Lithium Carbonate
- Product NDC
- 55154-4920
- 11-digit product format
- 551544920
- Labeler code
- 55154
- Product ID
- 55154-4920_7660a961-9333-4799-9302-aed7d6ce1b51
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lithium Carbonate
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- Cardinal Health 107, LLC
- Application
- NDA017812
- Marketing category
- NDA
- Marketing start
- 1987-07-28
- 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
Orange Book products#
| 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#
| Application-product | TE code |
|---|---|
| N017812-001 | AB |
| N017812-002 | AB |
| N017812-003 | 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.
| 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 | 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… | |
| 2024-10-29 15:01 UTC | 2024-10 | N017812-002 | LITHIUM CARBONATE | 150MG | CAPSULE / ORAL | AB | RLD | 1987-01-28 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N017812-003 | LITHIUM CARBONATE | 600MG | CAPSULE / ORAL | AB | RLD, RS | 1987-01-28 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017812-001 | LITHIUM CARBONATE | 300MG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017812-002 | LITHIUM CARBONATE | 150MG | CAPSULE / ORAL | AB | RLD | 1987-01-28 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017812-003 | LITHIUM CARBONATE | 600MG | CAPSULE / ORAL | AB | RLD, RS | 1987-01-28 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017812-001 | LITHIUM CARBONATE | 300MG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017812-002 | LITHIUM CARBONATE | 150MG | CAPSULE / ORAL | AB | RLD | 1987-01-28 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017812-003 | LITHIUM CARBONATE | 600MG | CAPSULE / ORAL | AB | RLD, RS | 1987-01-28 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017812-001 | LITHIUM CARBONATE | 300MG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017812-002 | LITHIUM CARBONATE | 150MG | CAPSULE / ORAL | AB | RLD | 1987-01-28 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017812-003 | LITHIUM CARBONATE | 600MG | CAPSULE / ORAL | AB | RLD, RS | 1987-01-28 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N017812-001 | LITHIUM CARBONATE | 300MG | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N017812-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N017812-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N017812-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017812-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017812-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017812-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N017812-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N017812-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N017812-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017812-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017812-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017812-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017812-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017812-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017812-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017812-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017812-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017812-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017812-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017812-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017812-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017812-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017812-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017812-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017812-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017812-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017812-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N017812-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N017812-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N017812-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017812-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017812-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017812-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017812-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017812-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017812-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017812-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017812-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017812-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N017812-001 | AB | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lithium Carbonate
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LITHIUM CARBONATE | 300 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2BMD2GNA4V | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 197889 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0e6b0a2d-b79c-44d8-b785-5267df9e8f72 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b3053bb1-353b-4a0b-bca5-28fe7228957c | Product name | 2 | 20250124 |
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| 7792dadb-52b6-46b6-8fdf-80b1171065b5 | Product name | 1 | 20180810 |
| 8ce6e144-236f-b7be-f690-f06e0c8c6bd3 | Product name | 2 | 20170725 |
| f09af6ee-c6dd-d0ce-77ad-93508bcdaced | Product name | 4 | 20161205 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55154-4920-0 | Lithium Carbonate | 10 in 1 BAG | CAPSULE, GELATIN COATED | 10 | 12 | |
| 55154-4920-0 | Lithium Carbonate | 1 in 1 BLISTER PACK | CAPSULE, GELATIN COATED | 1 | 12 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55154-4920 | LITHIUM CARBONATE CAPSULE, GELATIN COATED [CARDINAL HEALTH 107, LLC] | 11 | Current NDC, Legacy NDC, 2 package rows | 20240929_0e6b0a2d-b79c-44d8-b785-5267df9e8f72.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Lithium Carbonate | LITHIUM CARBONATE | REMEDYREPACK INC. | 05312159-3d8a-45e0-99cb-b83a7b200cd3 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | 017812 NDA017812 |
| Lithium Carbonate | LITHIUM CARBONATE | REMEDYREPACK INC. | b074ca9f-66b2-4e83-b67d-cb317b46411b | 2026-06-15 | Boxed warning, Warnings, Adverse reactions | 017812 NDA017812 |
| Lithium Carbonate | LITHIUM CARBONATE | Cardinal Health 107, LLC | 0e6b0a2d-b79c-44d8-b785-5267df9e8f72 | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | 017812 NDA017812 55154-4920 |
| Lithium Carbonate | LITHIUM CARBONATE | PD-Rx Pharmaceuticals, Inc. | 16ebe1f9-501d-468b-a37d-f6a46f8f32d1 | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | 017812 NDA017812 |
| Lithium Carbonate | LITHIUM CARBONATE | PD-Rx Pharmaceuticals, Inc. | c4973d87-d014-42f4-ba13-ae628ca1a451 | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | 017812 NDA017812 |
| Lithium Carbonate | LITHIUM CARBONATE | Hikma Pharmaceuticals USA Inc. | 7dc9c6d2-6d9a-49e4-a8ab-437b0ed5f84e | 2022-11-22 | Boxed warning, Warnings, Adverse reactions | 017812 NDA017812 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197889 | lithium carbonate 300 MG Oral Capsule | PSN | 0e6b0a2d-b79c-44d8-b785-5267df9e8f72 | 12 |
| 197889 | lithium carbonate 300 MG Oral Capsule | SCD | 0e6b0a2d-b79c-44d8-b785-5267df9e8f72 | 12 |
| 197889 | LiCO3 300 MG Oral Capsule | SY | 0e6b0a2d-b79c-44d8-b785-5267df9e8f72 | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55154-4920-0 | 55154492000 | 10 BLISTER PACK in 1 BAG (55154-4920-0) / 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK | 10 blister pack | 1987-07-28 | 0000-00-00 | No | No | Current |