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

Additional Listing Data#

Finished product
Yes
Brand name base
Sevelamer carbonate
Listing expiration
2026-12-31

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
70771-1520-0Sevelamer carbonate1000 in 1 BOTTLETABLET, FILM COATED10003
70771-1520-2Sevelamer carbonate10 in 1 BLISTER PACKTABLET, FILM COATED103
70771-1520-4Sevelamer carbonate10 in 1 CARTONTABLET, FILM COATED103
70771-1520-8Sevelamer carbonate270 in 1 BOTTLETABLET, FILM COATED2703

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1520SEVELAMER CARBONATE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]3Current NDC, Legacy NDC, 4 package rows20240815_cbdee883-ccc7-4c55-965d-b608a214b375.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749206sevelamer carbonate 800 MG Oral TabletPSNcbdee883-ccc7-4c55-965d-b608a214b3753
749206sevelamer carbonate 800 MG Oral TabletSCDcbdee883-ccc7-4c55-965d-b608a214b3753

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1520-0707711520001000 TABLET, FILM COATED in 1 BOTTLE (70771-1520-0) 2020-09-170000-00-00NoNoCurrent
70771-1520-27077115200210 in 1 BLISTER PACKHistorical
70771-1520-47077115200410 BLISTER PACK in 1 CARTON (70771-1520-4) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1520-2) 10 blister pack2020-09-170000-00-00NoNoCurrent
70771-1520-870771152008270 TABLET, FILM COATED in 1 BOTTLE (70771-1520-8) 2020-09-170000-00-00NoNoCurrent