FDA.reportPublic FDA data

NDC 60505-6271-01 - Azacitidine

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
60505-6271
Requested NDC
60505-6271-01
Package NDCs from labels
60505-6271-1, 60505-6271-01
Manufacturer
Apotex Corp | Jiangsu Hansoh Pharmaceutical Group Co., Ltd.
Effective date
2026-09-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Azacitidine - Apotex Corp | Jiangsu Hansoh Pharmaceutical Group Co., Ltd.Apotex Corp | Jiangsu Hansoh Pharmaceutical Group Co., Ltd.2026-09-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-6271-1Azacitidine1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-6271AZACITIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APOTEX CORP]4Current NDC, 1 package rows20240920_a6a5ca37-37e8-ab65-bc0b-9c0682ab52f7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6271-1EA - Each60505-627126c4d272-31f7-44df-b060-c9f5343af6bd12024-01-04

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 · 37 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AzacitidineAZACITIDINEApotex Corpa6a5ca37-37e8-ab65-bc0b-9c0682ab52f72026-09-08Warnings, Adverse reactionsExact identifier
application number: ANDA215905
ndc (package): 60505-6271-1
ndc (product): 60505-6271
ndc11 (package): 60505627101
rxcui: 485246
spl id: f2b031f6-9ae2-fc0b-85a9-7a7c631e3f7b
spl set id: a6a5ca37-37e8-ab65-bc0b-9c0682ab52f7
unii: M801H13NRU
ONUREGAZACITIDINECelgene Corporation0e95e33f-8aba-4f19-b332-2416580d358b2026-06-12Warnings, Adverse reactionsExact identifier
unii: M801H13NRU
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
AzacitidineAZACITIDINEBluePoint Laboratories.cd9db533-8a49-4d01-99e2-b2db8db1ed382026-03-26Warnings, Adverse reactionsExact identifier
rxcui: 485246
unii: M801H13NRU
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
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
AzacitidineAZACITIDINECivica, Inc.2d15b3ec-ed08-48c6-a400-34e55974afad2025-08-25Warnings, Adverse reactionsExact identifier
rxcui: 485246
unii: M801H13NRU
AzacitidineAZACITIDINESomerset Therapeutics LLC3bc4f406-2ec7-7169-e063-6394a90a81d92025-08-07Warnings, Adverse reactionsExact identifier
rxcui: 485246
unii: M801H13NRU
AZACITIDINEAZACITIDINEArmas Pharmaceuticals Inc.5c0a2d5f-8c34-4c04-8425-7543965cedd42025-08-05Warnings, Adverse reactionsExact identifier
rxcui: 485246
unii: M801H13NRU
AzacitidineAZACITIDINEMeitheal Pharmaceuticals Inc.3b96b508-046b-49ae-aefe-6d39c89a1d0e2025-07-21Warnings, Adverse reactionsExact identifier
rxcui: 485246
unii: M801H13NRU
AzacitidineAZACITIDINEMeitheal Pharmaceuticals Inc.97b0917a-03fa-4cc4-91cf-1bed57a988c92025-07-21Warnings, Adverse reactionsExact identifier
rxcui: 485246
unii: M801H13NRU
AzacitidineAZACITIDINEFresenius Kabi USA, LLC3b594aba-e798-4105-b801-0b0d970747c12025-06-18Warnings, Adverse reactionsExact identifier
rxcui: 485246
unii: M801H13NRU
AzacitidineAZACITIDINEReliance Life Sciences Private Limited5804d999-96eb-4fd1-b7d8-de7867c5f1d62025-05-29Warnings, Adverse reactionsExact identifier
rxcui: 485246
unii: M801H13NRU
AzacitidineAZACITIDINEBluePoint Laboratories5f0f9ee3-a5b1-4a25-a34c-7f38c8433f4a2025-05-26Warnings, Adverse reactionsExact identifier
rxcui: 485246
unii: M801H13NRU
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
AzacitidineAZACITIDINECamber Pharmaceuticals, Inc.f02c9bef-e47f-4b70-95f6-9341d87346ed2025-04-08Warnings, Adverse reactionsExact identifier
rxcui: 485246
unii: M801H13NRU

Reported adverse events (FAERS/openFDA)#

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