Levetiracetam
- Product NDC
- 16571-788
- 11-digit product format
- 165710788
- Labeler code
- 16571
- Product ID
- 16571-788_12dcedc8-07a7-41c4-be05-2ccde6050fce
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levetiracetam
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA078993
- Marketing category
- ANDA
- Marketing start
- 2009-01-15
- Marketing end
- 0000-00-00
- Substance
- LEVETIRACETAM
- Active strength
- 500 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 16571-788 | D | Discontinued by firm | 2026-08-07 | ||
| excluded package | package | 16571-788 | 16571-788-12 | D | Discontinued by firm | 2026-08-07 | |
| excluded package | package | 16571-788 | 16571-788-50 | D | Discontinued by firm | 2026-08-07 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 16571-788 | 16571-788-12 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078993-001 | LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET / ORAL | AB | 2009-01-15 | |
| A078993-002 | LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET / ORAL | AB | 2009-01-15 | |
| A078993-003 | LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET / ORAL | AB | 2009-01-15 | |
| A078993-004 | LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET / ORAL | AB | 2009-01-15 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078993-001 | AB |
| A078993-002 | AB |
| A078993-003 | AB |
| A078993-004 | 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 | A078993-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | AB | 2009-01-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078993-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | AB | 2009-01-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078993-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | AB | 2009-01-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078993-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | AB | 2009-01-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078993-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | AB | 2009-01-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078993-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | AB | 2009-01-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078993-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | AB | 2009-01-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078993-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | AB | 2009-01-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078993-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | AB | 2009-01-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078993-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | AB | 2009-01-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078993-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | AB | 2009-01-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078993-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | AB | 2009-01-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078993-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | AB | 2009-01-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078993-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | AB | 2009-01-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078993-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | AB | 2009-01-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078993-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | AB | 2009-01-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078993-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | AB | 2009-01-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078993-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | AB | 2009-01-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078993-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | AB | 2009-01-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078993-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | AB | 2009-01-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078993-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | AB | 2009-01-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078993-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | AB | 2009-01-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078993-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | AB | 2009-01-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078993-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | AB | 2009-01-15 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078993-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | AB | 2009-01-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078993-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | AB | 2009-01-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078993-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | AB | 2009-01-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078993-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | AB | 2009-01-15 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078993-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | AB | 2009-01-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078993-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | AB | 2009-01-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078993-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | AB | 2009-01-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078993-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | AB | 2009-01-15 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078993-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | AB | 2009-01-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078993-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | AB | 2009-01-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078993-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | AB | 2009-01-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078993-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | AB | 2009-01-15 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078993-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | AB | 2009-01-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078993-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | AB | 2009-01-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078993-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | AB | 2009-01-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078993-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | AB | 2009-01-15 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078993-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078993-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078993-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078993-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078993-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078993-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078993-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078993-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078993-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078993-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078993-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078993-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078993-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078993-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078993-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078993-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078993-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078993-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078993-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078993-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078993-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078993-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078993-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078993-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078993-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078993-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078993-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078993-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078993-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078993-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078993-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078993-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078993-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078993-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078993-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078993-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078993-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078993-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078993-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078993-004 | AB | 1 | d06236e962d9… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 16571-788-12 | EA - Each | 16571-788 | cbbd2a49-31f9-491e-95d7-eb15df35aac3 | 1 | 2021-11-09 |
| 16571-788-50 | EA - Each | 16571-788 | 2439f6f7-5425-498f-9027-2638510d5933 | 1 | 2021-11-09 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Levetiracetam | LEVETIRACETAM | Unit Dose Solutions, Inc. | 551626eb-3282-e439-e063-6294a90a8314 | 2026-06-25 | Warnings, Adverse reactions | 078993 ANDA078993 |
| Levetiracetam | LEVETIRACETAM | Coupler LLC | 53843871-23e3-974e-e063-6394a90a8042 | 2026-06-05 | Warnings, Adverse reactions | 078993 ANDA078993 |
| Levetiracetam | LEVETIRACETAM | Coupler LLC | 51b66893-f7d6-8f9d-e063-6294a90a8e9b | 2026-05-13 | Warnings, Adverse reactions | 078993 ANDA078993 |
| Levetiracetam | LEVETIRACETAM | Coupler LLC | 5037a86a-21f2-d793-e063-6394a90a2cb5 | 2026-04-24 | Warnings, Adverse reactions | 078993 ANDA078993 |
| Levetiracetam | LEVETIRACETAM | A-S Medication Solutions | 6e31e766-6504-4f20-8831-1953363cace0 | 2025-11-21 | Warnings, Adverse reactions | 078993 ANDA078993 |
| Levetiracetam | LEVETIRACETAM | A-S Medication Solutions | 01aef7f7-6092-4e39-8451-dc02d8db9254 | 2025-11-21 | Warnings, Adverse reactions | 078993 ANDA078993 |
| Levetiracetam | LEVETIRACETAM | A-S Medication Solutions | 58ed7049-44c6-4f97-9174-c0e1504586a6 | 2025-11-19 | Warnings, Adverse reactions | 078993 ANDA078993 |
| Levetiracetam | LEVETIRACETAM | A-S Medication Solutions | 5eb7bea5-c95f-4a38-a5bb-c20d1549c797 | 2025-11-19 | Warnings, Adverse reactions | 078993 ANDA078993 |
| Levetiracetam | LEVETIRACETAM | A-S Medication Solutions | bc12f0b0-e05c-48e4-ad08-0ff14a818a64 | 2025-11-19 | Warnings, Adverse reactions | 078993 ANDA078993 |
| Levetiracetam | LEVETIRACETAM | Major Pharmaceuticals | c4b27429-50a3-467c-a5ff-7e49a01a1088 | 2025-09-11 | Warnings, Adverse reactions | 078993 ANDA078993 |
| Levetiracetam | LEVETIRACETAM | Cardinal Health 107, LLC | 0348fec4-d919-4307-ac90-35360819bc00 | 2025-06-09 | Warnings, Adverse reactions | 078993 ANDA078993 |
| Levetiracetam | LEVETIRACETAM | BluePoint Laboratories | 8b74b8bc-d95c-4471-8f74-c3117243bf89 | 2024-12-11 | Warnings, Adverse reactions | 078993 ANDA078993 |
| Levetiracetam | LEVETIRACETAM | American Health Packaging | fc8bf57e-8aa2-4d3c-856d-b19de65e3ba0 | 2024-11-18 | Warnings, Adverse reactions | 078993 ANDA078993 |
| Levetiracetam | LEVETIRACETAM | American Health Packaging | 031a32e1-675a-4efe-a66b-40beb4fe5101 | 2024-06-21 | Warnings, Adverse reactions | 078993 ANDA078993 |
| Levetiracetam | LEVETIRACETAM | Aurobindo Pharma Limited | 2471ee03-d747-4113-86d0-1aa93c8f3eba | 2024-04-04 | Warnings, Adverse reactions | 078993 ANDA078993 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 16571-788-12 | 16571078812 | 120 TABLET, FILM COATED in 1 BOTTLE (16571-788-12) | 2009-01-15 | 0000-00-00 | No | No | Current |
| 16571-788-50 | 16571078850 | 500 TABLET, FILM COATED in 1 BOTTLE (16571-788-50) | 2009-01-15 | 0000-00-00 | No | No | Current |