NDC 50474-001

Keppra

Levetiracetam

Keppra is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Ucb, Inc.. The primary component is Levetiracetam.

• Product ID: 50474-001_5d675a50-b11f-4fd5-e053-2a91aa0a9474
• NDC: 50474-001
• Product Type: Human Prescription Drug
• Proprietary Name: Keppra
• Generic Name: Levetiracetam
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2003-10-20
• Marketing Category: NDA / NDA
• Application Number: NDA021505
• Labeler Name: UCB, Inc.
• Substance Name: LEVETIRACETAM
• Active Ingredient Strength: 100 mg/mL
• Pharm Classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 50474-001-48

473 mL in 1 BOTTLE, PLASTIC (50474-001-48)

• Marketing Start Date: 2003-10-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50474-001-48 [50474000148]

Keppra SOLUTION

• Marketing Category: NDA
• Application Number: NDA021505
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2003-10-20

NDC 50474-001-45 [50474000145]

Keppra SOLUTION

• Marketing Category: NDA
• Application Number: NDA021505
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2003-10-20
• Marketing End Date: 2012-01-03

Drug Details

Active Ingredients

Ingredient	Strength
LEVETIRACETAM	100 mg/mL

OpenFDA Data

• SPL SET ID: 3ca9df05-a506-4ec8-a4fe-320f1219ab21
• Manufacturer:
  • UCB, Inc.
• UNII:
  • 44YRR34555
• RxNorm Concept Unique ID - RxCUI:
  • 404595
  • 261336
  • 261335
  • 387003
  • 311290
  • 284391
  • 311289
  • 311288
  • 630807
  • 403884
• UPC Code:
  • 0350474594407
  • 0350474595404

Pharmacological Class

• Decreased Central Nervous System Disorganized Electrical Activity [PE]

Medicade Reported Pricing

50474000148 KEPPRA 100 MG/ML ORAL SOLN

Pricing Unit: ML | Drug Type:

NDC Crossover Matching brand name "Keppra" or generic name "Levetiracetam"

NDC	Brand Name	Generic Name
21695-070	Keppra	Keppra
50474-595	Keppra	Keppra
50474-597	Keppra	Keppra
50474-002	Keppra	Keppra
50474-594	Keppra	Keppra
50474-001	Keppra	Keppra
50474-596	Keppra	Keppra
55289-097	Keppra	Keppra
65084-457	Keppra	Keppra
65084-458	Keppra	Keppra
65084-459	Keppra	Keppra
0054-0224	Levetiracetam	Levetiracetam
0121-0799	Levetiracetam	LEVETIRACETAM
0121-1598	Levetiracetam	LEVETIRACETAM
0121-2397	Levetiracetam	LEVETIRACETAM
0121-4799	Levetiracetam	LEVETIRACETAM
0121-4802	LEVETIRACETAM	LEVETIRACETAM
0143-9574	Levetiracetam	Levetiracetam
0143-9673	Levetiracetam	Levetiracetam
0228-2167	Levetiracetam	Levetiracetam
0378-5613	Levetiracetam	levetiracetam
0378-5615	Levetiracetam	levetiracetam
0378-5617	Levetiracetam	levetiracetam