NDC 0006-3076

PREVYMIS

Letermovir

PREVYMIS is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Letermovir.

• Product ID: 0006-3076_15b7076c-fc58-4fe4-8549-ccfb47914a26
• NDC: 0006-3076
• Product Type: Human Prescription Drug
• Proprietary Name: PREVYMIS
• Generic Name: Letermovir
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-11-08
• Marketing Category: NDA / NDA
• Application Number: NDA209939
• Labeler Name: Merck Sharp & Dohme Corp.
• Substance Name: LETERMOVIR
• Active Ingredient Strength: 480 mg/1
• 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 0006-3076-02

4 DOSE PACK in 1 CARTON (0006-3076-02) > 7 TABLET, FILM COATED in 1 DOSE PACK (0006-3076-01)

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

NDC SPL Data Element Entries

NDC 0006-3076-03 [00006307603]

PREVYMIS TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA209939
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-11-08

NDC 0006-3076-04 [00006307604]

PREVYMIS TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA209939
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-11-08

NDC 0006-3076-02 [00006307602]

PREVYMIS TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA209939
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-11-08

NDC 0006-3076-01 [00006307601]

PREVYMIS TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA209939
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-11-08

Drug Details

Active Ingredients

Ingredient	Strength
LETERMOVIR	480 mg/1

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