FDA.reportPublic FDA data

sevelamer hydrochloride

Product NDC
68462-446
11-digit product format
684620446
Labeler code
68462
Product ID
68462-446_5b27539f-4664-4a6b-abe4-2abcc7ad2279
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sevelamer hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA204724
Marketing category
ANDA
Marketing start
2019-02-08
Substance
SEVELAMER HYDROCHLORIDE
Active strength
400 mg/1
Pharmacologic classes
Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
sevelamer hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SEVELAMER HYDROCHLORIDE400 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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
86e7ef73-ca63-701e-e952-6c80aa5122b8Product name920210309
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-446-26sevelamer hydrochloride360 in 1 BOTTLETABLET, FILM COATED3607
68462-446-30sevelamer hydrochloride30 in 1 BOTTLETABLET, FILM COATED307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-446-26EA - Each68462-44660229578-9203-4242-ae46-96fa89a2b28e12019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-446SEVELAMER HYDROCHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]6Current NDC, Legacy NDC, 2 package rows20240104_2cd6512f-0edd-4a30-a4fa-aa996038633c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857216sevelamer HCl 400 MG Oral TabletPSN2cd6512f-0edd-4a30-a4fa-aa996038633c7
857224sevelamer HCl 800 MG Oral TabletPSN2cd6512f-0edd-4a30-a4fa-aa996038633c7
857216sevelamer hydrochloride 400 MG Oral TabletSCD2cd6512f-0edd-4a30-a4fa-aa996038633c7
857224sevelamer hydrochloride 800 MG Oral TabletSCD2cd6512f-0edd-4a30-a4fa-aa996038633c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68462-446-2668462044626360 TABLET, FILM COATED in 1 BOTTLE (68462-446-26) 2019-02-080000-00-00NoNoCurrent
68462-446-306846204463030 TABLET, FILM COATED in 1 BOTTLE (68462-446-30) 2019-02-080000-00-00NoNoCurrent