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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
- ndc11799290150784 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"
}Related drugs
Other records sharing ATC code G03DC02.
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