FDA.reportPublic FDA data

Sevelamer Carbonate

Product NDC
65162-058
11-digit product format
651620058
Labeler code
65162
Product ID
65162-058_53f81fb7-7bbc-430f-a2e4-841b58e2cb7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sevelamer Carbonate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA207288
Marketing category
ANDA
Marketing start
2017-11-28
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
2026-12-31

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
65162-058-03Sevelamer Carbonate30 in 1 BOTTLETABLET, FILM COATED308
65162-058-06Sevelamer Carbonate60 in 1 BOTTLETABLET, FILM COATED608
65162-058-09Sevelamer Carbonate90 in 1 BOTTLETABLET, FILM COATED908
65162-058-11Sevelamer Carbonate1000 in 1 BOTTLETABLET, FILM COATED10008
65162-058-27Sevelamer Carbonate270 in 1 BOTTLETABLET, FILM COATED2708
65162-058-50Sevelamer Carbonate500 in 1 BOTTLETABLET, FILM COATED5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-058-27EA - Each65162-058de4c772c-b65e-43d1-bee7-d595c437eaae12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-058SEVELAMER CARBONATE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC]8Current NDC, Legacy NDC, 6 package rows20240206_94d8cfb1-ff2a-4956-8954-17635ac505d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749206sevelamer carbonate 800 MG Oral TabletPSN94d8cfb1-ff2a-4956-8954-17635ac505d98
749206sevelamer carbonate 800 MG Oral TabletSCD94d8cfb1-ff2a-4956-8954-17635ac505d98
749206sevelamer carbonate 800 MG Oral TabletPSN7f701cb4-3089-375f-e053-2991aa0a51b95
749206sevelamer carbonate 800 MG Oral TabletSCD7f701cb4-3089-375f-e053-2991aa0a51b95
749206sevelamer carbonate 800 MG Oral TabletPSN09b5e422-18c9-49dc-be3d-5d24648184af4
749206sevelamer carbonate 800 MG Oral TabletSCD09b5e422-18c9-49dc-be3d-5d24648184af4
749206sevelamer carbonate 800 MG Oral TabletPSN90caaf0e-de31-48bc-8286-c02ef380e8b22
749206sevelamer carbonate 800 MG Oral TabletSCD90caaf0e-de31-48bc-8286-c02ef380e8b22
749206sevelamer carbonate 800 MG Oral TabletPSN852938de-6381-4466-84ee-685d2005ff2a1
749206sevelamer carbonate 800 MG Oral TabletSCD852938de-6381-4466-84ee-685d2005ff2a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65162-058-036516200580330 TABLET, FILM COATED in 1 BOTTLE (65162-058-03) 2023-07-13NoNoHistorical
65162-058-066516200580660 TABLET, FILM COATED in 1 BOTTLE (65162-058-06) 2023-07-13NoNoHistorical
65162-058-096516200580990 TABLET, FILM COATED in 1 BOTTLE (65162-058-09) 2017-11-280000-00-00NoNoCurrent
65162-058-11651620058111000 TABLET, FILM COATED in 1 BOTTLE (65162-058-11) 2017-11-280000-00-00NoNoCurrent
65162-058-2765162005827270 TABLET, FILM COATED in 1 BOTTLE (65162-058-27) 2017-11-280000-00-00NoNoCurrent
65162-058-5065162005850500 TABLET, FILM COATED in 1 BOTTLE (65162-058-50) 2017-11-280000-00-00NoNoCurrent