Home NDC 0054-4527 Lithium Carbonate
Product NDC 0054-4527
11-digit product format 000544527
Labeler code 0054
Product ID 0054-4527_a9e58e66-6569-4c3b-993f-b4236904296e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lithium Carbonate
Dosage form TABLET
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application NDA018558
Marketing category NDA
Marketing start 1982-01-29
Substance LITHIUM CARBONATE
Active strength 300 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018558-001 LITHIUM CARBONATE LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N018558-001 AB
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 2 · 41 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 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL AB RLD, RS 1982-01-29 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 300 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 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197889 Internal RxNorm lookup 197890 Internal RxNorm lookup 197893 Internal RxNorm lookup 311355 Internal RxNorm lookup 756059 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 0054-4527-25 Lithium Carbonate 100 in 1 BOTTLE TABLET 100 28 0054-4527-31 Lithium Carbonate 1000 in 1 BOTTLE TABLET 1000 28
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LITHIUM CARBONATE ACTIVE INGREDIENT 2BMD2GNA4V LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC] 11 LITHIUM CITRATE ACTIVE INGREDIENT 5Z6E9K79YV LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC] 11 LITHIUM CATION ACTIVE MOIETY 8H8Z5UER66 LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC] 11 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC] 11 CALCIUM STEARATE INACTIVE INGREDIENT 776XM7047L LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC] 11 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC] 11 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC] 11 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC] 11 GELATIN INACTIVE INGREDIENT 2G86QN327L LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC] 11 POVIDONE K29/32 INACTIVE INGREDIENT 390RMW2PEQ LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC] 11 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC] 11 RASPBERRY INACTIVE INGREDIENT 4N14V5R27W LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC] 11 SHELLAC INACTIVE INGREDIENT 46N107B71O LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC] 11 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC] 11 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC] 11 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC] 11 SORBITOL INACTIVE INGREDIENT 506T60A25R LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC] 11 TALC INACTIVE INGREDIENT 7SEV7J4R1U LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC] 11 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC] 11 WATER INACTIVE INGREDIENT 059QF0KO0R LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [ROXANE LABORATORIES, INC] 11 LITHIUM CARBONATE ACTIVE INGREDIENT 2BMD2GNA4V LITHIUM CARBONATE TABLET [STAT RX USA LLC] 1 LITHIUM CATION ACTIVE MOIETY 8H8Z5UER66 LITHIUM CARBONATE TABLET [STAT RX USA LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-4527 LITHIUM CARBONATE TABLET LITHIUM CARBONATE CAPSULE, GELATIN COATED LITHIUM SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 28 Current NDC, Legacy NDC, 2 package rows 20231129_7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e.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 · 3 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 0054-4527-25 00054452725 100 TABLET in 1 BOTTLE (0054-4527-25) 100 tablet 1982-01-29 0000-00-00 No No Current 0054-4527-31 00054452731 1000 TABLET in 1 BOTTLE (0054-4527-31) 1000 tablet 1982-01-29 0000-00-00 No No Current