FDA.reportPublic FDA data

SEVELAMER CARBONATE

Product NDC
64380-880
11-digit product format
643800880
Labeler code
64380
Product ID
64380-880_f0d25733-65a5-4143-a027-3412ff7a167d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sevelamer carbonate
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA211917
Marketing category
ANDA
Marketing start
2024-02-02
Substance
SEVELAMER CARBONATE
Active strength
800 mg/930mg
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/930mg

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
64380-880-00SEVELAMER CARBONATE800 mg in 1 PACKETFOR SUSPENSION8006
64380-880-80SEVELAMER CARBONATE90 in 1 CARTONFOR SUSPENSION906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-880-00EA - Each64380-880830e8181-461e-4dcb-bd2b-a7e46ba4421612024-02-14
64380-880-80EA - Each64380-88071250ea8-4cf5-4f23-a6cf-79cfcc24a2e312024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-880SEVELAMER CARBONATE FOR SUSPENSION [STRIDES PHARMA SCIENCE LIMITED]6Current NDC, 2 package rows20240224_c17bff97-8347-43f8-822e-1cb9736562b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861375sevelamer carbonate 0.8 GM Powder for Oral SuspensionPSNc17bff97-8347-43f8-822e-1cb9736562b66
861370sevelamer carbonate 2.4 GM Powder for Oral SuspensionPSNc17bff97-8347-43f8-822e-1cb9736562b66
861370sevelamer carbonate 2400 MG Powder for Oral SuspensionSCDc17bff97-8347-43f8-822e-1cb9736562b66
861375sevelamer carbonate 800 MG Powder for Oral SuspensionSCDc17bff97-8347-43f8-822e-1cb9736562b66
861375sevelamer carbonate 0.8 GM Powder for Oral SuspensionSYc17bff97-8347-43f8-822e-1cb9736562b66
861370sevelamer carbonate 2.4 GM Powder for Oral SuspensionSYc17bff97-8347-43f8-822e-1cb9736562b66

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64380-880-0064380088000800 mg in 1 PACKET800 mgHistorical
64380-880-806438008808090 PACKET in 1 CARTON (64380-880-80) / 800 mg in 1 PACKET (64380-880-00) 90 packet2024-02-02NoNoCurrent