Levetiracetam
- Product NDC
- 43489-124
- 11-digit product format
- 434890124
- Labeler code
- 43489
- Product ID
- 43489-124_b9ca151f-094c-1c00-e053-2a95a90a0f86
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levetiracetam
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- China Resources Saike Pharmaceutical Co., Ltd.
- Application
- ANDA205102
- Marketing category
- ANDA
- Marketing start
- 2015-12-18
- 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 43489-124-03 | 2023-01-30 | C162847 | 48780-1 | f386c64a-36b8-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use LEVETIRACETAM TABLETS, USP, safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS, USP. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999 |
| 43489-124-08 | 2023-01-30 | C162847 | 48780-1 | f386c64a-36b8-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use LEVETIRACETAM TABLETS, USP, safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS, USP. LEVETIRACETAM tablets, for oral use Initial U.S. Approval: 1999 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43489-124-03 | Levetiracetam | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | | 12 |
| 43489-124-08 | Levetiracetam | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43489-124 | LEVETIRACETAM TABLET, FILM COATED [CHINA RESOURCES SAIKE PHARMACEUTICAL CO., LTD.] | 12 | Legacy NDC, 2 package rows | 20210127_0b3b3c98-afa4-4f61-bab0-62c4afa27757.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43489-124-03 | 43489012403 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43489-124-03) | 2015-12-18 | 0000-00-00 | No | No | Current |
| 43489-124-08 | 43489012408 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43489-124-08) | 2015-12-18 | 0000-00-00 | No | No | Current |