Julie

Orange BookUNIISPLATC G03AD01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerJulie Products Inc.

CountryUS (United States)

ATC codeG03AD01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8279153201
1 BLISTER PACK in 1 CARTON (82791-532-01) / 1 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

5W7SIA7YZW

LEVONORGESTREL

RxCUI 6373

Orange Book

A206867

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "5W7SIA7YZW",
    "rxcui": "6373",
    "inchikey": "WWYNJERNGUHSAO-XUDSTZEESA-N",
    "display_name": "LEVONORGESTREL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "40bb96f0-d5f1-1ec3-e063-6294a90a74b1": {
      "match": "brand_token",
      "title": "JULIE MORNING AFTER PILL (LEVONORGESTREL) TABLET [JULIE PRODUCTS INC.]",
      "spl_version": "2",
      "published_date": "2025-11-27"
    }
  },
  "productid": "82791-532_f8a4d097-d78e-4487-81b3-a2da5086b0d8",
  "productndc": "82791-532",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "206867",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1.5MG",
        "product_no": "001",
        "approval_date": "Dec 8, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LEVONORGESTREL",
  "proprietary_name": "Julie",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206867",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levonorgestrel",
  "start_marketing_date": "20221028",
  "active_numerator_strength": "1.5"
}

Related drugs

Other records sharing ATC code G03AD01.

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