NDC 51224-013

Levetiracetam

Levetiracetam

Levetiracetam is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Tagi Pharma, Inc.. The primary component is Levetiracetam.

• Product ID: 51224-013_483a2f8c-8a16-4255-a68b-23ab6b46eb4a
• NDC: 51224-013
• Product Type: Human Prescription Drug
• Proprietary Name: Levetiracetam
• Generic Name: Levetiracetam
• Dosage Form: Injection, Solution, Concentrate
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2018-11-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA209781
• Labeler Name: TAGI Pharma, 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: 2022-12-31

Packaging

NDC 51224-013-10

10 VIAL, SINGLE-USE in 1 CARTON (51224-013-10) > 5 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2018-11-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51224-013-25 [51224001325]

Levetiracetam INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: ANDA
• Application Number: ANDA209781
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-11-30

NDC 51224-013-10 [51224001310]

Levetiracetam INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: ANDA
• Application Number: ANDA209781
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-11-30

Drug Details

Active Ingredients

Ingredient	Strength
LEVETIRACETAM	100 mg/mL

OpenFDA Data

• SPL SET ID: 72f7ddd9-1b2c-4e26-8060-20e10c1c5d1c
• Manufacturer:
  • TAGI Pharma, Inc.
• UNII:
  • 44YRR34555
• RxNorm Concept Unique ID - RxCUI:
  • 647121
• UPC Code:
  • 0351224013100
  • 0351224013254

Pharmacological Class

• Decreased Central Nervous System Disorganized Electrical Activity [PE]

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

NDC	Brand Name	Generic Name
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
67850-012	Levetiracetam	Levetiracetam
67850-014	Levetiracetam	Levetiracetam
67850-013	Levetiracetam	Levetiracetam
67850-011	Levetiracetam	Levetiracetam
68001-116	Levetiracetam	Levetiracetam
68001-113	Levetiracetam	Levetiracetam
68001-115	Levetiracetam	Levetiracetam
68001-114	Levetiracetam	Levetiracetam
68001-117	Levetiracetam	Levetiracetam
68001-118	Levetiracetam	Levetiracetam
68071-4508	Levetiracetam	Levetiracetam
68083-153	Levetiracetam	Levetiracetam
68083-154	Levetiracetam	Levetiracetam
68083-152	Levetiracetam	Levetiracetam
68084-870	Levetiracetam	Levetiracetam
68084-859	Levetiracetam	Levetiracetam
68084-893	Levetiracetam	Levetiracetam
68084-882	Levetiracetam	Levetiracetam
68180-118	Levetiracetam	Levetiracetam
68180-113	Levetiracetam	Levetiracetam
68180-115	Levetiracetam	Levetiracetam
68180-117	Levetiracetam	Levetiracetam
68180-112	Levetiracetam	Levetiracetam
68180-114	Levetiracetam	Levetiracetam
68180-099	levetiracetam	levetiracetam
68258-7089	Levetiracetam	Levetiracetam
68382-165	levetiracetam	levetiracetam
68382-168	levetiracetam	levetiracetam
0472-0235	Levetiracetam	Levetiracetam
68788-7074	Levetiracetam	Levetiracetam
68788-6798	Levetiracetam	Levetiracetam
68788-6838	Levetiracetam	Levetiracetam
68788-7190	Levetiracetam	Levetiracetam
68788-6966	Levetiracetam	Levetiracetam
69076-750	Levetiracetam	Levetiracetam
69076-500	Levetiracetam	Levetiracetam
70518-0197	Levetiracetam	Levetiracetam
70518-0365	Levetiracetam	Levetiracetam