LEVETIRACETAM
- Product NDC
- 55488-0519
- Requested package NDC
- 55488-0519-1
- 11-digit product format
- 554880519
- Labeler code
- 55488
- Product ID
- 55488-0519_7ccdb5b2-160c-44eb-bbc3-b869e5323754
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LEVETIRACETAM
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Changzhou Pharmaceutical Factory
- Application
- ANDA212688
- Marketing category
- ANDA
- Marketing start
- 2020-06-11
- Marketing end
- 0000-00-00
- Substance
- LEVETIRACETAM
- Active strength
- 750 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 | 55488-0519 | 55488-0519-1 | I | Inactivated by FDA | 2026-08-11 |
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… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | bd6a592717d7… | 303034d00443… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A212688-001 | LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-06-11 | |
| A212688-002 | LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-05-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A212688-001 | AB |
| A212688-002 | 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 | A212688-001 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-06-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212688-002 | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-05-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212688-001 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-06-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212688-002 | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-05-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212688-001 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-06-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212688-002 | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-05-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212688-001 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-06-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212688-002 | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-05-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212688-001 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-06-11 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212688-002 | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-05-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212688-001 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-06-11 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212688-002 | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-05-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212688-001 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-06-11 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212688-002 | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-05-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212688-001 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-06-11 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212688-002 | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-05-05 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212688-001 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-06-11 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212688-002 | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-05-05 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A212688-001 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-06-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A212688-002 | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-05-05 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212688-001 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-06-11 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212688-002 | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-05-05 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212688-001 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-06-11 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212688-002 | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-05-05 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212688-001 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-06-11 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212688-002 | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-05-05 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A212688-001 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-06-11 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A212688-002 | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-05-05 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212688-001 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-06-11 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A212688-001 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-06-11 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A212688-001 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-06-11 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | A212688-001 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-06-11 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A212688-001 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-06-11 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A212688-001 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | 2020-06-11 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A212688-001 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | 2020-06-11 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A212688-001 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-06-11 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A212688-001 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-06-11 | c0c555d07b60… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A212688-001 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-06-11 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A212688-002 | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-05-05 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A212688-001 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2020-06-11 | 1c564ffb4f44… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A212688-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212688-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212688-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212688-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A212688-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212688-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212688-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212688-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212688-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212688-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212688-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212688-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212688-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212688-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212688-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212688-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212688-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212688-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A212688-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A212688-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212688-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212688-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212688-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212688-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212688-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212688-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A212688-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A212688-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212688-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A212688-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A212688-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A212688-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A212688-001 | AB | 1 | 782e0a99824c… |
| 2020-12-22 03:56 UTC | 2020-12 | A212688-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A212688-001 | AB | 1 | c0c555d07b60… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A212688-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A212688-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A212688-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A212688-002 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A212688-001 | AB | 1 | ea1830bbd6c7… |
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#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55488-0519-1 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-8f26-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use LEVETIRACETAM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM EXTENDED-RELEASE TABLETS. LEVETIRACETAM extended-release tablets, for oral use Initial U.S. Approval: 1999 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55488-0519-1 | LEVETIRACETAMExtended-release | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55488-0519 | LEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, EXTENDED RELEASE [CHANGZHOU PHARMACEUTICAL FACTORY] | 3 | Legacy NDC, 1 package rows | 20200625_5d3ce612-94de-4ad3-b873-27cb09304d45.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 Extended-release | LEVETIRACETAM | Omnivium Pharmaceuticals LLC | 1a31134d-6b63-4d14-8445-0ed132e6c88d | 2026-01-16 | Warnings, Adverse reactions | 212688 ANDA212688 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 846378 | levETIRAcetam 750 MG 24HR Extended Release Oral Tablet | PSN | 5d3ce612-94de-4ad3-b873-27cb09304d45 | 3 |
| 846378 | 24 HR levetiracetam 750 MG Extended Release Oral Tablet | SCD | 5d3ce612-94de-4ad3-b873-27cb09304d45 | 3 |
| 846378 | levetiracetam 750 MG 24 HR Extended Release Oral Tablet | SY | 5d3ce612-94de-4ad3-b873-27cb09304d45 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55488-0519-1 | 55488051901 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (55488-0519-1) | 2020-06-11 | 0000-00-00 | No | No | Current |