NDC 43485-103

Spritam

Levetiracetam

Spritam is a Oral Tablet, For Suspension in the Human Prescription Drug category. It is labeled and distributed by Aprecia Pharmaceuticals, Llc. The primary component is Levetiracetam.

• Product ID: 43485-103_15ec15e4-e891-4ef7-bd05-99d43e61124e
• NDC: 43485-103
• Product Type: Human Prescription Drug
• Proprietary Name: Spritam
• Generic Name: Levetiracetam
• Dosage Form: Tablet, For Suspension
• Route of Administration: ORAL
• Marketing Start Date: 2016-02-05
• Marketing Category: NDA / NDA
• Application Number: NDA207958
• Labeler Name: Aprecia Pharmaceuticals, LLC
• Substance Name: LEVETIRACETAM
• Active Ingredient Strength: 750 mg/1
• Pharm Classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 43485-103-60

60 BLISTER PACK in 1 CARTON (43485-103-60) > 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (43485-103-01)

• Marketing Start Date: 2016-02-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43485-103-60 [43485010360]

Spritam TABLET, FOR SUSPENSION

• Marketing Category: NDA
• Application Number: NDA207958
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-02-05

NDC 43485-103-01 [43485010301]

Spritam TABLET, FOR SUSPENSION

• Marketing Category: NDA
• Application Number: NDA207958
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-02-05

Drug Details

Active Ingredients

Ingredient	Strength
LEVETIRACETAM	750 mg/1

OpenFDA Data

• SPL SET ID: be651c31-383f-11e4-916c-0800200c9a66
• Manufacturer:
  • Aprecia Pharmaceuticals, LLC
• UNII:
  • 44YRR34555
• RxNorm Concept Unique ID - RxCUI:
  • 1736051
  • 1736050
  • 1736044
  • 1736045
  • 1736048
  • 1736053
  • 1736037
  • 1736047

Pharmacological Class

• Decreased Central Nervous System Disorganized Electrical Activity [PE]

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

NDC	Brand Name	Generic Name
43485-102	Spritam	Spritam
43485-104	Spritam	Spritam
43485-101	Spritam	Spritam
43485-103	Spritam	Spritam
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