NDC 0409-1886

LEVETIRACETAM

Levetiracetam

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

• Product ID: 0409-1886_03374e0c-71b6-459e-be3f-acf24456d71b
• NDC: 0409-1886
• Product Type: Human Prescription Drug
• Proprietary Name: LEVETIRACETAM
• Generic Name: Levetiracetam
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2012-11-02
• Marketing Category: ANDA / ANDA
• Application Number: ANDA202869
• Labeler Name: Hospira, 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: 2020-12-31

Packaging

NDC 0409-1886-05

25 VIAL, SINGLE-USE in 1 CARTON (0409-1886-05) > 5 mL in 1 VIAL, SINGLE-USE (0409-1886-15)

• Marketing Start Date: 2018-03-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0409-1886-22 [00409188622]

LEVETIRACETAM INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA202869
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-06-13

NDC 0409-1886-05 [00409188605]

LEVETIRACETAM INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA202869
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-03-01

NDC 0409-1886-15 [00409188615]

LEVETIRACETAM INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA202869
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-03-01

NDC 0409-1886-01 [00409188601]

LEVETIRACETAM INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA202869
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2012-11-02
• Marketing End Date: 2012-08-08

NDC 0409-1886-02 [00409188602]

LEVETIRACETAM INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA202869
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2012-11-02

Drug Details

Active Ingredients

Ingredient	Strength
LEVETIRACETAM	100 mg/mL

OpenFDA Data

• SPL SET ID: ed1b74a8-2a9b-4315-b051-673c7941cb13
• Manufacturer:
  • Hospira, Inc.
• UNII:
  • 44YRR34555
• RxNorm Concept Unique ID - RxCUI:
  • 647121

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