Levetiracetam
- Product NDC
- 66298-0427
- 11-digit product format
- 662980427
- Labeler code
- 66298
- Product ID
- 66298-0427_4420aa12-72f1-f196-e063-6294a90ad85d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LEVETIRACETAM
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Hp Halden Pharma AS
- Application
- ANDA208619
- Marketing category
- ANDA
- Marketing start
- 2025-12-12
- Substance
- LEVETIRACETAM
- Active strength
- 5 mg/mL
- 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 |
|---|---|---|---|---|---|---|---|
| A208619-001 | LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 500MG/100ML (5MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2023-01-31 | |
| A208619-002 | LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 1GM/100ML (10MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2023-01-31 | |
| A208619-003 | LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 1.5GM/100ML (15MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2023-01-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A208619-001 | AP |
| A208619-002 | AP |
| A208619-003 | AP |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A208619-001 | LEVETIRACETAM IN SODIUM CHLORIDE | 500MG/100ML (5MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2023-01-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A208619-002 | LEVETIRACETAM IN SODIUM CHLORIDE | 1GM/100ML (10MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2023-01-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A208619-003 | LEVETIRACETAM IN SODIUM CHLORIDE | 1.5GM/100ML (15MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2023-01-31 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A208619-001 | LEVETIRACETAM IN SODIUM CHLORIDE | 500MG/100ML (5MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2023-01-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A208619-002 | LEVETIRACETAM IN SODIUM CHLORIDE | 1GM/100ML (10MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2023-01-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A208619-003 | LEVETIRACETAM IN SODIUM CHLORIDE | 1.5GM/100ML (15MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2023-01-31 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208619-001 | LEVETIRACETAM IN SODIUM CHLORIDE | 500MG/100ML (5MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2023-01-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208619-002 | LEVETIRACETAM IN SODIUM CHLORIDE | 1GM/100ML (10MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2023-01-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208619-003 | LEVETIRACETAM IN SODIUM CHLORIDE | 1.5GM/100ML (15MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2023-01-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208619-001 | LEVETIRACETAM IN SODIUM CHLORIDE | 500MG/100ML (5MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2023-01-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208619-002 | LEVETIRACETAM IN SODIUM CHLORIDE | 1GM/100ML (10MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2023-01-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208619-003 | LEVETIRACETAM IN SODIUM CHLORIDE | 1.5GM/100ML (15MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2023-01-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208619-001 | LEVETIRACETAM IN SODIUM CHLORIDE | 500MG/100ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2023-01-31 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208619-002 | LEVETIRACETAM IN SODIUM CHLORIDE | 1GM/100ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2023-01-31 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208619-003 | LEVETIRACETAM IN SODIUM CHLORIDE | 1.5GM/100ML (15MG/ML) | INJECTABLE / INTRAVENOUS | 2023-01-31 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208619-001 | LEVETIRACETAM IN SODIUM CHLORIDE | 500MG/100ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2023-01-31 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208619-002 | LEVETIRACETAM IN SODIUM CHLORIDE | 1GM/100ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2023-01-31 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208619-003 | LEVETIRACETAM IN SODIUM CHLORIDE | 1.5GM/100ML (15MG/ML) | INJECTABLE / INTRAVENOUS | 2023-01-31 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208619-001 | LEVETIRACETAM IN SODIUM CHLORIDE | 500MG/100ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2023-01-31 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208619-002 | LEVETIRACETAM IN SODIUM CHLORIDE | 1GM/100ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2023-01-31 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208619-003 | LEVETIRACETAM IN SODIUM CHLORIDE | 1.5GM/100ML (15MG/ML) | INJECTABLE / INTRAVENOUS | 2023-01-31 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208619-001 | LEVETIRACETAM IN SODIUM CHLORIDE | 500MG/100ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2023-01-31 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208619-002 | LEVETIRACETAM IN SODIUM CHLORIDE | 1GM/100ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2023-01-31 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208619-003 | LEVETIRACETAM IN SODIUM CHLORIDE | 1.5GM/100ML (15MG/ML) | INJECTABLE / INTRAVENOUS | 2023-01-31 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208619-001 | LEVETIRACETAM IN SODIUM CHLORIDE | 500MG/100ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2023-01-31 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208619-002 | LEVETIRACETAM IN SODIUM CHLORIDE | 1GM/100ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2023-01-31 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208619-003 | LEVETIRACETAM IN SODIUM CHLORIDE | 1.5GM/100ML (15MG/ML) | INJECTABLE / INTRAVENOUS | 2023-01-31 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208619-001 | LEVETIRACETAM IN SODIUM CHLORIDE | 500MG/100ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2023-01-31 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208619-002 | LEVETIRACETAM IN SODIUM CHLORIDE | 1GM/100ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2023-01-31 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208619-003 | LEVETIRACETAM IN SODIUM CHLORIDE | 1.5GM/100ML (15MG/ML) | INJECTABLE / INTRAVENOUS | 2023-01-31 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208619-001 | LEVETIRACETAM IN SODIUM CHLORIDE | 500MG/100ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2023-01-31 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208619-002 | LEVETIRACETAM IN SODIUM CHLORIDE | 1GM/100ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2023-01-31 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208619-003 | LEVETIRACETAM IN SODIUM CHLORIDE | 1.5GM/100ML (15MG/ML) | INJECTABLE / INTRAVENOUS | 2023-01-31 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A208619-001 | LEVETIRACETAM IN SODIUM CHLORIDE | 500MG/100ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2023-01-31 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A208619-002 | LEVETIRACETAM IN SODIUM CHLORIDE | 1GM/100ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2023-01-31 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A208619-003 | LEVETIRACETAM IN SODIUM CHLORIDE | 1.5GM/100ML (15MG/ML) | INJECTABLE / INTRAVENOUS | 2023-01-31 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208619-001 | LEVETIRACETAM IN SODIUM CHLORIDE | 500MG/100ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2023-01-31 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208619-002 | LEVETIRACETAM IN SODIUM CHLORIDE | 1GM/100ML (10MG/ML) | INJECTABLE / INTRAVENOUS | 2023-01-31 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208619-003 | LEVETIRACETAM IN SODIUM CHLORIDE | 1.5GM/100ML (15MG/ML) | INJECTABLE / INTRAVENOUS | 2023-01-31 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208619-001 | LEVETIRACETAM IN SODIUM CHLORIDE | 500MG/100ML (5MG/ML) | INJECTABLE / INTRAVENOUS | 2023-01-31 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A208619-001 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A208619-002 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A208619-003 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A208619-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A208619-002 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A208619-003 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A208619-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208619-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208619-003 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208619-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208619-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208619-003 | AP | 1 | 31067a03dcf5… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A208619-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A208619-002 | AP | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A208619-003 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A208619-001 | AP | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A208619-002 | AP | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A208619-003 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A208619-001 | AP | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A208619-002 | AP | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A208619-003 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A208619-001 | AP | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A208619-002 | AP | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A208619-003 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A208619-001 | AP | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A208619-002 | AP | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A208619-003 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A208619-001 | AP | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A208619-002 | AP | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A208619-003 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A208619-001 | AP | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A208619-002 | AP | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A208619-003 | AP | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A208619-001 | AP | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A208619-002 | AP | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A208619-003 | AP | 1 | 053a50430f4f… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A208619-001 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A208619-002 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A208619-003 | AP | 1 | a50c72e98297… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Levetiracetam
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LEVETIRACETAM | 5 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 44YRR34555 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1193362 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1d9abcce-8ef7-422b-bf4b-5835bf4dbb34 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66298-0427-1 | Levetiracetam | 24 in 1 CARTON | INJECTION | 24 | 1 | |
| 66298-0427-1 | Levetiracetam | 100 mL in 1 BAG | INJECTION | 100 | 1 |
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 | Fresenius Kabi USA, LLC | da858849-1d18-4d38-b53d-d4dd1cd8fabc | 2026-02-05 | Warnings, Adverse reactions | 208619 ANDA208619 |
| Levetiracetam | LEVETIRACETAM | Hp Halden Pharma AS | 1d9abcce-8ef7-422b-bf4b-5835bf4dbb34 | 2025-11-21 | Warnings, Adverse reactions | 208619 ANDA208619 66298-0427 |
| Levetiracetam | LEVETIRACETAM | Hp Halden Pharma AS | 6951de41-4a16-4cca-8039-44fc81407081 | 2025-11-21 | Warnings, Adverse reactions | 208619 ANDA208619 |
| Levetiracetam | LEVETIRACETAM | Hp Halden Pharma AS | 35bb1e5f-d5cd-4e7f-a056-48c0cf9ebd76 | 2025-11-21 | Warnings, Adverse reactions | 208619 ANDA208619 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1193362 | levETIRAcetam 500 MG in 100 ML Injection | PSN | 1d9abcce-8ef7-422b-bf4b-5835bf4dbb34 | 1 |
| 1193362 | 100 ML levetiracetam 5 MG/ML Injection | SCD | 1d9abcce-8ef7-422b-bf4b-5835bf4dbb34 | 1 |
| 1193362 | levetiracetam 500 MG per 100 ML Injection | SY | 1d9abcce-8ef7-422b-bf4b-5835bf4dbb34 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 66298-0427-1 | 66298042701 | 24 BAG in 1 CARTON (66298-0427-1) / 100 mL in 1 BAG | 24 bag | 2025-12-12 | No | No | Current |