NDC 50242-123

ESBRIET

Pirfenidone

ESBRIET is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Genentech, Inc.. The primary component is Pirfenidone.

• Product ID: 50242-123_037b768f-6ad3-4167-a2ef-c9784c36599f
• NDC: 50242-123
• Product Type: Human Prescription Drug
• Proprietary Name: ESBRIET
• Generic Name: Pirfenidone
• Dosage Form: Tablet, Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-01-11
• Marketing Category: NDA / NDA
• Application Number: NDA208780
• Labeler Name: Genentech, Inc.
• Substance Name: PIRFENIDONE
• Active Ingredient Strength: 801 mg/1
• Pharm Classes: Pyridone [EPC],Pyridones [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 50242-123-01

1 BOTTLE, PLASTIC in 1 CARTON (50242-123-01) > 90 TABLET, COATED in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2017-01-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50242-123-01 [50242012301]

ESBRIET TABLET, COATED

• Marketing Category: NDA
• Application Number: NDA208780
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-01-11

Drug Details

Active Ingredients

Ingredient	Strength
PIRFENIDONE	801 mg/1

OpenFDA Data

• SPL SET ID: 2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e
• Manufacturer:
  • Genentech, Inc.
• UNII:
  • D7NLD2JX7U
• RxNorm Concept Unique ID - RxCUI:
  • 1868020
  • 1868018
  • 1592285
  • 1592279
  • 1868016
  • 1868014

Pharmacological Class

• Pyridone [EPC]
• Pyridones [CS]

NDC Crossover Matching brand name "ESBRIET" or generic name "Pirfenidone"

NDC	Brand Name	Generic Name
50242-121	ESBRIET	PIRFENIDONE
50242-122	ESBRIET	PIRFENIDONE
50242-123	ESBRIET	PIRFENIDONE
64116-121	Esbriet	Esbriet
0480-3610	Pirfenidone	Pirfenidone
0480-3611	Pirfenidone	Pirfenidone
0781-2158	Pirfenidone	Pirfenidone
0781-8085	Pirfenidone	Pirfenidone
0781-8086	Pirfenidone	Pirfenidone
16729-467	PIRFENIDONE	PIRFENIDONE
16729-468	PIRFENIDONE	PIRFENIDONE
31722-872	Pirfenidone	Pirfenidone
31722-873	Pirfenidone	Pirfenidone
42385-923	Pirfenidone	Pirfenidone
42385-924	Pirfenidone	Pirfenidone
42385-925	Pirfenidone	Pirfenidone
42385-926	Pirfenidone	Pirfenidone
42571-335	Pirfenidone	Pirfenidone
42571-336	Pirfenidone	Pirfenidone
50228-441	PIRFENIDONE	PIRFENIDONE
50228-442	PIRFENIDONE	PIRFENIDONE
50228-443	PIRFENIDONE	PIRFENIDONE
60219-1640	Pirfenidone	Pirfenidone
60219-1641	Pirfenidone	Pirfenidone
60219-1642	Pirfenidone	Pirfenidone
62332-479	Pirfenidone	Pirfenidone