NDC 68083-153

Levetiracetam

Levetiracetam

Levetiracetam is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Levetiracetam.

• Product ID: 68083-153_3e1fe76f-a307-43e5-9330-c169a11c1f38
• NDC: 68083-153
• Product Type: Human Prescription Drug
• Proprietary Name: Levetiracetam
• Generic Name: Levetiracetam
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2017-11-07
• Marketing Category: ANDA / ANDA
• Application Number: ANDA206880
• Labeler Name: Gland Pharma Limited
• Substance Name: LEVETIRACETAM
• Active Ingredient Strength: 10 mg/mL
• Pharm Classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 68083-153-10

10 BAG in 1 CARTON (68083-153-10) > 100 mL in 1 BAG (68083-153-01)

• Marketing Start Date: 2017-11-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68083-153-01 [68083015301]

Levetiracetam INJECTION

• Marketing Category: ANDA
• Application Number: ANDA206880
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-11-07

NDC 68083-153-10 [68083015310]

Levetiracetam INJECTION

• Marketing Category: ANDA
• Application Number: ANDA206880
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-11-07

Drug Details

Active Ingredients

Ingredient	Strength
LEVETIRACETAM	10 mg/mL

OpenFDA Data

• SPL SET ID: aa883d9c-c6cd-44ab-a1de-058985e4f97f
• Manufacturer:
  • Gland Pharma Limited
• UNII:
  • 44YRR34555
• RxNorm Concept Unique ID - RxCUI:
  • 1193360
  • 1193362
  • 1193358
• UPC Code:
  • 0368083153014

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