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United States · US · US:70748-173_cc130cfa-f3e5-460d-92a8-69cc0f958dd2
Sevelamer hydrochloride
Orange BookUNIISPLATC V03AE02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLupin Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeV03AE02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc117074817326180 TABLET in 1 BOTTLE (70748-173-26)
Annotations
UNII (FDA Substance ID)
GLS2PGI8QG
SEVELAMER HYDROCHLORIDE
RxCUI 237125
Orange Book
A213145
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "GLS2PGI8QG",
"rxcui": "237125",
"inchikey": null,
"display_name": "SEVELAMER HYDROCHLORIDE",
"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": "70748-173_cc130cfa-f3e5-460d-92a8-69cc0f958dd2",
"productndc": "70748-173",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "213145",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "001",
"approval_date": "Jun 16, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "800MG",
"product_no": "002",
"approval_date": "Jun 16, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SEVELAMER HYDROCHLORIDE",
"proprietary_name": "Sevelamer hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA213145",
"marketing_category": "ANDA",
"nonproprietary_name": "Sevelamer hydrochloride",
"start_marketing_date": "20220225",
"active_numerator_strength": "800"
}Related drugs
Other records sharing ATC code V03AE02.
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