Levetiracetam
- Product NDC
- 70518-0947
- Requested package NDC
- 70518-0947-1
- 11-digit product format
- 705180947
- Labeler code
- 70518
- Product ID
- 70518-0947_e9e61a32-d816-2fa3-e053-2a95a90a63ee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levetiracetam
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA090515
- Marketing category
- ANDA
- Marketing start
- 2018-01-10
- 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 | 70518-0947 | 70518-0947-1 | 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 |
|---|---|---|---|---|---|---|---|
| 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… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 76e81f18-c6b9-f226-530a-a6296d5cd5f4 | Product name | 6 | 20251106 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 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 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 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 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70518-0947 | LEVETIRACETAM TABLET, FILM COATED [REMEDYREPACK INC.] | 16 | Legacy NDC | 20250504_1f4a0acc-d5f5-438d-96a0-897dfebdf6e4.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 |
|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|---|
| 70518-0947-1 | 70518094701 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0947-1) | 2020-05-28 | 0000-00-00 | No | No | Current |