Optionelle

Orange BookUNIIATC G03AD01

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

Identification

ManufacturerStrides Pharma Inc

CountryUS (United States)

ATC codeG03AD01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5955628601
1 BLISTER PACK in 1 CARTON (59556-286-01) / 1 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

5W7SIA7YZW

LEVONORGESTREL

RxCUI 6373

Orange Book

A202380

Raw payload (JSON)

{
  "unii": {
    "unii": "5W7SIA7YZW",
    "rxcui": "6373",
    "inchikey": "WWYNJERNGUHSAO-XUDSTZEESA-N",
    "display_name": "LEVONORGESTREL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "productid": "59556-286_18f8537b-15ab-4597-aa74-396d684ff624",
  "productndc": "59556-286",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202380",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1.5MG",
        "product_no": "001",
        "approval_date": "May 29, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LEVONORGESTREL",
  "proprietary_name": "Optionelle",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202380",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levonorgestrel Tablet, 1.5 mg",
  "start_marketing_date": "20220915",
  "active_numerator_strength": "1.5"
}

Related drugs

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