Nulibry

Orange BookUNIIATC A16AX19

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerSentynl Therapeutics, Inc.

CountryUS (United States)

ATC codeA16AX19

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4235829501
1 VIAL, SINGLE-DOSE in 1 CARTON (42358-295-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

X41B5W735T

FOSDENOPTERIN HYDROBROMIDE

RxCUI 2531287

Orange Book

N214018

Raw payload (JSON)

{
  "unii": {
    "unii": "X41B5W735T",
    "rxcui": "2531287",
    "inchikey": "GGLKTKQOHMCQHF-UNHNTEMGSA-N",
    "display_name": "FOSDENOPTERIN HYDROBROMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "productid": "42358-295_f2d66860-2840-4060-82ba-5fa50f4724c4",
  "productndc": "42358-295",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "214018",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 9.5MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Feb 26, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FOSDENOPTERIN HYDROBROMIDE",
  "proprietary_name": "Nulibry",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA214018",
  "marketing_category": "NDA",
  "nonproprietary_name": "fosdenopterin hydrobromide",
  "start_marketing_date": "20210330",
  "active_numerator_strength": "9.5"
}

Related drugs

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