ALYACEN 1/35

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
6846239429
3 BLISTER PACK in 1 CARTON (68462-394-29) / 1 KIT in 1 BLISTER PACK (68462-394-84)

Annotations

Orange Book

A091634

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "5c02b4d3-1e2f-439a-ae45-02304ee190d1": {
      "match": "brand_token",
      "title": "ALYACEN 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [GLENMARK PHARMACEUTICALS INC., USA]",
      "spl_version": "10",
      "published_date": "2026-02-02"
    }
  },
  "productid": "68462-394_9d4967e6-42df-4468-99a6-9b57499497d9",
  "productndc": "68462-394",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "091634",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.035MG;1MG",
        "product_no": "001",
        "approval_date": "Jan 19, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "ALYACEN 1/35",
  "active_ingred_unit": null,
  "application_number": "ANDA091634",
  "marketing_category": "ANDA",
  "nonproprietary_name": "norethindrone and ethinyl estradiol",
  "start_marketing_date": "20120119",
  "active_numerator_strength": null
}

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