Home NDC 72789-173 Lithium Carbonate
Product NDC 72789-173
11-digit product format 727890173
Labeler code 72789
Product ID 72789-173_5df907ed-4750-3dd1-e063-6294a90ac635
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lithium Carbonate
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application NDA017812
Marketing category NDA
Marketing start 1980-11-26
Substance LITHIUM CARBONATE
Active strength 300 mg/1
Pharmacologic classes Mood Stabilizer [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 45 .
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 N017812-001 LITHIUM CARBONATE LITHIUM CARBONATE 300MG CAPSULE / ORAL AB RLD, Approved before 1982 N017812-002 LITHIUM CARBONATE LITHIUM CARBONATE 150MG CAPSULE / ORAL AB RLD 1987-01-28 N017812-003 LITHIUM CARBONATE LITHIUM CARBONATE 600MG CAPSULE / ORAL AB RLD, RS 1987-01-28
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 · 135 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 2026-11-14 07:37:17 2026-10 N017812-001 LITHIUM CARBONATE 300MG CAPSULE / ORAL AB RLD, Approved before 1982 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N017812-002 LITHIUM CARBONATE 150MG CAPSULE / ORAL AB RLD 1987-01-28 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 N017812-003 LITHIUM CARBONATE 600MG CAPSULE / ORAL AB RLD, RS 1987-01-28 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 N017812-001 LITHIUM CARBONATE 300MG CAPSULE / ORAL AB RLD, Approved before 1982 c2088c7a36db…2026-10-15 13:18:30 2026-09 N017812-002 LITHIUM CARBONATE 150MG CAPSULE / ORAL AB RLD 1987-01-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 N017812-003 LITHIUM CARBONATE 600MG CAPSULE / ORAL AB RLD, RS 1987-01-28 c2088c7a36db…2026-09-14 22:38:34 2026-08 N017812-001 LITHIUM CARBONATE 300MG CAPSULE / ORAL AB RLD, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N017812-002 LITHIUM CARBONATE 150MG CAPSULE / ORAL AB RLD 1987-01-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N017812-003 LITHIUM CARBONATE 600MG CAPSULE / ORAL AB RLD, RS 1987-01-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N017812-001 LITHIUM CARBONATE 300MG CAPSULE / ORAL AB RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N017812-002 LITHIUM CARBONATE 150MG CAPSULE / ORAL AB RLD 1987-01-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N017812-003 LITHIUM CARBONATE 600MG CAPSULE / ORAL AB RLD, RS 1987-01-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N017812-001 LITHIUM CARBONATE 300MG CAPSULE / ORAL AB RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N017812-002 LITHIUM CARBONATE 150MG CAPSULE / ORAL AB RLD 1987-01-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N017812-003 LITHIUM CARBONATE 600MG CAPSULE / ORAL AB RLD, RS 1987-01-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017812-001 LITHIUM CARBONATE 300MG CAPSULE / ORAL AB RLD, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017812-002 LITHIUM CARBONATE 150MG CAPSULE / ORAL AB RLD 1987-01-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017812-003 LITHIUM CARBONATE 600MG CAPSULE / ORAL AB RLD, RS 1987-01-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N017812-001 LITHIUM CARBONATE 300MG CAPSULE / ORAL AB RLD, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N017812-002 LITHIUM CARBONATE 150MG CAPSULE / ORAL AB RLD 1987-01-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N017812-003 LITHIUM CARBONATE 600MG CAPSULE / ORAL AB RLD, RS 1987-01-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017812-001 LITHIUM CARBONATE 300MG CAPSULE / ORAL AB RLD, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017812-002 LITHIUM CARBONATE 150MG CAPSULE / ORAL AB RLD 1987-01-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017812-003 LITHIUM CARBONATE 600MG CAPSULE / ORAL AB RLD, RS 1987-01-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017812-001 LITHIUM CARBONATE 300MG CAPSULE / ORAL AB RLD, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017812-002 LITHIUM CARBONATE 150MG CAPSULE / ORAL AB RLD 1987-01-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017812-003 LITHIUM CARBONATE 600MG CAPSULE / ORAL AB RLD, RS 1987-01-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017812-001 LITHIUM CARBONATE 300MG CAPSULE / ORAL AB RLD, Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017812-002 LITHIUM CARBONATE 150MG CAPSULE / ORAL AB RLD 1987-01-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017812-003 LITHIUM CARBONATE 600MG CAPSULE / ORAL AB RLD, RS 1987-01-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017812-001 LITHIUM CARBONATE 300MG CAPSULE / ORAL AB RLD, Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017812-002 LITHIUM CARBONATE 150MG CAPSULE / ORAL AB RLD 1987-01-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017812-003 LITHIUM CARBONATE 600MG CAPSULE / ORAL AB RLD, RS 1987-01-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017812-001 LITHIUM CARBONATE 300MG CAPSULE / ORAL AB RLD, Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017812-002 LITHIUM CARBONATE 150MG CAPSULE / ORAL AB RLD 1987-01-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017812-003 LITHIUM CARBONATE 600MG CAPSULE / ORAL AB RLD, RS 1987-01-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017812-001 LITHIUM CARBONATE 300MG CAPSULE / ORAL AB RLD, Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017812-002 LITHIUM CARBONATE 150MG CAPSULE / ORAL AB RLD 1987-01-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017812-003 LITHIUM CARBONATE 600MG CAPSULE / ORAL AB RLD, RS 1987-01-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N017812-001 LITHIUM CARBONATE 300MG CAPSULE / ORAL AB RLD, Approved before 1982 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 135 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 2027-12-31 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 197889 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 72789-173-01 Lithium Carbonate 100 in 1 BOTTLE, PLASTIC CAPSULE, GELATIN COATED 100 30
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72789-173 LITHIUM CARBONATE CAPSULE, GELATIN COATED [PD-RX PHARMACEUTICALS, INC.] 29 Current NDC, Legacy NDC, 1 package rows 20241011_c4973d87-d014-42f4-ba13-ae628ca1a451.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 · 5 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): 017812 application number: NDA017812 Lithium Carbonate LITHIUM CARBONATE REMEDYREPACK INC. 05312159-3d8a-45e0-99cb-b83a7b200cd3 2026-07-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 017812 application number: NDA017812 Lithium Carbonate LITHIUM CARBONATE REMEDYREPACK INC. b074ca9f-66b2-4e83-b67d-cb317b46411b 2026-06-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 017812 application number: NDA017812 Lithium Carbonate LITHIUM CARBONATE Cardinal Health 107, LLC 0e6b0a2d-b79c-44d8-b785-5267df9e8f72 2026-06-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 017812 application number: NDA017812 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): 017812 application number: NDA017812
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 72789-173-01 72789017301 100 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (72789-173-01) 2021-03-09 0000-00-00 No No Current