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United States · US · US:0378-7292_952f8023-4a5f-746d-c678-388b50e8909c

NORETHINDRONE

Orange BookUNIISPLATC G03DC02

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

Identification

ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeG03DC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0378729253
    3 POUCH in 1 CARTON (0378-7292-53) / 1 BLISTER PACK in 1 POUCH (0378-7292-85) / 28 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
T18F433X4S
NORETHINDRONE
RxCUI 7514
Orange Book
A201483
AB1
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "T18F433X4S",
    "rxcui": "7514",
    "inchikey": "VIKNJXKGJWUCNN-XGXHKTLJSA-N",
    "display_name": "NORETHINDRONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "38924c83-53aa-4279-8f0e-1a5d8f5fd8ad": {
      "match": "brand_token",
      "title": "NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [A-S MEDICATION SOLUTIONS]",
      "spl_version": "7",
      "published_date": "2026-03-27"
    }
  },
  "productid": "0378-7292_952f8023-4a5f-746d-c678-388b50e8909c",
  "productndc": "0378-7292",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "201483",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "0.35MG",
        "product_no": "001",
        "approval_date": "Jun 24, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NORETHINDRONE",
  "proprietary_name": "NORETHINDRONE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA201483",
  "marketing_category": "ANDA",
  "nonproprietary_name": "norethindrone",
  "start_marketing_date": "20130712",
  "active_numerator_strength": ".35"
}

Related drugs

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