Levetiracetam
- Product NDC
- 76494-528
- Requested package NDC
- 76494-528-12
- 11-digit product format
- 764940528
- Labeler code
- 76494
- Product ID
- 76494-528_bf716ab6-d438-4a19-8193-dbc05b4eabad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levetiracetam
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Prinston Pharmaceutical Inc.
- Application
- ANDA078106
- Marketing category
- ANDA
- Marketing start
- 2012-09-11
- Substance
- LEVETIRACETAM
- Active strength
- 250 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 76494-528 | 76494-528-12 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 9bebd1f3094a… | 5416666fcb17… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 76494-528 | 76494-528-12 | E | Excluded after deficient or non-compliant submission was not corrected | excluded / ndc_excluded.zip | 110d247fa046… | a55b01930146… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078106-001 | LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET / ORAL | AB | 2009-02-10 | |
| A078106-002 | LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET / ORAL | AB | 2009-02-10 | |
| A078106-003 | LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET / ORAL | AB | 2009-02-10 | |
| A078106-004 | LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET / ORAL | AB | 2009-02-10 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078106-001 | AB |
| A078106-002 | AB |
| A078106-003 | AB |
| A078106-004 | 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 | A078106-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | AB | 2009-02-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078106-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | AB | 2009-02-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078106-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | AB | 2009-02-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078106-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | AB | 2009-02-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078106-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | AB | 2009-02-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078106-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | AB | 2009-02-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078106-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | AB | 2009-02-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078106-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | AB | 2009-02-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078106-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | AB | 2009-02-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078106-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | AB | 2009-02-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078106-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | AB | 2009-02-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078106-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | AB | 2009-02-10 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078106-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | AB | 2009-02-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078106-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | AB | 2009-02-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078106-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | AB | 2009-02-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078106-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | AB | 2009-02-10 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078106-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | AB | 2009-02-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078106-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | AB | 2009-02-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078106-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | AB | 2009-02-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078106-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | AB | 2009-02-10 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078106-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | AB | 2009-02-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078106-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | AB | 2009-02-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078106-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | AB | 2009-02-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078106-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | AB | 2009-02-10 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078106-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | AB | 2009-02-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078106-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | AB | 2009-02-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078106-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | AB | 2009-02-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078106-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | AB | 2009-02-10 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078106-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | AB | 2009-02-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078106-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | AB | 2009-02-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078106-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | AB | 2009-02-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078106-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | AB | 2009-02-10 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078106-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | AB | 2009-02-10 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078106-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | AB | 2009-02-10 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078106-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | AB | 2009-02-10 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078106-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | AB | 2009-02-10 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078106-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | AB | 2009-02-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078106-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | AB | 2009-02-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078106-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | AB | 2009-02-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078106-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | AB | 2009-02-10 | 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 | A078106-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078106-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078106-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078106-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078106-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078106-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078106-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078106-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078106-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078106-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078106-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078106-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078106-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078106-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078106-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078106-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078106-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078106-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078106-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078106-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078106-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078106-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078106-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078106-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078106-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078106-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078106-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078106-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078106-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078106-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078106-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078106-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078106-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078106-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078106-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078106-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078106-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078106-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078106-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078106-004 | AB | 1 | d06236e962d9… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Levetiracetam
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LEVETIRACETAM | 250 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 44YRR34555 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| d818ef84-9b3e-434b-92d9-910cfa8af7da | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 76e81f18-c6b9-f226-530a-a6296d5cd5f4 | Product name | 6 | 20251106 |
| 087c9486-f4a9-a565-c6fb-d6fa49f4572a | Product name | 6 | 20230317 |
| 525a8d4d-1988-fc3f-e292-27fd384de4f0 | Product name | 8 | 20230104 |
| 32b651f8-caa7-6882-11c7-54c4ad21796b | Product name | 8 | 20201216 |
| ce453ca5-90cf-41ed-9de4-de519f70a0f2 | Product name | 2 | 20160303 |
| 66666eb8-1fa6-4a60-bae9-e564e73b4cd5 | Product name | 1 | 20150728 |
| eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477 | Product name | 1 | 20150410 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76494-528-12 | Levetiracetam | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | 12 |
DailyMed Socrata Ingredients#
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 | Bryant Ranch Prepack | ed8e88d0-993e-4683-bdcf-31578130d3df | 2024-04-03 | Warnings, Adverse reactions | 078106 ANDA078106 |
| Levetiracetam | LEVETIRACETAM | Solco Healthcare US, LLC | 57f09129-7151-4a75-9d73-9dd32f74ba43 | 2024-03-27 | Warnings, Adverse reactions | 078106 ANDA078106 |
| Levetiracetam | LEVETIRACETAM | Solco Healthcare US, LLC | dd713e60-478c-43cd-b680-ff594a0b3864 | 2024-03-27 | Warnings, Adverse reactions | 078106 ANDA078106 |
| Levetiracetam | LEVETIRACETAM | Prinston Pharmaceutical Inc. | d818ef84-9b3e-434b-92d9-910cfa8af7da | 2020-08-01 | Warnings, Adverse reactions | 078106 ANDA078106 76494-528-12 76494-528 76494052812 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 387003 | levETIRAcetam 1000 MG Oral Tablet | PSN | d818ef84-9b3e-434b-92d9-910cfa8af7da | 12 |
| 311288 | levETIRAcetam 250 MG Oral Tablet | PSN | d818ef84-9b3e-434b-92d9-910cfa8af7da | 12 |
| 311289 | levETIRAcetam 500 MG Oral Tablet | PSN | d818ef84-9b3e-434b-92d9-910cfa8af7da | 12 |
| 311290 | levETIRAcetam 750 MG Oral Tablet | PSN | d818ef84-9b3e-434b-92d9-910cfa8af7da | 12 |
| 387003 | levetiracetam 1000 MG Oral Tablet | SCD | d818ef84-9b3e-434b-92d9-910cfa8af7da | 12 |
| 311288 | levetiracetam 250 MG Oral Tablet | SCD | d818ef84-9b3e-434b-92d9-910cfa8af7da | 12 |
| 311289 | levetiracetam 500 MG Oral Tablet | SCD | d818ef84-9b3e-434b-92d9-910cfa8af7da | 12 |
| 311290 | levetiracetam 750 MG Oral Tablet | SCD | d818ef84-9b3e-434b-92d9-910cfa8af7da | 12 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 76494-528-12 | 76494052812 | 120 TABLET, FILM COATED in 1 BOTTLE (76494-528-12) | 2012-09-11 | 0000-00-00 | No | No | Current |