Levonorgestrel

Orange BookUNIISPLATC G03AD01

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

Identification

ManufacturerNovel Laboratories, Inc.

CountryUS (United States)

ATC codeG03AD01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4003262230
1 TABLET in 1 CARTON (40032-622-30)

Annotations

UNII (FDA Substance ID)

5W7SIA7YZW

LEVONORGESTREL

RxCUI 6373

Orange Book

A202508

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": "40032-622_af913ba6-b143-43c5-86fc-a36fd494b29d",
  "productndc": "40032-622",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202508",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1.5MG",
        "product_no": "001",
        "approval_date": "Feb 22, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVONORGESTREL",
  "proprietary_name": "Levonorgestrel",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202508",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levonorgestrel",
  "start_marketing_date": "20130215",
  "active_numerator_strength": "1.5"
}

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