Levetiracetam
- Product NDC
- 0378-5619
- 11-digit product format
- 003785619
- Labeler code
- 0378
- Product ID
- 0378-5619_8eaa3318-fe96-4d3e-9f49-3286cb04bfbf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levetiracetam
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA090261
- Marketing category
- ANDA
- Marketing start
- 2009-12-10
- Substance
- LEVETIRACETAM
- Active strength
- 1000 mg/1
- 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/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 44YRR34555 |
| Rxcui | 311289, 311290, 387003 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-5619-91 | Levetiracetam | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 41 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LEVETIRACETAM | ACTIVE INGREDIENT | 44YRR34555 | LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 16 | |
| LEVETIRACETAM | ACTIVE MOIETY | 44YRR34555 | LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 16 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 16 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 16 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 16 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 16 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 16 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 16 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 16 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 16 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 16 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 16 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 16 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-5619 | LEVETIRACETAM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 38 | Current NDC, Legacy NDC, 1 package rows | 20241011_0a987d59-560f-4650-96ec-31aec81953b5.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 |
|---|
| 0378-5619-91 | 00378561991 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5619-91) | 2009-12-10 | 0000-00-00 | No | No | Current |