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United States · US · US:67066-005_40a8cfc0-9a1b-f924-e063-6294a90afce0

ChiRhoStim

Orange BookUNIISPL

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

Identification

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

Packs · 1

  • ndc11
    6706600501
    8 mL in 1 VIAL, SINGLE-USE (67066-005-01)

Annotations

UNII (FDA Substance ID)
A0426J905J
SECRETIN HUMAN
RxCUI 606396
Orange Book
N021256
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "A0426J905J",
    "rxcui": "606396",
    "inchikey": null,
    "display_name": "SECRETIN HUMAN",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "b4dfe70f-0a86-4488-9ba1-dcd8f86cbfcd": {
      "match": "brand_token",
      "title": "CHIRHOSTIM (HUMAN SECRETIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION CHIRHOSTIM 40 (HUMAN SECRETIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CHIRHOCLIN, INC.]",
      "spl_version": "20251008",
      "published_date": "2025-11-17"
    }
  },
  "productid": "67066-005_40a8cfc0-9a1b-f924-e063-6294a90afce0",
  "productndc": "67066-005",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "021256",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "16MCG/VIAL",
        "product_no": "001",
        "approval_date": "Apr 9, 2004"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "40MCG/VIAL",
        "product_no": "002",
        "approval_date": "Jun 21, 2007"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SECRETIN HUMAN",
  "proprietary_name": "ChiRhoStim",
  "active_ingred_unit": "ug/8mL",
  "application_number": "NDA021256",
  "marketing_category": "NDA",
  "nonproprietary_name": "Human Secretin",
  "start_marketing_date": "20040801",
  "active_numerator_strength": "16"
}

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