Selenious Acid

Orange BookUNIISPL

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

Identification

ManufacturerAmerican Regent, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0517656005
5 VIAL, PHARMACY BULK PACKAGE in 1 BOX (0517-6560-05) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE (0517-6560-01)

Annotations

UNII (FDA Substance ID)

H6241UJ22B

SELENIUM

RxCUI 9641

Orange Book

N209379

APAPAP

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "H6241UJ22B",
    "rxcui": "9641",
    "inchikey": "BUGBHKTXTAQXES-UHFFFAOYSA-N",
    "display_name": "SELENIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "4adcba5d-74c7-4353-b54d-539ef89754d6": {
      "match": "brand_token",
      "title": "SELENIOUS ACID INJECTION, SOLUTION [PANGEA PHARMACEUTICALS, LLC]",
      "spl_version": "3",
      "published_date": "2026-01-08"
    }
  },
  "productid": "0517-6560_4f6657ea-8dfd-4a74-8a36-9855ca7fd34a",
  "productndc": "0517-6560",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "209379",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)",
        "product_no": "001",
        "approval_date": "Apr 30, 2019"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML)",
        "product_no": "002",
        "approval_date": "Jan 25, 2021"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML)",
        "product_no": "003",
        "approval_date": "Aug 30, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SELENIUM",
  "proprietary_name": "Selenious Acid",
  "active_ingred_unit": "ug/mL",
  "application_number": "NDA209379",
  "marketing_category": "NDA",
  "nonproprietary_name": "Selenious Acid",
  "start_marketing_date": "20190701",
  "active_numerator_strength": "60"
}

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