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United States · US · US:49884-161_2801477f-6c1b-443b-a543-bdbfe8cb3d45

CALCITONIN SALMON

Orange BookUNIISPLATC H05BA01

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

Identification

ManufacturerEndo USA, Inc.
CountryUS (United States)
ATC codeH05BA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4988416111
    3.7 mL in 1 BOTTLE, GLASS (49884-161-11)

Annotations

UNII (FDA Substance ID)
7SFC6U2VI5
CALCITONIN SALMON
RxCUI 36118
Orange Book
A076979
AB
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": "NASAL",
  "spl_meta": {
    "2b8c6917-c217-45bf-a0ac-a2fa0f7d497a": {
      "match": "brand_token",
      "title": "CALCITONIN SALMON INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]",
      "spl_version": "2",
      "published_date": "2026-05-28"
    }
  },
  "productid": "49884-161_2801477f-6c1b-443b-a543-bdbfe8cb3d45",
  "productndc": "49884-161",
  "dosage_form": "SPRAY, METERED",
  "orange_book": {
    "appl_no": "076979",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200 IU/SPRAY",
        "product_no": "001",
        "approval_date": "Jun 8, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CALCITONIN SALMON",
  "proprietary_name": "CALCITONIN SALMON",
  "active_ingred_unit": "[iU]/.09mL",
  "application_number": "ANDA076979",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CALCITONIN SALMON",
  "start_marketing_date": "20090608",
  "active_numerator_strength": "200"
}

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