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 | 50242-122_037b768f-6ad3-4167-a2ef-c9784c36599f |
NDC | 50242-122 |
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 | 267 mg/1 |
Pharm Classes | Pyridone [EPC],Pyridones [CS] |
NDC Exclude Flag | N |
Listing Certified Through | 2021-12-31 |
Marketing Start Date | 2018-01-22 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA208780 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2017-10-23 |
Marketing Category | NDA |
Application Number | NDA208780 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2018-01-22 |
Marketing Category | NDA |
Application Number | NDA208780 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2017-01-11 |
Marketing End Date | 2019-04-07 |
Marketing Category | NDA |
Application Number | NDA208780 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | EA |
Marketing Start Date | 2017-01-11 |
Marketing End Date | 2017-11-15 |
Ingredient | Strength |
---|---|
PIRFENIDONE | 267 mg/1 |
SPL SET ID: | 2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ESBRIET 86332703 4688507 Live/Registered |
GENENTECH, INC. 2014-07-09 |
ESBRIET 77527761 4132175 Live/Registered |
GENENTECH, INC. 2008-07-21 |