NDC 67919-012

CUBICIN RF

Daptomycin

CUBICIN RF is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Daptomycin.

• Product ID: 67919-012_03f7ac93-6e4d-4ad5-8d11-f33531425ea4
• NDC: 67919-012
• Product Type: Human Prescription Drug
• Proprietary Name: CUBICIN RF
• Generic Name: Daptomycin
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2016-07-06
• Marketing Category: NDA / NDA
• Application Number: NDA021572
• Labeler Name: Merck Sharp & Dohme Corp.
• Substance Name: DAPTOMYCIN
• Active Ingredient Strength: 500 mg/10mL
• Pharm Classes: Lipopeptide Antibacterial [EPC],Lipopeptides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 67919-012-02

1 VIAL, SINGLE-USE in 1 CARTON (67919-012-02) > 10 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2016-09-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67919-012-02 [67919001202]

CUBICIN RF INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA021572
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-09-13

NDC 67919-012-01 [67919001201]

CUBICIN RF INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA021572
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-07-06

Drug Details

Active Ingredients

Ingredient	Strength
DAPTOMYCIN	500 mg/10mL

OpenFDA Data

• SPL SET ID: 34c1faa3-a3d8-4fe6-8ca1-7016c17339d2
• Manufacturer:
  • Merck Sharp & Dohme Corp.
• UNII:
  • NWQ5N31VKK
• RxNorm Concept Unique ID - RxCUI:
  • 404652
  • 403920

Pharmacological Class

• Lipopeptide Antibacterial [EPC]
• Lipopeptides [CS]
• Lipopeptide Antibacterial [EPC]
• Lipopeptides [CS]

NDC Crossover Matching brand name "CUBICIN RF" or generic name "Daptomycin"

NDC	Brand Name	Generic Name
67919-012	CUBICIN RF	CUBICIN RF
0143-9378	Daptomycin	Daptomycin
0409-0106	Daptomycin	DAPTOMYCIN
0409-0120	Daptomycin	DAPTOMYCIN
0409-0122	Daptomycin	DAPTOMYCIN
0409-2757	Daptomycin	DAPTOMYCIN
0409-5933	Daptomycin	Daptomycin
0703-0125	Daptomycin	Daptomycin
0781-3295	daptomycin	daptomycin
16714-892	Daptomycin	Daptomycin
16729-434	Daptomycin	Daptomycin
16729-435	DAPTOMYCIN	Daptomycin
25021-174	daptomycin	daptomycin
25021-179	Daptomycin	Daptomycin