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United States · US · US:65162-058_53f81fb7-7bbc-430f-a2e4-841b58e2cb7c
Sevelamer Carbonate
Orange BookUNIISPLATC V03AE02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeV03AE02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc11651620580330 TABLET, FILM COATED in 1 BOTTLE (65162-058-03)
- ndc11651620580660 TABLET, FILM COATED in 1 BOTTLE (65162-058-06)
- ndc11651620580990 TABLET, FILM COATED in 1 BOTTLE (65162-058-09)
- ndc1165162058111000 TABLET, FILM COATED in 1 BOTTLE (65162-058-11)
- ndc116516205827270 TABLET, FILM COATED in 1 BOTTLE (65162-058-27)
- ndc116516205850500 TABLET, FILM COATED in 1 BOTTLE (65162-058-50)
Annotations
UNII (FDA Substance ID)
9YCX42I8IU
SEVELAMER CARBONATE
RxCUI 660890
Orange Book
A207288
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": "65162-058_53f81fb7-7bbc-430f-a2e4-841b58e2cb7c",
"productndc": "65162-058",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "207288",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "800MG",
"product_no": "001",
"approval_date": "Nov 28, 2017"
}
],
"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": "ANDA207288",
"marketing_category": "ANDA",
"nonproprietary_name": "Sevelamer Carbonate",
"start_marketing_date": "20171128",
"active_numerator_strength": "800"
}Related drugs
Other records sharing ATC code V03AE02.
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