Prescription drug · NDA
Esbriet (Pirfenidone) NDC 83107-029
Pirfenidone 801 mg/1 · Tablet, Coated · Oral · Legacy Pharma USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83107-029-90 | 8310700299083107002990 | 1 BOTTLE, PLASTIC in 1 CARTON (83107-029-90) / 90 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Jun 4, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Esbriet
- Generic name (nonproprietary)
- pirfenidone
- Active ingredients
- Pirfenidone — 801 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Legacy Pharma USA Inc.NDC labeler code 83107
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208780
- Marketing start
- Listing expires
- Other FDA classes
- Pyridones (Chemical structure)
- Identifiers
- Product ID 83107-029_372827fa-ccfe-42b6-e063-6394a90af5e8SPL ID 372827fa-ccfe-42b6-e063-6394a90af5e8SPL set ID 81f17f7d-cb04-4052-8682-dd3e330210abRxCUI 1868014, 1868016, 1868018, 1868020UNII D7NLD2JX7U
- Pharmacologic class
- Pyridone
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N483107002990followed by a unit qualifier and the quantityPackage 83107-0029-90. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
ESBRIET is indicated for the treatment of idiopathic pulmonary fibrosis (IPF). ESBRIET is a pyridone indicated for the treatment of idiopathic pulmonary fibrosis (IPF). ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 83107-029
- What is NDC 83107-029?
- 83107-029 is the product NDC for Esbriet (pirfenidone), Pirfenidone 801 mg/1 tablet, coated, listed with the FDA by Legacy Pharma USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Esbriet (Pirfenidone).
- What is the active ingredient?
- Pirfenidone.
- Who is the labeler?
- Legacy Pharma USA Inc., NDC labeler code 83107. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Esbriet?
- 3 other product NDCs are listed under this name. See all Esbriet NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Esbriet products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Esbrietpirfenidone | Pirfenidone 267 mg/1 | Tablet, CoatedOral | Legacy Pharma USA Inc. | 83107-028 | 83107-0028-27 |
| Esbrietpirfenidone | Pirfenidone 267 mg/1 | Tablet, CoatedOral | Genentech, Inc. | 50242-122 | 50242-0122-06 |
| Esbrietpirfenidone | Pirfenidone 801 mg/1 | Tablet, CoatedOral | Genentech, Inc. | 50242-123 | 50242-0123-01 |
Other NDCs under NDA 208780
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Esbrietpirfenidone | Pirfenidone 267 mg/1 | Tablet, CoatedOral | Genentech, Inc. | 50242-122 |
| Esbrietpirfenidone | Pirfenidone 801 mg/1 | Tablet, CoatedOral | Genentech, Inc. | 50242-123 |
| Esbrietpirfenidone | Pirfenidone 267 mg/1 | Tablet, CoatedOral | Legacy Pharma USA Inc. | 83107-028 |