FDA.reportPublic FDA data

NDC 0409-3397 - 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
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 2 of 3 · 58 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SODIUM BICARBONATESODIUM BICARBONATEProPharma Distribution3867f743-c2cf-a646-e063-6394a90a82e12025-12-18Warnings, Adverse reactionsName fallback
brand name: SODIUM BICARBONATE
Ascorbic AcidASCORBIC ACIDFresenius Kabi USA, LLC1606e29f-0e80-4069-b688-daab9cbff20a2025-12-17Warnings, Adverse reactionsName fallback
brand name: Ascorbic Acid
Sodium BicarbonateSODIUM BICARBONATECivicaa10fdfbc-94a0-49ab-b26c-de1df042bc892025-11-24Warnings, Adverse reactionsName fallback
brand name: Sodium Bicarbonate
SODIUM BICARBONATESODIUM BICARBONATEGlenmark Pharmaceuticals Inc., USAf38d0dfc-9bcc-4224-a202-885c9ad0beae2025-11-20Warnings, Adverse reactionsName fallback
brand name: SODIUM BICARBONATE
SODIUM BICARBONATESODIUM BICARBONATEHenry Schein, Inc.da484a2f-154f-48b4-8467-7a86729204c32025-11-07Warnings, Adverse reactionsName fallback
brand name: SODIUM BICARBONATE
Sodium BicarbonateSODIUM BICARBONATEHospira, Inc.ea20a5eb-641e-48cd-bcfa-74c04c45dfda2025-11-06Warnings, Adverse reactionsName fallback
brand name: Sodium Bicarbonate
GlycineGLYCINEICU Medical Inc.c10a4657-cf64-4a71-a247-363dd58993bc2025-10-21Warnings, Adverse reactionsName fallback
brand name: Glycine
Sodium BicarbonateSODIUM BICARBONATEFresenius Kabi USA, LLC0ab55004-bb63-436d-ad77-cd37969053702025-09-23Warnings, Adverse reactionsName fallback
brand name: Sodium Bicarbonate
Sodium BicarbonateSODIUM BICARBONATEProPharma Distribution3d71b046-3e0b-054a-e063-6294a90a563a2025-08-28Warnings, Adverse reactionsName fallback
brand name: Sodium Bicarbonate
Sodium BicarbonateSODIUM BICARBONATEBryant Ranch Prepackccf8e08c-2efb-4a92-a4c2-042dba2eacfa2025-08-13Warnings, Adverse reactionsName fallback
brand name: Sodium Bicarbonate
Sodium BicarbonateSODIUM BICARBONATEHenry Schein, Inc.ea9ad1a6-84f2-44d8-bf93-fb8f3d3fce9c2025-08-12Warnings, Adverse reactionsName fallback
brand name: Sodium Bicarbonate
Sodium BicarbonateSODIUM BICARBONATEWestminster Pharmaceuticals, LLC9dcfc778-5fd6-4c68-8d37-a5385e3746172025-07-08WarningsName fallback
brand name: Sodium Bicarbonate
SODIUM BICARBONATESODIUM BICARBONATEAnthea Pharma Private Limited0df8cf62-4b49-4ec4-aae4-c4a3e6d765492025-06-26Warnings, Adverse reactionsName fallback
brand name: SODIUM BICARBONATE
Sodium BicarbonateSODIUM BICARBONATEWorld Perfumes Inca83544e4-ec09-1e95-e053-2995a90ab7b92025-01-15WarningsName fallback
brand name: Sodium Bicarbonate
SODIUM BICARBONATESODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirst9545d58c-1c49-79b3-e053-2995a90a9d402025-01-08Warnings, Adverse reactionsName fallback
brand name: SODIUM BICARBONATE
Sodium BicarbonateSODIUM BICARBONATECardinal Health 107, LLCf7c88834-aa7c-4aaa-ab9b-0cbcd1f4da3f2024-11-07WarningsName fallback
brand name: Sodium Bicarbonate
Sodium BicarbonateSODIUM BICARBONATERising Pharma Holdings, Inc.f5a90c33-f29d-4d4b-b5e6-0b3c2514ce3e2024-11-01Boxed warning, WarningsName fallback
brand name: Sodium Bicarbonate
SODIUM BICARBONATESODIUM BICARBONATE INJECTION,Long Grove Pharmaceuticals, LLCa26d709b-b294-4b02-9a88-7e840f099a332024-09-25Warnings, Adverse reactionsName fallback
brand name: SODIUM BICARBONATE
SODIUM BICARBONATESODIUM BICARBONATESun Pharmaceutical Industries Limited5ae65432-04a1-4b6b-8536-2535064fc7822024-03-06Warnings, Adverse reactionsName fallback
brand name: SODIUM BICARBONATE
Sodium BicarbonateSODIUM BICARBONATESteriscience Specialties Private Limitedeb2996b4-c04c-4678-b8a9-5cbbe509bb702024-03-04Warnings, Adverse reactionsName fallback
brand name: Sodium Bicarbonate

Reported adverse events (FAERS/openFDA)#

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