ESBRIET
- Product NDC
- 83107-029
- 11-digit product format
- 831070029
- Labeler code
- 83107
- Product ID
- 83107-029_372827fa-ccfe-42b6-e063-6394a90af5e8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PIRFENIDONE
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Legacy Pharma USA Inc.
- Application
- NDA208780
- Marketing category
- NDA
- Marketing start
- 2025-05-31
- Substance
- PIRFENIDONE
- Active strength
- 801 mg/1
- Pharmacologic classes
- Pyridone [EPC], Pyridones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ESBRIET
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PIRFENIDONE | 801 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | D7NLD2JX7U |
| Rxcui | 1868014, 1868016, 1868018, 1868020 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 82ab2cd4-4ada-41b1-950d-75fef25f7bac | Product name | 3 | 20250818 |
| d62f4d7c-9247-4aa4-ad93-12349422d49e | Product name | 2 | 20240530 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83107-029-90 | ESBRIET | 1 in 1 CARTON | TABLET, COATED | 1 | 1 | |
| 83107-029-90 | ESBRIET | 90 in 1 BOTTLE, PLASTIC | TABLET, COATED | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 83107-029-90 | EA - Each | 83107-029 | 9fa2f9af-e42f-42db-ac32-6502fd5a0c51 | 1 | 2025-11-13 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1868016 | Esbriet 267 MG Oral Tablet | PSN | 81f17f7d-cb04-4052-8682-dd3e330210ab | 1 |
| 1868020 | Esbriet 801 MG Oral Tablet | PSN | 81f17f7d-cb04-4052-8682-dd3e330210ab | 1 |
| 1868014 | pirfenidone 267 MG Oral Tablet | PSN | 81f17f7d-cb04-4052-8682-dd3e330210ab | 1 |
| 1868018 | pirfenidone 801 MG Oral Tablet | PSN | 81f17f7d-cb04-4052-8682-dd3e330210ab | 1 |
| 1868016 | pirfenidone 267 MG Oral Tablet [Esbriet] | SBD | 81f17f7d-cb04-4052-8682-dd3e330210ab | 1 |
| 1868020 | pirfenidone 801 MG Oral Tablet [Esbriet] | SBD | 81f17f7d-cb04-4052-8682-dd3e330210ab | 1 |
| 1868014 | pirfenidone 267 MG Oral Tablet | SCD | 81f17f7d-cb04-4052-8682-dd3e330210ab | 1 |
| 1868018 | pirfenidone 801 MG Oral Tablet | SCD | 81f17f7d-cb04-4052-8682-dd3e330210ab | 1 |
| 1868016 | Esbriet 267 MG Oral Tablet | SY | 81f17f7d-cb04-4052-8682-dd3e330210ab | 1 |
| 1868020 | Esbriet 801 MG Oral Tablet | SY | 81f17f7d-cb04-4052-8682-dd3e330210ab | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 83107-029-90 | 83107002990 | 1 BOTTLE, PLASTIC in 1 CARTON (83107-029-90) / 90 TABLET, COATED in 1 BOTTLE, PLASTIC | 2025-06-04 | No | No | Current |