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United States · US · US:0480-3475_3f6f53f3-b61a-45d9-94ed-d2946a17212e

Nora BE

Orange BookUNIISPLATC G03DC02

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

Identification

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

Packs · 1

  • ndc11
    0480347516
    6 PACKAGE in 1 CARTON (0480-3475-16) / 28 TABLET in 1 PACKAGE

Annotations

UNII (FDA Substance ID)
T18F433X4S
NORETHINDRONE
RxCUI 7514
Orange Book
N017060
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": {
    "426ac898-7745-4645-bf9b-bae319e260e8": {
      "match": "brand_token",
      "title": "NORA BE (NORETHINDRONE) TABLET [TEVA PHARMACEUTICALS, INC.]",
      "spl_version": "3",
      "published_date": "2024-11-04"
    }
  },
  "productid": "0480-3475_3f6f53f3-b61a-45d9-94ed-d2946a17212e",
  "productndc": "0480-3475",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "017060",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB1",
        "strength": "0.35MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NORETHINDRONE",
  "proprietary_name": "Nora BE",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA017060",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Norethindrone",
  "start_marketing_date": "20231201",
  "active_numerator_strength": ".35"
}

Related drugs

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