Norgestimate 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
6846256529
3 BLISTER PACK in 1 CARTON (68462-565-29) / 1 KIT in 1 BLISTER PACK (68462-565-84)

Annotations

Orange Book

A200494

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": "68462-565_fbb3fa97-10f6-482a-8d60-e67563ec2bfb",
  "productndc": "68462-565",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "200494",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG",
        "product_no": "001",
        "approval_date": "Jun 17, 2011"
      }
    ],
    "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": "ANDA200494",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Norgestimate and Ethinyl Estradiol",
  "start_marketing_date": "20110617",
  "active_numerator_strength": null
}

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