FDA.reportPublic FDA data

Sevelamer Carbonate

Product NDC
69452-127
11-digit product format
694520127
Labeler code
69452
Product ID
69452-127_204ad91c-58e0-5be6-e063-6294a90a5574
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sevelamer Carbonate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA209374
Marketing category
ANDA
Marketing start
2021-09-01
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
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
69452-127-19Sevelamer Carbonate90 in 1 CARTONPOWDER, FOR SUSPENSION903
69452-127-60Sevelamer Carbonate1 in 1 PACKETPOWDER, FOR SUSPENSION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-127-19EA - Each69452-127b9cf3d9e-050c-49e4-b083-60e27af4641012022-02-07
69452-127-60EA - Each69452-1275b04b2c4-3f6f-4dc9-ba96-73e27b0665a312022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-127SEVELAMER CARBONATE POWDER, FOR SUSPENSION [BIONPHARMA INC.]3Current NDC, Legacy NDC, 2 package rows20240823_c3cf4807-ae5f-528e-e053-2a95a90ac640.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861375sevelamer carbonate 0.8 GM Powder for Oral SuspensionPSNc3cf4807-ae5f-528e-e053-2a95a90ac6403
861370sevelamer carbonate 2.4 GM Powder for Oral SuspensionPSNc3cf4807-ae5f-528e-e053-2a95a90ac6403
861370sevelamer carbonate 2400 MG Powder for Oral SuspensionSCDc3cf4807-ae5f-528e-e053-2a95a90ac6403
861375sevelamer carbonate 800 MG Powder for Oral SuspensionSCDc3cf4807-ae5f-528e-e053-2a95a90ac6403
861375sevelamer carbonate 0.8 GM Powder for Oral SuspensionSYc3cf4807-ae5f-528e-e053-2a95a90ac6403
861370sevelamer carbonate 2.4 GM Powder for Oral SuspensionSYc3cf4807-ae5f-528e-e053-2a95a90ac6403

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69452-127-196945201271990 PACKET in 1 CARTON (69452-127-19) / 1 POWDER, FOR SUSPENSION in 1 PACKET (69452-127-60) 90 packet2021-10-010000-00-00NoNoCurrent
69452-127-60694520127601 in 1 PACKETHistorical