Home NDC 51754-0103 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212071-001 CUPRIC CHLORIDE CUPRIC CHLORIDE EQ 0.4MG COPPER/ML INJECTABLE / INJECTION AP 2022-10-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212071-001 AP
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A212071-001 CUPRIC CHLORIDE EQ 0.4MG COPPER/ML INJECTABLE / INJECTION AP 2022-10-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A212071-001 CUPRIC CHLORIDE EQ 0.4MG COPPER/ML INJECTABLE / INJECTION AP 2022-10-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212071-001 CUPRIC CHLORIDE EQ 0.4MG COPPER/ML INJECTABLE / INJECTION AP 2022-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212071-001 CUPRIC CHLORIDE EQ 0.4MG COPPER/ML INJECTABLE / INJECTION AP 2022-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212071-001 CUPRIC CHLORIDE EQ 0.4MG COPPER/ML INJECTABLE / INJECTION AP 2022-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212071-001 CUPRIC CHLORIDE EQ 0.4MG COPPER/ML INJECTABLE / INJECTION AP 2022-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212071-001 CUPRIC CHLORIDE EQ 0.4MG COPPER/ML INJECTABLE / INJECTION AP 2022-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212071-001 CUPRIC CHLORIDE EQ 0.4MG COPPER/ML INJECTABLE / INJECTION AP 2022-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212071-001 CUPRIC CHLORIDE EQ 0.4MG COPPER/ML INJECTABLE / INJECTION AP 2022-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212071-001 CUPRIC CHLORIDE EQ 0.4MG COPPER/ML INJECTABLE / INJECTION AP 2022-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212071-001 CUPRIC CHLORIDE EQ 0.4MG COPPER/ML INJECTABLE / INJECTION AP 2022-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212071-001 CUPRIC CHLORIDE EQ 0.4MG COPPER/ML INJECTABLE / INJECTION AP 2022-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212071-001 CUPRIC CHLORIDE EQ 0.4MG COPPER/ML INJECTABLE / INJECTION AP 2022-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212071-001 CUPRIC CHLORIDE EQ 0.4MG COPPER/ML INJECTABLE / INJECTION AP 2022-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212071-001 CUPRIC CHLORIDE EQ 0.4MG COPPER/ML INJECTABLE / INJECTION AP 2022-10-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212071-001 CUPRIC CHLORIDE EQ 0.4MG COPPER/ML INJECTABLE / INJECTION AP 2022-10-31 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212071-001 CUPRIC CHLORIDE EQ 0.4MG COPPER/ML INJECTABLE / INJECTION AP 2022-10-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212071-001 CUPRIC CHLORIDE EQ 0.4MG COPPER/ML INJECTABLE / INJECTION AP 2022-10-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212071-001 CUPRIC CHLORIDE EQ 0.4MG COPPER/ML INJECTABLE / INJECTION AP 2022-10-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212071-001 CUPRIC CHLORIDE EQ 0.4MG COPPER/ML INJECTABLE / INJECTION AP 2022-10-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212071-001 CUPRIC CHLORIDE EQ 0.4MG COPPER/ML INJECTABLE / INJECTION AP 2022-10-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212071-001 CUPRIC CHLORIDE EQ 0.4MG COPPER/ML INJECTABLE / INJECTION AP 2022-10-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212071-001 CUPRIC CHLORIDE EQ 0.4MG COPPER/ML INJECTABLE / INJECTION AP 2022-10-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212071-001 CUPRIC CHLORIDE EQ 0.4MG COPPER/ML INJECTABLE / INJECTION AP 2022-10-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212071-001 CUPRIC CHLORIDE EQ 0.4MG COPPER/ML INJECTABLE / INJECTION AP 2022-10-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212071-001 CUPRIC CHLORIDE EQ 0.4MG COPPER/ML INJECTABLE / INJECTION AP 2022-10-31 3a93d1ddd44b…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212071-001 CUPRIC CHLORIDE EQ 0.4MG COPPER/ML INJECTABLE / INJECTION AP 2022-10-31 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base CUPRIC CHLORIDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CUPRIC CHLORIDE .4 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination S2QG84156O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 204536 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51754-0103-3 CUPRIC CHLORIDE 10 in 1 CARTON INJECTION, SOLUTION 10 1 51754-0103-3 CUPRIC CHLORIDE 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 1 51754-0103-4 CUPRIC CHLORIDE 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 1 51754-0103-4 CUPRIC CHLORIDE 25 in 1 CARTON INJECTION, SOLUTION 25 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51754-0103 CUPRIC CHLORIDE INJECTION, SOLUTION [EXELA PHARMA SCIENCES, LLC] 1 Current NDC, 4 package rows 20230810_daaa6f3a-148e-4f1c-bd44-bb2242145b88.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 51754-0103-3 51754010303 10 VIAL, SINGLE-DOSE in 1 CARTON (51754-0103-3) / 10 mL in 1 VIAL, SINGLE-DOSE 2023-02-01 No No Current 51754-0103-4 51754010304 25 VIAL, SINGLE-DOSE in 1 CARTON (51754-0103-4) / 10 mL in 1 VIAL, SINGLE-DOSE 2023-02-01 No No Current