51754-01037cab3abe-dbb0-4b9b-bc14-6116be5f966012023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51754-0103CUPRIC CHLORIDE INJECTION, SOLUTION [EXELA PHARMA SCIENCES, LLC]1Current NDC, 4 package rows20230810_daaa6f3a-148e-4f1c-bd44-bb2242145b88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204536copper 4 MG in 10 ML InjectionPSNdaaa6f3a-148e-4f1c-bd44-bb2242145b881
20453610 ML cupric chloride 1.07 MG/ML InjectionSCDdaaa6f3a-148e-4f1c-bd44-bb2242145b881
204536copper 4 MG per 10 ML InjectionSYdaaa6f3a-148e-4f1c-bd44-bb2242145b881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51754-0103-35175401030310 VIAL, SINGLE-DOSE in 1 CARTON (51754-0103-3) / 10 mL in 1 VIAL, SINGLE-DOSE2023-02-01NoNoHistorical
51754-0103-45175401030425 VIAL, SINGLE-DOSE in 1 CARTON (51754-0103-4) / 10 mL in 1 VIAL, SINGLE-DOSE2023-02-01NoNoHistorical