Levetiracetam
- Product NDC
- 50090-3264
- 11-digit product format
- 500903264
- Labeler code
- 50090
- Product ID
- 50090-3264_e5e6cad4-6e7f-413c-a281-e213670b4bd5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levetiracetam
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA090843
- Marketing category
- ANDA
- Marketing start
- 2013-05-31
- Marketing end
- 0000-00-00
- Substance
- LEVETIRACETAM
- Active strength
- 1000 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
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#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-3264-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-f0a4-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use LEVETIRACETAM safely and effectively. See full prescribing information for LEVETIRACETAM. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-3264-0 | Levetiracetam | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-3264-0 | EA - Each | 50090-3264 | cb978ccc-ca03-4d42-a725-651ad8f1afc1 | 1 | 2019-05-02 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-3264 | LEVETIRACETAM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] | 4 | Legacy NDC, 1 package rows | 20200122_9329702d-ffda-4e80-b3b2-8eca403e569f.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 387003 | levETIRAcetam 1000 MG Oral Tablet | PSN | 9329702d-ffda-4e80-b3b2-8eca403e569f | 4 |
| 387003 | levetiracetam 1000 MG Oral Tablet | SCD | 9329702d-ffda-4e80-b3b2-8eca403e569f | 4 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50090-3264-0 | 50090326400 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-3264-0) | 2017-11-14 | 0000-00-00 | No | No | Current |