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United States · US · US:47781-652_78a0b591-7cbc-7cd1-1b40-b83f3699c2cf

teriparatide

Orange BookUNIISPLATC H05AA02

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

Identification

ManufacturerAlvogen, Inc.
CountryUS (United States)
ATC codeH05AA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4778165289
    1 SYRINGE in 1 CARTON (47781-652-89) / 2.24 mL in 1 SYRINGE

Annotations

UNII (FDA Substance ID)
10T9CSU89I
TERIPARATIDE
RxCUI 32915
Orange Book
N211939
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": {
    "9d3f65e2-e8f0-4d33-b79e-989013dd3ca3": {
      "match": "brand_token",
      "title": "TERIPARATIDE INJECTION [BLUEPOINT LABORATORIES]",
      "spl_version": "1",
      "published_date": "2026-03-20"
    }
  },
  "productid": "47781-652_78a0b591-7cbc-7cd1-1b40-b83f3699c2cf",
  "productndc": "47781-652",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "211939",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.56MG/2.24ML (0.25MG/ML)",
        "product_no": "001",
        "approval_date": "Oct 4, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TERIPARATIDE",
  "proprietary_name": "teriparatide",
  "active_ingred_unit": "ug/mL",
  "application_number": "NDA211939",
  "marketing_category": "NDA",
  "nonproprietary_name": "teriparatide",
  "start_marketing_date": "20191114",
  "active_numerator_strength": "250"
}

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