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United States · US · US:55741-005_eb48cc50-744a-4e77-b520-18a9522530ae

Lutera

Orange BookSPL

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

Identification

ManufacturerDr. Reddy�s Laboratories Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5574100506
    6 BLISTER PACK in 1 CARTON (55741-005-06) / 1 KIT in 1 BLISTER PACK
  • ndc11
    5574100528
    1 BLISTER PACK in 1 PACKET (55741-005-28) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book
A090721
AB1
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "47fc432b-2259-47d2-bba9-5e3aae583990": {
      "match": "brand_token",
      "title": "LUTERA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [DR. REDDY’S LABORATORIES INC.]",
      "spl_version": "1",
      "published_date": "2026-02-16"
    }
  },
  "productid": "55741-005_eb48cc50-744a-4e77-b520-18a9522530ae",
  "productndc": "55741-005",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "090721",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "0.02MG;0.1MG",
        "product_no": "001",
        "approval_date": "Mar 28, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Lutera",
  "active_ingred_unit": null,
  "application_number": "ANDA090721",
  "marketing_category": "ANDA",
  "nonproprietary_name": "levonorgestrel and ethinyl estradiol",
  "start_marketing_date": "20260213",
  "active_numerator_strength": null
}

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