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United States · US · US:70954-825_b56e04f0-490d-4f10-a0ed-31c288f4f4c5
Clomiphene citrate
Orange BookUNIISPLATC G03GB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeG03GB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11709548252010 BLISTER PACK in 1 CARTON (70954-825-20) / 1 TABLET in 1 BLISTER PACK (70954-825-10)
- ndc11709548253030 BLISTER PACK in 1 CARTON (70954-825-30) / 1 TABLET in 1 BLISTER PACK (70954-825-10)
Annotations
UNII (FDA Substance ID)
1B8447E7YI
CLOMIPHENE CITRATE
RxCUI 142431
Orange Book
A219781
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": "70954-825_b56e04f0-490d-4f10-a0ed-31c288f4f4c5",
"productndc": "70954-825",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "219781",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "Oct 17, 2025"
}
],
"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": "ANDA219781",
"marketing_category": "ANDA",
"nonproprietary_name": "Clomiphene citrate",
"start_marketing_date": "20251017",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code G03GB02.
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