NDC 50242-122
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 | 50242-122_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 |
Packaging
NDC 50242-122-06
1 BOTTLE, PLASTIC in 1 CARTON (50242-122-06) > 270 TABLET, COATED in 1 BOTTLE, PLASTIC
| Marketing Start Date | 2018-01-22 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 50242-122-86 [50242012286]
ESBRIET TABLET, COATED
| Marketing Category | NDA |
| Application Number | NDA208780 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-10-23 |
NDC 50242-122-06 [50242012206]
ESBRIET TABLET, COATED
| Marketing Category | NDA |
| Application Number | NDA208780 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2018-01-22 |
NDC 50242-122-05 [50242012205]
ESBRIET TABLET, COATED
| 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 |
NDC 50242-122-03 [50242012203]
ESBRIET TABLET, COATED
| 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 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| PIRFENIDONE | 267 mg/1 |
OpenFDA Data
| SPL SET ID: | 2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
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 |
Trademark Results [ESBRIET]
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 |
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