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United States · US · US:59651-425_50c8c596-e201-4370-8487-421925c60b4e

Etyqa

Orange BookUNIISPLATC G03CA

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

Identification

ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeG03CA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5965142528
    1 BLISTER PACK in 1 CARTON (59651-425-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    5965142587
    1 POUCH in 1 CARTON (59651-425-87) / 1 BLISTER PACK in 1 POUCH / 28 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
4TI98Z838E
ESTRADIOL
RxCUI 4083
Orange Book
A214729
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "4TI98Z838E",
    "rxcui": "4083",
    "inchikey": "VOXZDWNPVJITMN-ZBRFXRBCSA-N",
    "display_name": "ESTRADIOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "afbc2a33-5eb2-4f01-91e9-07d8050da6ce": {
      "match": "brand_token",
      "title": "ETYQA (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]",
      "spl_version": "2",
      "published_date": "2024-03-08"
    }
  },
  "productid": "59651-425_50c8c596-e201-4370-8487-421925c60b4e",
  "productndc": "59651-425",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "214729",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.5MG;0.1MG",
        "product_no": "001",
        "approval_date": "Jun 30, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "1MG;0.5MG",
        "product_no": "002",
        "approval_date": "Jun 30, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESTRADIOL; NORETHINDRONE ACETATE",
  "proprietary_name": "Etyqa",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA214729",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ESTRADIOL AND NORETHINDRONE ACETATE",
  "start_marketing_date": "20230630",
  "active_numerator_strength": ".5; .1"
}

Related drugs

Other records sharing ATC code G03CA.

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