Sevelamer Hydrochloride

Product NDC
72162-2500
11-digit product format
721622500
Labeler code
72162
Product ID
72162-2500_3533646c-b24d-d606-e063-6394a90a5a0b
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
400 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 HYDROCHLORIDE400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiGLS2PGI8QG
Rxcui857216

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
72162-2500-2Sevelamer Hydrochloride360 in 1 BOTTLETABLET, FILM COATED360100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2500-2EA - Each72162-2500bbe11d29-efbc-422d-86eb-b82c02cc936012025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2500SEVELAMER HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20250519_35337152-9b92-40c0-e063-6294a90a8dd5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857216sevelamer HCl 400 MG Oral TabletPSN35337152-9b92-40c0-e063-6294a90a8dd5100
857216sevelamer hydrochloride 400 MG Oral TabletSCD35337152-9b92-40c0-e063-6294a90a8dd5100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2500-272162250002360 TABLET, FILM COATED in 1 BOTTLE (72162-2500-2) 2025-05-15NoNoCurrent