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United States · US · US:0002-8400_31aeb334-c6d1-4018-af85-17ef69850001

Forteo

Orange BookUNIISPLATC H05AA02

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

Identification

ManufacturerEli Lilly and Company
CountryUS (United States)
ATC codeH05AA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0002840001
    1 SYRINGE in 1 CARTON (0002-8400-01) / 2.24 mL in 1 SYRINGE

Annotations

UNII (FDA Substance ID)
10T9CSU89I
TERIPARATIDE
RxCUI 32915
Orange Book
N021318
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "10T9CSU89I",
    "rxcui": "32915",
    "inchikey": null,
    "display_name": "TERIPARATIDE",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "aae667c5-381f-4f92-93df-2ed6158d07b0": {
      "match": "brand_token",
      "title": "FORTEO (TERIPARATIDE) INJECTION, SOLUTION [ELI LILLY AND COMPANY]",
      "spl_version": "42",
      "published_date": "2025-08-01"
    }
  },
  "productid": "0002-8400_31aeb334-c6d1-4018-af85-17ef69850001",
  "productndc": "0002-8400",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "021318",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.75MG/3ML (0.25MG/ML)",
        "product_no": "001",
        "approval_date": "Nov 26, 2002"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "0.56MG/2.24ML (0.25MG/ML)",
        "product_no": "002",
        "approval_date": "Jun 25, 2008"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TERIPARATIDE",
  "proprietary_name": "Forteo",
  "active_ingred_unit": "ug/mL",
  "application_number": "NDA021318",
  "marketing_category": "NDA",
  "nonproprietary_name": "Teriparatide",
  "start_marketing_date": "20021126",
  "active_numerator_strength": "250"
}

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