Levonorgestrel

Orange BookUNIISPLATC G03AD01

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

Identification

ManufacturerRugby Laboratories

CountryUS (United States)

ATC codeG03AD01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0536143363
1 BLISTER PACK in 1 CARTON (0536-1433-63) / 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": {
    "18c143b6-2f83-4dcb-b84a-855739212f25": {
      "match": "brand_token",
      "title": "LEVONORGESTREL AND ETHINYL ESTRADIOL KIT [APOTEX CORP.]",
      "spl_version": "1",
      "published_date": "2026-04-06"
    }
  },
  "productid": "0536-1433_f00936ad-0402-4b54-96eb-6d741e39a67f",
  "productndc": "0536-1433",
  "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": "Levonorgestrel",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206867",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levonorgestrel",
  "start_marketing_date": "20240524",
  "active_numerator_strength": "1.5"
}

Related drugs

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