ExEm Foam

Orange BookSPL

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

Identification

ManufacturerGISKIT PHARMA B.V.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7325431001
1 KIT in 1 CARTON (73254-310-01) * 5 mL in 1 SYRINGE, PLASTIC * 5 mL in 1 SYRINGE, PLASTIC

Annotations

Orange Book

N212279

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": "INTRAUTERINE",
  "spl_meta": {
    "b8cb3e4d-ed22-4e88-abca-508c794b4b91": {
      "match": "brand_token",
      "title": "EXEM FOAM (AIR POLYMER-TYPE A INTRAUTERINE FOAM) KIT [GISKIT PHARMA B.V.]",
      "spl_version": "7",
      "published_date": "2023-11-09"
    }
  },
  "productid": "73254-310_09acadb7-c0a2-d753-e063-6294a90af9a9",
  "productndc": "73254-310",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "212279",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "10ML",
        "product_no": "001",
        "approval_date": "Nov 7, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "ExEm Foam",
  "active_ingred_unit": null,
  "application_number": "NDA212279",
  "marketing_category": "NDA",
  "nonproprietary_name": "Air Polymer-Type A Intrauterine Foam",
  "start_marketing_date": "20201016",
  "active_numerator_strength": null
}

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