Prescription drug · ANDA
Roflumilast NDC 42571-369
Roflumilast 250 ug/1 · Tablet · Oral · Micro Labs Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42571-369-05 | 42571036905 | 500 TABLET in 1 BOTTLE (42571-369-05)Marketed from May 1, 2023 | |
| 42571-369-11 | 42571036911 | 10 BLISTER PACK in 1 CARTON (42571-369-11) / 10 TABLET in 1 BLISTER PACK (42571-369-32)Marketed from May 1, 2023 | |
| 42571-369-30 | 42571036930 | 30 TABLET in 1 BOTTLE (42571-369-30)Marketed from May 1, 2023 | |
| 42571-369-83 | 42571036983 | 28 TABLET in 1 BOTTLE (42571-369-83)Marketed from May 1, 2023 | |
| 42571-369-90 | 42571036990 | 90 TABLET in 1 BOTTLE (42571-369-90)Marketed from May 1, 2023 |
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)
- Roflumilast
- Generic name (nonproprietary)
- roflumilast
- Active ingredients
- Roflumilast — 250 ug/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Micro Labs LimitedNDC labeler code 42571
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208180
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 4 Inhibitors (Mechanism)
- Identifiers
- Product ID 42571-369_3aacb2a6-70a4-650d-e063-6394a90af9fcSPL ID 3aacb2a6-70a4-650d-e063-6394a90af9fcSPL set ID dc2a689f-cfa4-4863-9623-a9813dcf86a9RxCUI 1091839, 2001319UNII 0P6C6ZOP5UUPC 0342571259327, 0342571369835, 0342571259303
- 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
N442571036905followed by a unit qualifier and the quantityPackage 42571-0369-05. 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)
Roflumilast tablets are 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. Limitations of Use Roflumilast tablet is not a bronchodilator and is not indicated for the relief of acute bronchospasm. Roflumilast tablet 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose. Roflumilast 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: Roflumilast…
Excerpt only. Read the full label for complete information.
About NDC 42571-369
- What is NDC 42571-369?
- 42571-369 is the product NDC for Roflumilast, Roflumilast 250 ug/1 tablet, listed with the FDA by Micro Labs Limited. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Roflumilast.
- What is the active ingredient?
- Roflumilast.
- Who is the labeler?
- Micro Labs Limited, NDC labeler code 42571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Roflumilast?
- 26 other product NDCs are listed under this name. See all Roflumilast NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Roflumilast products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| roflumilast | Roflumilast 500 ug/1 | TabletOral | AvKARE | 73190-087 | 73190-0087-3073190-0087-90 |
| roflumilast | Roflumilast 250 ug/1 | TabletOral | AvKARE | 73190-086 | 73190-0086-28 |
| Roflumilast | Roflumilast 250 ug/1 | TabletOral | Amici Pharma Inc. | 69292-630 | 69292-0630-1069292-0630-1469292-0630-20+1 more |
| Roflumilast | Roflumilast 500 ug/1 | TabletOral | Amici Pharma Inc. | 69292-631 | 69292-0631-3069292-0631-90 |
| Roflumilast | Roflumilast 500 ug/1 | TabletOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-802 | 59746-0802-0559746-0802-3059746-0802-90 |
| Roflumilast | Roflumilast 250 ug/1 | TabletOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-801 | 59746-0801-70 |
| Roflumilast | Roflumilast 250 ug/1 | TabletOral | MAJOR PHARMACEUTICALS | 0904-7493 | 00904-7493-71 |
| Roflumilast | Roflumilast 250 ug/1 | TabletOral | Ascend Laboratories, LLC | 67877-730 | 67877-0730-0567877-0730-3067877-0730-87+2 more |
| Roflumilast | Roflumilast 500 ug/1 | TabletOral | Ascend Laboratories, LLC | 67877-480 | 67877-0480-0567877-0480-3067877-0480-33+1 more |
| Roflumilast | Roflumilast 250 ug/1 | TabletOral | Aurobindo Pharma Limited | 59651-801 | 59651-0801-2059651-0801-28 |
Other NDCs under ANDA 208180
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 |
|---|---|---|---|---|
| Roflumilast | Roflumilast 500 ug/1 | TabletOral | Bryant Ranch Prepack | 72162-2385 |
| Roflumilast | Roflumilast 500 ug/1 | TabletOral | Micro Labs Limited | 42571-259 |