Home NDC 72789-174 Lithium Carbonate
Product NDC 72789-174
11-digit product format 727890174
Labeler code 72789
Product ID 72789-174_2becc6b3-fa7f-6bdc-e063-6394a90a8098
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lithium Carbonate
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, 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 43 .
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 RLD, RS 1982-01-29
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 · 43 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 2026-09-14 22:38:34 2026-08 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL RLD, RS 1982-01-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 N018558-001 LITHIUM CARBONATE 300MG TABLET / ORAL RLD, RS 1982-01-29 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197890 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 72789-174-01 Lithium Carbonate 100 in 1 BOTTLE, PLASTIC TABLET 100 26
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72789-174 LITHIUM CARBONATE TABLET [PD-RX PHARMACEUTICALS, INC.] 26 Current NDC, Legacy NDC, 1 package rows 20250119_d20ed2aa-aa56-4709-9e7a-9243c71465c9.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lithium Carbonate LITHIUM CARBONATE Hikma Pharmaceuticals USA Inc. b839ff4b-f62d-41ab-a823-550a756d58ec 2026-08-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 018558 application number: NDA018558 Lithium Carbonate LITHIUM CARBONATE REMEDYREPACK INC. c84cce95-cfcb-4426-aac6-d2f48f946ada 2026-07-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 018558 application number: NDA018558 Lithium Carbonate LITHIUM CARBONATE PD-Rx Pharmaceuticals, Inc. d20ed2aa-aa56-4709-9e7a-9243c71465c9 2025-01-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 018558 application number: NDA018558 ndc (product): 72789-174 Lithium Carbonate LITHIUM CARBONATE Hikma Pharmaceuticals USA Inc. 7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e 2022-11-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 018558 application number: NDA018558
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 72789-174-01 72789017401 100 TABLET in 1 BOTTLE, PLASTIC (72789-174-01) 100 tablet 2021-03-09 0000-00-00 No No Current