dactinomycin

Generic: dactinomycin

Labeler: xgen pharmaceuticals djb, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dactinomycin
Generic Name dactinomycin
Labeler xgen pharmaceuticals djb, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

dactinomycin .5 mg/mL

Manufacturer
XGen Pharmaceuticals DJB, Inc.

Identifiers & Regulatory

Product NDC 39822-2100
Product ID 39822-2100_19853d49-64c6-f1cd-e063-6294a90a9c95
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203999
Listing Expiration 2026-12-31
Marketing Start 2019-07-31

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 398222100
Hyphenated Format 39822-2100

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 ANDA203999 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (39822-2100-2) / 1 mL in 1 VIAL, SINGLE-DOSE (39822-2100-1)
source: ndc

Packages (1)

39822-2100-2 1 VIAL, SINGLE-DOSE in 1 CARTON (39822-2100-2) / 1 mL in 1 VIAL, SINGLE-DOSE (39822-2100-1)

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": "19853d49-64c6-f1cd-e063-6294a90a9c95", "openfda": {"nui": ["N0000180850", "N0000000233", "N0000000150"], "unii": ["1CC1JFE158"], "rxcui": ["239179"], "spl_set_id": ["efe03d73-eb11-45ff-a3cb-09a540ed352f"], "pharm_class_epc": ["Actinomycin [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Protein Synthesis Inhibitors [MoA]"], "manufacturer_name": ["XGen Pharmaceuticals DJB, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (39822-2100-2)  / 1 mL in 1 VIAL, SINGLE-DOSE (39822-2100-1)", "package_ndc": "39822-2100-2", "marketing_start_date": "20190731"}], "brand_name": "dactinomycin", "product_id": "39822-2100_19853d49-64c6-f1cd-e063-6294a90a9c95", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Actinomycin [EPC]", "Nucleic Acid Synthesis Inhibitors [MoA]", "Protein Synthesis Inhibitors [MoA]"], "product_ndc": "39822-2100", "generic_name": "dactinomycin", "labeler_name": "XGen Pharmaceuticals DJB, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "dactinomycin", "active_ingredients": [{"name": "DACTINOMYCIN", "strength": ".5 mg/mL"}], "application_number": "ANDA203999", "marketing_category": "ANDA", "marketing_start_date": "20190731", "listing_expiration_date": "20261231"}