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United States · US · US:16714-359_a0973aa1-ac56-4811-8221-cdf0e79c3f90

Falmina

Orange BookSPL

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

Identification

ManufacturerNorthstar Rx LLC
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    1671435901
    1 BLISTER PACK in 1 PACKET (16714-359-01) / 1 KIT in 1 BLISTER PACK
  • ndc11
    1671435902
    1 BLISTER PACK in 1 CARTON (16714-359-02) / 1 KIT in 1 BLISTER PACK
  • ndc11
    1671435903
    3 BLISTER PACK in 1 CARTON (16714-359-03) / 1 KIT in 1 BLISTER PACK
  • ndc11
    1671435904
    6 BLISTER PACK in 1 CARTON (16714-359-04) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book
A090721
AB1
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "cf6f069e-4b78-4adb-b5be-100b9d85aab7": {
      "match": "brand_token",
      "title": "FALMINA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [NORTHSTAR RX LLC]",
      "spl_version": "8",
      "published_date": "2025-03-04"
    }
  },
  "productid": "16714-359_a0973aa1-ac56-4811-8221-cdf0e79c3f90",
  "productndc": "16714-359",
  "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": "Falmina",
  "active_ingred_unit": null,
  "application_number": "ANDA090721",
  "marketing_category": "ANDA",
  "nonproprietary_name": "levonorgestrel and ethinyl estradiol",
  "start_marketing_date": "20130913",
  "active_numerator_strength": null
}

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