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United States · US · US:65862-776_d407dedd-a4c1-4811-91a8-db402646613f

Mili

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 · 6

  • ndc11
    6586277628
    1 BLISTER PACK in 1 CARTON (65862-776-28) / 1 KIT in 1 BLISTER PACK
  • ndc11
    6586277685
    3 BLISTER PACK in 1 CARTON (65862-776-85) / 1 KIT in 1 BLISTER PACK
  • ndc11
    6586277686
    6 BLISTER PACK in 1 CARTON (65862-776-86) / 1 KIT in 1 BLISTER PACK
  • ndc11
    6586277687
    1 POUCH in 1 CARTON (65862-776-87) / 1 KIT in 1 POUCH
  • ndc11
    6586277688
    3 POUCH in 1 CARTON (65862-776-88) / 1 KIT in 1 POUCH
  • ndc11
    6586277692
    6 POUCH in 1 CARTON (65862-776-92) / 1 KIT in 1 POUCH

Annotations

Orange Book
A205449
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "76f14485-321d-4d4f-a3b0-aab195fd0dd1": {
      "match": "brand_token",
      "title": "MILI (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [AUROBINDO PHARMA LIMITED]",
      "spl_version": "12",
      "published_date": "2024-12-19"
    }
  },
  "productid": "65862-776_d407dedd-a4c1-4811-91a8-db402646613f",
  "productndc": "65862-776",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "205449",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.035MG;0.25MG",
        "product_no": "001",
        "approval_date": "Jul 7, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Mili",
  "active_ingred_unit": null,
  "application_number": "ANDA205449",
  "marketing_category": "ANDA",
  "nonproprietary_name": "norgestimate and ethinyl estradiol",
  "start_marketing_date": "20160707",
  "active_numerator_strength": null
}

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