LEVETIRACETAM
- Product NDC
- 43547-346
- 11-digit product format
- 435470346
- Labeler code
- 43547
- Product ID
- 43547-346_801f853c-1f42-4d65-ae2d-2bace0d5f3f8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LEVETIRACETAM
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Solco healthcare U.S., LLC
- Application
- ANDA203468
- Marketing category
- ANDA
- Marketing start
- 2014-05-01
- Substance
- LEVETIRACETAM
- Active strength
- 750 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 | 750 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 44YRR34555 |
| Rxcui | 807832, 846378 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43547-346-06 | LEVETIRACETAM | 60 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 60 | | 14 |
| 43547-346-50 | LEVETIRACETAM | 500 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 500 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LEVETIRACETAM | ACTIVE INGREDIENT | 44YRR34555 | LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [SOLCO HEALTHCARE US, LLC] | 5 | |
| LEVETIRACETAM | ACTIVE MOIETY | 44YRR34555 | LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [SOLCO HEALTHCARE US, LLC] | 5 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [SOLCO HEALTHCARE US, LLC] | 5 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [SOLCO HEALTHCARE US, LLC] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [SOLCO HEALTHCARE US, LLC] | 5 | |
| POLYETHYLENE GLYCOL 3350 | INACTIVE INGREDIENT | G2M7P15E5P | LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [SOLCO HEALTHCARE US, LLC] | 5 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [SOLCO HEALTHCARE US, LLC] | 5 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [SOLCO HEALTHCARE US, LLC] | 5 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [SOLCO HEALTHCARE US, LLC] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [SOLCO HEALTHCARE US, LLC] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43547-346 | LEVETIRACETAM TABLET, FILM COATED, EXTENDED RELEASE [SOLCO HEALTHCARE U.S., LLC] | 13 | Current NDC, Legacy NDC, 2 package rows | 20240617_bc8644ed-3320-47b5-adf3-8b972bea8abd.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 |
|---|
| 43547-346-06 | 43547034606 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43547-346-06) | 2014-05-01 | 0000-00-00 | No | No | Current |
| 43547-346-50 | 43547034650 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43547-346-50) | 2014-05-01 | 0000-00-00 | No | No | Current |