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United States · US · US:79929-015_16aaf795-d546-9f9c-e063-6394a90a09c4

Affodel

Orange BookUNIISPLATC G03DC02

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

Identification

ManufacturerNaari Pte. Limited
CountryUS (United States)
ATC codeG03DC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7992901507
    84 BLISTER PACK in 1 CARTON (79929-015-07) / 28 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
T18F433X4S
NORETHINDRONE
RxCUI 7514
Orange Book
A206807
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": {
    "8ec64ec8-fbc9-440d-9838-654a605d57da": {
      "match": "brand_token",
      "title": "AFFODEL (NORETHINDRONE) TABLET [NAARI PTE. LIMITED]",
      "spl_version": "3",
      "published_date": "2024-05-31"
    }
  },
  "productid": "79929-015_16aaf795-d546-9f9c-e063-6394a90a09c4",
  "productndc": "79929-015",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "206807",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "0.35MG",
        "product_no": "001",
        "approval_date": "Dec 13, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NORETHINDRONE",
  "proprietary_name": "Affodel",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206807",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Norethindrone",
  "start_marketing_date": "20240531",
  "active_numerator_strength": ".35"
}

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