Levetiracetam
- Product NDC
- 53808-1057
- 11-digit product format
- 538081057
- Labeler code
- 53808
- Product ID
- 53808-1057_a212d98c-9694-4845-ab4e-3d0a3789e810
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levetiracetam
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- State of Florida DOH Central Pharmacy
- Application
- ANDA078993
- Marketing category
- ANDA
- Marketing start
- 2014-11-01
- Marketing end
- 0000-00-00
- Substance
- LEVETIRACETAM
- Active strength
- 750 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 53808-1057-1 | Levetiracetam | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LEVETIRACETAM | ACTIVE INGREDIENT | 44YRR34555 | LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| LEVETIRACETAM | ACTIVE MOIETY | 44YRR34555 | LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| HYPROMELLOSE 2910 (3 MPA.S) | INACTIVE INGREDIENT | 0VUT3PMY82 | LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| POLYETHYLENE GLYCOL 4000 | INACTIVE INGREDIENT | 4R4HFI6D95 | LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53808-1057 | LEVETIRACETAM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 2 | Legacy NDC, 1 package rows | 20150113_4f2642ac-703f-4447-ab2c-2c15511e5a81.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53808-1057-1 | 53808105701 | 30 in 1 BLISTER PACK | Historical |