FDA.reportPublic FDA data

NDC 67184-0535-01 - Decitabine

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
67184-0535
Requested NDC
67184-0535-01
Package NDCs from labels
67184-0535-1, 67184-0535-01
Manufacturer
Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical (Hainan) Co., Ltd.
Effective date
2021-10-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DecitabineQilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical (Hainan) Co., Ltd.2021-10-18HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67184-0535-1Decitabine20 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,202
67184-0535-1Decitabine1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67184-0535DECITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [QILU PHARMACEUTICAL CO., LTD.]2Current NDC, Legacy NDC, 2 package rows20211020_5b2dce6f-c715-47dc-971e-06244ccd7548.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 2 of 4 · 76 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Helleborus comp. AHELLEBORUS COMP. AUriel Pharmacy Inc.150e57ad-3ed7-5cc9-e063-6394a90a25fe2025-11-21WarningsExact identifier
unii: 4J9FJ0HL51
Ionosol MB and DextroseDEXTROSE MONOHYDRATE, SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM PHOSPHATE, MONOBASIC, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEICU Medical Inc.1b457b1d-0e80-4578-ba6f-dedf513fc9622025-10-30Warnings, Adverse reactionsExact identifier
unii: 4J9FJ0HL51
Potassium PhosphatesPOTASSIUM PHOSPHATESHospira, Inc.2fcbc814-c7a4-469a-8b1d-6819b961bfb92025-09-30Warnings, Adverse reactionsExact identifier
unii: 4J9FJ0HL51
DecitabineDECITABINEBluePoint Laboratoriesde303068-589e-4e0a-90ed-e60b2c1a2b562025-09-29Warnings, Adverse reactionsExact identifier
rxcui: 636631
unii: 776B62CQ27
POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATES IN SODIUM CHLORIDEAmneal Pharmaceuticals LLCdce22c93-aa48-48a9-ac8b-716400d33c9e2025-09-01Warnings, Adverse reactionsExact identifier
unii: 4J9FJ0HL51
DecitabineDECITABINEBluePoint Laboratories00caa305-fef4-471b-b9c3-4bcf5fe7b2442025-08-05Warnings, Adverse reactionsExact identifier
application number: ANDA212826
rxcui: 636631
unii: 776B62CQ27
DecitabineDECITABINEMeitheal Pharmaceuticals Inc.a3771445-1c68-4883-a014-74f8793f31362025-07-23Warnings, Adverse reactionsExact identifier
rxcui: 636631
unii: 776B62CQ27
Potassium PhosphatesPOTASSIUM PHOSPHATESFresenius Kabi USA, LLC357c3020-ea6f-4401-a2e7-cebb82b031442025-04-15Warnings, Adverse reactionsExact identifier
unii: 4J9FJ0HL51
Bestmade Natural Products BM182 PelletsGRAPHITES, HEPAR SULF, MERC SOL, MURIATIC ACIDBestmade Natural Products3242e013-2952-2b56-e063-6294a90a16932025-04-08WarningsExact identifier
unii: QTT17582CB
Potassium PhosphatesPOTASSIUM PHOSPHATESCipla USA Inc.f1f26a17-d2e2-48f5-9054-8ee7e380556e2025-02-28Warnings, Adverse reactionsExact identifier
unii: 4J9FJ0HL51
Potassium PhosphatesPOTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASICFresenius Kabi USA, LLC475f5cd7-45bd-412a-b419-9962585d6cda2025-02-28Warnings, Adverse reactionsExact identifier
unii: 4J9FJ0HL51
Bestmade Natural Products BM62AMMONIUM BENZOICUM, AURUM MUR, CALC ARS, CARDUUS MAR, CROTALUS HORRIDUS, MURIATIC ACID, NUX VOM, PHOSPHORUS, VIPERABestmade Natural Products2ce99cb7-fe9e-5da2-e063-6294a90afc4e2025-01-30WarningsExact identifier
unii: QTT17582CB
D-114ALUMINUM METALLICUM, AILANTHUS, BAPTISIA TINCTORIA, FRAGARIA VESCA, YOSCYAMUS NIGER, MURIATICUM ACIDDNA Labsf6f7d369-64ef-0ed9-e053-6294a90a40fa2025-01-13WarningsExact identifier
unii: QTT17582CB
Stress Away Anxiety ReliefACONITUM NAP, ALFALFA, AVENA, CHAMOMILLA, GELSEMIUM, HUMULUS IUPULUS, IGNATIA, KALI ARS, KALI PHOS, MURIATICUM AC, NAT PHOS, PASSIFLORA, PHOSPHORUS, STAPHYSAGRIA, STRAMONIUMSilver Star Brands05e04129-e7c1-4e11-e063-6394a90a09ca2025-01-01WarningsExact identifier
unii: QTT17582CB
POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC INJECTION,Amneal Pharmaceuticals Private Limited89136c51-a60b-4269-bd05-9489f060a7342024-12-31Warnings, Adverse reactionsExact identifier
unii: 4J9FJ0HL51
decitabineDECITABINEHikma Pharmaceuticals USA Inc.8c5d6067-16a1-43ab-9e52-a33c600a5c442024-12-26Warnings, Adverse reactionsExact identifier
rxcui: 636631
unii: 776B62CQ27
Stress Away Anxiety ReliefACONITUM NAP, ALFALFA, AVENA, CHAMOMILLA, GELSEMIUM, HUMULUS LUPULUS, IGNATIA, KALI ARS, KALI PHOS, MURIATICUM AC, NAT PHOS, PASSIFLORA, PHOS, STAPHYSAG, STRAMONIUMSilver Star Brands9d75666e-3214-2bab-e053-2a95a90af7192024-12-03WarningsExact identifier
unii: QTT17582CB
Potassium PhosphatePOTASSIUM PHOSPHATESomerset Therapeutics, LLC52f07402-1869-4a97-9c92-9729dc611f852024-07-11Warnings, Adverse reactionsExact identifier
unii: 4J9FJ0HL51
DecitabineDECITABINEAccord Healthcare Inc.b46df7d7-d98e-4c7e-b1ee-e03e258781c42024-07-09Warnings, Adverse reactionsExact identifier
rxcui: 636631
unii: 776B62CQ27
DecitabineDECITABINECamber Pharmaceuticals, Inc.5662c353-05d0-4bd8-87e4-c92ec9ca861e2024-06-26Warnings, Adverse reactionsExact identifier
rxcui: 636631
unii: 776B62CQ27

Reported adverse events (FAERS/openFDA)#

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