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United States · US · US:51662-1394_10322444-6e5a-3ab9-e063-6294a90a7b2b

CYANOCOBALAMIN

Orange BookUNIISPLATC B03BA51

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

Identification

ManufacturerHF Acquisition Co LLC, DBA HealthFirst
CountryUS (United States)
ATC codeB03BA51
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5166213941
    30 mL in 1 VIAL, MULTI-DOSE (51662-1394-1)
  • ndc11
    5166213943
    10 POUCH in 1 CASE (51662-1394-3) / 1 mL in 1 POUCH (51662-1394-2)

Annotations

UNII (FDA Substance ID)
P6YC3EG204
CYANOCOBALAMIN
RxCUI 11248
Orange Book
A080515
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": "51662-1394_10322444-6e5a-3ab9-e063-6294a90a7b2b",
  "productndc": "51662-1394",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "080515",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1MG/ML",
        "product_no": "002",
        "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": "ANDA080515",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CYANOCOBALAMIN",
  "start_marketing_date": "20191018",
  "active_numerator_strength": "1000"
}

Related drugs

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