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United States · US · US:43386-622_6dce7821-019c-4344-9634-5a51060920d5

My Way

Orange BookUNIISPLATC G03AD01

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

Identification

ManufacturerLupin Pharmaceuticals,Inc.
CountryUS (United States)
ATC codeG03AD01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4338662230
    1 TABLET in 1 CARTON (43386-622-30)

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": {
    "500d9418-69a8-f4f3-e063-6394a90a9b66": {
      "match": "brand_token",
      "title": "MY CHOICE (LEVONORGESTREL) TABLET [OHM LABORATORIES INC]",
      "spl_version": "1",
      "published_date": "2026-05-01"
    }
  },
  "productid": "43386-622_6dce7821-019c-4344-9634-5a51060920d5",
  "productndc": "43386-622",
  "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 OTC DRUG",
  "substance_name": "LEVONORGESTREL",
  "proprietary_name": "My Way",
  "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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