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United States · US · US:43598-051_621ce5a0-32c4-a1fc-1e71-a9da8b50212f

Calcitonin Salmon

Orange BookUNIISPLATC H05BA01

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

Identification

ManufacturerDr. Reddy's Laboratories, Inc.
CountryUS (United States)
ATC codeH05BA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4359805111
    1 VIAL, MULTI-DOSE in 1 CARTON (43598-051-11) / 2 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)
7SFC6U2VI5
CALCITONIN SALMON
RxCUI 36118
Orange Book
A215715
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": {
    "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": "43598-051_621ce5a0-32c4-a1fc-1e71-a9da8b50212f",
  "productndc": "43598-051",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "215715",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "200 IU/ML",
        "product_no": "001",
        "approval_date": "Apr 11, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CALCITONIN SALMON",
  "proprietary_name": "Calcitonin Salmon",
  "active_ingred_unit": "[USP'U]/mL",
  "application_number": "ANDA215715",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Calcitonin Salmon",
  "start_marketing_date": "20240617",
  "active_numerator_strength": "200"
}

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