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United States · US · US:67457-675_ebb1716e-a4f1-42c4-82ac-ba5c062cfba0

Miacalcin

Orange BookUNIISPLATC H05BA01

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

Identification

ManufacturerMylan Institutional LLC
CountryUS (United States)
ATC codeH05BA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6745767502
    1 VIAL, MULTI-DOSE in 1 CARTON (67457-675-02) / 2 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)
7SFC6U2VI5
CALCITONIN SALMON
RxCUI 36118
Orange Book
N017808
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "7SFC6U2VI5",
    "rxcui": "36118",
    "inchikey": null,
    "display_name": "CALCITONIN SALMON",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; SUBCUTANEOUS",
  "spl_meta": {
    "753ecc6a-07be-4fc6-9032-cc6ad116a662": {
      "match": "brand_token",
      "title": "MIACALCIN (CALCITONIN SALMON) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]",
      "spl_version": "4",
      "published_date": "2025-07-31"
    }
  },
  "productid": "67457-675_ebb1716e-a4f1-42c4-82ac-ba5c062cfba0",
  "productndc": "67457-675",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "017808",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "100 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Jul 3, 1986"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "200 IU/ML",
        "product_no": "002",
        "approval_date": "Mar 29, 1991"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CALCITONIN SALMON",
  "proprietary_name": "Miacalcin",
  "active_ingred_unit": "[USP'U]/mL",
  "application_number": "NDA017808",
  "marketing_category": "NDA",
  "nonproprietary_name": "calcitonin salmon",
  "start_marketing_date": "20160916",
  "active_numerator_strength": "200"
}

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