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United States · US · US:70700-316_a54bf859-7035-5948-0a50-9c42bb791c9f

Orquidea

Orange BookUNIISPLATC G03DC02

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

Identification

ManufacturerXiromed, LLC
CountryUS (United States)
ATC codeG03DC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7070031685
    3 POUCH in 1 CARTON (70700-316-85) / 1 BLISTER PACK in 1 POUCH (70700-316-84) / 28 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
T18F433X4S
NORETHINDRONE
RxCUI 7514
Orange Book
A201483
AB1
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "T18F433X4S",
    "rxcui": "7514",
    "inchikey": "VIKNJXKGJWUCNN-XGXHKTLJSA-N",
    "display_name": "NORETHINDRONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "6e9f61a1-93ff-291a-bea8-9307a3b0378e": {
      "match": "brand_token",
      "title": "ORQUIDEA (NORETHINDRONE) TABLET [XIROMED, LLC]",
      "spl_version": "1",
      "published_date": "2025-02-07"
    }
  },
  "productid": "70700-316_a54bf859-7035-5948-0a50-9c42bb791c9f",
  "productndc": "70700-316",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "201483",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "0.35MG",
        "product_no": "001",
        "approval_date": "Jun 24, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NORETHINDRONE",
  "proprietary_name": "Orquidea",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA201483",
  "marketing_category": "ANDA",
  "nonproprietary_name": "norethindrone",
  "start_marketing_date": "20250129",
  "active_numerator_strength": ".35"
}

Related drugs

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