AUROVELA Fe

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 · 2

ndc11
6586294158
5 POUCH in 1 CARTON (65862-941-58) / 1 BLISTER PACK in 1 POUCH (65862-941-87) / 1 KIT in 1 BLISTER PACK
ndc11
6586294188
3 POUCH in 1 CARTON (65862-941-88) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

A207580

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": "65862-941_837c477f-da74-4754-90a5-a33af31a6fea",
  "productndc": "65862-941",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "207580",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.03MG;1.5MG",
        "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 Fe",
  "active_ingred_unit": null,
  "application_number": "ANDA207580",
  "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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