Levetiracetam
- Product NDC
- 65162-539
- 11-digit product format
- 651620539
- Labeler code
- 65162
- Product ID
- 65162-539_3a499e5a-b4c5-46b8-b667-ee79134e488a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levetiracetam
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA090767
- Marketing category
- ANDA
- Marketing start
- 2013-02-28
- 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 | 311288, 311289, 311290, 387003 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65162-539-06 | Levetiracetam | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 26 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LEVETIRACETAM | ACTIVE INGREDIENT | 44YRR34555 | LEVETIRACETAM TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 12 | |
| LEVETIRACETAM | ACTIVE MOIETY | 44YRR34555 | LEVETIRACETAM TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 12 | |
| COPOVIDONE K25-31 | INACTIVE INGREDIENT | D9C330MD8B | LEVETIRACETAM TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 12 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | LEVETIRACETAM TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 12 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | LEVETIRACETAM TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 12 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | LEVETIRACETAM TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 12 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | LEVETIRACETAM TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 12 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LEVETIRACETAM TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 12 | |
| POLYETHYLENE GLYCOL 3350 | INACTIVE INGREDIENT | G2M7P15E5P | LEVETIRACETAM TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 12 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | LEVETIRACETAM TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 12 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | LEVETIRACETAM TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 12 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LEVETIRACETAM TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 12 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | LEVETIRACETAM TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 12 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LEVETIRACETAM TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 12 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-539 | LEVETIRACETAM TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC] | 26 | Current NDC, Legacy NDC, 1 package rows | 20241030_d7932a2c-a3b7-46df-a306-1f17716160a0.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 |
|---|
| 65162-539-06 | 65162053906 | 60 TABLET, FILM COATED in 1 BOTTLE (65162-539-06) | 2013-02-28 | 0000-00-00 | No | No | Current |