Levetiracetam
- Product NDC
- 14335-050
- 11-digit product format
- 143350050
- Labeler code
- 14335
- Product ID
- 14335-050_7bcb0387-53da-281d-e053-2991aa0ac67b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levetiracetam
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Hainan Poly Pharm. Co., Ltd.
- Application
- ANDA209781
- Marketing category
- ANDA
- Marketing start
- 2018-11-30
- Marketing end
- 0000-00-00
- Substance
- LEVETIRACETAM
- Active strength
- 100 mg/mL
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 14335-050-10 | Levetiracetam | 10 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 10 | | 3 |
| 14335-050-10 | Levetiracetam | 5 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION, CONCENTRATE | 5 | | 3 |
| 14335-050-25 | Levetiracetam | 5 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION, CONCENTRATE | 5 | | 3 |
| 14335-050-25 | Levetiracetam | 25 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 25 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 14335-050 | LEVETIRACETAM INJECTION, SOLUTION, CONCENTRATE [HAINAN POLY PHARM. CO., LTD.] | 3 | Legacy NDC, 4 package rows | 20181130_80019d2e-4aec-41f0-ab91-03ca9ffd798d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 14335-050-10 | 14335005010 | 10 in 1 CARTON | | Historical |
| 14335-050-25 | 14335005025 | 5 mL in 1 VIAL, SINGLE-USE | 5 ml | Historical |