Sevelamer carbonate

Product NDC
69097-893
11-digit product format
690970893
Labeler code
69097
Product ID
69097-893_b4a439b7-08e8-4d1b-abea-f7976010d323
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SEVELAMER CARBONATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA203860
Marketing category
ANDA
Marketing start
2017-10-26
Substance
SEVELAMER CARBONATE
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 carbonate
Listing expiration
2026-12-31

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
86e7ef73-ca63-701e-e952-6c80aa5122b8Product name920210309

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69097-893-93Sevelamer carbonate270 in 1 BOTTLETABLET, FILM COATED2702

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-893-93EA - Each69097-893fe30b2b5-2604-4915-8ab1-afe57a1b2d8c12017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-893SEVELAMER CARBONATE TABLET, FILM COATED [CIPLA USA INC.]2Current NDC, Legacy NDC, 1 package rows20181227_f63450bd-d075-4810-a277-e8bc41e4a5af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749206sevelamer carbonate 800 MG Oral TabletPSN0883b9aa-8562-486c-9ab7-9f82f71015fe2
749206sevelamer carbonate 800 MG Oral TabletPSNf63450bd-d075-4810-a277-e8bc41e4a5af2
749206sevelamer carbonate 800 MG Oral TabletSCD0883b9aa-8562-486c-9ab7-9f82f71015fe2
749206sevelamer carbonate 800 MG Oral TabletSCDf63450bd-d075-4810-a277-e8bc41e4a5af2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69097-893-9369097089393270 TABLET, FILM COATED in 1 BOTTLE (69097-893-93) 2017-10-260000-00-00NoNoCurrent