NDC codes

FDA NDC Directory
Product NDC (as listed)61825-311Labeler and product segments. Claims need a package NDC.
Product NDC at billing width61825-0311Add 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
61825-311-106182503111061825031110100 CAPSULE in 1 BOTTLE (61825-311-10)Marketed from Dec 10, 2024

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)
Fenopron TmSuffix: TM
Generic name (nonproprietary)
fenoprofen calcium
Active ingredients
Fenoprofen calcium — 300 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Galt Pharmaceuticals, LLCNDC labeler code 61825
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214475
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 61825-311_1ad61a67-8758-4f2f-b7d5-f00f62ea69aaSPL ID 1ad61a67-8758-4f2f-b7d5-f00f62ea69aaSPL set ID 2ed1a69a-2375-4cc8-ac2f-1201d7e0b9d0RxCUI 197695, 2699827UNII 0X2CW1QABJ

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

N461825031110 followed by a unit qualifier and the quantity

Package 61825-0311-10. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

FENOPRON TM is indicated for: Relief of mild to moderate pain in adults Relief of the signs and symptoms of rheumatoid arthritis Relief of the signs and symptoms of osteoarthritis Fenoprofen calcium is a nonsteroidal anti-inflammatory drug indicated for: Relief of mild to moderate pain in adults. ( 1 ) Relief of the signs and symptoms of rheumatoid arthritis. ( 1 ) Relief of the signs and symptoms of osteoarthritis. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 61825-311

What is NDC 61825-311?
61825-311 is the product NDC for Fenopron Tm (fenoprofen calcium), Fenoprofen calcium 300 mg/1 capsule, listed with the FDA by Galt Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Fenopron Tm (Fenoprofen calcium).
What is the active ingredient?
Fenoprofen calcium.
Who is the labeler?
Galt Pharmaceuticals, LLC, NDC labeler code 61825. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Fenopron Tm?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 214475

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

FDA NDC Directory listings under ANDA 214475
ProductStrengthForm · routeLabelerProduct NDC
Fenoprofen CalciumFenoprofen calcium 400 mg/1CapsuleOralRising Pharma Holdings, Inc.16571-688
Fenoprofen CalciumFenoprofen calcium 200 mg/1CapsuleOralRising Pharma Holdings, Inc.16571-886
Fenoprofen CalciumFenoprofen calcium 300 mg/1CapsuleOralRising Pharma Holdings, Inc.16571-887
Fenoprofen CalciumFenoprofen calcium 400 mg/1CapsuleOralProficient Rx LP71205-828
Fenoprofen CalciumFenoprofen calcium 400 mg/1CapsuleOralAtland Pharmaceuticals, LLC71993-308
Fenoprofen calciumFenoprofen calcium 200 mg/1CapsuleOralAtland Pharmaceuticals, LLC71993-313

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