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United States · US · US:54092-257_b29f2b53-6f45-447d-afb3-297ccc4ef8db
Fosrenol
Orange BookUNIISPLATC V03AE03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTakeda Pharmaceuticals America, Inc.
CountryUS (United States)
ATC codeV03AE03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1154092257029 CARTON in 1 CARTON (54092-257-02) / 10 POWDER in 1 CARTON (54092-257-01)
Annotations
UNII (FDA Substance ID)
490D9F069T
LANTHANUM CARBONATE
RxCUI 234416
Orange Book
N204734
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "490D9F069T",
"rxcui": "234416",
"inchikey": "PKOQIYFBOVTYOH-UHFFFAOYSA-H",
"display_name": "LANTHANUM CARBONATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"f10776b2-2c25-4343-aabe-68f302e5cb54": {
"match": "brand_token",
"title": "FOSRENOL (LANTHANUM CARBONATE) TABLET, CHEWABLE FOSRENOL (LANTHANUM CARBONATE) POWDER [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
"spl_version": "58",
"published_date": "2025-04-07"
}
},
"productid": "54092-257_b29f2b53-6f45-447d-afb3-297ccc4ef8db",
"productndc": "54092-257",
"dosage_form": "POWDER",
"orange_book": {
"appl_no": "204734",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 750MG BASE",
"product_no": "001",
"approval_date": "Sep 24, 2014"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 1GM BASE",
"product_no": "002",
"approval_date": "Sep 24, 2014"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LANTHANUM CARBONATE",
"proprietary_name": "Fosrenol",
"active_ingred_unit": "mg/1",
"application_number": "NDA204734",
"marketing_category": "NDA",
"nonproprietary_name": "lanthanum carbonate",
"start_marketing_date": "20140924",
"active_numerator_strength": "1000"
}Related drugs
Other records sharing ATC code V03AE03.
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