FDA.reportPublic FDA data

NDC 72162-2464-02 - Mitomycin

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
72162-2464
Requested NDC
72162-2464-02
Package NDCs from labels
72162-2464-2, 72162-2464-02
Manufacturer
Bryant Ranch Prepack
Effective date
2025-03-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Mitomycin - Bryant Ranch PrepackBryant Ranch Prepack2025-03-06HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2464-2Mitomycin1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1100
72162-2464-2Mitomycin10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,10100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2464MITOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BRYANT RANCH PREPACK]100Current NDC, 2 package rows20250309_799a06b1-7697-42a3-b31a-c9d621b34f6f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2464-2EA - Each72162-24649678cca6-ed6a-45b9-b14a-66f2687cda6c12025-05-14

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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MitomycinMITOMYCINHikma Pharmaceuticals USA Inc.5917f7a7-cd20-407b-8dda-9fd58c5f47a62026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1740898
rxcui: 1740900
unii: 50SG953SK6
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
unii: 3OWL53L36A
MitomycinMITOMYCINBryant Ranch Prepack5f41676f-f687-47db-871c-35bbf2447a982025-11-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202670
rxcui: 1740894
unii: 50SG953SK6
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MitomycinMITOMYCINAccord Healthcare, Inc.ff676355-313d-4575-8f2f-e4a1e95274772025-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1740898
rxcui: 1740894
rxcui: 1740900
unii: 50SG953SK6
MUTAMYCINMITOMYCINAccord BioPharma Inc.cbf0f6ba-3a53-4791-9a85-5c6b271eeb8e2025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1740898
rxcui: 1740894
rxcui: 1740900
unii: 50SG953SK6
MitomycinMITOMYCINBryant Ranch Prepack799a06b1-7697-42a3-b31a-c9d621b34f6f2025-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202670
ndc (package): 72162-2464-2
ndc (product): 72162-2464
ndc11 (package): 72162246402
rxcui: 1740894
spl id: 5344ba2c-faed-481f-9230-722e9854fd2f
spl set id: 799a06b1-7697-42a3-b31a-c9d621b34f6f
unii: 50SG953SK6
MITOMYCINMITOMYCINBluePoint Laboratories57129df7-d6b1-419e-90ec-54f9b5182e7c2024-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1740898
rxcui: 1740894
rxcui: 1740900
unii: 50SG953SK6
MANNITOLMANNITOLHF Acquisition Co LLC, DBA HealthFirst999ce711-2d5b-0d7d-e053-2995a90a26892024-01-27Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MITOMYCINMITOMYCINEugia US LLCf5a010cf-5954-4e6d-acfa-fb414efdf4712023-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1740898
rxcui: 1740894
rxcui: 1740900
unii: 50SG953SK6
MitomycinMITOMYCINArchis Pharma LLCcef5026c-8bc3-4428-a178-6effff4dcb3f2023-09-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202670
ndc (product): 72819-152
rxcui: 1740894
spl id: 05e37cd7-f0c4-3bde-e063-6294a90a2acf
spl set id: cef5026c-8bc3-4428-a178-6effff4dcb3f
unii: 50SG953SK6
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MitomycinMITOMYCINArchis Pharma LLC2ecd0f9c-0980-4ac5-bd1b-0a0aee799b6f2023-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202670
ndc (product): 72819-152
rxcui: 1740898
rxcui: 1740894
rxcui: 1740900
spl id: fd60f15a-95d0-b4ae-e053-6394a90a355c
spl set id: 2ecd0f9c-0980-4ac5-bd1b-0a0aee799b6f
unii: 50SG953SK6
MitomycinMITOMYCINSagent Pharmaceuticals10c41a58-c305-4240-80d2-caa0704126482023-05-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1740894
rxcui: 1740900
unii: 50SG953SK6

Reported adverse events (FAERS/openFDA)#

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