Home NDC 80830-2301 CUPRIC CHLORIDE
Product NDC 80830-2301
11-digit product format 808302301
Labeler code 80830
Product ID 80830-2301_0483ece7-d1e5-4787-a73e-1b41c75f26a7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CUPRIC CHLORIDE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Amneal Pharmaceuticals Private Limited
Application ANDA217287
Marketing category ANDA
Marketing start 2026-01-29
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217287-001 CUPRIC CHLORIDE CUPRIC CHLORIDE EQ 0.4MG COPPER/ML INJECTABLE / INJECTION 2026-01-26
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 2026-02-19 14:30 UTC 2026-02 A217287-001 CUPRIC CHLORIDE EQ 0.4MG COPPER/ML INJECTABLE / INJECTION AP 2026-01-26 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217287-001 CUPRIC CHLORIDE EQ 0.4MG COPPER/ML INJECTABLE / INJECTION 2026-01-26 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A217287-001 AP 1 011fe1cb6892…
Additional Listing Data#
Finished product Yes
Brand name base CUPRIC CHLORIDE
Listing expiration 2027-12-31 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 80830-2301-1 CUPRIC CHLORIDE 10 mL in 1 VIAL INJECTION, SOLUTION 10 9 80830-2301-5 CUPRIC CHLORIDE 25 in 1 CARTON INJECTION, SOLUTION 25 9
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 Units Marketing start Sample Exclude flag Status 80830-2301-1 80830230101 10 mL in 1 VIAL 10 ml Historical 80830-2301-5 80830230105 25 VIAL in 1 CARTON (80830-2301-5) / 10 mL in 1 VIAL (80830-2301-1) 25 vial 2026-01-29 No No Current