Keppra
- Product NDC
- 50474-599
- 11-digit product format
- 504740599
- Labeler code
- 50474
- Product ID
- 50474-599_38534148-3717-03b3-e063-6394a90a0f1e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levetiracetam
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- UCB, Inc.
- Application
- NDA022285
- Marketing category
- NDA
- Marketing start
- 2009-04-01
- 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
- Keppra
- Brand name suffix
- XR
- 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, 807834, 846378, 847673 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50474-599-66 | Keppra XR | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 60 | | 31 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| levetiracetam | ACTIVE INGREDIENT | 44YRR34555 | KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [UCB, INC.] | 14 | |
| levetiracetam | ACTIVE MOIETY | 44YRR34555 | KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [UCB, INC.] | 14 | |
| alcohol | INACTIVE INGREDIENT | 3K9958V90M | KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [UCB, INC.] | 14 | |
| butyl alcohol | INACTIVE INGREDIENT | 8PJ61P6TS3 | KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [UCB, INC.] | 14 | |
| FD&C Red No. 40 | INACTIVE INGREDIENT | WZB9127XOA | KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [UCB, INC.] | 14 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [UCB, INC.] | 14 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [UCB, INC.] | 14 | |
| methyl alcohol | INACTIVE INGREDIENT | Y4S76JWI15 | KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [UCB, INC.] | 14 | |
| Polyethylene Glycol 3350 | INACTIVE INGREDIENT | G2M7P15E5P | KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [UCB, INC.] | 14 | |
| polyethylene glycol 6000 | INACTIVE INGREDIENT | 30IQX730WE | KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [UCB, INC.] | 14 | |
| polyvinyl alcohol | INACTIVE INGREDIENT | 532B59J990 | KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [UCB, INC.] | 14 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [UCB, INC.] | 14 | |
| shellac | INACTIVE INGREDIENT | 46N107B71O | KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [UCB, INC.] | 14 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [UCB, INC.] | 14 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [UCB, INC.] | 14 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50474-599 | KEPPRA XR (LEVETIRACETAM) TABLET, FILM COATED, EXTENDED RELEASE [UCB, INC.] | 30 | Current NDC, Legacy NDC, 1 package rows | 20240430_2919e43b-69a8-434c-a2d2-1f3ecd7554c0.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 |
|---|
| 50474-599-66 | 50474059966 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50474-599-66) | 2009-04-01 | 0000-00-00 | No | No | Current |