Lanthanum carbonate

Product NDC
0093-5939
Requested package NDC
0093-5939-00
11-digit product format
000935939
Labeler code
0093
Product ID
0093-5939_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
750 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished packagepackage0093-59390093-5939-00UNFINISHEDActive or certified unfinished drug listing2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-261d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-1768b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-2905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-0848b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-0827f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-098d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-1450b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08906f6e251498…bf70b80e44f0…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A090977-001LANTHANUM CARBONATELANTHANUM CARBONATEEQ 500MG BASETABLET, CHEWABLE / ORALAB2022-01-27
A090977-002LANTHANUM CARBONATELANTHANUM CARBONATEEQ 750MG BASETABLET, CHEWABLE / ORALAB2022-01-27
A090977-003LANTHANUM CARBONATELANTHANUM CARBONATEEQ 1GM BASETABLET, CHEWABLE / ORALAB2022-01-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090977-001AB
A090977-002AB
A090977-003AB

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.

Product history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090977-001LANTHANUM CARBONATEEQ 500MG BASETABLET, CHEWABLE / ORALAB2022-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090977-002LANTHANUM CARBONATEEQ 750MG BASETABLET, CHEWABLE / ORALAB2022-01-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090977-003LANTHANUM CARBONATEEQ 1GM BASETABLET, CHEWABLE / ORALAB2022-01-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090977-001LANTHANUM CARBONATEEQ 500MG BASETABLET, CHEWABLE / ORALAB2022-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090977-002LANTHANUM CARBONATEEQ 750MG BASETABLET, CHEWABLE / ORALAB2022-01-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090977-003LANTHANUM CARBONATEEQ 1GM BASETABLET, CHEWABLE / ORALAB2022-01-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A090977-001LANTHANUM CARBONATEEQ 500MG BASETABLET, CHEWABLE / ORALAB2022-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090977-002LANTHANUM CARBONATEEQ 750MG BASETABLET, CHEWABLE / ORALAB2022-01-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090977-003LANTHANUM CARBONATEEQ 1GM BASETABLET, CHEWABLE / ORALAB2022-01-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090977-001LANTHANUM CARBONATEEQ 500MG BASETABLET, CHEWABLE / ORALAB2022-01-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090977-002LANTHANUM CARBONATEEQ 750MG BASETABLET, CHEWABLE / ORALAB2022-01-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090977-003LANTHANUM CARBONATEEQ 1GM BASETABLET, CHEWABLE / ORALAB2022-01-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090977-001LANTHANUM CARBONATEEQ 500MG BASETABLET, CHEWABLE / ORALAB2022-01-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090977-002LANTHANUM CARBONATEEQ 750MG BASETABLET, CHEWABLE / ORALAB2022-01-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090977-003LANTHANUM CARBONATEEQ 1GM BASETABLET, CHEWABLE / ORALAB2022-01-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090977-001LANTHANUM CARBONATEEQ 500MG BASETABLET, CHEWABLE / ORALAB2022-01-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090977-002LANTHANUM CARBONATEEQ 750MG BASETABLET, CHEWABLE / ORALAB2022-01-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090977-003LANTHANUM CARBONATEEQ 1GM BASETABLET, CHEWABLE / ORALAB2022-01-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090977-001LANTHANUM CARBONATEEQ 500MG BASETABLET, CHEWABLE / ORALAB2022-01-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090977-002LANTHANUM CARBONATEEQ 750MG BASETABLET, CHEWABLE / ORALAB2022-01-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090977-003LANTHANUM CARBONATEEQ 1GM BASETABLET, CHEWABLE / ORALAB2022-01-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090977-001LANTHANUM CARBONATEEQ 500MG BASETABLET, CHEWABLE / ORALAB2022-01-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090977-002LANTHANUM CARBONATEEQ 750MG BASETABLET, CHEWABLE / ORALAB2022-01-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090977-003LANTHANUM CARBONATEEQ 1GM BASETABLET, CHEWABLE / ORALAB2022-01-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090977-001LANTHANUM CARBONATEEQ 500MG BASETABLET, CHEWABLE / ORALAB2022-01-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090977-002LANTHANUM CARBONATEEQ 750MG BASETABLET, CHEWABLE / ORALAB2022-01-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090977-003LANTHANUM CARBONATEEQ 1GM BASETABLET, CHEWABLE / ORALAB2022-01-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090977-001LANTHANUM CARBONATEEQ 500MG BASETABLET, CHEWABLE / ORALAB2022-01-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A090977-002LANTHANUM CARBONATEEQ 750MG BASETABLET, CHEWABLE / ORALAB2022-01-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A090977-003LANTHANUM CARBONATEEQ 1GM BASETABLET, CHEWABLE / ORALAB2022-01-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090977-001LANTHANUM CARBONATEEQ 500MG BASETABLET, CHEWABLE / ORALAB2022-01-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090977-002LANTHANUM CARBONATEEQ 750MG BASETABLET, CHEWABLE / ORALAB2022-01-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090977-003LANTHANUM CARBONATEEQ 1GM BASETABLET, CHEWABLE / ORALAB2022-01-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090977-001LANTHANUM CARBONATEEQ 500MG BASETABLET, CHEWABLE / ORALAB2022-01-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090977-002LANTHANUM CARBONATEEQ 750MG BASETABLET, CHEWABLE / ORALAB2022-01-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090977-003LANTHANUM CARBONATEEQ 1GM BASETABLET, CHEWABLE / ORALAB2022-01-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090977-001LANTHANUM CARBONATEEQ 500MG BASETABLET, CHEWABLE / ORALAB2022-01-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090977-002LANTHANUM CARBONATEEQ 750MG BASETABLET, CHEWABLE / ORALAB2022-01-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090977-003LANTHANUM CARBONATEEQ 1GM BASETABLET, CHEWABLE / ORALAB2022-01-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090977-001LANTHANUM CARBONATEEQ 500MG BASETABLET, CHEWABLE / ORALAB2022-01-278072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090977-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090977-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090977-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090977-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090977-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090977-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090977-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090977-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090977-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090977-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090977-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090977-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090977-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090977-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090977-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090977-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090977-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090977-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090977-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090977-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090977-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090977-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090977-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090977-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090977-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090977-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090977-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090977-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090977-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090977-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090977-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090977-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090977-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090977-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090977-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090977-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090977-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090977-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090977-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090977-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LANTHANUM CARBONATE750 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
e4b88992-ecb0-455b-b68c-5c4e6d3cf521Available 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
0093-5939-85Lanthanum carbonate15 in 1 BOTTLETABLET, CHEWABLE158
0093-5939-98Lanthanum carbonate6 in 1 CARTONTABLET, CHEWABLE68

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-5939-85EA - Each0093-593996b36675-86c3-4510-bfce-6f8b45e635c912022-06-06
0093-5939-98EA - Each0093-5939960486a2-b813-417f-a39c-5a8bcf8c3d2d12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-5939LANTHANUM CARBONATE TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA, INC.]8Current NDC, Legacy NDC, 2 package rows20250402_e4b88992-ecb0-455b-b68c-5c4e6d3cf521.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 CARBONATETeva Pharmaceuticals USA, Inc.e4b88992-ecb0-455b-b68c-5c4e6d3cf5212025-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090977
application number: ANDA090977
ndc (product): 0093-5939

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 formatDescriptionMarketing startStatus
0093-5939-0000093593900813 TABLET, CHEWABLE in 1 BOX (0093-5939-00)17-FEB-22Current