NDC 67386-621

CARNEXIV

Carbamazepine

CARNEXIV is a Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Lundbeck Pharmaceuticals Llc. The primary component is Carbamazepine.

• Product ID: 67386-621_030e102c-37e2-414b-8523-9abd1c6d251d
• NDC: 67386-621
• Product Type: Human Prescription Drug
• Proprietary Name: CARNEXIV
• Generic Name: Carbamazepine
• Dosage Form: Injection, Powder, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2014-10-21
• Marketing Category: NDA / NDA
• Application Number: NDA206030
• Labeler Name: Lundbeck Pharmaceuticals LLC
• Substance Name: CARBAMAZEPINE
• Active Ingredient Strength: 10 mg/mL
• Pharm Classes: Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 67386-621-52

1 VIAL, GLASS in 1 CARTON (67386-621-52) > 20 mL in 1 VIAL, GLASS

• Marketing Start Date: 2014-10-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67386-621-52 [67386062152]

CARNEXIV INJECTION, POWDER, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA206030
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-10-21

Drug Details

Active Ingredients

Ingredient	Strength
CARBAMAZEPINE	10 mg/mL

OpenFDA Data

• SPL SET ID: fd22916c-ee35-4b57-9b1b-68d106422f5d
• Manufacturer:
  • Lundbeck Pharmaceuticals LLC
• UNII:
  • 33CM23913M
• RxNorm Concept Unique ID - RxCUI:
  • 2119862
  • 2119860
• UPC Code:
  • 0367386621527

Pharmacological Class

• Decreased Central Nervous System Disorganized Electrical Activity [PE]
• Mood Stabilizer [EPC]
• Cytochrome P450 3A4 Inducers [MoA]
• Cytochrome P450 1A2 Inducers [MoA]
• Cytochrome P450 2B6 Inducers [MoA]
• Cytochrome P450 2C9 Inducers [MoA]
• Cytochrome P450 2C19 Inducers [MoA]

NDC Crossover Matching brand name "CARNEXIV" or generic name "Carbamazepine"

NDC	Brand Name	Generic Name
67386-621	CARNEXIV	CARNEXIV
0093-0109	Carbamazepine	Carbamazepine
0093-0778	Carbamazepine	Carbamazepine
0093-0090	Epitol	Carbamazepine
0078-0508	Tegretol	carbamazepine
0078-0509	Tegretol	carbamazepine
0078-0510	Tegretol	carbamazepine
0078-0511	Tegretol	carbamazepine
0078-0512	Tegretol	carbamazepine