MANGANESE

Product NDC
0409-4091
11-digit product format
004094091
Labeler code
0409
Product ID
0409-4091_b418544e-41b6-45b9-a581-4b6ee020c64e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MANGANESE CHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA018962
Marketing category
NDA
Marketing start
2005-01-31
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINERMANGANESE CHLORIDEEQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N018962-001AP

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-2684e616aacf4f…
2026-08-18 06:07:402026-07N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONAPRLD, RS1986-06-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONRLD, RS1986-06-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONRLD, RS1986-06-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONRLD, RS1986-06-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONRLD, RS1986-06-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONRLD, RS1986-06-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONRLD, RS1986-06-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONRLD, RS1986-06-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONRLD, RS1986-06-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONRLD, RS1986-06-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONRLD, RS1986-06-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONRLD, RS1986-06-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONRLD, RS1986-06-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONRLD, RS1986-06-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONRLD, RS1986-06-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONRLD, RS1986-06-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONRLD, RS1986-06-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONRLD, RS1986-06-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONRLD, RS1986-06-2687673890dc5c…
2021-03-12 10:30 UTC2021-03N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONRLD, RS1986-06-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONRLD, RS1986-06-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONRLD, RS1986-06-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONRLD, RS1986-06-263f01610625f2…
2019-09-15 20:21 UTC2019-09N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONRLD, RS1986-06-26b00525d2431f…
2019-07-19 19:46 UTC2019-07N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONRLD, RS1986-06-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONRLD, RS1986-06-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONRLD, RS1986-06-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONRLD, RS1986-06-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONRLD, RS1986-06-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONRLD, RS1986-06-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONRLD, RS1986-06-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONRLD, RS1986-06-263f0d92c62455…
2023-05-13 08:27 UTC2023-05N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONRLD, RS1986-06-26053a50430f4f…
2023-01-26 05:58 UTC2023-01N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONRLD, RS1986-06-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONRLD, RS1986-06-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018962-001MANGANESE CHLORIDE IN PLASTIC CONTAINEREQ 0.1MG MANGANESE/MLINJECTABLE / INJECTIONRLD, RS1986-06-26f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N018962-001AP184e616aacf4f…
2026-08-18 06:07:402026-07N018962-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018962-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018962-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018962-001AP16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N018962-001AP1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
MANGANESE
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
QQE170PANOInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
237521Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6e979070-5035-4076-e09c-b52466be3c68Available on FDA.report

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
0409-4091-01MANGANESE25 in 1 TRAYINJECTION, SOLUTION2520
0409-4091-11MANGANESE10 mL in 1 VIAL, PLASTICINJECTION, SOLUTION1020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-4091-01ML - Milliliter0409-4091844311ae-ab80-4d8b-a044-2ffbb1f3b72f12012-07-24
0409-4091-11ML - Milliliter0409-4091e37e6734-d382-42d0-a360-f941d35cbe0412019-07-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-4091MANGANESE (MANGANESE CHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]19Current NDC, Legacy NDC, 2 package rows20241018_6e979070-5035-4076-e09c-b52466be3c68.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MANGANESEMANGANESE CHLORIDEHospira, Inc.6e979070-5035-4076-e09c-b52466be3c682026-04-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 018962
application number: NDA018962
ndc (product): 0409-4091

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
237521manganese 1 MG in 10 ML InjectionPSN6e979070-5035-4076-e09c-b52466be3c6820
23752110 ML manganese chloride 0.1 MG/ML InjectionSCD6e979070-5035-4076-e09c-b52466be3c6820
237521manganese 1 MG (as manganese chloride 3.6 MG) per 10 ML InjectionSY6e979070-5035-4076-e09c-b52466be3c6820

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-4091-010040940910125 VIAL, PLASTIC in 1 TRAY (0409-4091-01) / 10 mL in 1 VIAL, PLASTIC (0409-4091-11) 2005-01-310000-00-00NoNoCurrent
0409-4091-110040940911110 mL in 1 VIAL, PLASTIC10 mlHistorical