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United States · US · US:0517-0130_28421ba1-7e37-429c-9c66-62cc36f5847c

Cyanocobalamin

Orange BookUNIISPLATC B03BA51

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

Identification

ManufacturerAmerican Regent, Inc.
CountryUS (United States)
ATC codeB03BA51
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0517013001
    1 VIAL, MULTI-DOSE in 1 BOX (0517-0130-01) / 30 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)
P6YC3EG204
CYANOCOBALAMIN
RxCUI 11248
Orange Book
A080737
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": "0517-0130_28421ba1-7e37-429c-9c66-62cc36f5847c",
  "productndc": "0517-0130",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "080737",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "1MG/ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYANOCOBALAMIN",
  "proprietary_name": "Cyanocobalamin",
  "active_ingred_unit": "ug/mL",
  "application_number": "ANDA080737",
  "marketing_category": "ANDA",
  "nonproprietary_name": "cyanocobalamin",
  "start_marketing_date": "20030529",
  "active_numerator_strength": "1000"
}

Related drugs

Other records sharing ATC code B03BA51.

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