levonorgestrel and ethinyl estradiol

Orange BookSPL

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

Identification

ManufacturerGlenmark Pharmaceuticals Inc., USA

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6846267295
3 POUCH in 1 CARTON (68462-672-95) / 1 BLISTER PACK in 1 POUCH (68462-672-91) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

A203164

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "18c143b6-2f83-4dcb-b84a-855739212f25": {
      "match": "brand_token",
      "title": "LEVONORGESTREL AND ETHINYL ESTRADIOL KIT [APOTEX CORP.]",
      "spl_version": "1",
      "published_date": "2026-04-06"
    }
  },
  "productid": "68462-672_f0db17c7-0387-420c-8ba4-5d0752e5a4ee",
  "productndc": "68462-672",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "203164",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.03MG;0.15MG",
        "product_no": "001",
        "approval_date": "Jun 12, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "levonorgestrel and ethinyl estradiol",
  "active_ingred_unit": null,
  "application_number": "ANDA203164",
  "marketing_category": "ANDA",
  "nonproprietary_name": "levonorgestrel and ethinyl estradiol",
  "start_marketing_date": "20150612",
  "active_numerator_strength": null
}

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