What is NDC 60505-0165?

60505-0165 is the product NDC for Fluvoxamine Maleate, Fluvoxamine maleate 50 mg/1 tablet, listed with the FDA by Apotex Corp. It has 1 package NDC, shown above in 10- and 11-digit form.

Apotex Corp, NDC labeler code 60505. 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 60505-0165

NDC codes

FDA NDC Directory

Product NDC (as listed)60505-0165Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60505-0165Add 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
60505-0165-1	6050501650160505016501	100 TABLET in 1 BOTTLE (60505-0165-1)Marketed from Jul 10, 2001

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 — 50 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Apotex CorpNDC labeler code 60505
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075902
Marketing start: Jul 10, 2001
Listing expires: Dec 31, 2027
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 60505-0165_2aa18614-fba5-8c56-f4fd-e8cb590e2284SPL ID 2aa18614-fba5-8c56-f4fd-e8cb590e2284
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

N460505016501 followed by a unit qualifier and the quantity

Package 60505-0165-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 60505-0165

What is NDC 60505-0165?: 60505-0165 is the product NDC for Fluvoxamine Maleate, Fluvoxamine maleate 50 mg/1 tablet, listed with the FDA by Apotex Corp. It has 1 package NDC, 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?: Apotex Corp, NDC labeler code 60505. 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	TabletOral	Preferred Pharmaceuticals Inc.	68788-4011	68788-4011-0368788-4011-0668788-4011-09
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

All 38 Fluvoxamine Maleate NDCs

Other NDCs under ANDA 075902

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

FDA NDC Directory listings under ANDA 075902
Product	Strength	Form · route	Labeler	Product NDC
Fluvoxamine Maleate	Fluvoxamine maleate 25 mg/1	TabletOral	Apotex Corp	60505-0164
Fluvoxamine Maleate	Fluvoxamine maleate 100 mg/1	TabletOral	Apotex Corp	60505-0166
Fluvoxamine Maleate	Fluvoxamine maleate 50 mg/1	TabletOral	American Health Packaging	68084-837
Fluvoxamine Maleate	Fluvoxamine maleate 100 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8175
Fluvoxamine Maleate	Fluvoxamine maleate 50 mg/1	TabletOral	Bryant Ranch Prepack	71335-1974
Fluvoxamine Maleate	Fluvoxamine maleate 100 mg/1	TabletOral	Bryant Ranch Prepack	71335-2008
Fluvoxamine Maleate	Fluvoxamine maleate 100 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-221