Balcoltra

Orange BookSPL

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

Identification

ManufacturerAvion Pharmaceuticals

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
7585460202
2 BLISTER PACK in 1 CARTON (75854-602-02) / 1 KIT in 1 BLISTER PACK
ndc11
7585460203
3 BLISTER PACK in 1 CARTON (75854-602-03) / 1 KIT in 1 BLISTER PACK
ndc11
7585460228
1 BLISTER PACK in 1 CARTON (75854-602-28) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

N208612

AB3

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "752ab698-4b48-4614-8016-d1d33ee7c007": {
      "match": "brand_token",
      "title": "BALCOLTRA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AVION PHARMACEUTICALS]",
      "spl_version": "6",
      "published_date": "2025-12-10"
    }
  },
  "productid": "75854-602_57bb625e-d567-432d-a6c2-44b329de9b7b",
  "productndc": "75854-602",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "208612",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB3",
        "strength": "0.02MG;0.1MG",
        "product_no": "001",
        "approval_date": "Jan 9, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Balcoltra",
  "active_ingred_unit": null,
  "application_number": "NDA208612",
  "marketing_category": "NDA",
  "nonproprietary_name": "levonorgestrel and ethinyl estradiol",
  "start_marketing_date": "20180410",
  "active_numerator_strength": null
}

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