NDC codes

FDA NDC Directory
Product NDC (as listed)51407-975Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51407-0975Add 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
51407-975-905140709759090 TABLET in 1 BOTTLE (51407-975-90)Marketed from Feb 13, 2025

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 — 500 ug/1
Dosage form
Tablet
Route
Oral
Labeler
Golden State Medical Supply, Inc.NDC labeler code 51407
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212490
Marketing start
Listing expires
Other FDA classes
Phosphodiesterase 4 Inhibitors (Mechanism)
Identifiers
Product ID 51407-975_30dd6be3-6f60-c6a9-e063-6294a90afaa4SPL ID 30dd6be3-6f60-c6a9-e063-6294a90afaa4SPL set ID 30dd6eae-6435-cae1-e063-6294a90a003bRxCUI 1091839UNII 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

N451407097590 followed by a unit qualifier and the quantity

Package 51407-0975-90. 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 is 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 is 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 is 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: Ro…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51407-975

What is NDC 51407-975?
51407-975 is the product NDC for Roflumilast, Roflumilast 500 ug/1 tablet, listed with the FDA by Golden State Medical Supply, Inc.. 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?
Golden State Medical Supply, Inc., NDC labeler code 51407. 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 250 ug/1TabletOralMAJOR PHARMACEUTICALS0904-749300904-7493-71
RoflumilastRoflumilast 250 ug/1TabletOralAscend Laboratories, LLC67877-73067877-0730-0567877-0730-3067877-0730-87+2 more
RoflumilastRoflumilast 500 ug/1TabletOralAscend Laboratories, LLC67877-48067877-0480-0567877-0480-3067877-0480-33+1 more
RoflumilastRoflumilast 250 ug/1TabletOralAurobindo Pharma Limited59651-80159651-0801-2059651-0801-28

All 27 Roflumilast NDCs

Other NDCs under ANDA 212490

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

FDA NDC Directory listings under ANDA 212490
ProductStrengthForm · routeLabelerProduct NDC
RoflumilastRoflumilast 250 ug/1TabletOralAscend Laboratories, LLC67877-730
RoflumilastRoflumilast 500 ug/1TabletOralAscend Laboratories, LLC67877-480

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