Low-Ogestrel

Orange BookSPL

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

Identification

ManufacturerMayne Pharma Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5186256406
6 BLISTER PACK in 1 CARTON (51862-564-06) / 1 KIT in 1 BLISTER PACK (51862-564-01)

Annotations

Orange Book

A075288

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "8755b020-d439-4ba2-a60b-6c57a15ece55": {
      "match": "brand_token",
      "title": "LOW-OGESTREL (NORGESTREL AND ETHINYL ESTRADIOL) KIT [MAYNE PHARMA INC.]",
      "spl_version": "14",
      "published_date": "2025-07-31"
    }
  },
  "productid": "51862-564_051f62cc-9a4a-40bc-9a9b-e7942354c0dc",
  "productndc": "51862-564",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "075288",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.03MG;0.3MG",
        "product_no": "001",
        "approval_date": "Jul 28, 1999"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.03MG;0.3MG",
        "product_no": "002",
        "approval_date": "Jul 28, 1999"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Low-Ogestrel",
  "active_ingred_unit": null,
  "application_number": "ANDA075288",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Norgestrel and Ethinyl Estradiol",
  "start_marketing_date": "20160803",
  "active_numerator_strength": null
}

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