Levetiracetam
- Product NDC
- 0121-1598
- 11-digit product format
- 001211598
- Labeler code
- 0121
- Product ID
- 0121-1598_f63f4202-d0c1-4ef3-8dc5-8bb4cab6a613
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LEVETIRACETAM
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- PAI Holdings, LLC dba PAI Pharma
- Application
- ANDA201157
- Marketing category
- ANDA
- Marketing start
- 2015-06-04
- Substance
- LEVETIRACETAM
- Active strength
- 1000 mg/10mL
- 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 table| Ingredient | Strength |
|---|
| LEVETIRACETAM | 1000 mg/10mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 44YRR34555 |
| Rxcui | 403884 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0121-1598-10 | Levetiracetam | 10 mL in 1 CUP, UNIT-DOSE | SOLUTION | 10 | | 23 |
| 0121-1598-20 | Levetiracetam | 2 in 1 CASE | SOLUTION | 2 | | 23 |
| 0121-1598-20 | Levetiracetam | 10 in 1 TRAY | SOLUTION | 10 | | 23 |
| 0121-1598-40 | Levetiracetam | 4 in 1 CASE | SOLUTION | 4 | | 23 |
| 0121-1598-40 | Levetiracetam | 10 in 1 TRAY | SOLUTION | 10 | | 23 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LEVETIRACETAM | ACTIVE INGREDIENT | 44YRR34555 | LEVETIRACETAM SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 6 | |
| LEVETIRACETAM | ACTIVE MOIETY | 44YRR34555 | LEVETIRACETAM SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 6 | |
| ACESULFAME POTASSIUM | INACTIVE INGREDIENT | 23OV73Q5G9 | LEVETIRACETAM SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 6 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | LEVETIRACETAM SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 6 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | LEVETIRACETAM SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 6 | |
| MALTITOL | INACTIVE INGREDIENT | D65DG142WK | LEVETIRACETAM SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 6 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | LEVETIRACETAM SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 6 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | LEVETIRACETAM SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 6 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | LEVETIRACETAM SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 6 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | LEVETIRACETAM SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0121-1598 | LEVETIRACETAM SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] | 23 | Current NDC, Legacy NDC, 5 package rows | 20240507_9dca1330-52ca-47a4-a134-ec55c9d5786d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0121-1598-10 | 00121159810 | 10 mL in 1 CUP, UNIT-DOSE | 10 ml | | | | | Historical |
| 0121-1598-20 | 00121159820 | 2 TRAY in 1 CASE (0121-1598-20) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1598-10) | 2 tray | 2022-10-10 | 0000-00-00 | No | No | Current |
| 0121-1598-40 | 00121159840 | 4 TRAY in 1 CASE (0121-1598-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1598-10) | 4 tray | 2015-06-04 | 0000-00-00 | No | No | Current |