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United States · US · US:65862-939_e42c0b14-e08a-4e77-8ead-8b44fb472f5f

Aurovela 1/20

In shortageOrange 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
    6586293954
    5 POUCH in 1 CARTON (65862-939-54) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK
  • ndc11
    6586293988
    3 POUCH in 1 CARTON (65862-939-88) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
423D2T571U
ETHINYL ESTRADIOL
RxCUI 4124
Orange Book
A207506
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Ethinyl Estradiol; Ethinyl Diacetate Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "423D2T571U",
    "rxcui": "4124",
    "inchikey": "BFPYWIDHMRZLRN-SLHNCBLASA-N",
    "display_name": "ETHINYL ESTRADIOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "3eb092dc-2ec1-4d55-b1fe-69505608e04a": {
      "match": "brand_token",
      "title": "AUROVELA 24 FE (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [AUROBINDO PHARMA LIMITED]",
      "spl_version": "14",
      "published_date": "2023-11-23"
    }
  },
  "productid": "65862-939_e42c0b14-e08a-4e77-8ead-8b44fb472f5f",
  "productndc": "65862-939",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "207506",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.02MG;1MG",
        "product_no": "001",
        "approval_date": "Jun 16, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ETHINYL ESTRADIOL; NORETHINDRONE ACETATE",
  "shortage_reason": "Ethinyl Estradiol; Ethinyl Diacetate Tablet",
  "shortage_status": "current",
  "proprietary_name": "Aurovela 1/20",
  "active_ingred_unit": "ug/1; mg/1",
  "application_number": "ANDA207506",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Norethindrone Acetate and Ethinyl Estradiol",
  "start_marketing_date": "20170616",
  "active_numerator_strength": "20; 1"
}

Related drugs

Other records sharing ATC code G03CA.

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