Fluvoxamine Maleate NDC 31722-065

NDC codes

FDA NDC Directory

Product NDC (as listed)31722-065Labeler and product segments. Claims need a package NDC.

Product NDC at billing width31722-0065Add 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	Copy
31722-065-01	31722006501	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-065-01)Marketed from Jul 30, 2025
31722-065-30	31722006530	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-065-30)Marketed from Jul 30, 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): Fluvoxamine Maleate
Generic name (nonproprietary): fluvoxamine maleate
Active ingredients: Fluvoxamine maleate — 150 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Camber Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217024
Marketing start: Jul 30, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 31722-065_3d922dc6-629d-73e8-e063-6294a90a7d09SPL ID 3d922dc6-629d-73e8-e063-6294a90a7d09SPL set ID e5574f41-d4df-42d5-baae-b317fb7c88bfRxCUI 903873, 903879UNII 5LGN83G74VUPC 0331722064309
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

N431722006501 followed by a unit qualifier and the quantity

Package 31722-0065-01. 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 30, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Fluvoxamine maleate extended-release capsules are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of obsessive compulsive disorder (OCD) ( 1 ). Efficacy was demonstrated in: • One 12-week study with fluvoxamine maleate extended-release capsules in adults ( 14.1 ) . • Two 10-week studies with immediate-release (IR) fluvoxamine tablets in adults and one 10-week study with IR fluvoxamine tablets in children and adolescents ( 14.1 , 14.3 ) . • One maintenance study with IR fluvoxamine tablets ( 14.2 ) . 1.1 Obsesive Compulsive Disorder Fluvoxamine maleate extended-release capsules are indicated for the treatment of obsessive compulsive disorder (OCD), as defined in th…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 217024

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

FDA NDC Directory listings under ANDA 217024
Product	Strength	Form · route	Labeler	Product NDC
Fluvoxamine Maleate	Fluvoxamine maleate 100 mg/1	Capsule, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-064