Home NDC 0093-5938-00 Lanthanum carbonate
Product NDC 0093-5938
Requested package NDC 0093-5938-00
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 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 date Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 906f6e251498…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090977-001 LANTHANUM CARBONATE LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 A090977-002 LANTHANUM CARBONATE LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 A090977-003 LANTHANUM CARBONATE LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2022-01-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A090977-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090977-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090977-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090977-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090977-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090977-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090977-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090977-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090977-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090977-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090977-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090977-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090977-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090977-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090977-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090977-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090977-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090977-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090977-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090977-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090977-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090977-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090977-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090977-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090977-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090977-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090977-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090977-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090977-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090977-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090977-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090977-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090977-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090977-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090977-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090977-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090977-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090977-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090977-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090977-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-27 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 96 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Lanthanum carbonate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LANTHANUM CARBONATE 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 490D9F069T Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 477347 Internal RxNorm lookup 602635 Internal RxNorm lookup 642452 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0093-5938-54 Lanthanum carbonate 45 in 1 BOTTLE TABLET, CHEWABLE 45 8 0093-5938-98 Lanthanum carbonate 2 in 1 CARTON TABLET, CHEWABLE 2 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-5938 LANTHANUM CARBONATE TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA, INC.] 8 Current NDC, Legacy NDC, 2 package rows 20250402_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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Status 0093-5938-00 00093593800 1220 TABLET, CHEWABLE in 1 BOX (0093-5938-00) 17-FEB-22 Current