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

Additional Listing Data#

Finished product
Yes
Brand name base
Manganese
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MANGANESE CHLORIDE.1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQQE170PANO
Rxcui237521

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-530-02Manganese10 mL in 1 VIAL, PLASTICINJECTION, SOLUTION101
65219-530-10Manganese25 in 1 TRAYINJECTION, SOLUTION251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-530-02ML - Milliliter65219-53023cf0e6e-5ac0-4226-8b2a-8918acea427812025-12-16
65219-530-10ML - Milliliter65219-53006d3d1ef-f547-4b3b-867a-0716c99b993212025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
237521manganese 1 MG in 10 ML InjectionPSN6feb30f0-8b6e-4729-8618-907baf29a2c71
23752110 ML manganese chloride 0.1 MG/ML InjectionSCD6feb30f0-8b6e-4729-8618-907baf29a2c71
237521manganese 1 MG (as manganese chloride 3.6 MG) per 10 ML InjectionSY6feb30f0-8b6e-4729-8618-907baf29a2c71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65219-530-026521905300210 mL in 1 VIAL, PLASTIC10 mlHistorical
65219-530-106521905301025 VIAL, PLASTIC in 1 TRAY (65219-530-10) / 10 mL in 1 VIAL, PLASTIC (65219-530-02) 2025-11-17NoNoHistorical