Roflumilast NDC 0904-7493

NDC codes

FDA NDC Directory

Product NDC (as listed)0904-7493Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00904-7493Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0904-7493-71	00904749371	28 TABLET in 1 BOTTLE (0904-7493-71)Marketed from Oct 27, 2025

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 — 250 ug/1
Dosage form: Tablet
Route: Oral
Labeler: MAJOR PHARMACEUTICALS
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208256
Marketing start: Oct 27, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Phosphodiesterase 4 Inhibitors (Mechanism)
Identifiers: Product ID 0904-7493_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

N400904749371 followed by a unit qualifier and the quantity

Package 00904-7493-71. 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 Dec 4, 2025.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 208256

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 208256
Product	Strength	Form · route	Labeler	Product NDC
Roflumilast	Roflumilast 500 ug/1	TabletOral	Major Pharmaceuticals	0904-7483
Roflumilast	Roflumilast 500 ug/1	TabletOral	Novadoz Pharmaceuticals LLC	72205-200
Roflumilast	Roflumilast 250 ug/1	TabletOral	Novadoz Pharmaceuticals LLC	72205-201
Roflumilast	Roflumilast 500 ug/1	TabletOral	MAJOR PHARMACEUTICALS	0904-7399