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United States · US · US:58468-0132_cb4453a2-c47b-4352-839f-f022ac67368e
Renvela
Orange BookUNIISPLATC V03AE02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGenzyme Corporation
CountryUS (United States)
ATC codeV03AE02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11584680132290 PACKET in 1 CARTON (58468-0132-2) / 1 POWDER, FOR SUSPENSION in 1 PACKET (58468-0132-1)
Annotations
UNII (FDA Substance ID)
9YCX42I8IU
SEVELAMER CARBONATE
RxCUI 660890
Orange Book
N022318
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "9YCX42I8IU",
"rxcui": "660890",
"inchikey": null,
"display_name": "SEVELAMER CARBONATE",
"substance_type": "polymer",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"e6328460-a57b-450b-a48c-6dcd4b476360": {
"match": "brand_token",
"title": "RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION RENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED [GENZYME CORPORATION]",
"spl_version": "47",
"published_date": "2025-11-28"
}
},
"productid": "58468-0132_cb4453a2-c47b-4352-839f-f022ac67368e",
"productndc": "58468-0132",
"dosage_form": "POWDER, FOR SUSPENSION",
"orange_book": {
"appl_no": "022318",
"products": [
{
"rs": false,
"rld": true,
"te_code": "AB",
"strength": "800MG/PACKET",
"product_no": "001",
"approval_date": "Aug 12, 2009"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "2.4GM/PACKET",
"product_no": "002",
"approval_date": "Feb 18, 2009"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SEVELAMER CARBONATE",
"proprietary_name": "Renvela",
"active_ingred_unit": "mg/1",
"application_number": "NDA022318",
"marketing_category": "NDA",
"nonproprietary_name": "SEVELAMER CARBONATE",
"start_marketing_date": "20090812",
"active_numerator_strength": "800"
}Related drugs
Other records sharing ATC code V03AE02.
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