FDA.reportPublic FDA data

Panhematin

Product NDC
55292-702
Requested package NDC
55292-702-55
11-digit product format
552920702
Labeler code
55292
Product ID
55292-702_ff0139fe-eb46-4d22-95f1-849de7ce9462
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hemin
Dosage form
POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Recordati Rare Diseases, Inc.
Application
BLA101246
Marketing category
BLA
Marketing start
1983-07-20
Substance
HEMIN
Active strength
7 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage55292-70255292-702-55IInactivated by FDAexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HEMIN7 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
743LRP9S7NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1926452Internal RxNorm lookup
1926454Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9984267a-4d57-4444-9bb5-16bca7dea691Available on FDA.report

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
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
2020-09-25These 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

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 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

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

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
PanhematinHEMINRecordati Rare Diseases, Inc.9984267a-4d57-4444-9bb5-16bca7dea6912026-02-26Warnings, Adverse reactionsExact identifier
application number: BLA101246
ndc (package): 55292-702-55
ndc (product): 55292-702
ndc11 (package): 55292070255

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
101246PanhematinHemin for Injection351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1926452hemin 350 MG InjectionPSN9984267a-4d57-4444-9bb5-16bca7dea69116
1926454Panhematin 350 MG InjectionPSN9984267a-4d57-4444-9bb5-16bca7dea69116
1926454hemin 350 MG Injection [Panhematin]SBD9984267a-4d57-4444-9bb5-16bca7dea69116
1926452hemin 350 MG InjectionSCD9984267a-4d57-4444-9bb5-16bca7dea69116
1926454Panhematin 350 MG InjectionSY9984267a-4d57-4444-9bb5-16bca7dea69116

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55292-702-55552920702551 VIAL in 1 CARTON (55292-702-55) / 48 mL in 1 VIAL (55292-702-54) 1 vial1983-07-200000-00-00NoNoCurrent