Levetiracetam
- Product NDC
- 0615-7976
- Requested package NDC
- 0615-7976-39
- 11-digit product format
- 006157976
- Labeler code
- 0615
- Product ID
- 0615-7976_b1888f15-4a0c-4ff9-bc48-d27959ff1c1f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levetiracetam
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA090515
- Marketing category
- ANDA
- Marketing start
- 2012-01-09
- Marketing end
- 0000-00-00
- Substance
- LEVETIRACETAM
- Active strength
- 250 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 package | package | 0615-7976 | 0615-7976-39 | D | Discontinued by firm | 2026-08-03 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090515-001 | LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET / ORAL | AB | 2010-10-08 | |
| A090515-002 | LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET / ORAL | AB | 2010-10-08 | |
| A090515-003 | LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET / ORAL | AB | 2010-10-08 | |
| A090515-004 | LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET / ORAL | AB | 2010-10-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090515-001 | AB |
| A090515-002 | AB |
| A090515-003 | AB |
| A090515-004 | 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 | A090515-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | AB | 2010-10-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090515-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | AB | 2010-10-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090515-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | AB | 2010-10-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090515-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | AB | 2010-10-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090515-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | AB | 2010-10-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090515-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | AB | 2010-10-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090515-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | AB | 2010-10-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090515-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | AB | 2010-10-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090515-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | AB | 2010-10-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090515-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | AB | 2010-10-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090515-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | AB | 2010-10-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090515-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | AB | 2010-10-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090515-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | AB | 2010-10-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090515-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | AB | 2010-10-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090515-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | AB | 2010-10-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090515-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | AB | 2010-10-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090515-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | AB | 2010-10-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090515-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | AB | 2010-10-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090515-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | AB | 2010-10-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090515-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | AB | 2010-10-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090515-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | AB | 2010-10-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090515-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | AB | 2010-10-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090515-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | AB | 2010-10-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090515-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | AB | 2010-10-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090515-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | AB | 2010-10-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090515-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | AB | 2010-10-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090515-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | AB | 2010-10-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090515-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | AB | 2010-10-08 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090515-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | AB | 2010-10-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090515-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | AB | 2010-10-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090515-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | AB | 2010-10-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090515-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | AB | 2010-10-08 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090515-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | AB | 2010-10-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090515-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | AB | 2010-10-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090515-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | AB | 2010-10-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090515-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | AB | 2010-10-08 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090515-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | AB | 2010-10-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090515-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | AB | 2010-10-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090515-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | AB | 2010-10-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090515-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | AB | 2010-10-08 | 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 | A090515-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090515-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090515-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090515-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090515-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090515-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090515-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090515-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090515-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090515-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090515-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090515-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090515-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090515-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090515-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090515-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090515-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090515-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090515-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090515-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090515-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090515-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090515-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090515-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090515-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090515-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090515-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090515-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090515-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090515-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090515-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090515-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090515-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090515-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090515-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090515-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090515-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090515-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090515-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090515-004 | AB | 1 | d06236e962d9… |
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 | REMEDYREPACK INC. | dfc218c5-672a-420a-b59e-2e0b054e99ad | 2026-07-14 | Warnings, Adverse reactions | 090515 ANDA090515 |
| Levetiracetam | LEVETIRACETAM | REMEDYREPACK INC. | ae405796-1eca-4890-bcb2-e1b07654a24d | 2026-07-08 | Warnings, Adverse reactions | 090515 ANDA090515 |
| Levetiracetam | LEVETIRACETAM | Injecta Medcial LLC | 52fa0eec-3dd9-59ca-e063-6394a90a9791 | 2026-05-29 | Warnings, Adverse reactions | 090515 ANDA090515 |
| Levetiracetam | LEVETIRACETAM | Preferred Pharmaceuticals, Inc. | 419b3dba-ae21-4268-ac8b-342aaa609554 | 2026-05-18 | Warnings, Adverse reactions | 090515 ANDA090515 |
| LEVETIRACETAM | LEVETIRACETAM | DIRECT RX | c3b62114-a590-f4db-e053-2995a90a9d30 | 2026-03-05 | Warnings, Adverse reactions | 090515 ANDA090515 |
| Levetiracetam | LEVETIRACETAM | A-S Medication Solutions | 30f43d3b-c944-4f25-b5d3-009294944962 | 2026-02-02 | Warnings, Adverse reactions | 090515 ANDA090515 |
| Levetiracetam | LEVETIRACETAM | Northwind Health Company, LLC | fc4c72e2-9cba-88d9-e053-6394a90a0426 | 2026-01-01 | Warnings, Adverse reactions | 090515 ANDA090515 |
| Levetiracetam | LEVETIRACETAM | A-S Medication Solutions | b9597cd5-5745-494a-bd72-93071ed221da | 2025-11-18 | Warnings, Adverse reactions | 090515 ANDA090515 |
| Levetiracetam | LEVETIRACETAM | PD-Rx Pharmaceuticals, Inc. | 792db8dc-177b-4864-8600-12823819082d | 2025-10-08 | Warnings, Adverse reactions | 090515 ANDA090515 |
| Levetiracetam | LEVETIRACETAM | Quallent Pharmaceuticals Health LLC | 3756f052-919c-4817-a56e-1091fd514d9d | 2025-10-07 | Warnings, Adverse reactions | 090515 ANDA090515 |
| Levetiracetam | LEVETIRACETAM | NorthStar RxLLC | 3884cb76-822b-400d-9b24-49c286c9b6f7 | 2025-10-07 | Warnings, Adverse reactions | 090515 ANDA090515 |
| Levetiracetam | LEVETIRACETAM | XLCare Pharmaceuticals Inc. | 567f09e6-ccd5-4688-a22b-0bc66a5fe31e | 2024-09-06 | Warnings, Adverse reactions | 090515 ANDA090515 |
| Levetiracetam | LEVETIRACETAM | Bryant Ranch Prepack | bc8b413f-2f07-4e6a-bb8e-a1f2119ae1cf | 2024-05-30 | Warnings, Adverse reactions | 090515 ANDA090515 |
| Levetiracetam | LEVETIRACETAM | Bryant Ranch Prepack | adbcb0f7-0421-47e2-854e-e1cfefb6386f | 2024-05-29 | Warnings, Adverse reactions | 090515 ANDA090515 |
| Levetiracetam | LEVETIRACETAM | Camber Pharmaceuticals, Inc. | 63b36274-89f0-42d8-9f09-f9e78e179af4 | 2024-04-29 | Warnings, Adverse reactions | 090515 ANDA090515 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0615-7976-39 | 00615797639 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7976-39) | 2016-05-04 | 0000-00-00 | No | No | Current |