Home NDC 0517-9310-25 Trace Elements 4
Product NDC 0517-9310
Requested package NDC 0517-9310-25
11-digit product format 005179310
Labeler code 0517
Product ID 0517-9310_a4c2c372-14d8-4887-a390-c9b6b7b387cf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trace Elements 4
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler American Regent, Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 1994-02-24
Marketing end 0000-00-00
Substance ZINC SULFATE HEPTAHYDRATE; CUPRIC SULFATE; MANGANESE SULFATE; CHROMIC CHLORIDE
Active strength 2 mg/mL; mg/mL; ug/mL; ug/mL
Pharmacologic classes Copper Absorption Inhibitor [EPC],Decreased Copper Ion Absorption [PE],Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CHROMIC CHLORIDE ACTIVE INGREDIENT KB1PCR9DMW TRACE ELEMENTS 4 INJECTION, SOLUTION [AMERICAN REGENT, INC.] 2 CUPRIC SULFATE ACTIVE INGREDIENT LRX7AJ16DT TRACE ELEMENTS 4 INJECTION, SOLUTION [AMERICAN REGENT, INC.] 2 MANGANESE SULFATE ACTIVE INGREDIENT W00LYS4T26 TRACE ELEMENTS 4 INJECTION, SOLUTION [AMERICAN REGENT, INC.] 2 ZINC SULFATE HEPTAHYDRATE ACTIVE INGREDIENT N57JI2K7WP TRACE ELEMENTS 4 INJECTION, SOLUTION [AMERICAN REGENT, INC.] 2 CHROMIC CATION ACTIVE MOIETY X1N4508KF1 TRACE ELEMENTS 4 INJECTION, SOLUTION [AMERICAN REGENT, INC.] 2 CUPRIC CATION ACTIVE MOIETY 8CBV67279L TRACE ELEMENTS 4 INJECTION, SOLUTION [AMERICAN REGENT, INC.] 2 MANGANESE CATION (2+) ACTIVE MOIETY H6EP7W5457 TRACE ELEMENTS 4 INJECTION, SOLUTION [AMERICAN REGENT, INC.] 2 ZINC CATION ACTIVE MOIETY 13S1S8SF37 TRACE ELEMENTS 4 INJECTION, SOLUTION [AMERICAN REGENT, INC.] 2 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH TRACE ELEMENTS 4 INJECTION, SOLUTION [AMERICAN REGENT, INC.] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I TRACE ELEMENTS 4 INJECTION, SOLUTION [AMERICAN REGENT, INC.] 2 SULFURIC ACID INACTIVE INGREDIENT O40UQP6WCF TRACE ELEMENTS 4 INJECTION, SOLUTION [AMERICAN REGENT, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R TRACE ELEMENTS 4 INJECTION, SOLUTION [AMERICAN REGENT, INC.] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0517-9310-25 00517931025 25 VIAL, MULTI-DOSE in 1 TRAY (0517-9310-25) > 10 mL in 1 VIAL, MULTI-DOSE 1994-02-24 0000-00-00 No No Current