Brisdelle (paroxetine) NDC 83107-027

NDC codes

FDA NDC Directory

Product NDC (as listed)83107-027Labeler and product segments. Claims need a package NDC.

Product NDC at billing width83107-0027Add 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
83107-027-30	83107002730	30 CAPSULE in 1 BLISTER PACK (83107-027-30)Marketed from Feb 18, 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): Brisdelle
Generic name (nonproprietary): paroxetine
Active ingredients: Paroxetine mesylate — 7.5 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Legacy Pharma USA, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 204516
Marketing start: Feb 18, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 83107-027_a33eb37f-c69b-41f3-9d18-540bfd226aa6SPL ID a33eb37f-c69b-41f3-9d18-540bfd226aa6SPL set ID 502311b3-b617-4cbd-a3ab-a60f2c62880aRxCUI 1430122, 1430128UNII 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

N483107002730 followed by a unit qualifier and the quantity

Package 83107-0027-30. 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 Apr 28, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

BRISDELLE is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. Limitations of Use: BRISDELLE is not indicated for the treatment of any psychiatric condition. BRISDELLE has a lower recommended paroxetine dosage than that used to treat major depressive disorder, obsessive compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety disorder, and post-traumatic stress disorder. The safety and effectiveness of the lower BRISDELLE dosage has not been established for any psychiatric condition. Patients who require paroxetine for treatment of a psychiatric condition should discontinue BRISDELLE and initiate a paroxetine-contai…

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
Paroxetine	Paroxetine mesylate 7.5 mg/1	CapsuleOral	Padagis US LLC	0574-0279