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United States · US · US:55150-364_a0566c8d-7cb0-4ee7-8599-f2e8dc8992c7

Cyanocobalamin

Orange BookUNIISPLATC B03BA51

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

Identification

ManufacturerAuroMedics Pharma LLC
CountryUS (United States)
ATC codeB03BA51
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    5515036401
    1 VIAL, MULTI-DOSE in 1 CARTON (55150-364-01) / 1 mL in 1 VIAL, MULTI-DOSE
  • ndc11
    5515036410
    10 VIAL, MULTI-DOSE in 1 CARTON (55150-364-10) / 1 mL in 1 VIAL, MULTI-DOSE
  • ndc11
    5515036425
    25 VIAL, MULTI-DOSE in 1 CARTON (55150-364-25) / 1 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)
P6YC3EG204
CYANOCOBALAMIN
RxCUI 11248
Orange Book
A213874
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",
  "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": "55150-364_a0566c8d-7cb0-4ee7-8599-f2e8dc8992c7",
  "productndc": "55150-364",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "213874",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1MG/ML",
        "product_no": "001",
        "approval_date": "Dec 8, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYANOCOBALAMIN",
  "proprietary_name": "Cyanocobalamin",
  "active_ingred_unit": "ug/mL",
  "application_number": "ANDA213874",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cyanocobalamin",
  "start_marketing_date": "20201208",
  "active_numerator_strength": "1000"
}

Related drugs

Other records sharing ATC code B03BA51.

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