FDA.reportPublic FDA data

Lanthanum carbonate

Product NDC
0093-5938
11-digit product format
000935938
Labeler code
0093
Product ID
0093-5938_b0906a9f-445f-4900-ab71-7cc2a633a3a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lanthanum carbonate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA090977
Marketing category
ANDA
Marketing start
2022-05-25
Substance
LANTHANUM CARBONATE
Active strength
500 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
Lanthanum carbonate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LANTHANUM CARBONATE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii490D9F069T
Rxcui477347, 602635, 642452

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cd999b70-ef95-1812-9f06-f589ecff7593Product name520251216

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-5938-54Lanthanum carbonate45 in 1 BOTTLETABLET, CHEWABLE458
0093-5938-98Lanthanum carbonate2 in 1 CARTONTABLET, CHEWABLE28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-5938-54EA - Each0093-593840f28e0a-244c-4571-b390-3575fcd76bcc12022-06-06
0093-5938-98EA - Each0093-59384afc7ff9-570f-404d-aea7-e09d7aa09ef112022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-5938LANTHANUM CARBONATE TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA, INC.]8Current NDC, Legacy NDC, 2 package rows20250402_e4b88992-ecb0-455b-b68c-5c4e6d3cf521.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
602635lanthanum carbonate 1000 MG Chewable TabletPSNe4b88992-ecb0-455b-b68c-5c4e6d3cf5218
477347lanthanum carbonate 500 MG Chewable TabletPSNe4b88992-ecb0-455b-b68c-5c4e6d3cf5218
642452lanthanum carbonate 750 MG Chewable TabletPSNe4b88992-ecb0-455b-b68c-5c4e6d3cf5218
602635lanthanum carbonate 1000 MG Chewable TabletSCDe4b88992-ecb0-455b-b68c-5c4e6d3cf5218
477347lanthanum carbonate 500 MG Chewable TabletSCDe4b88992-ecb0-455b-b68c-5c4e6d3cf5218
642452lanthanum carbonate 750 MG Chewable TabletSCDe4b88992-ecb0-455b-b68c-5c4e6d3cf5218

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-5938-540009359385445 in 1 BOTTLEHistorical
0093-5938-98000935938982 BOTTLE in 1 CARTON (0093-5938-98) / 45 TABLET, CHEWABLE in 1 BOTTLE (0093-5938-54) 2 bottle2022-05-250000-00-00NoNoCurrent