Lithium Carbonate
- Product NDC
- 63629-7903
- 11-digit product format
- 636297903
- Labeler code
- 63629
- Product ID
- 63629-7903_f1fdf4e1-dad7-4a8f-8837-93f7cee0019a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lithium Carbonate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA091616
- Marketing category
- ANDA
- Marketing start
- 2011-02-14
- Marketing end
- 0000-00-00
- Substance
- LITHIUM CARBONATE
- Active strength
- 450 mg/1
- Pharmacologic classes
- Mood Stabilizer [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 63629-7903 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 63629-7903 | 63629-7903-1 | D | Discontinued by firm | 2026-08-03 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091616-001 | LITHIUM CARBONATE | LITHIUM CARBONATE | 450MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-02-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091616-001 | 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A091616-001 | LITHIUM CARBONATE | 450MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-02-14 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A091616-001 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Lithium Carbonate ER | LITHIUM CARBONATE | Coupler LLC | 51b503f5-211f-a9cc-e063-6294a90a9895 | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | 091616 ANDA091616 |
| Lithium Carbonate ER | LITHIUM CARBONATE | REMEDYREPACK INC. | bd4b07d3-ce42-440f-aec3-19f4d1c445a9 | 2026-03-20 | Boxed warning, Warnings, Adverse reactions | 091616 ANDA091616 |
| Lithium Carbonate ER | LITHIUM CARBONATE | Glenmark Pharmaceuticals Inc., USA | 525a9d9b-cbb1-4644-a28a-8bba96f09348 | 2026-01-30 | Boxed warning, Warnings, Adverse reactions | 091616 ANDA091616 |
| Lithium Carbonate ER | LITHIUM CARBONATE | AvKARE | d8ddff4d-2b77-a8f2-e053-2a95a90a5fc0 | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | 091616 ANDA091616 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63629-7903-1 | 63629790301 | 30 TABLET in 1 BOTTLE (63629-7903-1) | 30 tablet | 2011-02-14 | 0000-00-00 | No | No | Current |