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United States · US · US:68180-903_23d6a959-fc74-4a2a-8eb9-15735efec545

Kaitlib Fe

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
    6818090373
    3 BLISTER PACK in 1 CARTON (68180-903-73) / 1 KIT in 1 BLISTER PACK * 24 TABLET, CHEWABLE in 1 BLISTER PACK (68180-356-74) * 4 TABLET, CHEWABLE in 1 BLISTER PACK (68180-358-74)

Annotations

Orange Book
A203448
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "4826031b-c2b7-4cd0-a4da-59068bd34430": {
      "match": "brand_token",
      "title": "KAITLIB FE (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [LUPIN PHARMACEUTICALS, INC.]",
      "spl_version": "14",
      "published_date": "2025-12-03"
    }
  },
  "productid": "68180-903_23d6a959-fc74-4a2a-8eb9-15735efec545",
  "productndc": "68180-903",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "203448",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "0.025MG;0.8MG",
        "product_no": "001",
        "approval_date": "Dec 17, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Kaitlib Fe",
  "active_ingred_unit": null,
  "application_number": "ANDA203448",
  "marketing_category": "ANDA",
  "nonproprietary_name": "norethindrone and ethinyl estradiol",
  "start_marketing_date": "20210207",
  "active_numerator_strength": null
}

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