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United States · US · US:58624-5001_ff5f602e-c050-40d7-81f5-1c8dfba1d32f
SEVELAMER CARBONATE
Orange BookUNIISPLATC V03AE02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerShandong Xinhua Pharmaceutical Co., Ltd.
CountryUS (United States)
ATC codeV03AE02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11586245001230 TABLET, FILM COATED in 1 BOTTLE (58624-5001-2)
- ndc11586245001418399 TABLET, FILM COATED in 1 CARTON (58624-5001-4)
Annotations
UNII (FDA Substance ID)
9YCX42I8IU
SEVELAMER CARBONATE
RxCUI 660890
Orange Book
A215998
AB
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": {
"51ce2ed6-3acf-a6ea-e063-6294a90a21aa": {
"match": "brand_token",
"title": "SEVELAMER CARBONATE TABLET, FILM COATED [INSIGNAMEDEX LLC]",
"spl_version": "2",
"published_date": "2026-05-25"
}
},
"productid": "58624-5001_ff5f602e-c050-40d7-81f5-1c8dfba1d32f",
"productndc": "58624-5001",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "215998",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "800MG",
"product_no": "001",
"approval_date": "Oct 24, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SEVELAMER CARBONATE",
"proprietary_name": "SEVELAMER CARBONATE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA215998",
"marketing_category": "ANDA",
"nonproprietary_name": "SEVELAMER CARBONATE",
"start_marketing_date": "20250227",
"active_numerator_strength": "800"
}Related drugs
Other records sharing ATC code V03AE02.
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