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United States · US · US:64980-690_621c3a1f-d194-4381-bde0-1574f108ac4e
Clomiphene Citrate
Orange BookUNIISPLATC G03GB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRISING PHARMA HOLDINGS, INC.
CountryUS (United States)
ATC codeG03GB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11649806900110 TABLET in 1 BOTTLE (64980-690-01)
- ndc11649806900330 TABLET in 1 BOTTLE (64980-690-03)
- ndc1164980690901 BLISTER PACK in 1 CARTON (64980-690-90) / 10 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
1B8447E7YI
CLOMIPHENE CITRATE
RxCUI 142431
Orange Book
A216739
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": {
"79f64995-7425-44c6-9f44-f7d20daeff65": {
"match": "brand_token",
"title": "CLOMIPHENE CITRATE TABLET [ACCORD HEALTHCARE INC.]",
"spl_version": "3",
"published_date": "2025-12-02"
}
},
"productid": "64980-690_621c3a1f-d194-4381-bde0-1574f108ac4e",
"productndc": "64980-690",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "216739",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "Nov 8, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CLOMIPHENE CITRATE",
"proprietary_name": "Clomiphene Citrate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA216739",
"marketing_category": "ANDA",
"nonproprietary_name": "Clomiphene Citrtae",
"start_marketing_date": "20241119",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code G03GB02.
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