Prescription drug · NDA
Esbriet (Pirfenidone) NDC 50242-122
Pirfenidone 267 mg/1 · Tablet, Coated · Oral · Genentech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50242-122-06 | 5024201220650242012206 | 1 BOTTLE, PLASTIC in 1 CARTON (50242-122-06) / 270 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from Jan 22, 2018 |
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 — 267 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Genentech, Inc.NDC labeler code 50242
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208780
- Marketing start
- Marketing end
- Other FDA classes
- Pyridones (Chemical structure)
- Identifiers
- Product ID 50242-122_86848f3d-1ab2-457b-9f36-eba22bea36ddSPL ID 86848f3d-1ab2-457b-9f36-eba22bea36ddSPL set ID 2e8c3537-36d7-4de5-9b5c-7a624b9a9e6eRxCUI 1592279, 1592285, 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
N450242012206followed by a unit qualifier and the quantityPackage 50242-0122-06. 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 50242-122
- What is NDC 50242-122?
- 50242-122 is the product NDC for Esbriet (pirfenidone), Pirfenidone 267 mg/1 tablet, coated, listed with the FDA by Genentech, 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?
- Genentech, Inc., NDC labeler code 50242. 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 801 mg/1 | Tablet, CoatedOral | Legacy Pharma USA Inc. | 83107-029 | 83107-0029-90 |
| 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 801 mg/1 | Tablet, CoatedOral | Genentech, Inc. | 50242-123 |
| Esbrietpirfenidone | Pirfenidone 267 mg/1 | Tablet, CoatedOral | Legacy Pharma USA Inc. | 83107-028 |
| Esbrietpirfenidone | Pirfenidone 801 mg/1 | Tablet, CoatedOral | Legacy Pharma USA Inc. | 83107-029 |