Sevelamer carbonate

Product NDC
70771-1520
11-digit product format
707711520
Labeler code
70771
Product ID
70771-1520_39b27e86-2261-45f0-bdbf-13edbc8d6310
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sevelamer carbonate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA207759
Marketing category
ANDA
Marketing start
2020-09-17
Substance
SEVELAMER CARBONATE
Active strength
800 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
9YCX42I8IUSEVELAMER CARBONATE845273-93-0SEVELAMER CARBONATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70771-1520-0707711520001000 TABLET, FILM COATED in 1 BOTTLE (70771-1520-0) 2020-09-17NoNoHistorical
70771-1520-47077115200410 BLISTER PACK in 1 CARTON (70771-1520-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1520-2) 10 blister pack2020-09-17NoNoHistorical
70771-1520-870771152008270 TABLET, FILM COATED in 1 BOTTLE (70771-1520-8) 2020-09-17NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Sevelamer TabletsZydus Lifesciences Limited2024-08-12HUMAN PRESCRIPTION DRUG LABEL3