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United States · US · US:16714-440_843ad7a1-bcee-4568-acd1-31673b04b913

DEBLITANE

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
    1671444001
    1 BLISTER PACK in 1 PACKET (16714-440-01) / 1 KIT in 1 BLISTER PACK
  • ndc11
    1671444002
    1 BLISTER PACK in 1 CARTON (16714-440-02) / 1 KIT in 1 BLISTER PACK
  • ndc11
    1671444003
    3 BLISTER PACK in 1 CARTON (16714-440-03) / 1 KIT in 1 BLISTER PACK
  • ndc11
    1671444004
    6 BLISTER PACK in 1 CARTON (16714-440-04) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book
A202014
AB1
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "e75367ff-78af-4bd2-a99d-d291cb1d21eb": {
      "match": "brand_token",
      "title": "DEBLITANE (NORETHINDRONE) KIT [NORTHSTAR RX LLC]",
      "spl_version": "6",
      "published_date": "2025-12-10"
    }
  },
  "productid": "16714-440_843ad7a1-bcee-4568-acd1-31673b04b913",
  "productndc": "16714-440",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "202014",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "0.35MG",
        "product_no": "001",
        "approval_date": "Sep 13, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "DEBLITANE",
  "active_ingred_unit": null,
  "application_number": "ANDA202014",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Norethindrone",
  "start_marketing_date": "20130913",
  "active_numerator_strength": null
}

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