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 1 of 4 · 76 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC INJECTION,Amneal Pharmaceuticals Private Limited98315c6e-308d-423b-a046-4be1f54d30ae2026-09-01Warnings, Adverse reactionsExact identifier
unii: 4J9FJ0HL51
POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC INJECTION,Amneal Pharmaceuticals Private Limited125121b8-bc4c-44ee-906e-e72f652a5aa62026-09-01Warnings, Adverse reactionsExact identifier
unii: 4J9FJ0HL51
DecitabineDECITABINEBluePoint Laboratories5975fa81-1e29-4d56-e063-6394a90a9cd52026-08-20Warnings, Adverse reactionsExact identifier
rxcui: 636631
unii: 776B62CQ27
DecitabineDECITABINESagent Pharmaceuticals749f8d8c-e378-42a1-b94a-136b606dadb42026-08-06Warnings, Adverse reactionsExact identifier
application number: ANDA212826
rxcui: 636631
unii: 776B62CQ27
Potassium PhosphatesPOTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASICCIVICA, INC.f7702b2f-d0d1-4696-896d-571607fc0dc82026-07-10Warnings, Adverse reactionsExact identifier
unii: 4J9FJ0HL51
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDTotal Operations Management LLC DBA:Bestmade Natural Products Micro5423bde6-3e31-38b0-e063-6294a90afb2d2026-06-13WarningsExact identifier
unii: QTT17582CB
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDBM Private Limited540d11e3-e4a1-0ca2-e063-6394a90a3c262026-06-12WarningsExact identifier
unii: QTT17582CB
INQOVICEDAZURIDINE AND DECITABINETaiho Pharmaceutical Co., Ltd.91a0f80b-f865-4d06-a40d-4d148d99ee712026-05-25Warnings, Adverse reactionsExact identifier
unii: 776B62CQ27
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643bc58-bb0e-5c79-e053-2991aa0a02ae2026-05-19WarningsExact identifier
unii: QTT17582CB
DecitabineDECITABINEBryant Ranch Prepackc731a9f0-46ee-41c3-8f89-179cab13bdd22026-05-06Warnings, Adverse reactionsExact identifier
rxcui: 636631
unii: 776B62CQ27
Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium PhosphateDIBASIC SODIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE AND MONOBASIC SODIUM PHOSPHATERising Pharma Holdings, Inc.b01eac95-dbe3-4b21-a922-187e0fc8ad232026-04-07Adverse reactionsExact identifier
unii: 4J9FJ0HL51
DecitabineDECITABINEDr. Reddy's Laboratories Inc.358764ca-4c69-d516-af0c-bf8a348d26ca2026-03-25Warnings, Adverse reactionsExact identifier
rxcui: 636631
unii: 776B62CQ27
DecitabineDECITABINEDr.Reddy's Laboratories Limited4e1f4eb4-19b2-eee8-3402-bd2ccf6227912026-03-25Warnings, Adverse reactionsExact identifier
rxcui: 636631
unii: 776B62CQ27
PHOSPHA 250 NEUTRALDIBASIC SODIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE AND MONOBASIC SODIUM PHOSPHATERising Pharma Holdings, Inc.9432adfc-6add-4ab4-ae93-2e2daf348be22026-03-25Adverse reactionsExact identifier
unii: 4J9FJ0HL51
POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATESGLENMARK PHARMACEUTICALS INC., USA70c7710c-a354-4941-bd46-e64d6ea6b5dc2026-03-20Warnings, Adverse reactionsExact identifier
unii: 4J9FJ0HL51
Skin Irritations and Itch ReliefAGARICUS MUSCARIUS, ALUMINA, ANAGALLIS ARVENSIS, ANTIMONIUM TARTARICUM, APIS MELLIFICA, ARSENICUM ALBUM, ARSENICUM IODATUM, BOVISTA, CAUSTICUM, DOLICHOS PRURIENS, FAGOPYRUM ESCULENTUM, GRAPHITES, KALI MURIATICUM, MURIATICUM ACIDUM, OLEANDER, PETROLEUM, PIX LIQUIDA, RADIUM BROMATUM (12X, 30X, 1LM), RHUS TOX, SELENIUM METALLICUM, SULPHUR AND URTICA URENS.King Bio Inc.d139d2f1-0369-4963-9f3d-c4cc0f1ea2dd2026-03-10WarningsExact identifier
unii: QTT17582CB
Endotoxin Terrain Drops 2143ENDOTOXIN TERRAIN DROPSProfessional Complementary Health Formulas58842566-005a-48b5-973d-20cde2fbd7012026-01-08WarningsExact identifier
unii: QTT17582CB
Abdominal Pain Drops 2051ABDOMINAL PAIN DROPSProfessional Complementary Health Formulasf1b1dde6-bb37-4774-a58c-b4f648f9c2b52026-01-08WarningsExact identifier
unii: QTT17582CB
HemorrhoidAESCULUS HIPP, HAMAMELIS, ALOE, CALC PHOS, CARBO AN, CARBO VEG, LACHESIS, LYCOPODIUM, MURIATICUM AC, NITRICUM AC, NUX VOM, PAEONIA, RATANHIA, SEPIA, SULPHURNatural Creations, Incdb1b3aef-ba92-417c-b6f6-58e950ed42142025-12-16WarningsExact identifier
unii: QTT17582CB
DecitabineDECITABINEMeitheal Pharmaceuticals Inc.a535a235-e1d2-4520-93fe-b7dd9b0477842025-12-15Warnings, Adverse reactionsExact identifier
rxcui: 636631
unii: 776B62CQ27

Reported adverse events (FAERS/openFDA)#

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