🇺🇸
United States · US · US:83390-107_3ce28083-f9f3-c59f-e063-6394a90a92e1
Clomiphene Citrate
Orange BookUNIISPLATC G03GB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCosette Pharmaceuticals NC Laboratories, LLC
CountryUS (United States)
ATC codeG03GB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1183390107091 BLISTER PACK in 1 CARTON (83390-107-09) / 10 TABLET in 1 BLISTER PACK
- ndc1183390107303 BLISTER PACK in 1 CARTON (83390-107-30) / 10 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
1B8447E7YI
CLOMIPHENE CITRATE
RxCUI 142431
Orange Book
A075528
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": "83390-107_3ce28083-f9f3-c59f-e063-6394a90a92e1",
"productndc": "83390-107",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "075528",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "Aug 30, 1999"
}
],
"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": "ANDA075528",
"marketing_category": "ANDA",
"nonproprietary_name": "Clomiphene Citrate",
"start_marketing_date": "20250821",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code G03GB02.
Access this data programmatically
Query Clomiphene Citrate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.