Nylia 1/35

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
6586289888
3 POUCH in 1 CARTON (65862-898-88) / 1 BLISTER PACK in 1 POUCH (65862-898-28) / 1 KIT in 1 BLISTER PACK
ndc11
6586289892
6 POUCH in 1 CARTON (65862-898-92) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

A207056

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "4ade84c1-e172-443f-aac7-0e8407aaa7de": {
      "match": "brand_token",
      "title": "NYLIA 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [A-S MEDICATION SOLUTIONS]",
      "spl_version": "8",
      "published_date": "2024-10-30"
    }
  },
  "productid": "65862-898_ea0b61da-d6b9-4ad7-85b4-5c3afd6e32b0",
  "productndc": "65862-898",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "207056",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.035MG;1MG",
        "product_no": "001",
        "approval_date": "Oct 21, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Nylia 1/35",
  "active_ingred_unit": null,
  "application_number": "ANDA207056",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Norethindrone and Ethinyl Estradiol",
  "start_marketing_date": "20161021",
  "active_numerator_strength": null
}

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