LEVETIRACETAM
- Product NDC
- 43547-346
- 11-digit product format
- 435470346
- Labeler code
- 43547
- Product ID
- 43547-346_801f853c-1f42-4d65-ae2d-2bace0d5f3f8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LEVETIRACETAM
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Solco healthcare U.S., LLC
- Application
- ANDA203468
- Marketing category
- ANDA
- Marketing start
- 2014-05-01
- Substance
- LEVETIRACETAM
- Active strength
- 750 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203468-001 | LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | |
| A203468-002 | LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203468-001 | AB |
| A203468-002 | 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 | A203468-001 | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203468-002 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203468-001 | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203468-002 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203468-001 | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203468-002 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203468-001 | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203468-002 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203468-001 | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203468-002 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203468-001 | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203468-002 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203468-001 | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203468-002 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203468-001 | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203468-002 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203468-001 | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203468-002 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203468-001 | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203468-002 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203468-001 | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203468-002 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203468-001 | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203468-002 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203468-001 | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203468-002 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A203468-001 | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A203468-002 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A203468-001 | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A203468-002 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A203468-001 | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A203468-002 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A203468-001 | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A203468-002 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A203468-001 | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A203468-002 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A203468-001 | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A203468-002 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A203468-001 | LEVETIRACETAM | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A203468-002 | LEVETIRACETAM | 750MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2015-05-21 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A203468-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203468-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203468-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203468-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203468-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203468-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203468-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203468-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203468-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203468-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203468-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203468-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203468-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203468-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203468-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203468-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203468-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203468-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A203468-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203468-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203468-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203468-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203468-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203468-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203468-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203468-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A203468-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A203468-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A203468-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A203468-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A203468-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A203468-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A203468-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A203468-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A203468-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A203468-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A203468-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A203468-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A203468-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A203468-002 | AB | 1 | 782e0a99824c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LEVETIRACETAM
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LEVETIRACETAM | 750 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 44YRR34555 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| bc8644ed-3320-47b5-adf3-8b972bea8abd | Available on FDA.report |
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 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43547-346-06 | LEVETIRACETAM | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | 14 | |
| 43547-346-50 | LEVETIRACETAM | 500 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 500 | 14 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43547-346-06 | EA - Each | 43547-346 | 2a00a335-a76c-4205-b427-252e5db21c33 | 1 | 2015-10-02 |
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 | ace53552-d616-45e8-9f99-2f0041d0b430 | 2026-07-06 | Warnings, Adverse reactions | 203468 ANDA203468 |
| LEVETIRACETAM | LEVETIRACETAM | REMEDYREPACK INC. | 9bdef24b-c50e-4e6a-8650-59d78009f472 | 2026-03-09 | Warnings, Adverse reactions | 203468 ANDA203468 |
| Levetiracetam ER | LEVETIRACETAM ER | Direct_Rx | 03c449a1-9b40-a7da-e063-6394a90a984e | 2025-01-22 | Warnings, Adverse reactions | 203468 ANDA203468 |
| LEVETIRACETAM | LEVETIRACETAM | Solco healthcare U.S., LLC | bc8644ed-3320-47b5-adf3-8b972bea8abd | 2024-03-28 | Warnings, Adverse reactions | 203468 ANDA203468 43547-346 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 807832 | levETIRAcetam 500 MG 24HR Extended Release Oral Tablet | PSN | bc8644ed-3320-47b5-adf3-8b972bea8abd | 14 |
| 846378 | levETIRAcetam 750 MG 24HR Extended Release Oral Tablet | PSN | bc8644ed-3320-47b5-adf3-8b972bea8abd | 14 |
| 807832 | 24 HR levetiracetam 500 MG Extended Release Oral Tablet | SCD | bc8644ed-3320-47b5-adf3-8b972bea8abd | 14 |
| 846378 | 24 HR levetiracetam 750 MG Extended Release Oral Tablet | SCD | bc8644ed-3320-47b5-adf3-8b972bea8abd | 14 |
| 807832 | levetiracetam 500 MG 24 HR Extended Release Oral Tablet | SY | bc8644ed-3320-47b5-adf3-8b972bea8abd | 14 |
| 846378 | levetiracetam 750 MG 24 HR Extended Release Oral Tablet | SY | bc8644ed-3320-47b5-adf3-8b972bea8abd | 14 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 43547-346-06 | 43547034606 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43547-346-06) | 2014-05-01 | 0000-00-00 | No | No | Current |
| 43547-346-50 | 43547034650 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43547-346-50) | 2014-05-01 | 0000-00-00 | No | No | Current |