FDA.reportPublic FDA data

NDC 0409-3397-52 - NeutroSpec

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0409-3397
Requested NDC
0409-3397-52
Package NDCs from labels
0409-3397-52
Manufacturer
Mallinckrodt Inc.
Effective date
2007-10-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
NEUTROSPEC TM Kit for the Preparation of Technetium (99m Tc) fanolesomabMallinckrodt Inc.2007-10-01HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-3397-52NeutroSpec2 mL in 1 AMPULEINJECTION, SOLUTION2 mL500 mg in 1mL1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-3397NEUTROSPEC (TECHNETIUM (99M TC) FANOLESOMAB) [MALLINCKRODT INC.]1Unmatched20071101_af67a2f3-65b7-4a6e-9a51-315a280f976b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FanolesomabACTIVE INGREDIENT67ETM2384NNEUTROSPEC (TECHNETIUM (99M TC) FANOLESOMAB) [MALLINCKRODT INC.]1
Sodium AscorbateACTIVE INGREDIENTS033EH8359NEUTROSPEC (TECHNETIUM (99M TC) FANOLESOMAB) [MALLINCKRODT INC.]1
Ascorbic acidACTIVE MOIETYPQ6CK8PD0RNEUTROSPEC (TECHNETIUM (99M TC) FANOLESOMAB) [MALLINCKRODT INC.]1
FanolesomabACTIVE MOIETY67ETM2384NNEUTROSPEC (TECHNETIUM (99M TC) FANOLESOMAB) [MALLINCKRODT INC.]1
aluminumINACTIVE INGREDIENTNEUTROSPEC (TECHNETIUM (99M TC) FANOLESOMAB) [MALLINCKRODT INC.]1
disodium edetate dihydrateINACTIVE INGREDIENTNEUTROSPEC (TECHNETIUM (99M TC) FANOLESOMAB) [MALLINCKRODT INC.]1
glycineINACTIVE INGREDIENTTE7660XO1CNEUTROSPEC (TECHNETIUM (99M TC) FANOLESOMAB) [MALLINCKRODT INC.]1
maltose monohydrateINACTIVE INGREDIENTNEUTROSPEC (TECHNETIUM (99M TC) FANOLESOMAB) [MALLINCKRODT INC.]1
sodium bicarbonateINACTIVE INGREDIENT8MDF5V39QONEUTROSPEC (TECHNETIUM (99M TC) FANOLESOMAB) [MALLINCKRODT INC.]1
sodium hydrosulfiteINACTIVE INGREDIENTNEUTROSPEC (TECHNETIUM (99M TC) FANOLESOMAB) [MALLINCKRODT INC.]1
sodium potassium tartrate tetrahydrateINACTIVE INGREDIENTNEUTROSPEC (TECHNETIUM (99M TC) FANOLESOMAB) [MALLINCKRODT INC.]1
stannous tartrateINACTIVE INGREDIENTNEUTROSPEC (TECHNETIUM (99M TC) FANOLESOMAB) [MALLINCKRODT INC.]1
succinic acidINACTIVE INGREDIENTAB6MNQ6J6LNEUTROSPEC (TECHNETIUM (99M TC) FANOLESOMAB) [MALLINCKRODT INC.]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 3 of 3 · 58 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium BicarbonateSODIUM BICARBONATEBryant Ranch Prepack4493d7c5-f2c3-416e-a5c1-35398fc7f61d2024-02-29Boxed warning, WarningsName fallback
brand name: Sodium Bicarbonate
SODIUM BICARBONATESODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirsta5eedf57-2783-b3d0-e053-2a95a90a9ff52024-02-22Warnings, Adverse reactionsName fallback
brand name: SODIUM BICARBONATE
SODIUM BICARBONATESODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirst76131655-3a87-feac-e053-2991aa0a82a12024-01-28Warnings, Adverse reactionsName fallback
brand name: SODIUM BICARBONATE
Sodium BicarbonateSODIUM BICARBONATEPharma Nobis, LLCe42f674b-1a70-6a3c-e053-2995a90afa722023-12-22WarningsName fallback
brand name: Sodium Bicarbonate
Sodium BicarbonateSODIUM BICARBONATEA-S Medication Solutionsd89406d3-4356-4a8c-acc1-89efe1d270102023-11-14Warnings, Adverse reactionsName fallback
brand name: Sodium Bicarbonate
Sodium BicarbonateSODIUM BICARBONATEMedical Purchasing Solutions, LLC09cf38c2-0b44-eca1-e063-6294a90a72d82023-11-10Warnings, Adverse reactionsName fallback
brand name: Sodium Bicarbonate
Sodium BicarbonateSODIUM BICARBONATEAPNAR PHARMA LPe206c240-55c2-2d00-e053-2a95a90a17792023-10-21Boxed warning, WarningsName fallback
brand name: Sodium Bicarbonate
Sodium BicarbonateSODIUM BICARBONATEOMNIVIUM PHARMACEUTICALS LLC.aea54f8d-1cdd-4a5c-a2f7-7317ae4c8fbc2023-08-10Warnings, Adverse reactionsName fallback
brand name: Sodium Bicarbonate
Sodium BicarbonateSODIUM BICARBONATEA-S Medication Solutions619cb558-84e5-43ea-91e9-28c764f9f9c02023-06-21Warnings, Adverse reactionsName fallback
brand name: Sodium Bicarbonate
Sodium BicarbonateSODIUM BICARBONATEMedical Purchasing Solutions, LLCb620938d-ab2d-0934-e053-2a95a90a84832023-05-23Warnings, Adverse reactionsName fallback
brand name: Sodium Bicarbonate
Sodium BicarbonateSODIUM BICARBONATEMedical Purchasing Solutions, LLCd1636b56-ad83-4439-e053-2a95a90a135e2023-05-02Warnings, Adverse reactionsName fallback
brand name: Sodium Bicarbonate
Sodium BicarbonateSODIUM BICARBONATEInternational Medication Systems, Limited77698221-a01d-4568-a7bc-d3d4e982875d2021-12-15Warnings, Adverse reactionsName fallback
brand name: Sodium Bicarbonate
SODIUM BICARBONATESODIUM BICARBONATEMedical Purchasing Solutions, LLCbfc9c321-665c-ca97-e053-2995a90a79542021-04-12Warnings, Adverse reactionsName fallback
brand name: SODIUM BICARBONATE
GlycineGLYCINEB. Braun Medical Inc.f4d83550-42de-44c7-b8d5-1d0debc6aec22021-04-01Warnings, Adverse reactionsName fallback
brand name: Glycine
GlycineGLYCINEBaxter Healthcare Corporationd4665408-04d8-4ad7-8589-708d4defb8692018-01-02Warnings, Adverse reactionsName fallback
brand name: Glycine
SODIUM BICARBONATESODIUM BICARBONATEAphena Pharma Solutions - Tennessee, LLC15605a6d-6c90-47d5-9d1f-f66a3f27d5fc2017-12-13WarningsName fallback
brand name: SODIUM BICARBONATE
SODIUM BICARBONATESODIUM BICARBONATERichmond Pharmaceuticals, Inc.fa10d93d-b3ed-4675-a117-f573d9e72bca2017-10-30WarningsName fallback
brand name: SODIUM BICARBONATE
Sodium BicarbonateSODIUM BICARBONATEExela Pharma Sciences, LLCe9698a4f-1a95-4f28-a945-e8009d1d6dd42017-09-27Warnings, Adverse reactionsName fallback
brand name: Sodium Bicarbonate

Reported adverse events (FAERS/openFDA)#

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