FDA.reportPublic FDA data

NDC 55292-702-54 - Panhematin

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
55292-702
Requested NDC
55292-702-54
Package NDCs from labels
55292-702-54, 55292-702-55
Manufacturer
Recordati Rare Diseases, Inc.
Effective date
2026-02-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Panhematin - Recordati Rare Diseases, Inc.Recordati Rare Diseases, Inc.2026-02-26HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-01-30These highlights do not include all the information needed to use PANHEMATIN safely and effectively. See full prescribing information for PANHEMATIN. PANHEMATIN ® (hemin for injection) For intravenous infusion only. Initial U.S. Approval: 1983
2024-01-30These highlights do not include all the information needed to use PANHEMATIN safely and effectively. See full prescribing information for PANHEMATIN. PANHEMATIN ® (hemin for injection) For intravenous infusion only. Initial U.S. Approval: 1983
2021-04-02These highlights do not include all the information needed to use PANHEMATIN safely and effectively. See full prescribing information for PANHEMATIN. PANHEMATIN ® (hemin for injection) For intravenous infusion only. Initial U.S. Approval: 1983
2021-04-02These highlights do not include all the information needed to use PANHEMATIN safely and effectively. See full prescribing information for PANHEMATIN. PANHEMATIN ® (hemin for injection) For intravenous infusion only. Initial U.S. Approval: 1983
2020-09-27These highlights do not include all the information needed to use PANHEMATIN safely and effectively. See full prescribing information for PANHEMATIN. PANHEMATIN ® (hemin for injection) For intravenous infusion only. Initial U.S. Approval: 1983
2020-09-27These highlights do not include all the information needed to use PANHEMATIN safely and effectively. See full prescribing information for PANHEMATIN. PANHEMATIN ® (hemin for injection) For intravenous infusion only. Initial U.S. Approval: 1983
2020-09-25These highlights do not include all the information needed to use PANHEMATIN safely and effectively. See full prescribing information for PANHEMATIN. PANHEMATIN ® (hemin for injection) For intravenous infusion only. Initial U.S. Approval: 1983
2020-09-25These highlights do not include all the information needed to use PANHEMATIN safely and effectively. See full prescribing information for PANHEMATIN. PANHEMATIN ® (hemin for injection) For intravenous infusion only. Initial U.S. Approval: 1983
2020-07-22These highlights do not include all the information needed to use PANHEMATIN safely and effectively. See full prescribing information for PANHEMATIN. PANHEMATIN ® (hemin for injection) For intravenous infusion only. Initial U.S. Approval: 1983
2020-07-22These highlights do not include all the information needed to use PANHEMATIN safely and effectively. See full prescribing information for PANHEMATIN. PANHEMATIN ® (hemin for injection) For intravenous infusion only. Initial U.S. Approval: 1983

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55292-702-54Panhematin48 mL in 1 VIALPOWDER, FOR SOLUTION4816
55292-702-55Panhematin1 in 1 CARTONPOWDER, FOR SOLUTION116

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55292-702PANHEMATIN (HEMIN) POWDER, FOR SOLUTION [RECORDATI RARE DISEASES, INC.]12Current NDC, Legacy NDC, 2 package rows20240613_9984267a-4d57-4444-9bb5-16bca7dea691.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55292-702-54EA - Each55292-7028a530981-0d59-4dfb-a0e1-d454735e0af112017-07-07
55292-702-55EA - Each55292-7024eda9ed9-6174-4634-8c92-8fa8397edb5a12017-07-07

