Home NDC 46708-305 Lithium Carbonate
Product NDC 46708-305
11-digit product format 467080305
Labeler code 46708
Product ID 46708-305_f4a09dd5-000a-48d2-9681-d5bc360164f1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lithium Carbonate
Dosage form CAPSULE
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA079159
Marketing category ANDA
Marketing start 2016-12-27
Substance LITHIUM CARBONATE
Active strength 600 mg/1
Pharmacologic classes Mood Stabilizer [EPC]
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 A079159-001 LITHIUM CARBONATE LITHIUM CARBONATE 150MG CAPSULE / ORAL AB 2009-01-12 A079159-002 LITHIUM CARBONATE LITHIUM CARBONATE 300MG CAPSULE / ORAL AB 2009-01-12 A079159-003 LITHIUM CARBONATE LITHIUM CARBONATE 600MG CAPSULE / ORAL AB 2009-01-12
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 · 123 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 A079159-001 LITHIUM CARBONATE 150MG CAPSULE / ORAL AB 2009-01-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079159-002 LITHIUM CARBONATE 300MG CAPSULE / ORAL AB 2009-01-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079159-003 LITHIUM CARBONATE 600MG CAPSULE / ORAL AB 2009-01-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079159-001 LITHIUM CARBONATE 150MG CAPSULE / ORAL AB 2009-01-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079159-002 LITHIUM CARBONATE 300MG CAPSULE / ORAL AB 2009-01-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079159-003 LITHIUM CARBONATE 600MG CAPSULE / ORAL AB 2009-01-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079159-001 LITHIUM CARBONATE 150MG CAPSULE / ORAL AB 2009-01-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079159-002 LITHIUM CARBONATE 300MG CAPSULE / ORAL AB 2009-01-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079159-003 LITHIUM CARBONATE 600MG CAPSULE / ORAL AB 2009-01-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079159-001 LITHIUM CARBONATE 150MG CAPSULE / ORAL AB 2009-01-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079159-002 LITHIUM CARBONATE 300MG CAPSULE / ORAL AB 2009-01-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079159-003 LITHIUM CARBONATE 600MG CAPSULE / ORAL AB 2009-01-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079159-001 LITHIUM CARBONATE 150MG CAPSULE / ORAL AB 2009-01-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079159-002 LITHIUM CARBONATE 300MG CAPSULE / ORAL AB 2009-01-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079159-003 LITHIUM CARBONATE 600MG CAPSULE / ORAL AB 2009-01-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079159-001 LITHIUM CARBONATE 150MG CAPSULE / ORAL AB 2009-01-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079159-002 LITHIUM CARBONATE 300MG CAPSULE / ORAL AB 2009-01-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079159-003 LITHIUM CARBONATE 600MG CAPSULE / ORAL AB 2009-01-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079159-001 LITHIUM CARBONATE 150MG CAPSULE / ORAL AB 2009-01-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079159-002 LITHIUM CARBONATE 300MG CAPSULE / ORAL AB 2009-01-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079159-003 LITHIUM CARBONATE 600MG CAPSULE / ORAL AB 2009-01-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079159-001 LITHIUM CARBONATE 150MG CAPSULE / ORAL AB 2009-01-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079159-002 LITHIUM CARBONATE 300MG CAPSULE / ORAL AB 2009-01-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079159-003 LITHIUM CARBONATE 600MG CAPSULE / ORAL AB 2009-01-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079159-001 LITHIUM CARBONATE 150MG CAPSULE / ORAL AB 2009-01-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079159-002 LITHIUM CARBONATE 300MG CAPSULE / ORAL AB 2009-01-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079159-003 LITHIUM CARBONATE 600MG CAPSULE / ORAL AB 2009-01-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079159-001 LITHIUM CARBONATE 150MG CAPSULE / ORAL AB 2009-01-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A079159-002 LITHIUM CARBONATE 300MG CAPSULE / ORAL AB 2009-01-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A079159-003 LITHIUM CARBONATE 600MG CAPSULE / ORAL AB 2009-01-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079159-001 LITHIUM CARBONATE 150MG CAPSULE / ORAL AB 2009-01-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079159-002 LITHIUM CARBONATE 300MG CAPSULE / ORAL AB 2009-01-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079159-003 LITHIUM CARBONATE 600MG CAPSULE / ORAL AB 2009-01-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079159-001 LITHIUM CARBONATE 150MG CAPSULE / ORAL AB 2009-01-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079159-002 LITHIUM CARBONATE 300MG CAPSULE / ORAL AB 2009-01-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079159-003 LITHIUM CARBONATE 600MG CAPSULE / ORAL AB 2009-01-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079159-001 LITHIUM CARBONATE 150MG CAPSULE / ORAL AB 2009-01-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079159-002 LITHIUM CARBONATE 300MG CAPSULE / ORAL AB 2009-01-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079159-003 LITHIUM CARBONATE 600MG CAPSULE / ORAL AB 2009-01-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079159-001 LITHIUM CARBONATE 150MG CAPSULE / ORAL AB 2009-01-12 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Lithium Carbonate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LITHIUM CARBONATE 600 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2BMD2GNA4V Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197889 Internal RxNorm lookup 197893 Internal RxNorm lookup 311355 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 46708-305-30 Lithium Carbonate 30 in 1 BOTTLE CAPSULE 30 3 46708-305-31 Lithium Carbonate 100 in 1 BOTTLE CAPSULE 100 3 46708-305-71 Lithium Carbonate 500 in 1 BOTTLE CAPSULE 500 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-305 LITHIUM CARBONATE CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED] 3 Current NDC, Legacy NDC, 3 package rows 20230202_d1800f34-3d67-4b2f-874e-8639b125d853.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 46708-305-30 46708030530 30 CAPSULE in 1 BOTTLE (46708-305-30) 30 capsule 2016-12-27 0000-00-00 No No Current 46708-305-31 46708030531 100 CAPSULE in 1 BOTTLE (46708-305-31) 100 capsule 2016-12-27 0000-00-00 No No Current 46708-305-71 46708030571 500 CAPSULE in 1 BOTTLE (46708-305-71) 500 capsule 2016-12-27 0000-00-00 No No Current