Afirmelle

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
6586284988
3 POUCH in 1 CARTON (65862-849-88) / 1 BLISTER PACK in 1 POUCH (65862-849-28) / 1 KIT in 1 BLISTER PACK
ndc11
6586284992
6 POUCH in 1 CARTON (65862-849-92) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

A206886

AB1

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "dd6122cd-b7ba-4fe3-bde5-910882475b67": {
      "match": "brand_token",
      "title": "AFIRMELLE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AUROBINDO PHARMA LIMITED]",
      "spl_version": "10",
      "published_date": "2025-08-08"
    }
  },
  "productid": "65862-849_47af327f-2969-4cbf-9aa8-39c8003df043",
  "productndc": "65862-849",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "206886",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "0.02MG;0.1MG",
        "product_no": "001",
        "approval_date": "Nov 14, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Afirmelle",
  "active_ingred_unit": null,
  "application_number": "ANDA206886",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levonorgestrel and Ethinyl Estradiol",
  "start_marketing_date": "20161114",
  "active_numerator_strength": null
}

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