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United States · US · US:70771-1689_8940ec64-b0cd-4f10-bc19-251146c9e552

cyanocobalamin

Orange BookUNIISPLATC B03BA51

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

Identification

ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeB03BA51
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7077116896
    10 VIAL, MULTI-DOSE in 1 VIAL (70771-1689-6) / 10 mL in 1 VIAL, MULTI-DOSE (70771-1689-1)
  • ndc11
    7077116897
    25 VIAL, MULTI-DOSE in 1 CARTON (70771-1689-7) / 10 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)
P6YC3EG204
CYANOCOBALAMIN
RxCUI 11248
Orange Book
A214655
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": "70771-1689_8940ec64-b0cd-4f10-bc19-251146c9e552",
  "productndc": "70771-1689",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "214655",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1MG/ML",
        "product_no": "001",
        "approval_date": "Apr 15, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYANOCOBALAMIN",
  "proprietary_name": "cyanocobalamin",
  "active_ingred_unit": "ug/mL",
  "application_number": "ANDA214655",
  "marketing_category": "ANDA",
  "nonproprietary_name": "cyanocobalamin",
  "start_marketing_date": "20220505",
  "active_numerator_strength": "1000"
}

Related drugs

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