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United States · US · US:35573-470_a7991ccf-26b1-4ab0-bf9e-175152dccfed
MiloPhene
Orange BookUNIISPLATC G03GB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBurel Pharmaceuticals, LLC
CountryUS (United States)
ATC codeG03GB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11355734703030 TABLET in 1 BOTTLE (35573-470-30)
- ndc11355734707510 TABLET in 1 BOTTLE (35573-470-75)
Annotations
UNII (FDA Substance ID)
1B8447E7YI
CLOMIPHENE CITRATE
RxCUI 142431
Orange Book
A072196
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "1B8447E7YI",
"rxcui": "142431",
"inchikey": null,
"display_name": "CLOMIPHENE CITRATE",
"substance_type": "mixture",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"b56131e5-efc7-43af-ac13-4a2ae918df4e": {
"match": "brand_token",
"title": "MILOPHENE (CLOMIPHENE CITRATE) TABLET [BUREL PHARMACEUTICALS, LLC]",
"spl_version": "2",
"published_date": "2025-11-17"
}
},
"productid": "35573-470_a7991ccf-26b1-4ab0-bf9e-175152dccfed",
"productndc": "35573-470",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "072196",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "Dec 20, 1988"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CLOMIPHENE CITRATE",
"proprietary_name": "MiloPhene",
"active_ingred_unit": "mg/1",
"application_number": "ANDA072196",
"marketing_category": "ANDA",
"nonproprietary_name": "Clomiphene Citrate",
"start_marketing_date": "20250815",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code G03GB02.
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