VALTYA 1/35

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
7070030485
3 POUCH in 1 CARTON (70700-304-85) / 1 BLISTER PACK in 1 POUCH (70700-304-84) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

A204703

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "207dfcf6-5239-c907-e5fe-35372da57dd9": {
      "match": "brand_token",
      "title": "VALTYA 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [XIROMED LLC]",
      "spl_version": "1",
      "published_date": "2025-02-07"
    }
  },
  "productid": "70700-304_0a356e6d-57de-b7de-4a94-60a771cd543b",
  "productndc": "70700-304",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "204703",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.035MG;1MG",
        "product_no": "001",
        "approval_date": "Jul 28, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "VALTYA 1/35",
  "active_ingred_unit": null,
  "application_number": "ANDA204703",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ethynodiol diacetate and ethinyl estradiol",
  "start_marketing_date": "20250129",
  "active_numerator_strength": null
}

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