Norethindrone and ethinyl estradiol

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerNaari Pte Limited

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7992900707
3 BLISTER PACK in 1 CARTON (79929-007-07) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

A206864

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "38924c83-53aa-4279-8f0e-1a5d8f5fd8ad": {
      "match": "brand_token",
      "title": "NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [A-S MEDICATION SOLUTIONS]",
      "spl_version": "7",
      "published_date": "2026-03-27"
    }
  },
  "productid": "79929-007_16aaf795-d54a-9f9c-e063-6394a90a09c4",
  "productndc": "79929-007",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "206864",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.035MG;1MG",
        "product_no": "001",
        "approval_date": "Apr 28, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Norethindrone and ethinyl estradiol",
  "active_ingred_unit": null,
  "application_number": "ANDA206864",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Norethindrone and ethinyl estradiol",
  "start_marketing_date": "20221231",
  "active_numerator_strength": null
}

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