FDA.reportPublic FDA data

SEVELAMER CARBONATE

Product NDC
33342-288
11-digit product format
333420288
Labeler code
33342
Product ID
33342-288_c67610dd-5838-4acb-99c7-e66f507f1fc4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SEVELAMER CARBONATE
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA207291
Marketing category
ANDA
Marketing start
2024-04-26
Substance
SEVELAMER CARBONATE
Active strength
.8 g/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 CARBONATE.8 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9YCX42I8IU
Rxcui861370, 861375

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5085f16b-f856-182d-a646-425b62d3f565Product name620251118
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
86e7ef73-ca63-701e-e952-6c80aa5122b8Product name920210309
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-288-68SEVELAMER CARBONATE90 in 1 CARTONPOWDER, FOR SUSPENSION902
33342-288-68SEVELAMER CARBONATE1 in 1 PACKETPOWDER, FOR SUSPENSION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-288-68EA - Each33342-2889397a059-6bac-436a-8f89-58a7e943976a12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-288SEVELAMER CARBONATE POWDER, FOR SUSPENSION [MACLEODS PHARMACEUTICALS LIMITED]1Current NDC, 2 package rows20240514_48dbd7a7-32c7-45c1-ac8b-c478cf3282a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861375sevelamer carbonate 0.8 GM Powder for Oral SuspensionPSN48dbd7a7-32c7-45c1-ac8b-c478cf3282a62
861370sevelamer carbonate 2.4 GM Powder for Oral SuspensionPSN48dbd7a7-32c7-45c1-ac8b-c478cf3282a62
861370sevelamer carbonate 2400 MG Powder for Oral SuspensionSCD48dbd7a7-32c7-45c1-ac8b-c478cf3282a62
861375sevelamer carbonate 800 MG Powder for Oral SuspensionSCD48dbd7a7-32c7-45c1-ac8b-c478cf3282a62
861375sevelamer carbonate 0.8 GM Powder for Oral SuspensionSY48dbd7a7-32c7-45c1-ac8b-c478cf3282a62
861370sevelamer carbonate 2.4 GM Powder for Oral SuspensionSY48dbd7a7-32c7-45c1-ac8b-c478cf3282a62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-288-683334202886890 PACKET in 1 CARTON (33342-288-68) / 1 POWDER, FOR SUSPENSION in 1 PACKET90 packet2024-04-26NoNoHistorical