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

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
A217626-001CUPRIC CHLORIDECUPRIC CHLORIDEEQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAP2024-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217626-001AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A217626-001CUPRIC CHLORIDEEQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAP2024-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217626-001CUPRIC CHLORIDEEQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAP2024-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A217626-001CUPRIC CHLORIDEEQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAP2024-04-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217626-001CUPRIC CHLORIDEEQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAP2024-04-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217626-001CUPRIC CHLORIDEEQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAP2024-04-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217626-001CUPRIC CHLORIDEEQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAP2024-04-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217626-001CUPRIC CHLORIDEEQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAP2024-04-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217626-001CUPRIC CHLORIDEEQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAP2024-04-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217626-001CUPRIC CHLORIDEEQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAP2024-04-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217626-001CUPRIC CHLORIDEEQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAP2024-04-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217626-001CUPRIC CHLORIDEEQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAP2024-04-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217626-001CUPRIC CHLORIDEEQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAP2024-04-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217626-001CUPRIC CHLORIDEEQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAP2024-04-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217626-001CUPRIC CHLORIDEEQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAP2024-04-308072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217626-001CUPRIC CHLORIDEEQ 0.4MG COPPER/MLINJECTABLE / INJECTIONAP2024-04-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A217626-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217626-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217626-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217626-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217626-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217626-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217626-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217626-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217626-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217626-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217626-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217626-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217626-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217626-001AP18072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217626-001AP1a50c72e98297…

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 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
77e9dd68-baed-4d62-9284-daecd995de2cAvailable on FDA.report

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

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CUPRIC CHLORIDECUPRIC CHLORIDERenova Pharmaceuticals LLC86bb8a4d-6896-4901-9390-c9a194b6f0cb2026-05-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217626
application number: ANDA217626
CUPRIC CHLORIDECUPRIC CHLORIDEArchis Pharma LLC45586a5f-4864-4b01-9211-002c775852492024-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217626
application number: ANDA217626
ndc (product): 72819-234
CUPRIC CHLORIDECUPRIC CHLORIDEArchis Pharma LLC77e9dd68-baed-4d62-9284-daecd995de2c2024-10-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217626
application number: ANDA217626
ndc (product): 72819-234
CUPRIC CHLORIDECUPRIC CHLORIDENorthstar Rx LLCdb988413-2998-4fc0-bcdf-11076256bf6e2024-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217626
application number: ANDA217626

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) 2024-07-05NoNoCurrent
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) 2024-10-01NoNoCurrent