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 8 · 147 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PanhematinHEMINRecordati Rare Diseases, Inc.9984267a-4d57-4444-9bb5-16bca7dea6912026-02-26Warnings, Adverse reactionsExact identifier
application number: BLA101246
ndc (package): 55292-702-54
ndc (package): 55292-702-55
ndc (product): 55292-702
ndc11 (package): 55292070254
rxcui: 1926452
rxcui: 1926454
spl id: ff0139fe-eb46-4d22-95f1-849de7ce9462
spl set id: 9984267a-4d57-4444-9bb5-16bca7dea691
unii: 743LRP9S7N
Organophosphate Combination 9309ORGANOPHOSPHATE COMBINATIONProfessional Complementary Health Formulasf777015f-1df6-4821-af63-543175313aba2026-01-08WarningsExact identifier
unii: 45P3261C7T
Energy Regulation Combination 9308ENERGY REGULATION COMBINATIONProfessional Complementary Health Formulasb091febb-f18f-46d1-8bb8-d911de4c89352026-01-08WarningsExact identifier
unii: 45P3261C7T
Spa/Pool Detox 6027SPA/POOL DETOXProfessional Complementary Health Formulas14b8fca2-089d-44f7-8b70-ee877c8f7af12026-01-08WarningsExact identifier
unii: 45P3261C7T
Large Ring Combination 9302LARGE RING COMBINATIONProfessional Complementary Health Formulascced8a69-7bc0-42ad-b80a-58fc603bf7652026-01-08WarningsExact identifier
unii: 45P3261C7T
Genital Nosode Combination 9406GENITAL NOSODE COMBINATIONProfessional Complementary Health Formulas7acd5972-e8cc-4113-b719-587b5289487f2026-01-08WarningsExact identifier
unii: 45P3261C7T
Domestic Animals Nosode Combination 9407DOMESTIC ANIMALS NOSODE COMBINATIONProfessional Complementary Health Formulas222c28aa-e07b-4706-9fb5-585b190f1c5b2026-01-08WarningsExact identifier
unii: 45P3261C7T
Endotoxin Terrain Drops 2143ENDOTOXIN TERRAIN DROPSProfessional Complementary Health Formulas58842566-005a-48b5-973d-20cde2fbd7012026-01-08WarningsExact identifier
unii: QTT17582CB
Nitrogen Combination 9310NITROGEN COMBINATIONProfessional Complementary Health Formulas72a7c0f3-0a57-4aa8-8fe8-a3267b9acd532026-01-08WarningsExact identifier
unii: 45P3261C7T
Pneumonia/Meningitis Nosode Combination 9414PNEUMONIA/MENINGITIS NOSODE COMBINATIONProfessional Complementary Health Formulas823de3e3-4d20-446c-988d-d7a70a747f9a2026-01-08WarningsExact identifier
unii: 45P3261C7T
Organic Acid Combination 9305ORGANIC ACID COMBINATIONProfessional Complementary Health Formulasf2e752c9-2cf1-4511-bf07-5cf422af759c2026-01-08WarningsExact identifier
unii: 45P3261C7T
Glyoxal Combination 9303GLYOXAL COMBINATIONProfessional Complementary Health Formulasb392b61f-9bfb-4296-b99d-41f1101d26e52026-01-08WarningsExact identifier
unii: 45P3261C7T
Glycerin Combination 9304GLYCERIN COMBINATIONProfessional Complementary Health Formulas391d8517-9b89-4b62-97b5-5102b35bec462026-01-08WarningsExact identifier
unii: 45P3261C7T
Bridged Ring Combination 9311BRIDGED RING COMBINATIONProfessional Complementary Health Formulasb4033f70-d974-493d-8ded-eaa3240bdac52026-01-08WarningsExact identifier
unii: 45P3261C7T
Thio Combination 9306THIO COMBINATIONProfessional Complementary Health Formulas36e84795-bfb4-4483-9a2c-e14131ce1bea2026-01-08WarningsExact identifier
unii: 45P3261C7T
Abdominal Pain Drops 2051ABDOMINAL PAIN DROPSProfessional Complementary Health Formulasf1b1dde6-bb37-4774-a58c-b4f648f9c2b52026-01-08WarningsExact identifier
unii: QTT17582CB
Uric Acid Combination 9307URIC ACID COMBINATIONProfessional Complementary Health Formulas3f136f86-a9ed-4a04-98cb-81abe33cd1812026-01-08WarningsExact identifier
unii: 45P3261C7T
Fertility Drops 2174FERTILITY DROPSProfessional Complementary Health Formulas78985992-bb47-4045-82f3-a6094e48d50a2026-01-08WarningsExact identifier
unii: 45P3261C7T
GeriCare Sorbitol SolutionSORBITOLGERI-CARE PHARMACEUTICALS, CORPb4dd7a41-380e-d94b-e053-2a95a90ac34a2025-12-31WarningsExact identifier
unii: 506T60A25R
HepatatoxTRITICUM AESTIVUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, GLUTATHIONE, HEPAR SUIS, THYROIDINUM (SUIS), LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, ADRENOCORTICOTROPHIN, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM, PHENYL BUTAZONE, PETROLEUM JELLY, PLUMBUM METALLICUMBioActive Nutritional, Inca113a9f1-4792-41a5-8d1b-a6756f356e152025-12-18WarningsExact identifier
unii: 506T60A25R

Reported adverse events (FAERS/openFDA)#

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