Lanthanum Carbonate

Product NDC
67877-258
11-digit product format
678770258
Labeler code
67877
Product ID
67877-258_ba371296-8731-4ffa-ab36-aff022e48d52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lanthanum Carbonate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA202329
Marketing category
ANDA
Marketing start
2025-05-10
Substance
LANTHANUM CARBONATE
Active strength
1000 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202329-001LANTHANUM CARBONATELANTHANUM CARBONATEEQ 500MG BASETABLET, CHEWABLE / ORALAB2025-03-13
A202329-002LANTHANUM CARBONATELANTHANUM CARBONATEEQ 750MG BASETABLET, CHEWABLE / ORALAB2025-03-13
A202329-003LANTHANUM CARBONATELANTHANUM CARBONATEEQ 1GM BASETABLET, CHEWABLE / ORALAB2025-03-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A202329-001AB
A202329-002AB
A202329-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202329-001LANTHANUM CARBONATEEQ 500MG BASETABLET, CHEWABLE / ORALAB2025-03-13caaa826d4ba7…
2026-08-18 06:07:402026-07A202329-002LANTHANUM CARBONATEEQ 750MG BASETABLET, CHEWABLE / ORALAB2025-03-13caaa826d4ba7…
2026-08-18 06:07:402026-07A202329-003LANTHANUM CARBONATEEQ 1GM BASETABLET, CHEWABLE / ORALAB2025-03-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202329-001LANTHANUM CARBONATEEQ 500MG BASETABLET, CHEWABLE / ORALAB2025-03-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202329-002LANTHANUM CARBONATEEQ 750MG BASETABLET, CHEWABLE / ORALAB2025-03-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202329-003LANTHANUM CARBONATEEQ 1GM BASETABLET, CHEWABLE / ORALAB2025-03-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202329-001LANTHANUM CARBONATEEQ 500MG BASETABLET, CHEWABLE / ORALAB2025-03-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202329-002LANTHANUM CARBONATEEQ 750MG BASETABLET, CHEWABLE / ORALAB2025-03-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202329-003LANTHANUM CARBONATEEQ 1GM BASETABLET, CHEWABLE / ORALAB2025-03-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A202329-001LANTHANUM CARBONATEEQ 500MG BASETABLET, CHEWABLE / ORALAB2025-03-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202329-002LANTHANUM CARBONATEEQ 750MG BASETABLET, CHEWABLE / ORALAB2025-03-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202329-003LANTHANUM CARBONATEEQ 1GM BASETABLET, CHEWABLE / ORALAB2025-03-136a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A202329-001LANTHANUM CARBONATEEQ 500MG BASETABLET, CHEWABLE / ORALAB2025-03-13a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A202329-002LANTHANUM CARBONATEEQ 750MG BASETABLET, CHEWABLE / ORALAB2025-03-13a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A202329-003LANTHANUM CARBONATEEQ 1GM BASETABLET, CHEWABLE / ORALAB2025-03-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A202329-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202329-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202329-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202329-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202329-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202329-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202329-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202329-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202329-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202329-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202329-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202329-003AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A202329-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A202329-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A202329-003AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Lanthanum Carbonate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LANTHANUM CARBONATE1000 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
490D9F069TInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
477347Internal RxNorm lookup
602635Internal RxNorm lookup
642452Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
22b07167-2b7b-42ba-9ae9-cf58c98a2ab2Available on FDA.report

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
67877-258-11Lanthanum Carbonate10 in 1 BOTTLETABLET, CHEWABLE1015
67877-258-90Lanthanum Carbonate9 in 1 CARTONTABLET, CHEWABLE915

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-258-90EA - Each67877-25854e3bab9-4223-42b8-ae36-237e6e07146312025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-258LANTHANUM CARBONATE TABLET, CHEWABLE [ASCEND LABORATORIES, LLC]15Current NDC, 2 package rows20250511_22b07167-2b7b-42ba-9ae9-cf58c98a2ab2.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lanthanum CarbonateLANTHANUM CARBONATEAscend Laboratories, LLC22b07167-2b7b-42ba-9ae9-cf58c98a2ab22025-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202329
application number: ANDA202329
ndc (product): 67877-258

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
602635lanthanum carbonate 1000 MG Chewable TabletPSN22b07167-2b7b-42ba-9ae9-cf58c98a2ab215
477347lanthanum carbonate 500 MG Chewable TabletPSN22b07167-2b7b-42ba-9ae9-cf58c98a2ab215
642452lanthanum carbonate 750 MG Chewable TabletPSN22b07167-2b7b-42ba-9ae9-cf58c98a2ab215
602635lanthanum carbonate 1000 MG Chewable TabletSCD22b07167-2b7b-42ba-9ae9-cf58c98a2ab215
477347lanthanum carbonate 500 MG Chewable TabletSCD22b07167-2b7b-42ba-9ae9-cf58c98a2ab215
642452lanthanum carbonate 750 MG Chewable TabletSCD22b07167-2b7b-42ba-9ae9-cf58c98a2ab215

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67877-258-116787702581110 in 1 BOTTLEHistorical
67877-258-90678770258909 BOTTLE in 1 CARTON (67877-258-90) / 10 TABLET, CHEWABLE in 1 BOTTLE (67877-258-11) 9 bottle2025-05-10NoNoCurrent