INTROVALE

Orange BookSPL

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

Identification

ManufacturerXiromed LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7070020888
3 POUCH in 1 CARTON (70700-208-88) / 1 BLISTER PACK in 1 POUCH (70700-208-87) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

A200490

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "24abb5e1-5be4-87e7-404c-d8c2db25ffd0": {
      "match": "brand_token",
      "title": "INTROVALE (LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS) KIT [XIROMED LLC]",
      "spl_version": "1",
      "published_date": "2025-03-05"
    }
  },
  "productid": "70700-208_afa14bda-c9ec-485c-527a-622d0afb457a",
  "productndc": "70700-208",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "200490",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.03MG;0.15MG",
        "product_no": "001",
        "approval_date": "Apr 21, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "INTROVALE",
  "active_ingred_unit": null,
  "application_number": "ANDA200490",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levonorgestrel and Ethinyl Estradiol tablets",
  "start_marketing_date": "20250129",
  "active_numerator_strength": null
}

Access this data programmatically

Query INTROVALE and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs