Prescription drug · NDA
Daliresp (Roflumilast) NDC 0310-0095
Roflumilast 500 ug/1 · Tablet · Oral · AstraZeneca Pharmaceuticals LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0310-0095-30 | 00310009530 | 30 TABLET in 1 BOTTLE, PLASTIC (0310-0095-30)Marketed from Jul 1, 2015 | |
| 0310-0095-90 | 00310009590 | 90 TABLET in 1 BOTTLE, PLASTIC (0310-0095-90)Marketed from Jul 1, 2015 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Daliresp
- Generic name (nonproprietary)
- roflumilast
- Active ingredients
- Roflumilast — 500 ug/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- AstraZeneca Pharmaceuticals LPNDC labeler code 0310
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022522
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 4 Inhibitors (Mechanism)
- Identifiers
- Product ID 0310-0095_11cd495f-c5cf-4076-b69c-af202ec2a8a1SPL ID 11cd495f-c5cf-4076-b69c-af202ec2a8a1SPL set ID c9a1d0a8-581f-4f91-a2b8-f419192d0ebfRxCUI 1091839, 1091843, 2001319, 2001321UNII 0P6C6ZOP5U
- Pharmacologic class
- Phosphodiesterase 4 Inhibitor
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
N400310009530followed by a unit qualifier and the quantityPackage 00310-0095-30. 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)
DALIRESP ® is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. DALIRESP is a selective phosphodiesterase 4 inhibitor indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. ( 1 , 14 ) Limitations of Use : • DALIRESP is not a bronchodilator and is not indicated for the relief of acute bronchospasm. ( 1, 14 ) • DALIRESP 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose. ( 2, 14 ) Limitations of Use DALIRESP is not a b…
Excerpt only. Read the full label for complete information.
About NDC 0310-0095
- What is NDC 0310-0095?
- 0310-0095 is the product NDC for Daliresp (roflumilast), Roflumilast 500 ug/1 tablet, listed with the FDA by AstraZeneca Pharmaceuticals LP. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Daliresp (Roflumilast).
- What is the active ingredient?
- Roflumilast.
- Who is the labeler?
- AstraZeneca Pharmaceuticals LP, NDC labeler code 0310. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Daliresp?
- 1 other product NDC are listed under this name. See all Daliresp NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Daliresp products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Daliresproflumilast | Roflumilast 250 ug/1 | TabletOral | AstraZeneca Pharmaceuticals LP | 0310-0088 | 00310-0088-2800310-0088-39 |
Other NDCs under NDA 022522
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 |
|---|---|---|---|---|
| Daliresproflumilast | Roflumilast 250 ug/1 | TabletOral | AstraZeneca Pharmaceuticals LP | 0310-0088 |