Package 42358-295-01

Brand: nulibry

Generic: fosdenopterin hydrobromide
NDC Package

Package Facts

Identity

Package NDC 42358-295-01
Digits Only 4235829501
Product NDC 42358-295
Product ID 42358-295_f2d66860-2840-4060-82ba-5fa50f4724c4
Description

1 VIAL, SINGLE-DOSE in 1 CARTON (42358-295-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Marketing

Marketing Status
Marketed Since 2023-04-15
Brand nulibry
Generic fosdenopterin hydrobromide
Sample Package No

Linked Drug Pages (1)

Nulibry ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "f2d66860-2840-4060-82ba-5fa50f4724c4", "openfda": {"unii": ["X41B5W735T"], "rxcui": ["2531292", "2531297"], "spl_set_id": ["736aeea3-f206-454d-95d0-fd30964e8aab"], "manufacturer_name": ["Sentynl Therapeutics, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (42358-295-01)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE", "package_ndc": "42358-295-01", "marketing_start_date": "20230415"}], "brand_name": "Nulibry", "product_id": "42358-295_f2d66860-2840-4060-82ba-5fa50f4724c4", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Cyclic Pyranopterin Monophosphate [EPC]", "Cyclic Pyranopterin Monophosphate [EXT]"], "product_ndc": "42358-295", "generic_name": "fosdenopterin hydrobromide", "labeler_name": "Sentynl Therapeutics, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nulibry", "active_ingredients": [{"name": "FOSDENOPTERIN HYDROBROMIDE", "strength": "9.5 mg/1"}], "application_number": "NDA214018", "marketing_category": "NDA", "marketing_start_date": "20210330", "listing_expiration_date": "20261231"}