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United States · US · US:68462-316_6eb1e9bd-c526-4036-b9b4-ac88811d76e2

BRIELLYN

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on

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
    6846231629
    3 BLISTER PACK in 1 CARTON (68462-316-29) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book
A090538
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "c0e2c5b4-70ac-4b41-aa71-00e506dbb72f": {
      "match": "brand_token",
      "title": "BRIELLYN (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA]",
      "spl_version": "13",
      "published_date": "2026-02-02"
    }
  },
  "productid": "68462-316_6eb1e9bd-c526-4036-b9b4-ac88811d76e2",
  "productndc": "68462-316",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "090538",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.035MG;0.4MG",
        "product_no": "001",
        "approval_date": "Mar 22, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "BRIELLYN",
  "active_ingred_unit": null,
  "application_number": "ANDA090538",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Norethindrone and Ethinyl Estradiol",
  "start_marketing_date": "20110323",
  "active_numerator_strength": null
}

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