Kit for the Preparation of Technetium Tc99m Mertiatide

Orange BookUNIISPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4556706551
5 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (45567-0655-1)

Annotations

UNII (FDA Substance ID)

9NV2SR34P8

BETIATIDE

RxCUI 194098

Orange Book

A208994

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "9NV2SR34P8",
    "rxcui": "194098",
    "inchikey": "VDPYMEBVIDZKMD-UHFFFAOYSA-N",
    "display_name": "BETIATIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "54608807-4df6-49ba-b065-59a19ef224c4": {
      "match": "brand_token",
      "title": "KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEDRONATE (TECHNETIUM TC 99M MEDRONATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CARDINAL HEALTH 414, LLC]",
      "spl_version": "5",
      "published_date": "2025-09-10"
    }
  },
  "productid": "45567-0655_21ca1be3-2caf-535c-e063-6394a90a18e5",
  "productndc": "45567-0655",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "208994",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "N/A",
        "product_no": "001",
        "approval_date": "Jul 12, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BETIATIDE",
  "proprietary_name": "Kit for the Preparation of Technetium Tc99m Mertiatide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208994",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Betiatide",
  "start_marketing_date": "20190902",
  "active_numerator_strength": "1"
}

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