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United States · US · US:62756-718_61d03fd1-1f93-4f6c-940c-e436ab1b63a9

Opcicon One-Step

Orange BookUNIIATC G03AD01

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeG03AD01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6275671860
    1 BLISTER PACK in 1 CARTON (62756-718-60) / 1 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
5W7SIA7YZW
LEVONORGESTREL
RxCUI 6373
Orange Book
A202635
Raw payload (JSON)
{
  "unii": {
    "unii": "5W7SIA7YZW",
    "rxcui": "6373",
    "inchikey": "WWYNJERNGUHSAO-XUDSTZEESA-N",
    "display_name": "LEVONORGESTREL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "productid": "62756-718_61d03fd1-1f93-4f6c-940c-e436ab1b63a9",
  "productndc": "62756-718",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202635",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1.5MG",
        "product_no": "001",
        "approval_date": "Sep 11, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LEVONORGESTREL",
  "proprietary_name": "Opcicon One-Step",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202635",
  "marketing_category": "ANDA",
  "nonproprietary_name": "levonorgestrel",
  "start_marketing_date": "20140912",
  "active_numerator_strength": "1.5"
}

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