Prescription drug · ANDA
roflumilast NDC 73190-086
Roflumilast 250 ug/1 · Tablet · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73190-086-28 | 73190008628 | 2 BLISTER PACK in 1 BOX (73190-086-28) / 14 TABLET in 1 BLISTER PACK (73190-086-11)Marketed from Jun 24, 2026 |
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
- AvKARENDC labeler code 73190
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208247
- Marketing start
- Listing expires
- Other FDA classes
- Phosphodiesterase 4 Inhibitors (Mechanism)
- Identifiers
- Product ID 73190-086_5500b154-77bd-3d4a-e063-6394a90ade49SPL ID 5500b154-77bd-3d4a-e063-6394a90ade49SPL set ID 55009549-3f0c-1f58-e063-6294a90a6c03RxCUI 1091839, 2001319UNII 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
N473190008628followed by a unit qualifier and the quantityPackage 73190-0086-28. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
About NDC 73190-086
- What is NDC 73190-086?
- 73190-086 is the product NDC for roflumilast, Roflumilast 250 ug/1 tablet, listed with the FDA by AvKARE. It has 1 package NDC, 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?
- AvKARE, NDC labeler code 73190. 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 | 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 |
| Roflumilast | Roflumilast 500 ug/1 | TabletOral | Major Pharmaceuticals | 0904-7483 | 00904-7483-0300904-7483-89 |
Other NDCs under ANDA 208247
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 | AvKARE | 73190-087 |