FDA.reportPublic FDA data

dactinomycin

Product NDC
39822-2100
11-digit product format
398222100
Labeler code
39822
Product ID
39822-2100_19853d49-64c6-f1cd-e063-6294a90a9c95
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dactinomycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
XGen Pharmaceuticals DJB, Inc.
Application
ANDA203999
Marketing category
ANDA
Marketing start
2019-07-31
Substance
DACTINOMYCIN
Active strength
.5 mg/mL
Pharmacologic classes
Actinomycin [EPC], Nucleic Acid Synthesis Inhibitors [MoA], Protein Synthesis Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
dactinomycin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DACTINOMYCIN.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1CC1JFE158
Rxcui239179

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9d0e6e82-c06a-4e85-9990-e8f17d9b69a7Product name420210528

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
239179DACTINomycin 500 MCG InjectionPSNefe03d73-eb11-45ff-a3cb-09a540ed352f9
239179dactinomycin 0.5 MG InjectionSCDefe03d73-eb11-45ff-a3cb-09a540ed352f9
239179dactinomycin 500 MCG InjectionSYefe03d73-eb11-45ff-a3cb-09a540ed352f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
39822-2100-1398222100011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
39822-2100-2398222100021 VIAL, SINGLE-DOSE in 1 CARTON (39822-2100-2) / 1 mL in 1 VIAL, SINGLE-DOSE (39822-2100-1) 2019-07-310000-00-00NoNoCurrent