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United States · US · US:68083-660_32cdac6b-fccb-441e-87de-bcacc92c6998

Selenious Acid

Orange BookUNIISPL

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerGland Pharma Limited
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6808366005
    5 VIAL, PHARMACY BULK PACKAGE in 1 BOX (68083-660-05) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE

Annotations

UNII (FDA Substance ID)
H6241UJ22B
SELENIUM
RxCUI 9641
Orange Book
A219629
AP
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": "68083-660_32cdac6b-fccb-441e-87de-bcacc92c6998",
  "productndc": "68083-660",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "219629",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)",
        "product_no": "001",
        "approval_date": "Jul 8, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SELENIUM",
  "proprietary_name": "Selenious Acid",
  "active_ingred_unit": "ug/mL",
  "application_number": "ANDA219629",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Selenious Acid",
  "start_marketing_date": "20250708",
  "active_numerator_strength": "60"
}

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