FDA.reportPublic FDA data

Sevelamer Carbonate for Oral Suspension

Product NDC
43598-479
11-digit product format
435980479
Labeler code
43598
Product ID
43598-479_85e37025-d239-e504-38a0-c2db7ffa0100
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sevelamer Carbonate for Oral Suspension
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Dr. Reddys Laboratories Inc
Application
ANDA210464
Marketing category
ANDA
Marketing start
2018-10-25
Substance
SEVELAMER CARBONATE
Active strength
2400 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 for Oral Suspension
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SEVELAMER CARBONATE2400 mg/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
86e7ef73-ca63-701e-e952-6c80aa5122b8Product name920210309

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-479-01Sevelamer Carbonate for Oral Suspension1 in 1 PACKETPOWDER, FOR SUSPENSION13
43598-479-90Sevelamer Carbonate for Oral Suspension90 in 1 CARTONPOWDER, FOR SUSPENSION903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-479-01EA - Each43598-479bb62de50-c791-4f5f-9510-db70125ab64612019-04-11
43598-479-90EA - Each43598-479058dc831-b5fd-49bb-9f3e-bdc4de931cbc12019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-479SEVELAMER CARBONATE FOR ORAL SUSPENSION POWDER, FOR SUSPENSION [DR. REDDYS LABORATORIES INC]3Current NDC, Legacy NDC, 2 package rows20200707_de172c3d-17eb-3489-35fb-370a0893b663.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861375sevelamer carbonate 0.8 GM Powder for Oral SuspensionPSNde172c3d-17eb-3489-35fb-370a0893b6633
861370sevelamer carbonate 2.4 GM Powder for Oral SuspensionPSNde172c3d-17eb-3489-35fb-370a0893b6633
861370sevelamer carbonate 2400 MG Powder for Oral SuspensionSCDde172c3d-17eb-3489-35fb-370a0893b6633
861375sevelamer carbonate 800 MG Powder for Oral SuspensionSCDde172c3d-17eb-3489-35fb-370a0893b6633
861375sevelamer carbonate 0.8 GM Powder for Oral SuspensionSYde172c3d-17eb-3489-35fb-370a0893b6633
861370sevelamer carbonate 2.4 GM Powder for Oral SuspensionSYde172c3d-17eb-3489-35fb-370a0893b6633

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-479-01435980479011 in 1 PACKETHistorical
43598-479-904359804799090 PACKET in 1 CARTON (43598-479-90) / 1 POWDER, FOR SUSPENSION in 1 PACKET (43598-479-01) 90 packet2018-10-250000-00-00NoNoCurrent