NDC 70518-2109

Keppra XR

Levetiracetam

Keppra XR is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Levetiracetam.

• Product ID: 70518-2109_89952f8d-a091-d966-e053-2a95a90a15ba
• NDC: 70518-2109
• Product Type: Human Prescription Drug
• Proprietary Name: Keppra XR
• Generic Name: Levetiracetam
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2019-05-23
• Marketing Category: NDA / NDA
• Application Number: NDA022285
• Labeler Name: REMEDYREPACK INC.
• Substance Name: LEVETIRACETAM
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 70518-2109-0

30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70518-2109-0)

• Marketing Start Date: 2019-05-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70518-2109-0 [70518210900]

Keppra XR TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA022285
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-05-23

Drug Details

Active Ingredients

Ingredient	Strength
LEVETIRACETAM	500 mg/1

OpenFDA Data

• SPL SET ID: 4c380473-a466-4c01-aaf9-887e9ad25a26
• Manufacturer:
  • REMEDYREPACK INC.
• UNII:
  • 44YRR34555

Pharmacological Class

• Decreased Central Nervous System Disorganized Electrical Activity [PE]

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

NDC	Brand Name	Generic Name
50474-598	Keppra XR	Keppra XR
50474-599	Keppra XR	Keppra XR
65084-460	Keppra XR	Keppra XR
65084-461	Keppra XR	Keppra XR
70518-2109	Keppra XR	Keppra XR
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