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United States · US · US:0115-1366_b673720f-b62b-4afc-ac25-cb2ac4cf326f
sevelamer carbonate
Orange BookUNIISPLATC V03AE02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals of New York LLC
CountryUS (United States)
ATC codeV03AE02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11011513662990 PACKET in 1 CARTON (0115-1366-29) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0115-1366-30)
Annotations
UNII (FDA Substance ID)
9YCX42I8IU
SEVELAMER CARBONATE
RxCUI 660890
Orange Book
A211316
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": {
"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": "0115-1366_b673720f-b62b-4afc-ac25-cb2ac4cf326f",
"productndc": "0115-1366",
"dosage_form": "POWDER, FOR SUSPENSION",
"orange_book": {
"appl_no": "211316",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "800MG/PACKET",
"product_no": "001",
"approval_date": "Nov 20, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "2.4GM/PACKET",
"product_no": "002",
"approval_date": "Nov 20, 2020"
}
],
"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": "ANDA211316",
"marketing_category": "ANDA",
"nonproprietary_name": "sevelamer carbonate",
"start_marketing_date": "20201120",
"active_numerator_strength": "2400"
}Related drugs
Other records sharing ATC code V03AE02.
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