FDA.reportPublic FDA data

NDC 70121-1237-01 - 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
70121-1237
Requested NDC
70121-1237-01
Package NDCs from labels
70121-1237-1, 70121-1237-01
Manufacturer
Amneal Pharmaceuticals LLC
Effective date
2024-08-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AZACITIDINE - Amneal Pharmaceuticals LLCAmneal Pharmaceuticals LLC2024-08-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70121-1237-1AZACITIDINE1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1237AZACITIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMNEAL PHARMACEUTICALS LLC]8Current NDC, Legacy NDC, 1 package rows20240922_80a43736-0598-4e4b-85ba-e29daa290c8f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1237-1EA - Each70121-12379c6d024e-2839-4022-b7fa-91202485bc1d12023-02-06

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 · 38 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AzacitidineAZACITIDINEApotex Corpa6a5ca37-37e8-ab65-bc0b-9c0682ab52f72026-09-08Warnings, Adverse reactionsExact identifier
rxcui: 485246
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.