Home NDC 65219-530 Manganese
Product NDC 65219-530
11-digit product format 652190530
Labeler code 65219
Product ID 65219-530_456e609b-571c-4266-949c-5abbb71049e3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Manganese
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA217583
Marketing category ANDA
Marketing start 2025-11-17
Substance MANGANESE CHLORIDE
Active strength .1 mg/mL
Pharmacologic classes Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]
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 42 .
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 A217583-001 MANGANESE CHLORIDE MANGANESE CHLORIDE EQ 0.1MG MANGANESE/ML INJECTABLE / INJECTION AP 2025-07-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217583-001 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 2026-08-18 06:07:40 2026-07 A217583-001 MANGANESE CHLORIDE EQ 0.1MG MANGANESE/ML INJECTABLE / INJECTION AP 2025-07-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217583-001 MANGANESE CHLORIDE EQ 0.1MG MANGANESE/ML INJECTABLE / INJECTION AP 2025-07-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217583-001 MANGANESE CHLORIDE EQ 0.1MG MANGANESE/ML INJECTABLE / INJECTION AP 2025-07-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217583-001 MANGANESE CHLORIDE EQ 0.1MG MANGANESE/ML INJECTABLE / INJECTION AP 2025-07-07 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217583-001 MANGANESE CHLORIDE EQ 0.1MG MANGANESE/ML INJECTABLE / INJECTION AP 2025-07-07 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Manganese
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MANGANESE CHLORIDE .1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination QQE170PANO Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 237521 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 65219-530-02 Manganese 10 mL in 1 VIAL, PLASTIC INJECTION, SOLUTION 10 1 65219-530-10 Manganese 25 in 1 TRAY INJECTION, SOLUTION 25 1
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 65219-530-02 65219053002 10 mL in 1 VIAL, PLASTIC 10 ml Historical 65219-530-10 65219053010 25 VIAL, PLASTIC in 1 TRAY (65219-530-10) / 10 mL in 1 VIAL, PLASTIC (65219-530-02) 2025-11-17 No No Current