Back to search
🇺🇸

United States · US · US:50633-310_9955075c-c059-4b63-b387-e98ef13e60dc

Cyanokit

In shortageOrange BookUNIIATC B03BA03

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

Identification

ManufacturerBTG INTERNATIONAL INC.
CountryUS (United States)
ATC codeB03BA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5063331011
    1 VIAL, GLASS in 1 CARTON (50633-310-11) / 250 mL in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)
Q40X8H422O
HYDROXOCOBALAMIN
RxCUI 5514
Orange Book
N022041
FDA shortage
Currently in shortage
Hydroxocobalamin Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "Q40X8H422O",
    "rxcui": "5514",
    "inchikey": "YOZNUFWCRFCGIH-WZHZPDAFSA-K",
    "display_name": "HYDROXOCOBALAMIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "productid": "50633-310_9955075c-c059-4b63-b387-e98ef13e60dc",
  "productndc": "50633-310",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "022041",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "5GM/VIAL (5GM/KIT)",
        "product_no": "001",
        "approval_date": "Apr 8, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2.5GM/VIAL (5GM/KIT)",
        "product_no": "002",
        "approval_date": "Dec 15, 2006"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROXOCOBALAMIN",
  "shortage_reason": "Hydroxocobalamin Injection",
  "shortage_status": "current",
  "proprietary_name": "Cyanokit",
  "active_ingred_unit": "g/250mL",
  "application_number": "NDA022041",
  "marketing_category": "NDA",
  "nonproprietary_name": "Hydroxocobalamin",
  "start_marketing_date": "20211215",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code B03BA03.

Access this data programmatically

Query Cyanokit and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.