What is NDC 68788-4011?

68788-4011 is the product NDC for Fluvoxamine maleate, Fluvoxamine maleate 100 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Preferred Pharmaceuticals Inc., NDC labeler code 68788. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Fluvoxamine maleate?

37 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Fluvoxamine maleate NDC 68788-4011

NDC codes

FDA NDC Directory

Product NDC (as listed)68788-4011Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68788-4011Add 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
68788-4011-3	6878840110368788401103	30 TABLET in 1 BOTTLE (68788-4011-3)Marketed from Sep 4, 2025
68788-4011-6	6878840110668788401106	60 TABLET in 1 BOTTLE (68788-4011-6)Marketed from Sep 4, 2025
68788-4011-9	6878840110968788401109	90 TABLET in 1 BOTTLE (68788-4011-9)Marketed from Sep 4, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 100 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217917
Marketing start: Sep 4, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 68788-4011_642b7b5e-9f1c-479b-b9b3-bf06774f7b60SPL ID 642b7b5e-9f1c-479b-b9b3-bf06774f7b60SPL set ID 642b7b5e-9f1c-479b-b9b3-bf06774f7b60RxCUI 903884UNII 5LGN83G74V
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

N468788401103 followed by a unit qualifier and the quantity

Package 68788-4011-03. 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 Sep 4, 2025. 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)

About NDC 68788-4011

What is NDC 68788-4011?: 68788-4011 is the product NDC for Fluvoxamine maleate, Fluvoxamine maleate 100 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Fluvoxamine maleate.
What is the active ingredient?: Fluvoxamine maleate.
Who is the labeler?: Preferred Pharmaceuticals Inc., NDC labeler code 68788. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Fluvoxamine maleate?: 37 other product NDCs are listed under this name. See all Fluvoxamine maleate 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 Fluvoxamine maleate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Fluvoxamine Maleate	Fluvoxamine maleate 150 mg/1	Capsule, Extended releaseOral	Upsher-Smith Laboratories, LLC	0832-6026	00832-6026-30
Fluvoxamine Maleate	Fluvoxamine maleate 100 mg/1	Capsule, Extended releaseOral	Upsher-Smith Laboratories, LLC	0832-6025	00832-6025-30
Fluvoxamine Maleate	Fluvoxamine maleate 100 mg/1	Capsule, Extended releaseOral	AvKARE	73190-066	73190-0066-30
Fluvoxamine Maleate	Fluvoxamine maleate 150 mg/1	Capsule, Extended releaseOral	AvKARE	73190-067	73190-0067-30
Fluvoxamine Maleate	Fluvoxamine maleate 100 mg/1	Capsule, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-064	31722-0064-0131722-0064-30
Fluvoxamine Maleate	Fluvoxamine maleate 150 mg/1	Capsule, Extended releaseOral	Camber Pharmaceuticals, Inc.	31722-065	31722-0065-0131722-0065-30
Fluvoxamine maleate	Fluvoxamine maleate 100 mg/1	TabletOral	A-S Medication Solutions	50090-7728	50090-7728-00
Fluvoxamine maleate	Fluvoxamine maleate 25 mg/1	TabletOral	Bionpharma Inc.	69452-454	69452-0454-2069452-0454-3069452-0454-32
Fluvoxamine maleate	Fluvoxamine maleate 100 mg/1	TabletOral	Bionpharma Inc.	69452-455	69452-0455-2069452-0455-3069452-0455-32
Fluvoxamine maleate	Fluvoxamine maleate 100 mg/1	TabletOral	Bryant Ranch Prepack	71335-3006	71335-3006-0171335-3006-0271335-3006-03+2 more

All 38 Fluvoxamine maleate NDCs

Other NDCs under ANDA 217917

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

FDA NDC Directory listings under ANDA 217917
Product	Strength	Form · route	Labeler	Product NDC
Fluvoxamine maleate	Fluvoxamine maleate 100 mg/1	TabletOral	A-S Medication Solutions	50090-7728
Fluvoxamine maleate	Fluvoxamine maleate 25 mg/1	Tablet, Film coatedOral	Bionpharma Inc.	69452-287
Fluvoxamine maleate	Fluvoxamine maleate 50 mg/1	TabletOral	Bionpharma Inc.	69452-288
Fluvoxamine maleate	Fluvoxamine maleate 100 mg/1	Tablet, Film coatedOral	Bionpharma Inc.	69452-289
Fluvoxamine maleate	Fluvoxamine maleate 25 mg/1	TabletOral	Bionpharma Inc.	69452-454
Fluvoxamine maleate	Fluvoxamine maleate 100 mg/1	TabletOral	Bionpharma Inc.	69452-455
Fluvoxamine maleate	Fluvoxamine maleate 100 mg/1	TabletOral	Bryant Ranch Prepack	71335-3006