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United States · US · US:68180-875_c44722bd-9db7-4ea4-b150-7d514b1bc4f7

Vyfemla

Orange BookSPL

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

Identification

ManufacturerLupin Pharmaceuticals, Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6818087573
    3 POUCH in 1 CARTON (68180-875-73) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK * 21 TABLET in 1 BLISTER PACK (68180-495-74) * 7 TABLET in 1 BLISTER PACK (68180-500-74)

Annotations

Orange Book
A201886
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "175ce5c4-d332-4c97-a0b8-10821dc813ef": {
      "match": "brand_token",
      "title": "VYFEMLA ( NORETHINDRONE AND ETHINYL ESTRADIOL ) KIT [LUPIN PHARMACEUTICALS, INC.]",
      "spl_version": "6",
      "published_date": "2025-11-20"
    }
  },
  "productid": "68180-875_c44722bd-9db7-4ea4-b150-7d514b1bc4f7",
  "productndc": "68180-875",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "201886",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.035MG;0.4MG",
        "product_no": "001",
        "approval_date": "Sep 26, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Vyfemla",
  "active_ingred_unit": null,
  "application_number": "ANDA201886",
  "marketing_category": "ANDA",
  "nonproprietary_name": "norethindrone and ethinyl estradiol",
  "start_marketing_date": "20201104",
  "active_numerator_strength": null
}

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