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United States · US · US:70700-317_a3bb0699-e518-4526-e81e-df5e1afefe38
MELEYA
Orange BookUNIISPLATC G03DC02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerXiromed LLC
CountryUS (United States)
ATC codeG03DC02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170700317853 POUCH in 1 CARTON (70700-317-85) / 1 BLISTER PACK in 1 POUCH (70700-317-84) / 28 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
T18F433X4S
NORETHINDRONE
RxCUI 7514
Orange Book
A200980
AB2
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": {
"534c5717-382c-4109-3208-e21b32e4c4c9": {
"match": "brand_token",
"title": "MELEYA (NORETHINDRONE) TABLET [XIROMED LLC]",
"spl_version": "2",
"published_date": "2025-04-18"
}
},
"productid": "70700-317_a3bb0699-e518-4526-e81e-df5e1afefe38",
"productndc": "70700-317",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "200980",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB2",
"strength": "0.35MG",
"product_no": "001",
"approval_date": "Jun 12, 2013"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NORETHINDRONE",
"proprietary_name": "MELEYA",
"active_ingred_unit": "mg/1",
"application_number": "ANDA200980",
"marketing_category": "ANDA",
"nonproprietary_name": "Norethindrone",
"start_marketing_date": "20250129",
"active_numerator_strength": ".35"
}Related drugs
Other records sharing ATC code G03DC02.
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