NDC 0006-5003

PREVYMIS

Letermovir

PREVYMIS is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Letermovir.

• Product ID: 0006-5003_15b7076c-fc58-4fe4-8549-ccfb47914a26
• NDC: 0006-5003
• Product Type: Human Prescription Drug
• Proprietary Name: PREVYMIS
• Generic Name: Letermovir
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2017-11-08
• Marketing Category: NDA / NDA
• Application Number: NDA209940
• Labeler Name: Merck Sharp & Dohme Corp.
• Substance Name: LETERMOVIR
• Active Ingredient Strength: 20 mg/mL
• Pharm Classes: Cytomegalovirus DNA Terminase Complex Inhibitor [EPC],DNA Terminase Complex Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0006-5003-01

1 VIAL, SINGLE-DOSE in 1 CARTON (0006-5003-01) > 12 mL in 1 VIAL, SINGLE-DOSE (0006-5003-02)

• Marketing Start Date: 2017-11-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0006-5003-01 [00006500301]

PREVYMIS INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA209940
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-11-08

NDC 0006-5003-02 [00006500302]

PREVYMIS INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA209940
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-11-08

Drug Details

Active Ingredients

Ingredient	Strength
LETERMOVIR	20 mg/mL

OpenFDA Data

• SPL SET ID: 1b49df80-be4f-47e0-a0b7-123f3e69395b
• Manufacturer:
  • Merck Sharp & Dohme Corp.
• UNII:
  • 1H09Y5WO1F
• RxNorm Concept Unique ID - RxCUI:
  • 1988666
  • 1988652
  • 1988657
  • 1988673
  • 1988671
  • 1988661
  • 1988660
  • 1988675

Pharmacological Class

• Cytomegalovirus DNA Terminase Complex Inhibitor [EPC]
• DNA Terminase Complex Inhibitors [MoA]
• Cytochrome P450 3A Inhibitors [MoA]
• Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]
• Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]
• Cytochrome P450 2C8 Inhibitors [MoA]
• Cytochrome P450 2C9 Inducers [MoA]
• Cytochrome P450 2C19 Inducers [MoA]

NDC Crossover Matching brand name "PREVYMIS" or generic name "Letermovir"

NDC	Brand Name	Generic Name
0006-3075	PREVYMIS	LETERMOVIR
0006-3076	PREVYMIS	LETERMOVIR
0006-5003	PREVYMIS	LETERMOVIR
0006-5004	PREVYMIS	LETERMOVIR