Levetiracetam
- Product NDC
- 51079-821
- 11-digit product format
- 510790821
- Labeler code
- 51079
- Product ID
- 51079-821_4369847b-77af-cd07-e063-6394a90a9251
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levetiracetam
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Institutional Inc.
- Application
- ANDA076919
- Marketing category
- ANDA
- Marketing start
- 2008-11-04
- Substance
- LEVETIRACETAM
- Active strength
- 500 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 | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 44YRR34555 |
| Rxcui | 311289 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51079-821-01 | Levetiracetam | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 17 |
| 51079-821-20 | Levetiracetam | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 17 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LEVETIRACETAM | ACTIVE INGREDIENT | 44YRR34555 | LEVETIRACETAM TABLET, FILM COATED [CARDINAL HEALTH] | 9 | |
| LEVETIRACETAM | ACTIVE MOIETY | 44YRR34555 | LEVETIRACETAM TABLET, FILM COATED [CARDINAL HEALTH] | 9 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LEVETIRACETAM TABLET, FILM COATED [CARDINAL HEALTH] | 9 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | LEVETIRACETAM TABLET, FILM COATED [CARDINAL HEALTH] | 9 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | LEVETIRACETAM TABLET, FILM COATED [CARDINAL HEALTH] | 9 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LEVETIRACETAM TABLET, FILM COATED [CARDINAL HEALTH] | 9 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | LEVETIRACETAM TABLET, FILM COATED [CARDINAL HEALTH] | 9 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | LEVETIRACETAM TABLET, FILM COATED [CARDINAL HEALTH] | 9 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | LEVETIRACETAM TABLET, FILM COATED [CARDINAL HEALTH] | 9 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LEVETIRACETAM TABLET, FILM COATED [CARDINAL HEALTH] | 9 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | LEVETIRACETAM TABLET, FILM COATED [CARDINAL HEALTH] | 9 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LEVETIRACETAM TABLET, FILM COATED [CARDINAL HEALTH] | 9 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | LEVETIRACETAM TABLET, FILM COATED [CARDINAL HEALTH] | 9 | |
| LEVETIRACETAM | ACTIVE INGREDIENT | 44YRR34555 | LEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 5 | |
| LEVETIRACETAM | ACTIVE MOIETY | 44YRR34555 | LEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 5 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | LEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 5 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | LEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 5 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | LEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 5 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | LEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 5 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | LEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 5 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 5 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | LEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 5 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | LEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51079-821 | LEVETIRACETAM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 15 | Current NDC, Legacy NDC, 2 package rows | 20211224_08e1bfea-7f3f-42d9-823d-f75080e664ff.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 |
|---|
| 51079-821-01 | 51079082101 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 51079-821-20 | 51079082120 | 100 BLISTER PACK in 1 CARTON (51079-821-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-821-01) | 100 blister pack | 2008-11-04 | 0000-00-00 | No | No | Current |