NDC codes

FDA NDC Directory
Product NDC (as listed)62135-931Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62135-0931Add 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
62135-931-906213509319090 TABLET, FILM COATED in 1 BOTTLE (62135-931-90)Marketed from Dec 18, 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)
Fluvoxamine Maleate
Generic name (nonproprietary)
fluvoxamine maleate
Active ingredients
Fluvoxamine maleate — 25 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075900
Marketing start
Listing expires
Other FDA classes
Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 62135-931_2c617129-3c30-3713-e063-6294a90af923SPL ID 2c617129-3c30-3713-e063-6294a90af923SPL set ID b8320308-084f-43fb-9b1d-5620a0efaf46RxCUI 903884, 903887, 903891UNII 5LGN83G74VUPC 0362135933302, 0362135931902, 0362135932602
Pharmacologic class
Serotonin Reuptake 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

N462135093190 followed by a unit qualifier and the quantity

Package 62135-0931-90. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Fluvoxamine maleate tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD) ( 1 ). 1.1 Obsessive-Compulsive Disorder Fluvoxamine maleate tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD), as defined in DSM-III-R or DSM-IV. The obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. Obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional beh…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 075900

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

FDA NDC Directory listings under ANDA 075900
ProductStrengthForm · routeLabelerProduct NDC
Fluvoxamine MaleateFluvoxamine maleate 50 mg/1Tablet, Film coatedOralChartwell RX, LLC62135-932
Fluvoxamine MaleateFluvoxamine maleate 100 mg/1Tablet, Film coatedOralChartwell RX, LLC62135-933

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