Cyanocobalamin

Orange BookUNIISPLATC B03BA51

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerLupin Pharmaceuticals,Inc.

CountryUS (United States)

ATC codeB03BA51

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4338623760
1 CARTON in 1 BLISTER PACK (43386-237-60) / 4 SPRAY, METERED in 1 CARTON (43386-237-70)

Annotations

UNII (FDA Substance ID)

P6YC3EG204

CYANOCOBALAMIN

RxCUI 11248

Orange Book

A210629

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": "NASAL",
  "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": "43386-237_bb7b94e1-b5cd-486f-9e34-38fc9595547a",
  "productndc": "43386-237",
  "dosage_form": "SPRAY, METERED",
  "orange_book": {
    "appl_no": "210629",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG/SPRAY",
        "product_no": "001",
        "approval_date": "Jun 30, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYANOCOBALAMIN",
  "proprietary_name": "Cyanocobalamin",
  "active_ingred_unit": "ug/1",
  "application_number": "ANDA210629",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cyanocobalamin",
  "start_marketing_date": "20240129",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code B03BA51.

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