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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINERCUPRIC CHLORIDEEQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N018960-001AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONRLD, RS1986-06-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONRLD, RS1986-06-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONRLD, RS1986-06-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONRLD, RS1986-06-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONRLD, RS1986-06-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONRLD, RS1986-06-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONRLD, RS1986-06-2687673890dc5c…
2021-03-12 10:30 UTC2021-03N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONRLD, RS1986-06-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONRLD, RS1986-06-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONRLD, RS1986-06-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONRLD, RS1986-06-263f01610625f2…
2019-09-15 20:21 UTC2019-09N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONRLD, RS1986-06-26b00525d2431f…
2019-07-19 19:46 UTC2019-07N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONRLD, RS1986-06-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-263f0d92c62455…
2023-05-13 08:27 UTC2023-05N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-26053a50430f4f…
2023-01-26 05:58 UTC2023-01N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONRLD, RS1986-06-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONRLD, RS1986-06-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018960-001CUPRIC CHLORIDE IN PLASTIC CONTAINEREQ 0.4MG COPPER/MLINJECTABLE / INJECTIONRLD, RS1986-06-26cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N018960-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018960-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018960-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018960-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018960-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018960-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018960-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018960-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018960-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018960-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018960-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018960-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018960-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018960-001AP18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018960-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018960-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018960-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018960-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018960-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018960-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018960-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N018960-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N018960-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018960-001AP13a93d1ddd44b…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N018960-001AP1a50c72e98297…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S2QG84156OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
204536Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a84d61a4-8e7f-4be1-aba6-f633b334aafcAvailable on FDA.report

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#

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

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
COPPERCUPRIC CHLORIDEHospira, Inc.a84d61a4-8e7f-4be1-aba6-f633b334aafc2026-05-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 018960
application number: NDA018960
ndc (product): 0409-4092

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