nulibry

Generic: fosdenopterin hydrobromide

Labeler: sentynl therapeutics, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name nulibry
Generic Name fosdenopterin hydrobromide
Labeler sentynl therapeutics, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

fosdenopterin hydrobromide 9.5 mg/1

Manufacturer
Sentynl Therapeutics, Inc.

Identifiers & Regulatory

Product NDC 42358-295
Product ID 42358-295_f2d66860-2840-4060-82ba-5fa50f4724c4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214018
Listing Expiration 2026-12-31
Marketing Start 2021-03-30

Pharmacologic Class

Classes
cyclic pyranopterin monophosphate [epc] cyclic pyranopterin monophosphate [ext]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42358295
Hyphenated Format 42358-295

Supplemental Identifiers

RxCUI
2531292 2531297
UNII
X41B5W735T

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 nulibry (source: ndc)
Generic Name fosdenopterin hydrobromide (source: ndc)
Application Number NDA214018 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 9.5 mg/1
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (42358-295-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

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

Ingredients (1)

fosdenopterin hydrobromide (9.5 mg/1)

Linked Drug Pages (1)

Nulibry ndc-match (0.9)

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"}