Roflumilast NDC 72205-201

NDC codes

FDA NDC Directory

Product NDC (as listed)72205-201Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72205-0201Add 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
72205-201-24	72205020124	2 BLISTER PACK in 1 CARTON (72205-201-24) / 10 TABLET in 1 BLISTER PACK (72205-201-11)Marketed from Sep 24, 2022
72205-201-30	72205020130	30 TABLET in 1 BOTTLE (72205-201-30)Marketed from Dec 21, 2022
72205-201-32	72205020132	2 BLISTER PACK in 1 CARTON (72205-201-32) / 14 TABLET in 1 BLISTER PACK (72205-201-13)Marketed from Sep 24, 2022

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: Novadoz Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208256
Marketing start: Sep 7, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Phosphodiesterase 4 Inhibitors (Mechanism)
Identifiers: Product ID 72205-201_b56e7d3f-9930-43fa-baf4-63f9cee750f2SPL ID b56e7d3f-9930-43fa-baf4-63f9cee750f2SPL set ID 4d25f69c-58b7-4e2a-b835-4d0c76a83c7cRxCUI 1091839, 2001319UNII 0P6C6ZOP5UUPC 0372205200302, 0372205200906, 0372205201309
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

N472205020124 followed by a unit qualifier and the quantity

Package 72205-0201-24. 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 Aug 27, 2024.

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 250 ug/1	TabletOral	MAJOR PHARMACEUTICALS	0904-7493
Roflumilast	Roflumilast 500 ug/1	TabletOral	Novadoz Pharmaceuticals LLC	72205-200
Roflumilast	Roflumilast 500 ug/1	TabletOral	MAJOR PHARMACEUTICALS	0904-7399