Sevelamer Carbonate

Product NDC
71205-966
11-digit product format
712050966
Labeler code
71205
Product ID
71205-966_09aa537e-9f9c-4c0e-9ebf-59a4cf105ee4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sevelamer Carbonate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA200959
Marketing category
ANDA
Marketing start
2019-09-30
Marketing end
2027-11-30
Substance
SEVELAMER CARBONATE
Active strength
800 mg/1
Pharmacologic classes
Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sevelamer Carbonate

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SEVELAMER CARBONATE800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9YCX42I8IU
Rxcui749206

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
71205-966-67Sevelamer Carbonate270 in 1 BOTTLETABLET, FILM COATED2703

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-966-67EA - Each71205-966ae2c4d47-b33f-4ec2-bf76-bdb64a9e244312021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-966SEVELAMER CARBONATE TABLET, FILM COATED [PROFICIENT RX LP]3Current NDC, Legacy NDC, 1 package rows20240517_ee9da697-2d55-48e5-8e03-c64c8aaf1fb8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749206sevelamer carbonate 800 MG Oral TabletPSNee9da697-2d55-48e5-8e03-c64c8aaf1fb83
749206sevelamer carbonate 800 MG Oral TabletSCDee9da697-2d55-48e5-8e03-c64c8aaf1fb83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-966-6771205096667270 TABLET, FILM COATED in 1 BOTTLE (71205-966-67) 2020-06-092027-11-30NoNoCurrent