FDA.reportPublic FDA data

NDC 39822-2100-02 - dactinomycin

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
39822-2100
Requested NDC
39822-2100-02
Package NDCs from labels
39822-2100-1, 39822-2100-2, 39822-2100-02
Manufacturer
XGen Pharmaceuticals DJB, Inc.
Effective date
2024-05-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
dactinomycin - XGen Pharmaceuticals DJB, Inc.XGen Pharmaceuticals DJB, Inc.2024-05-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
39822-2100-1dactinomycin1 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,19
39822-2100-2dactinomycin1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39822-2100DACTINOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XGEN PHARMACEUTICALS DJB, INC.]9Current NDC, Legacy NDC, 2 package rows20240530_efe03d73-eb11-45ff-a3cb-09a540ed352f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39822-2100-1EA - Each39822-21007150a384-6494-494b-8ecd-7b859da7930e12019-09-05
39822-2100-2EA - Each39822-21004c7c4881-7697-4073-8f07-ea617cfc8e2f12019-09-05

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 1 ยท 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
DACTINOMYCINDACTINOMYCINEugia US LLC5da55538-2602-4704-a9da-603c9f7ff7dc2024-06-18Warnings, Adverse reactionsExact identifier
rxcui: 239179
unii: 1CC1JFE158
dactinomycinDACTINOMYCINXGen Pharmaceuticals DJB, Inc.efe03d73-eb11-45ff-a3cb-09a540ed352f2024-05-28Warnings, Adverse reactionsExact identifier
application number: ANDA203999
ndc (package): 39822-2100-1
ndc (package): 39822-2100-2
ndc (product): 39822-2100
ndc11 (package): 39822210002
rxcui: 239179
spl id: 19853d49-64c6-f1cd-e063-6294a90a9c95
spl set id: efe03d73-eb11-45ff-a3cb-09a540ed352f
unii: 1CC1JFE158
DactinomycinDACTINOMYCINHisun Pharmaceuticals USA, Inc.95d5c152-aa00-41e6-83e8-8df374a564472024-05-08Warnings, Adverse reactionsExact identifier
rxcui: 239179
unii: 1CC1JFE158
MANNITOLMANNITOLHF Acquisition Co LLC, DBA HealthFirst999ce711-2d5b-0d7d-e053-2995a90a26892024-01-27Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
DACTINOMYCINDACTINOMYCINEugia US LLCaa047ee8-f2e8-4720-84b1-d1c4532d6c632023-12-20Warnings, Adverse reactionsExact identifier
rxcui: 239179
unii: 1CC1JFE158
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
DactinomycinDACTINOMYCINMeitheal Pharmaceuticals Inc.2aaca42a-3b79-4151-a727-83253556a5402020-11-13Warnings, Adverse reactionsExact identifier
rxcui: 239179
unii: 1CC1JFE158

Reported adverse events (FAERS/openFDA)#

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