Home NDC 76282-478-90 Lanthanum carbonate
Product NDC 76282-478
Requested package NDC 76282-478-90
11-digit product format 762820478
Labeler code 76282
Product ID 76282-478_f8ec986e-eaed-4a41-abbe-220e17f29d76
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LANTHANUM CARBONATE
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Exelan Pharmaceuticals, Inc.
Application ANDA206868
Marketing category ANDA
Marketing start 2022-01-25
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 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 A206868-001 LANTHANUM CARBONATE LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 A206868-002 LANTHANUM CARBONATE LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 A206868-003 LANTHANUM CARBONATE LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2022-01-24
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 A206868-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206868-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206868-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206868-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206868-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206868-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206868-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206868-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206868-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206868-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206868-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206868-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206868-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206868-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206868-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206868-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206868-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206868-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206868-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206868-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206868-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206868-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206868-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206868-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206868-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206868-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206868-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206868-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206868-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206868-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206868-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206868-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206868-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206868-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206868-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206868-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206868-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206868-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206868-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206868-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2022-01-24 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 1000 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 76282-478-13 Lanthanum carbonate 10 in 1 BOTTLE TABLET, CHEWABLE 10 4 76282-478-90 Lanthanum carbonate 9 in 1 PACKAGE TABLET, CHEWABLE 9 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76282-478 LANTHANUM CARBONATE TABLET, CHEWABLE [EXELAN PHARMACEUTICALS, INC.] 3 Current NDC, Legacy NDC, 2 package rows 20230616_16b0e6f5-4fc9-448c-994a-cb9dd8b03654.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 76282-478-90 76282047890 9 BOTTLE in 1 PACKAGE (76282-478-90) / 10 TABLET, CHEWABLE in 1 BOTTLE (76282-478-13) 9 bottle 2022-01-25 0000-00-00 No No Current