Camrese

Orange BookSPL

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

Identification

ManufacturerTeva Pharmaceuticals USA, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0093313482
2 POUCH in 1 CARTON (0093-3134-82) / 1 BLISTER PACK in 1 POUCH (0093-3134-91) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

N021840

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "0e198d28-4986-4b93-833f-17c7ed4ce13e": {
      "match": "brand_token",
      "title": "CAMRESE (LEVONORGESTREL / ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA, INC.]",
      "spl_version": "18",
      "published_date": "2024-11-01"
    }
  },
  "productid": "0093-3134_04a4ff1e-d39b-4ae3-8d13-fe07bc2f582a",
  "productndc": "0093-3134",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "021840",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.03MG,0.01MG;0.15MG,N/A",
        "product_no": "001",
        "approval_date": "May 25, 2006"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Camrese",
  "active_ingred_unit": null,
  "application_number": "NDA021840",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Levonorgestrel / Ethinyl Estradiol and Ethinyl Estradiol",
  "start_marketing_date": "20110728",
  "active_numerator_strength": null
}

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