NDC 47133-574

Elepsia XR

Levetiracetam

Elepsia XR is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Sun Pharma Advanced Research Company Limited. The primary component is Levetiracetam.

• Product ID: 47133-574_658ed9f5-ef08-47cf-85e9-014fed2a7087
• NDC: 47133-574
• Product Type: Human Prescription Drug
• Proprietary Name: Elepsia XR
• Generic Name: Levetiracetam
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2015-03-13
• Marketing Category: NDA / NDA
• Application Number: NDA204417
• Labeler Name: Sun Pharma Advanced Research Company Limited
• Substance Name: LEVETIRACETAM
• Active Ingredient Strength: 1000 mg/1
• Pharm Classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 47133-574-13

500 TABLET, EXTENDED RELEASE in 1 BOTTLE (47133-574-13)

• Marketing Start Date: 2019-05-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 47133-574-88 [47133057488]

Elepsia XR TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA204417
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-05-17

NDC 47133-574-13 [47133057413]

Elepsia XR TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA204417
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-05-17

NDC 47133-574-83 [47133057483]

Elepsia XR TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA204417
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-05-17

Drug Details

Active Ingredients

Ingredient	Strength
LEVETIRACETAM	1000 mg/1

OpenFDA Data

• SPL SET ID: 12e147dc-4f5b-4117-8a8e-a8c429ad0217
• Manufacturer:
  • Sun Pharma Advanced Research Company Limited
• UNII:
  • 44YRR34555
• RxNorm Concept Unique ID - RxCUI:
  • 1605362
  • 1605374
  • 1605368
  • 1605372
• UPC Code:
  • 0347133575839
  • 0347133574832

Pharmacological Class

• Decreased Central Nervous System Disorganized Electrical Activity [PE]

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

NDC	Brand Name	Generic Name
47133-574	Elepsia XR	Elepsia XR
47133-575	Elepsia XR	Elepsia 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