Cosmegen

Product NDC
55292-811
11-digit product format
552920811
Labeler code
55292
Product ID
55292-811_2afdf978-8e90-40e9-872f-9f8775dcd41c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dactinomycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Recordati Rare Diseases, Inc.
Application
NDA050682
Marketing category
NDA
Marketing start
1964-12-10
Marketing end
0000-00-00
Substance
DACTINOMYCIN
Active strength
1 mg/mL
Pharmacologic classes
Actinomycin [EPC], Nucleic Acid Synthesis Inhibitors [MoA], Protein Synthesis Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55292-811-55EA - Each55292-811fb3959b1-2ed8-4b7a-9cc1-0cc54d37d06b12013-12-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55292-811-555529208115512 VIAL, SINGLE-DOSE in 1 CARTON (55292-811-55) > 1 mL in 1 VIAL, SINGLE-DOSE1964-12-100000-00-00NoNoCurrent