FDA.reportPublic FDA data

sevelamer hydrochloride

Product NDC
0904-7209
11-digit product format
009047209
Labeler code
0904
Product ID
0904-7209_53f9bd53-115d-48b3-b273-55e75d6a16a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sevelamer hydrochloride
Dosage form
TABLET, FILM COATED
Route
PARENTERAL
Labeler
Major Pharmaceuticals
Application
ANDA204724
Marketing category
ANDA
Marketing start
2024-08-19
Substance
SEVELAMER HYDROCHLORIDE
Active strength
800 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 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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
0904-7209-06sevelamer hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED13
0904-7209-06sevelamer hydrochloride50 in 1 CARTONTABLET, FILM COATED503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7209-06EA - Each0904-720959eab127-d241-4724-ab7e-cb1f293bf41512024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7209SEVELAMER HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1Current NDC, 2 package rows20240820_0500034d-458c-42c5-918d-9acd22f0c28b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857224sevelamer HCl 800 MG Oral TabletPSN0500034d-458c-42c5-918d-9acd22f0c28b3
857224sevelamer hydrochloride 800 MG Oral TabletSCD0500034d-458c-42c5-918d-9acd22f0c28b3
857224sevelamer HCl 800 MG Oral TabletPSNc13532a7-4c56-4084-839d-3dcfd4dc30f82
857224sevelamer hydrochloride 800 MG Oral TabletSCDc13532a7-4c56-4084-839d-3dcfd4dc30f82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7209-060090472090650 BLISTER PACK in 1 CARTON (0904-7209-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK50 blister pack2024-08-19NoNoHistorical