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United States · US · US:72657-108_88548851-6506-4cb2-8636-a30be9ee562e

SheWise

Orange BookUNIISPLATC G03AD01

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

Identification

ManufacturerGLENMARK THERAPEUTICS INC., USA
CountryUS (United States)
ATC codeG03AD01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7265710812
    1 BLISTER PACK in 1 CARTON (72657-108-12) / 1 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
5W7SIA7YZW
LEVONORGESTREL
RxCUI 6373
Orange Book
A207044
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": {
    "7be13a7e-b4ff-4fe1-82a6-f9914596d72a": {
      "match": "brand_token",
      "title": "SHEWISE (LEVONORGESTREL) TABLET [GLENMARK THERAPEUTICS INC., USA]",
      "spl_version": "4",
      "published_date": "2026-01-28"
    }
  },
  "productid": "72657-108_88548851-6506-4cb2-8636-a30be9ee562e",
  "productndc": "72657-108",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "207044",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1.5MG",
        "product_no": "001",
        "approval_date": "Mar 25, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LEVONORGESTREL",
  "proprietary_name": "SheWise",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207044",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levonorgestrel",
  "start_marketing_date": "20220729",
  "active_numerator_strength": "1.5"
}

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