FDA.reportPublic FDA data

Sevelamer Hydrochloride

Product NDC
33342-242
11-digit product format
333420242
Labeler code
33342
Product ID
33342-242_6926ebbe-2d74-4d5f-b642-c1bfe3a4e305
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sevelamer Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA206883
Marketing category
ANDA
Marketing start
2023-05-26
Substance
SEVELAMER HYDROCHLORIDE
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 Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SEVELAMER HYDROCHLORIDE800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiGLS2PGI8QG
Rxcui857216, 857224

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
33342-242-07Sevelamer Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
33342-242-57Sevelamer Hydrochloride180 in 1 BOTTLETABLET, FILM COATED1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-242-57EA - Each33342-2426efa4993-7541-4e85-a2d2-a6800611b30612024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-242SEVELAMER HYDROCHLORIDE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]1Current NDC, 2 package rows20230606_6926ebbe-2d74-4d5f-b642-c1bfe3a4e305.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857224sevelamer HCl 800 MG Oral TabletPSN3533d24b-508e-f012-e063-6394a90acaf5100
857224sevelamer hydrochloride 800 MG Oral TabletSCD3533d24b-508e-f012-e063-6394a90acaf5100
857216sevelamer HCl 400 MG Oral TabletPSN6926ebbe-2d74-4d5f-b642-c1bfe3a4e3051
857224sevelamer HCl 800 MG Oral TabletPSN6926ebbe-2d74-4d5f-b642-c1bfe3a4e3051
857216sevelamer hydrochloride 400 MG Oral TabletSCD6926ebbe-2d74-4d5f-b642-c1bfe3a4e3051
857224sevelamer hydrochloride 800 MG Oral TabletSCD6926ebbe-2d74-4d5f-b642-c1bfe3a4e3051

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
33342-242-073334202420730 TABLET, FILM COATED in 1 BOTTLE (33342-242-07) 2023-05-26NoNoHistorical
33342-242-5733342024257180 TABLET, FILM COATED in 1 BOTTLE (33342-242-57) 2023-05-26NoNoHistorical