MARLISSA

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
6846238829
3 BLISTER PACK in 1 CARTON (68462-388-29) / 1 KIT in 1 BLISTER PACK (68462-388-84)

Annotations

Orange Book

A091452

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "9379d99e-c416-4dab-a817-1c110e0d4b93": {
      "match": "brand_token",
      "title": "MARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA]",
      "spl_version": "14",
      "published_date": "2026-01-30"
    }
  },
  "productid": "68462-388_c243946a-6bbb-4d5f-8081-1858771fe9de",
  "productndc": "68462-388",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "091452",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.03MG;0.15MG",
        "product_no": "001",
        "approval_date": "Feb 29, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "MARLISSA",
  "active_ingred_unit": null,
  "application_number": "ANDA091452",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levonorgestrel and Ethinyl Estradiol",
  "start_marketing_date": "20120229",
  "active_numerator_strength": null
}

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