Sevelamer Hydrochloride

Product NDC
72162-2500
11-digit product format
721622500
Labeler code
72162
Product ID
72162-2500_3533646c-b24d-d606-e063-6394a90a5a0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sevelamer Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206883
Marketing category
ANDA
Marketing start
2023-05-26
Substance
SEVELAMER HYDROCHLORIDE
Active strength
400 mg/1
Pharmacologic classes
Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
GLS2PGI8QGSEVELAMER HYDROCHLORIDE152751-57-0SEVELAMER HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2500-272162250002360 TABLET, FILM COATED in 1 BOTTLE (72162-2500-2) 2025-05-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Sevelamer HydrochlorideBryant Ranch Prepack2025-05-15HUMAN PRESCRIPTION DRUG LABEL100