NDC 50881-028

PEMAZYRE

Pemigatinib

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

• Product ID: 50881-028_0954b874-3869-42e6-9d21-6a86108bb2ea
• NDC: 50881-028
• Product Type: Human Prescription Drug
• Proprietary Name: PEMAZYRE
• Generic Name: Pemigatinib
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2020-04-17
• Marketing Category: NDA / NDA
• Application Number: NDA213736
• Labeler Name: Incyte Corporation
• Substance Name: PEMIGATINIB
• Active Ingredient Strength: 14 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 50881-028-01

14 TABLET in 1 BOTTLE, PLASTIC (50881-028-01)

• Marketing Start Date: 2020-04-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50881-028-01 [50881002801]

PEMAZYRE TABLET

• Marketing Category: NDA
• Application Number: NDA213736
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2020-04-17

Drug Details

Active Ingredients

Ingredient	Strength
PEMIGATINIB	13.5 mg/1

OpenFDA Data

• SPL SET ID: 9e1f2222-1d89-4e63-989c-ccebe2ab1eb4
• Manufacturer:
  • Incyte Corporation
• UNII:
  • Y6BX7BL23K
• RxNorm Concept Unique ID - RxCUI:
  • 2359334
  • 2359344
  • 2359346
  • 2359340
  • 2359342
  • 2359348

NDC Crossover Matching brand name "PEMAZYRE" or generic name "Pemigatinib"

NDC	Brand Name	Generic Name
50881-026	PEMAZYRE	pemigatinib
50881-027	PEMAZYRE	pemigatinib
50881-028	PEMAZYRE	pemigatinib