dactinomycin

Generic: dactinomycin

Labeler: hisun pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

dactinomycin .5 mg/1

Manufacturer
Hisun Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 42658-008
Product ID 42658-008_1b25a447-d782-5889-e063-6294a90aebe5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207232
Listing Expiration 2026-12-31
Marketing Start 2024-05-08

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 42658008
Hyphenated Format 42658-008

Supplemental Identifiers

RxCUI
239179
UPC
0342658008015
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 ANDA207232 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (42658-008-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
source: ndc

Packages (1)

42658-008-01 1 VIAL in 1 CARTON (42658-008-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Ingredients (1)

dactinomycin (.5 mg/1)

Linked Drug Pages (1)

Dactinomycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "1b25a447-d782-5889-e063-6294a90aebe5", "openfda": {"nui": ["N0000180850", "N0000000233", "N0000000150"], "upc": ["0342658008015"], "unii": ["1CC1JFE158"], "rxcui": ["239179"], "spl_set_id": ["95d5c152-aa00-41e6-83e8-8df374a56447"], "pharm_class_epc": ["Actinomycin [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Protein Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Hisun Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (42658-008-01)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL", "package_ndc": "42658-008-01", "marketing_start_date": "20240508"}], "brand_name": "Dactinomycin", "product_id": "42658-008_1b25a447-d782-5889-e063-6294a90aebe5", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Actinomycin [EPC]", "Nucleic Acid Synthesis Inhibitors [MoA]", "Protein Synthesis Inhibitors [MoA]"], "product_ndc": "42658-008", "generic_name": "dactinomycin", "labeler_name": "Hisun Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dactinomycin", "active_ingredients": [{"name": "DACTINOMYCIN", "strength": ".5 mg/1"}], "application_number": "ANDA207232", "marketing_category": "ANDA", "marketing_start_date": "20240508", "listing_expiration_date": "20261231"}