NDC 50881-007

OPZELURA

Ruxolitinib

OPZELURA is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Incyte Corporation. The primary component is Ruxolitinib Phosphate.

• Product ID: 50881-007_035f1b9d-5789-49f6-90cb-6407eec3458b
• NDC: 50881-007
• Product Type: Human Prescription Drug
• Proprietary Name: OPZELURA
• Generic Name: Ruxolitinib
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2021-09-21
• Marketing Category: NDA /
• Application Number: NDA215309
• Labeler Name: Incyte Corporation
• Substance Name: RUXOLITINIB PHOSPHATE
• Active Ingredient Strength: 15 mg/g
• Pharm Classes: Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA], Kinase Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 50881-007-04

1 TUBE in 1 CARTON (50881-007-04) > 5 g in 1 TUBE

• Marketing Start Date: 2021-09-21
• NDC Exclude Flag: N
• Sample Package?: Y

Drug Details

NDC Crossover Matching brand name "OPZELURA" or generic name "Ruxolitinib"

NDC	Brand Name	Generic Name
50881-007	OPZELURA	ruxolitinib
50881-005	JAKAFI	ruxolitinib
50881-010	JAKAFI	ruxolitinib
50881-015	JAKAFI	ruxolitinib
50881-020	JAKAFI	ruxolitinib
50881-025	JAKAFI	ruxolitinib