Prescription drug · ANDA
Roflumilast NDC 0904-7399
Roflumilast 500 ug/1 · Tablet · Oral · MAJOR PHARMACEUTICALS
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7399-46 | 0090473994600904739946 | 30 TABLET in 1 BOTTLE (0904-7399-46)Marketed from Dec 26, 2023 | |
| 0904-7399-89 | 0090473998900904739989 | 90 TABLET in 1 BOTTLE (0904-7399-89)Marketed from Dec 26, 2023 |
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)
- Roflumilast
- Generic name (nonproprietary)
- roflumilast
- Active ingredients
- Roflumilast — 500 ug/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- MAJOR PHARMACEUTICALSNDC labeler code 0904
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208256
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 4 Inhibitors (Mechanism)
- Identifiers
- Product ID 0904-7399_44dcecac-a91b-4149-b030-d44e925bee4bSPL ID 44dcecac-a91b-4149-b030-d44e925bee4bSPL set ID c51b80f3-a591-4db9-81b4-b91603e35d7cRxCUI 1091839, 2001319UNII 0P6C6ZOP5UUPC 0309047493715
- 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
N400904739946followed by a unit qualifier and the quantityPackage 00904-7399-46. 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 Tablets are not a bronchodilator and is not indicated for the relief of acute bronchospasm. Roflumilast Tablets 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose. Roflumilast Tablets are 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:…
Excerpt only. Read the full label for complete information.
About NDC 0904-7399
- What is NDC 0904-7399?
- 0904-7399 is the product NDC for Roflumilast, Roflumilast 500 ug/1 tablet, listed with the FDA by MAJOR PHARMACEUTICALS. It has 2 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?
- MAJOR PHARMACEUTICALS, NDC labeler code 0904. 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 250 ug/1 | TabletOral | AvKARE | 73190-086 | 73190-0086-28 |
| roflumilast | Roflumilast 500 ug/1 | TabletOral | AvKARE | 73190-087 | 73190-0087-3073190-0087-90 |
| 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 250 ug/1 | TabletOral | Jubilant Cadista Pharmaceuticals Inc. | 59746-801 | 59746-0801-70 |
| 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 | MAJOR PHARMACEUTICALS | 0904-7493 | 00904-7493-71 |
| 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 | Ascend Laboratories, LLC | 67877-730 | 67877-0730-0567877-0730-3067877-0730-87+2 more |
| Roflumilast | Roflumilast 250 ug/1 | TabletOral | Aurobindo Pharma Limited | 59651-801 | 59651-0801-2059651-0801-28 |
Other NDCs under ANDA 208256
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 | Major Pharmaceuticals | 0904-7483 |
| Roflumilast | Roflumilast 250 ug/1 | TabletOral | MAJOR PHARMACEUTICALS | 0904-7493 |
| Roflumilast | Roflumilast 500 ug/1 | TabletOral | Novadoz Pharmaceuticals LLC | 72205-200 |
| Roflumilast | Roflumilast 250 ug/1 | TabletOral | Novadoz Pharmaceuticals LLC | 72205-201 |