Levetiracetam
- Product NDC
- 44567-502
- 11-digit product format
- 445670502
- Labeler code
- 44567
- Product ID
- 44567-502_5d75a4ee-4a82-48d9-809b-eabea28c6e96
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levetiracetam
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- WG Critical Care, LLC
- Application
- NDA202543
- Marketing category
- NDA
- Marketing start
- 2020-08-24
- Substance
- LEVETIRACETAM
- Active strength
- 10 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Levetiracetam
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LEVETIRACETAM | 10 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 44YRR34555 |
| Rxcui | 1193358, 1193360, 1193362 |
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 |
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| 525a8d4d-1988-fc3f-e292-27fd384de4f0 | Product name | 8 | 20230104 |
| 32b651f8-caa7-6882-11c7-54c4ad21796b | Product name | 8 | 20201216 |
| 48747306-602a-42cc-957b-5b0c69158eee | Product name | 1 | 20180604 |
| ce453ca5-90cf-41ed-9de4-de519f70a0f2 | Product name | 2 | 20160303 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| 66666eb8-1fa6-4a60-bae9-e564e73b4cd5 | Product name | 1 | 20150728 |
| eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477 | Product name | 1 | 20150410 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
| db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 44567-502-01 | Levetiracetam | 100 mL in 1 BAG | INJECTION | 100 | 6 | |
| 44567-502-10 | Levetiracetam | 10 in 1 CARTON | INJECTION | 10 | 6 | |
| 44567-502-02 | Levetiracetam | 100 mL in 1 BAG | INJECTION | 100 | 3 | |
| 44567-502-90 | Levetiracetam | 10 in 1 CARTON | INJECTION | 10 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 44567-502-01 | ML - Milliliter | 44567-502 | 4f16f625-d2db-4bf8-8a45-ed8976a60fc7 | 1 | 2022-07-06 |
| 44567-502-10 | ML - Milliliter | 44567-502 | d98dbcb7-df86-4eb7-8c5e-7b77fdbc8585 | 1 | 2022-06-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 44567-502 | LEVETIRACETAM INJECTION [WG CRITICAL CARE, LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240601_62f3d1c8-ca5b-4760-9fc9-41e4fb4cc926.zip |
| 44567-502 | LEVETIRACETAM INJECTION [WG CRITICAL CARE, LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240113_5e5b0ed3-b104-45a7-bb3e-ee56febb46e8.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1193358 | levETIRAcetam 1000 MG in 100 ML Injection | PSN | 62f3d1c8-ca5b-4760-9fc9-41e4fb4cc926 | 6 |
| 1193360 | levETIRAcetam 1500 MG in 100 ML Injection | PSN | 62f3d1c8-ca5b-4760-9fc9-41e4fb4cc926 | 6 |
| 1193362 | levETIRAcetam 500 MG in 100 ML Injection | PSN | 62f3d1c8-ca5b-4760-9fc9-41e4fb4cc926 | 6 |
| 1193358 | 100 ML levetiracetam 10 MG/ML Injection | SCD | 62f3d1c8-ca5b-4760-9fc9-41e4fb4cc926 | 6 |
| 1193360 | 100 ML levetiracetam 15 MG/ML Injection | SCD | 62f3d1c8-ca5b-4760-9fc9-41e4fb4cc926 | 6 |
| 1193362 | 100 ML levetiracetam 5 MG/ML Injection | SCD | 62f3d1c8-ca5b-4760-9fc9-41e4fb4cc926 | 6 |
| 1193358 | levetiracetam 1000 MG per 100 ML Injection | SY | 62f3d1c8-ca5b-4760-9fc9-41e4fb4cc926 | 6 |
| 1193360 | levetiracetam 1500 MG per 100 ML Injection | SY | 62f3d1c8-ca5b-4760-9fc9-41e4fb4cc926 | 6 |
| 1193362 | levetiracetam 500 MG per 100 ML Injection | SY | 62f3d1c8-ca5b-4760-9fc9-41e4fb4cc926 | 6 |
| 1193358 | levETIRAcetam 1000 MG in 100 ML Injection | PSN | 5e5b0ed3-b104-45a7-bb3e-ee56febb46e8 | 3 |
| 1193362 | levETIRAcetam 500 MG in 100 ML Injection | PSN | 5e5b0ed3-b104-45a7-bb3e-ee56febb46e8 | 3 |
| 1193358 | 100 ML levetiracetam 10 MG/ML Injection | SCD | 5e5b0ed3-b104-45a7-bb3e-ee56febb46e8 | 3 |
| 1193362 | 100 ML levetiracetam 5 MG/ML Injection | SCD | 5e5b0ed3-b104-45a7-bb3e-ee56febb46e8 | 3 |
| 1193358 | levetiracetam 1000 MG per 100 ML Injection | SY | 5e5b0ed3-b104-45a7-bb3e-ee56febb46e8 | 3 |
| 1193362 | levetiracetam 500 MG per 100 ML Injection | SY | 5e5b0ed3-b104-45a7-bb3e-ee56febb46e8 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 44567-502-01 | 44567050201 | 100 mL in 1 BAG | 100 ml | Historical | ||||
| 44567-502-02 | 44567050202 | 100 mL in 1 BAG | 100 ml | Historical | ||||
| 44567-502-10 | 44567050210 | 10 BAG in 1 CARTON (44567-502-10) / 100 mL in 1 BAG (44567-502-01) | 10 bag | 2020-08-24 | 0000-00-00 | No | No | Current |
| 44567-502-90 | 44567050290 | 10 BAG in 1 CARTON (44567-502-90) / 100 mL in 1 BAG (44567-502-02) | 10 bag | 2022-09-15 | 0000-00-00 | No | No | Current |