OSHIH

Orange BookSPL

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5965150488
3 POUCH in 1 CARTON (59651-504-88) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

A216558

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "7c07e339-3aae-4c77-a170-e6715bbe7563": {
      "match": "brand_token",
      "title": "OSHIH (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [AUROBINDO PHARMA LIMITED]",
      "spl_version": "2",
      "published_date": "2024-02-16"
    }
  },
  "productid": "59651-504_3bf10185-1849-49a1-9b3b-ba35a0413408",
  "productndc": "59651-504",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "216558",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.02MG;1MG",
        "product_no": "001",
        "approval_date": "Dec 6, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "OSHIH",
  "active_ingred_unit": null,
  "application_number": "ANDA216558",
  "marketing_category": "ANDA",
  "nonproprietary_name": "norethindrone acetate and ethinyl estradiol and ferrous fumarate",
  "start_marketing_date": "20231206",
  "active_numerator_strength": null
}

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