Levetiracetam
- Product NDC
- 68084-859
- 11-digit product format
- 680840859
- Labeler code
- 68084
- Product ID
- 68084-859_2737b5f9-5127-8b84-e063-6294a90aa140
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levetiracetam
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA078993
- Marketing category
- ANDA
- Marketing start
- 2015-02-04
- Substance
- LEVETIRACETAM
- Active strength
- 250 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 | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 44YRR34555 |
| Rxcui | 311288, 311290 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68084-859-01 | Levetiracetam | 100 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 100 | | 10 |
| 68084-859-11 | Levetiracetam | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LEVETIRACETAM | ACTIVE INGREDIENT | 44YRR34555 | LEVETIRACETAM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| LEVETIRACETAM | ACTIVE MOIETY | 44YRR34555 | LEVETIRACETAM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | LEVETIRACETAM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | LEVETIRACETAM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | LEVETIRACETAM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | LEVETIRACETAM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | LEVETIRACETAM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LEVETIRACETAM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | LEVETIRACETAM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | LEVETIRACETAM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LEVETIRACETAM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LEVETIRACETAM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | LEVETIRACETAM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LEVETIRACETAM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | LEVETIRACETAM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68084-859 | LEVETIRACETAM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 10 | Current NDC, Legacy NDC, 2 package rows | 20241121_fc8bf57e-8aa2-4d3c-856d-b19de65e3ba0.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 |
|---|
| 68084-859-01 | 68084085901 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-859-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-859-11) | 100 blister pack | 2015-02-04 | 0000-00-00 | No | No | Current |
| 68084-859-11 | 68084085911 | 1 in 1 BLISTER PACK | | | | | | Historical |