NDC 69102-104

ROWEEPRA

Levetiracetam

ROWEEPRA is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Owp Pharmaceuticals, Inc.. The primary component is Levetiracetam.

• Product ID: 69102-104_e8c79c4a-d4e1-0a76-467f-e5c6283750b1
• NDC: 69102-104
• Product Type: Human Prescription Drug
• Proprietary Name: ROWEEPRA
• Generic Name: Levetiracetam
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-03-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA090906
• Labeler Name: OWP Pharmaceuticals, 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 69102-104-01

120 TABLET, FILM COATED in 1 BOTTLE (69102-104-01)

• Marketing Start Date: 2017-03-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69102-104-01 [69102010401]

ROWEEPRA TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA090906
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-03-31

Drug Details

Active Ingredients

Ingredient	Strength
LEVETIRACETAM	500 mg/1

OpenFDA Data

• SPL SET ID: 73c018ed-1019-4b0f-9c70-db3f299cee39
• Manufacturer:
  • OWP Pharmaceuticals, Inc.
• UNII:
  • 44YRR34555
• RxNorm Concept Unique ID - RxCUI:
  • 387003
  • 311290
  • 1875866
  • 311289
  • 1875870
  • 1731020
• UPC Code:
  • 0369102104017
  • 0369102102013
  • 0369102103010

Pharmacological Class

• Decreased Central Nervous System Disorganized Electrical Activity [PE]
• Decreased Central Nervous System Disorganized Electrical Activity [PE]

Medicade Reported Pricing

69102010401 ROWEEPRA 500 MG TABLET

Pricing Unit: EA | Drug Type:

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

NDC	Brand Name	Generic Name
69102-102	ROWEEPRA	ROWEEPRA
69102-104	ROWEEPRA	ROWEEPRA
69102-103	ROWEEPRA	ROWEEPRA
69102-101	ROWEEPRA	ROWEEPRA
69102-108	Roweepra	Roweepra
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