Sevelamer carbonate

Product NDC
70710-2170
11-digit product format
707102170
Labeler code
70710
Product ID
70710-2170_c18f24f4-6578-43b0-9dda-6581e7137ffd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sevelamer carbonate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA219931
Marketing category
ANDA
Marketing start
2026-04-01
Substance
SEVELAMER CARBONATE
Active strength
800 mg/1
Pharmacologic classes
Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sevelamer carbonate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SEVELAMER CARBONATE800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9YCX42I8IU
Rxcui749206

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5085f16b-f856-182d-a646-425b62d3f565Product name620251118
86e7ef73-ca63-701e-e952-6c80aa5122b8Product name920210309

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-2170-3Sevelamer carbonate30 in 1 BOTTLETABLET, FILM COATED301
70710-2170-7Sevelamer carbonate180 in 1 BOTTLETABLET, FILM COATED1801
70710-2170-8Sevelamer carbonate270 in 1 BOTTLETABLET, FILM COATED2701

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749206sevelamer carbonate 800 MG Oral TabletPSN2ccf62c6-dbad-416d-8e02-631795bd75171
749206sevelamer carbonate 800 MG Oral TabletSCD2ccf62c6-dbad-416d-8e02-631795bd75171

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70710-2170-37071021700330 TABLET, FILM COATED in 1 BOTTLE (70710-2170-3) 2026-04-01NoNoHistorical
70710-2170-770710217007180 TABLET, FILM COATED in 1 BOTTLE (70710-2170-7) 2026-04-01NoNoHistorical
70710-2170-870710217008270 TABLET, FILM COATED in 1 BOTTLE (70710-2170-8) 2026-04-01NoNoHistorical