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United States · US · US:67296-1938_46c2bc8a-6bfb-c9bc-e063-6294a90ac788

Opill

Orange BookUNIISPL

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

Identification

ManufacturerRedpharm Drug
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6729619382
    1 BLISTER PACK in 1 CARTON (67296-1938-2) / 28 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
3J8Q1747Z2
NORGESTREL
RxCUI 7518
Orange Book
N017031
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "3J8Q1747Z2",
    "rxcui": "7518",
    "inchikey": "WWYNJERNGUHSAO-XUDSTZEESA-N;WWYNJERNGUHSAO-XHCJJCCMSA-N",
    "display_name": "NORGESTREL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "303264da-c919-e0ce-e063-6394a90a4cc7": {
      "match": "brand_token",
      "title": "OPILL (NORGESTREL) TABLET [REDPHARM DRUG]",
      "spl_version": "3",
      "published_date": "2025-12-26"
    }
  },
  "productid": "67296-1938_46c2bc8a-6bfb-c9bc-e063-6294a90ac788",
  "productndc": "67296-1938",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "017031",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.075MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NORGESTREL",
  "proprietary_name": "Opill",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA017031",
  "marketing_category": "NDA",
  "nonproprietary_name": "norgestrel",
  "start_marketing_date": "20240304",
  "active_numerator_strength": ".075"
}

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