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United States · US · US:0002-1200_63e1d0b5-c634-4699-91b2-643a6e765139

Amyvid

Orange BookUNIISPLATC V09AX05

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

Identification

ManufacturerEli Lilly and Company
CountryUS (United States)
ATC codeV09AX05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0002120048
    1 VIAL, MULTI-DOSE in 1 CAN (0002-1200-48) / 100 mL in 1 VIAL, MULTI-DOSE
  • ndc11
    0002120050
    1 VIAL, MULTI-DOSE in 1 CAN (0002-1200-50) / 50 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)
6W15Z5R0RU
FLORBETAPIR F-18
RxCUI 1427224
Orange Book
N202008
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "6W15Z5R0RU",
    "rxcui": "1427224",
    "inchikey": "YNDIAUKFXKEXSV-CRYLGTRXSA-N",
    "display_name": "FLORBETAPIR F-18",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "bb5a5043-0f51-11df-8a39-0800200c9a66": {
      "match": "brand_token",
      "title": "AMYVID (FLORBETAPIR F 18) INJECTION, SOLUTION [ELI LILLY AND COMPANY]",
      "spl_version": "25",
      "published_date": "2026-02-06"
    }
  },
  "productid": "0002-1200_63e1d0b5-c634-4699-91b2-643a6e765139",
  "productndc": "0002-1200",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "202008",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10ML (13.5-51mCi/ML)",
        "product_no": "001",
        "approval_date": "Apr 6, 2012"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10-30ML (13.5-51mCi/ML)",
        "product_no": "002",
        "approval_date": "Apr 6, 2012"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "10-50ML (13.5-51mCi/ML)",
        "product_no": "003",
        "approval_date": "Apr 6, 2012"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "10-100ML (13.5-51mCi/ML)",
        "product_no": "004",
        "approval_date": "Oct 13, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLORBETAPIR F-18",
  "proprietary_name": "Amyvid",
  "active_ingred_unit": "mCi/mL",
  "application_number": "NDA202008",
  "marketing_category": "NDA",
  "nonproprietary_name": "Florbetapir F 18",
  "start_marketing_date": "20120601",
  "active_numerator_strength": "51"
}

Related drugs

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