SEVELAMER CARBONATE

Product NDC
64380-880
11-digit product format
643800880
Labeler code
64380
Product ID
64380-880_f0d25733-65a5-4143-a027-3412ff7a167d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sevelamer carbonate
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA211917
Marketing category
ANDA
Marketing start
2024-02-02
Substance
SEVELAMER CARBONATE
Active strength
800 mg/930mg
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
9YCX42I8IUSEVELAMER CARBONATE845273-93-0SEVELAMER CARBONATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64380-880-806438008808090 PACKET in 1 CARTON (64380-880-80) / 800 mg in 1 PACKET (64380-880-00) 90 packet2024-02-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
SEVELAMER CARBONATEStrides Pharma Science Limited2024-02-23HUMAN PRESCRIPTION DRUG LABEL6