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 NDC11-digit (billing)PackageCopy
0904-7493-71009047493710090474937128 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 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 0904-7493_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 .

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)

About NDC 0904-7493

What is NDC 0904-7493?
0904-7493 is the product NDC for Roflumilast, Roflumilast 250 ug/1 tablet, listed with the FDA by MAJOR PHARMACEUTICALS. 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?
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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Roflumilast NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
roflumilastRoflumilast 250 ug/1TabletOralAvKARE73190-08673190-0086-28
roflumilastRoflumilast 500 ug/1TabletOralAvKARE73190-08773190-0087-3073190-0087-90
RoflumilastRoflumilast 250 ug/1TabletOralAmici Pharma Inc.69292-63069292-0630-1069292-0630-1469292-0630-20+1 more
RoflumilastRoflumilast 500 ug/1TabletOralAmici Pharma Inc.69292-63169292-0631-3069292-0631-90
RoflumilastRoflumilast 250 ug/1TabletOralJubilant Cadista Pharmaceuticals Inc.59746-80159746-0801-70
RoflumilastRoflumilast 500 ug/1TabletOralJubilant Cadista Pharmaceuticals Inc.59746-80259746-0802-0559746-0802-3059746-0802-90
RoflumilastRoflumilast 500 ug/1TabletOralAscend Laboratories, LLC67877-48067877-0480-0567877-0480-3067877-0480-33+1 more
RoflumilastRoflumilast 250 ug/1TabletOralAscend Laboratories, LLC67877-73067877-0730-0567877-0730-3067877-0730-87+2 more
RoflumilastRoflumilast 250 ug/1TabletOralAurobindo Pharma Limited59651-80159651-0801-2059651-0801-28
RoflumilastRoflumilast 500 ug/1TabletOralMajor Pharmaceuticals0904-748300904-7483-0300904-7483-89

All 27 Roflumilast NDCs

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
ProductStrengthForm · routeLabelerProduct NDC
RoflumilastRoflumilast 500 ug/1TabletOralMAJOR PHARMACEUTICALS0904-7399
RoflumilastRoflumilast 500 ug/1TabletOralMajor Pharmaceuticals0904-7483
RoflumilastRoflumilast 500 ug/1TabletOralNovadoz Pharmaceuticals LLC72205-200
RoflumilastRoflumilast 250 ug/1TabletOralNovadoz Pharmaceuticals LLC72205-201

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