Norgestimate and ethinyl estradiol

Orange BookSPL

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

Identification

ManufacturerLupin Pharmaceuticals, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6818083873
3 CARTON in 1 CARTON (68180-838-73) / 1 KIT in 1 CARTON

Annotations

Orange Book

A205588

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "35c6507c-555a-45ed-aaf6-8695831de71a": {
      "match": "brand_token",
      "title": "NORGESTIMATE AND ETHINYL ESTRADIOL KIT [A-S MEDICATION SOLUTIONS]",
      "spl_version": "12",
      "published_date": "2026-04-01"
    }
  },
  "productid": "68180-838_75083930-2ca4-48c9-a233-24783a0e50d4",
  "productndc": "68180-838",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "205588",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG",
        "product_no": "001",
        "approval_date": "Apr 26, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Norgestimate and ethinyl estradiol",
  "active_ingred_unit": null,
  "application_number": "ANDA205588",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Norgestimate and ethinyl estradiol",
  "start_marketing_date": "20190808",
  "active_numerator_strength": null
}

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