Sevelamer Hydrochloride

Product NDC
72162-2501
11-digit product format
721622501
Labeler code
72162
Product ID
72162-2501_3533c2ca-1653-8676-e063-6294a90a6a59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sevelamer Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
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
Rxcui857224

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
72162-2501-2Sevelamer Hydrochloride180 in 1 BOTTLETABLET, FILM COATED180100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2501-2EA - Each72162-2501fd9d5f1e-279b-4d36-92c0-a605cc0545d612025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2501SEVELAMER HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20250519_3533d24b-508e-f012-e063-6394a90acaf5.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2501-272162250102180 TABLET, FILM COATED in 1 BOTTLE (72162-2501-2) 2025-05-15NoNoCurrent