Home NDC 65219-088 Gadoterate Meglumine
Product NDC 65219-088
11-digit product format 652190088
Labeler code 65219
Product ID 65219-088_8b9a98ef-bee6-43fc-a39d-2e5a3c226653
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name gadoterate meglumine
Dosage form INJECTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA215982
Marketing category ANDA
Marketing start 2022-06-20
Substance GADOTERATE MEGLUMINE
Active strength 376.9 mg/mL
Pharmacologic classes Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 65219-088 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 65219-088 65219-088-50 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog .
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 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215982-001 GADOTERATE MEGLUMINE 37.69GM/100ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-15 5c6f7cd8ea54…2023-01-26 05:58 UTC 2023-01 A215982-001 GADOTERATE MEGLUMINE 37.69GM/100ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215982-001 GADOTERATE MEGLUMINE 37.69GM/100ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215982-001 GADOTERATE MEGLUMINE 37.69GM/100ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215982-001 GADOTERATE MEGLUMINE 37.69GM/100ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215982-001 GADOTERATE MEGLUMINE 37.69GM/100ML (376.9MG/ML) SOLUTION / INTRAVENOUS AP 2022-04-15 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Gadoterate Meglumine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GADOTERATE MEGLUMINE 376.9 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L0ND3981AG Internal UNII 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 65219-088-06 Gadoterate Meglumine 1 in 1 CARTON INJECTION 1 2 65219-088-06 Gadoterate Meglumine 100 mL in 1 VIAL INJECTION 100 2 65219-088-50 Gadoterate Meglumine 6 in 1 BOX INJECTION 6 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65219-088 GADOTERATE MEGLUMINE INJECTION [FRESENIUS KABI USA, LLC] 3 Current NDC, Legacy NDC 20240217_e0655aac-9508-4141-94f5-fcca6af1c41d.zip 65219-088 GADOTERATE MEGLUMINE INJECTION [FRESENIUS KABI USA, LLC] 1 Current NDC, Legacy NDC, 3 package rows 20220629_fbebe7f2-a0c2-4fd5-b421-8fbcbaf46709.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65219-088-06 65219008806 1 in 1 CARTON Historical 65219-088-50 65219008850 6 CARTON in 1 BOX (65219-088-50) / 1 VIAL in 1 CARTON (65219-088-06) / 100 mL in 1 VIAL 6 carton 2022-06-20 0000-00-00 No No Current