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United States · US · US:50102-300_ffb8f5fe-9e1a-4ca9-adc9-181093af01b9

Lyleq

Orange BookUNIIATC G03DC02

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

Identification

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

Packs · 1

  • ndc11
    5010230013
    3 PACKAGE in 1 CARTON (50102-300-13) / 1 BLISTER PACK in 1 PACKAGE (50102-300-11) / 28 TABLET in 1 BLISTER PACK (50102-300-01)

Annotations

UNII (FDA Substance ID)
T18F433X4S
NORETHINDRONE
RxCUI 7514
Orange Book
A207304
AB1
Raw payload (JSON)
{
  "unii": {
    "unii": "T18F433X4S",
    "rxcui": "7514",
    "inchikey": "VIKNJXKGJWUCNN-XGXHKTLJSA-N",
    "display_name": "NORETHINDRONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "productid": "50102-300_ffb8f5fe-9e1a-4ca9-adc9-181093af01b9",
  "productndc": "50102-300",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "207304",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "0.35MG",
        "product_no": "001",
        "approval_date": "Sep 23, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NORETHINDRONE",
  "proprietary_name": "Lyleq",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207304",
  "marketing_category": "ANDA",
  "nonproprietary_name": "NORETHINDRONE",
  "start_marketing_date": "20160923",
  "active_numerator_strength": ".35"
}

Related drugs

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