NDC 50881-010

JAKAFI

Ruxolitinib

JAKAFI is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Incyte Corporation. The primary component is Ruxolitinib.

• Product ID: 50881-010_00b95a6b-5e0f-4084-9761-ed13709c4458
• NDC: 50881-010
• Product Type: Human Prescription Drug
• Proprietary Name: JAKAFI
• Generic Name: Ruxolitinib
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2011-11-16
• Marketing Category: NDA / NDA
• Application Number: NDA202192
• Labeler Name: Incyte Corporation
• Substance Name: RUXOLITINIB
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 50881-010-01

28 TABLET in 1 BOTTLE, PLASTIC (50881-010-01)

• Marketing Start Date: 2011-11-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50881-010-60 [50881001060]

JAKAFI TABLET

• Marketing Category: NDA
• Application Number: NDA202192
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-11-16

NDC 50881-010-01 [50881001001]

JAKAFI TABLET

• Marketing Category: NDA
• Application Number: NDA202192
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-11-16

Drug Details

Active Ingredients

Ingredient	Strength
RUXOLITINIB	10 mg/1

OpenFDA Data

• SPL SET ID: f1c82580-87ae-11e0-bc84-0002a5d5c51b
• Manufacturer:
  • Incyte Corporation
• UNII:
  • 82S8X8XX8H
• RxNorm Concept Unique ID - RxCUI:
  • 1193349
  • 1193343
  • 1193341
  • 1193351
  • 1193347
  • 1193353
  • 1193345
  • 1193339
  • 1193337
  • 1193331

Pharmacological Class

• Kinase Inhibitor [EPC]
• Protein Kinase Inhibitors [MoA]

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

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