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United States · US · US:49884-270_4291e3b9-37cb-4aa8-ac03-992725a41c1d

Nascobal

Orange BookUNIISPLATC B03BA51

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

Identification

ManufacturerPar Health USA, LLC
CountryUS (United States)
ATC codeB03BA51
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4988427082
    4 SPRAY in 1 CARTON (49884-270-82)

Annotations

UNII (FDA Substance ID)
P6YC3EG204
CYANOCOBALAMIN
RxCUI 11248
Orange Book
N021642
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": {
    "697e0e52-c01b-4b53-9994-f79c46eb6b4f": {
      "match": "brand_token",
      "title": "NASCOBAL (CYANOCOBALAMIN) SPRAY [PAR HEALTH USA, LLC]",
      "spl_version": "15",
      "published_date": "2026-05-28"
    }
  },
  "productid": "49884-270_4291e3b9-37cb-4aa8-ac03-992725a41c1d",
  "productndc": "49884-270",
  "dosage_form": "SPRAY",
  "orange_book": {
    "appl_no": "021642",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "0.5MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Jan 31, 2005"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYANOCOBALAMIN",
  "proprietary_name": "Nascobal",
  "active_ingred_unit": "ug/1",
  "application_number": "NDA021642",
  "marketing_category": "NDA",
  "nonproprietary_name": "cyanocobalamin",
  "start_marketing_date": "20090813",
  "active_numerator_strength": "500"
}

Related drugs

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