Home NDC 68180-819 Lanthanum Carbonate
Product NDC 68180-819
11-digit product format 681800819
Labeler code 68180
Product ID 68180-819_4ea12e2c-97a4-461b-8d14-fa20499f0c6d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lanthanum Carbonate
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA090978
Marketing category ANDA
Marketing start 2017-08-30
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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090978-001 LANTHANUM CARBONATE LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 A090978-002 LANTHANUM CARBONATE LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 A090978-003 LANTHANUM CARBONATE LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2017-08-11
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 4 · 126 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 2026-08-18 06:07:40 2026-07 A090978-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090978-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090978-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090978-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090978-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090978-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090978-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090978-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090978-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090978-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090978-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090978-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090978-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090978-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090978-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090978-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090978-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090978-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090978-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090978-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090978-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090978-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090978-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090978-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090978-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090978-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090978-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090978-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090978-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090978-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090978-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090978-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090978-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090978-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090978-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090978-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090978-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090978-002 LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090978-003 LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090978-001 LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB 2017-08-11 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 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 68180-819-42 Lanthanum Carbonate 2 in 1 PACKAGE TABLET, CHEWABLE 2 16 68180-819-42 Lanthanum Carbonate 45 in 1 BOTTLE TABLET, CHEWABLE 45 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-819 LANTHANUM CARBONATE TABLET, CHEWABLE [LUPIN PHARMACEUTICALS, INC. ] 15 Current NDC, Legacy NDC, 2 package rows 20240313_91556a42-5e16-4f86-bae9-a8cdd6b182a6.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 Units Marketing start Marketing end Sample Exclude flag Status 68180-819-42 68180081942 2 BOTTLE in 1 PACKAGE (68180-819-42) / 45 TABLET, CHEWABLE in 1 BOTTLE 2 bottle 2017-08-30 0000-00-00 No No Current