dactinomycin

Generic: dactinomycin

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dactinomycin
Generic Name dactinomycin
Labeler eugia us llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

dactinomycin .5 mg/mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-431
Product ID 55150-431_ea070887-e81e-4998-87ae-86f52718d003
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203385
Listing Expiration 2026-12-31
Marketing Start 2021-03-15

Pharmacologic Class

Established (EPC)
actinomycin [epc]
Mechanism of Action
nucleic acid synthesis inhibitors [moa] protein synthesis inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150431
Hyphenated Format 55150-431

Supplemental Identifiers

RxCUI
239179
UNII
1CC1JFE158
NUI
N0000180850 N0000000233 N0000000150

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name dactinomycin (source: ndc)
Generic Name dactinomycin (source: ndc)
Application Number ANDA203385 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-431-01) / 1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

55150-431-01 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-431-01) / 1 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

dactinomycin (.5 mg/mL)

Linked Drug Pages (1)

DACTINOMYCIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "ea070887-e81e-4998-87ae-86f52718d003", "openfda": {"nui": ["N0000180850", "N0000000233", "N0000000150"], "unii": ["1CC1JFE158"], "rxcui": ["239179"], "spl_set_id": ["aa047ee8-f2e8-4720-84b1-d1c4532d6c63"], "pharm_class_epc": ["Actinomycin [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Protein Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (55150-431-01)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-431-01", "marketing_start_date": "20210315"}], "brand_name": "DACTINOMYCIN", "product_id": "55150-431_ea070887-e81e-4998-87ae-86f52718d003", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Actinomycin [EPC]", "Nucleic Acid Synthesis Inhibitors [MoA]", "Protein Synthesis Inhibitors [MoA]"], "product_ndc": "55150-431", "generic_name": "DACTINOMYCIN", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DACTINOMYCIN", "active_ingredients": [{"name": "DACTINOMYCIN", "strength": ".5 mg/mL"}], "application_number": "ANDA203385", "marketing_category": "ANDA", "marketing_start_date": "20210315", "listing_expiration_date": "20261231"}