Sevelamer Carbonate

Product NDC
33342-215
11-digit product format
333420215
Labeler code
33342
Product ID
33342-215_2b6f40af-8d33-4bd1-9eb9-4ae0bdf8bbcb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sevelamer Carbonate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA206100
Marketing category
ANDA
Marketing start
2023-04-19
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
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
33342-215-58Sevelamer Carbonate270 in 1 BOTTLETABLET, FILM COATED2703

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-215SEVELAMER CARBONATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3Current NDC, 1 package rows20240612_4c927d50-34a6-499b-b1c2-924d4eb73987.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749206sevelamer carbonate 800 MG Oral TabletPSN462a11b9-78a3-4d8b-ae5d-3d6528e4d743101
749206sevelamer carbonate 800 MG Oral TabletSCD462a11b9-78a3-4d8b-ae5d-3d6528e4d743101
749206sevelamer carbonate 800 MG Oral TabletPSN26307350-69bb-40c9-9d5b-e0be2c11d0df100
749206sevelamer carbonate 800 MG Oral TabletSCD26307350-69bb-40c9-9d5b-e0be2c11d0df100
749206sevelamer carbonate 800 MG Oral TabletPSN4c927d50-34a6-499b-b1c2-924d4eb739873
749206sevelamer carbonate 800 MG Oral TabletSCD4c927d50-34a6-499b-b1c2-924d4eb739873

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
33342-215-5833342021558270 TABLET, FILM COATED in 1 BOTTLE (33342-215-58) 2023-04-19NoNoHistorical