dactinomycin

Generic: dactinomycin

Labeler: meitheal pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

dactinomycin .5 mg/mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-129
Product ID 71288-129_d9bb02eb-3f9e-4932-bdcd-53b5bd6392b6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213463
Listing Expiration 2026-12-31
Marketing Start 2020-11-13

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 71288129
Hyphenated Format 71288-129

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 ANDA213463 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-129-02) / 1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

71288-129-02 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-129-02) / 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": "d9bb02eb-3f9e-4932-bdcd-53b5bd6392b6", "openfda": {"nui": ["N0000180850", "N0000000233", "N0000000150"], "unii": ["1CC1JFE158"], "rxcui": ["239179"], "spl_set_id": ["2aaca42a-3b79-4151-a727-83253556a540"], "pharm_class_epc": ["Actinomycin [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Protein Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-129-02)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "71288-129-02", "marketing_start_date": "20201113"}], "brand_name": "Dactinomycin", "product_id": "71288-129_d9bb02eb-3f9e-4932-bdcd-53b5bd6392b6", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Actinomycin [EPC]", "Nucleic Acid Synthesis Inhibitors [MoA]", "Protein Synthesis Inhibitors [MoA]"], "product_ndc": "71288-129", "generic_name": "Dactinomycin", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dactinomycin", "active_ingredients": [{"name": "DACTINOMYCIN", "strength": ".5 mg/mL"}], "application_number": "ANDA213463", "marketing_category": "ANDA", "marketing_start_date": "20201113", "listing_expiration_date": "20261231"}