Levetiracetam
- Product NDC
- 43063-617
- 11-digit product format
- 430630617
- Labeler code
- 43063
- Product ID
- 43063-617_509f6ed1-2ff1-ff40-e063-6394a90af667
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levetiracetam
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA078154
- Marketing category
- ANDA
- Marketing start
- 2009-01-15
- Substance
- LEVETIRACETAM
- Active strength
- 500 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Levetiracetam
- Listing expiration
- 2027-12-31
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 |
|---|
| 43063-617-60 | Levetiracetam | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 24 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LEVETIRACETAM | ACTIVE INGREDIENT | 44YRR34555 | LEVETIRACETAM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 9 | |
| LEVETIRACETAM | ACTIVE MOIETY | 44YRR34555 | LEVETIRACETAM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 9 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LEVETIRACETAM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 9 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LEVETIRACETAM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 9 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | LEVETIRACETAM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 9 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | LEVETIRACETAM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 9 | |
| HYPROMELLOSE 2910 (3 MPA.S) | INACTIVE INGREDIENT | 0VUT3PMY82 | LEVETIRACETAM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 9 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | LEVETIRACETAM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 9 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LEVETIRACETAM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 9 | |
| POLYETHYLENE GLYCOL 4000 | INACTIVE INGREDIENT | 4R4HFI6D95 | LEVETIRACETAM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 9 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | LEVETIRACETAM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 9 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | LEVETIRACETAM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 9 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LEVETIRACETAM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 9 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | LEVETIRACETAM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 9 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LEVETIRACETAM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 9 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43063-617 | LEVETIRACETAM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 22 | Current NDC, Legacy NDC, 1 package rows | 20240625_c4b2da6a-ed50-4a54-90bd-32f76b178736.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 |
|---|
| 43063-617-60 | 43063061760 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-617-60) | 2015-08-01 | 0000-00-00 | No | No | Current |