Paroxetine NDC 0574-0279

NDC codes

FDA NDC Directory

Product NDC (as listed)0574-0279Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00574-0279Add 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
0574-0279-30	00574027930	30 CAPSULE in 1 BOTTLE (0574-0279-30)Marketed from Oct 3, 2017

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Paroxetine
Generic name (nonproprietary): paroxetine
Active ingredients: Paroxetine mesylate — 7.5 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Padagis US LLC
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 204516
Marketing start: Oct 3, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 0574-0279_2da9c1a5-7b6c-4990-b6a5-1b06e1dd85cdSPL ID 2da9c1a5-7b6c-4990-b6a5-1b06e1dd85cdSPL set ID 1383d713-79b9-45bd-bd06-65707f28bc99RxCUI 1430122UNII M711N184JE
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

N400574027930 followed by a unit qualifier and the quantity

Package 00574-0279-30. 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 1, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Paroxetine Capsules are indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. Limitation of Use: Paroxetine capsules are not indicated for the treatment of any psychiatric condition. Paroxetine capsules contain a lower dose of paroxetine than that used to treat depression, obsessive compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety disorder, and post-traumatic stress disorder. The safety and efficacy of this lower dose of paroxetine in paroxetine capsules have not been established for any psychiatric condition. Patients who require paroxetine for treatment of a psychiatric condition should discontinue paroxetine …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 204516

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

FDA NDC Directory listings under NDA 204516
Product	Strength	Form · route	Labeler	Product NDC
Brisdelleparoxetine	Paroxetine mesylate 7.5 mg/1	CapsuleOral	Legacy Pharma USA, Inc.	83107-027