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United States · US · US:68001-640_44f5a26b-5965-9a7b-e063-6294a90a682a

Cyanocobalamin

Orange BookUNIISPLATC B03BA51

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

Identification

ManufacturerBluePoint Laboratories
CountryUS (United States)
ATC codeB03BA51
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6800164060
    25 VIAL in 1 CARTON (68001-640-60) / 1 mL in 1 VIAL (68001-640-59)

Annotations

UNII (FDA Substance ID)
P6YC3EG204
CYANOCOBALAMIN
RxCUI 11248
Orange Book
A217839
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "P6YC3EG204",
    "rxcui": "11248",
    "inchikey": "FDJOLVPMNUYSCM-UVKKECPRSA-L",
    "display_name": "CYANOCOBALAMIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; SUBCUTANEOUS",
  "spl_meta": {
    "a66eb3c4-3e1d-4d49-b963-4fa2334cc9b6": {
      "match": "brand_token",
      "title": "CYANOCOBALAMIN INJECTION [HIKMA PHARMACEUTICALS USA INC.]",
      "spl_version": "10",
      "published_date": "2026-05-11"
    }
  },
  "productid": "68001-640_44f5a26b-5965-9a7b-e063-6294a90a682a",
  "productndc": "68001-640",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "217839",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1MG/ML",
        "product_no": "001",
        "approval_date": "Jul 10, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYANOCOBALAMIN",
  "proprietary_name": "Cyanocobalamin",
  "active_ingred_unit": "ug/mL",
  "application_number": "ANDA217839",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cyanocobalamin",
  "start_marketing_date": "20250407",
  "active_numerator_strength": "1000"
}

Related drugs

Other records sharing ATC code B03BA51.

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