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United States · US · US:60505-6188_8f15c891-ec65-6632-c161-e7bddfc3b3f2

Teriparatide

Orange BookUNIISPLATC H05AA02

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

Identification

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

Packs · 1

  • ndc11
    6050561880
    1 SYRINGE in 1 CARTON (60505-6188-0) / 2.4 mL in 1 SYRINGE

Annotations

UNII (FDA Substance ID)
10T9CSU89I
TERIPARATIDE
RxCUI 32915
Orange Book
A211097
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": {
    "9d3f65e2-e8f0-4d33-b79e-989013dd3ca3": {
      "match": "brand_token",
      "title": "TERIPARATIDE INJECTION [BLUEPOINT LABORATORIES]",
      "spl_version": "1",
      "published_date": "2026-03-20"
    }
  },
  "productid": "60505-6188_8f15c891-ec65-6632-c161-e7bddfc3b3f2",
  "productndc": "60505-6188",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "211097",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "0.56MG/2.24ML (0.25MG/ML)",
        "product_no": "001",
        "approval_date": "Nov 16, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TERIPARATIDE",
  "proprietary_name": "Teriparatide",
  "active_ingred_unit": "ug/mL",
  "application_number": "ANDA211097",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Teriparatide",
  "start_marketing_date": "20231116",
  "active_numerator_strength": "250"
}

Related drugs

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