LILETTA

Orange BookUNIISPLATC G03AD01

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

Identification

ManufacturerAllergan, Inc.

CountryUS (United States)

ATC codeG03AD01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 0

No packs registered.

Annotations

UNII (FDA Substance ID)

5W7SIA7YZW

LEVONORGESTREL

RxCUI 6373

Orange Book

N206229

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": "INTRAUTERINE",
  "spl_meta": {
    "aaf0eb2a-f88a-4f26-a445-0fd30176c326": {
      "match": "brand_token",
      "title": "LILETTA (LEVONORGESTREL) INTRAUTERINE DEVICE [ALLERGAN, INC.]",
      "spl_version": "22",
      "published_date": "2024-10-24"
    }
  },
  "productid": "0023-5858_2bd36b89-e6f6-4da1-97c4-3516f2a06b73",
  "productndc": "0023-5858",
  "dosage_form": "INTRAUTERINE DEVICE",
  "orange_book": {
    "appl_no": "206229",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "52MG",
        "product_no": "001",
        "approval_date": "Feb 26, 2015"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVONORGESTREL",
  "proprietary_name": "LILETTA",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA206229",
  "marketing_category": "NDA",
  "nonproprietary_name": "Levonorgestrel",
  "start_marketing_date": "20160531",
  "active_numerator_strength": "52"
}

Related drugs

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