drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calcium

Orange BookSPL

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

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
6818089473
3 POUCH in 1 CARTON (68180-894-73) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book

A205947

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "48f4301c-0426-43cd-af37-c4d8fc7aeb67": {
      "match": "brand_token",
      "title": "DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM ( DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM ) KIT [LUPIN PHARMACEUTICALS, INC.]",
      "spl_version": "9",
      "published_date": "2025-12-09"
    }
  },
  "productid": "68180-894_f5347764-c224-4ba9-b57a-90a228f1ee07",
  "productndc": "68180-894",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "205947",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "3MG,N/A;0.02MG,N/A;0.451MG,0.451MG",
        "product_no": "001",
        "approval_date": "Jun 13, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calcium",
  "active_ingred_unit": null,
  "application_number": "ANDA205947",
  "marketing_category": "ANDA",
  "nonproprietary_name": "drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calcium",
  "start_marketing_date": "20180822",
  "active_numerator_strength": null
}

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