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United States · US · US:65862-934_8b98eb73-94c9-43f2-bc65-de59a5ed1aed

Aurovela 24 Fe

Orange BookSPL

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

Identification

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

Packs · 3

  • ndc11
    6586293458
    5 POUCH in 1 CARTON (65862-934-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
  • ndc11
    6586293487
    1 POUCH in 1 CARTON (65862-934-87) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
  • ndc11
    6586293488
    3 POUCH in 1 CARTON (65862-934-88) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book
A207504
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "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": "65862-934_8b98eb73-94c9-43f2-bc65-de59a5ed1aed",
  "productndc": "65862-934",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "207504",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.02MG;1MG",
        "product_no": "001",
        "approval_date": "Jun 15, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Aurovela 24 Fe",
  "active_ingred_unit": null,
  "application_number": "ANDA207504",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate",
  "start_marketing_date": "20170615",
  "active_numerator_strength": null
}

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