Fluoxetine NDC 59651-324

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-324Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0324Add 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
59651-324-30	59651032430	30 TABLET, FILM COATED in 1 BOTTLE (59651-324-30)Marketed from Jun 10, 2020

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): Fluoxetine
Generic name (nonproprietary): fluoxetine
Active ingredients: Fluoxetine hydrochloride — 60 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Aurobindo Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213265
Marketing start: Jun 10, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 59651-324_5f402504-f531-4cbf-95d5-fe23b90630b2SPL ID 5f402504-f531-4cbf-95d5-fe23b90630b2SPL set ID 5336ce59-7a6c-4db9-8512-299cc5e599c0RxCUI 1190110UNII I9W7N6B1KJUPC 0359651324301
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

N459651032430 followed by a unit qualifier and the quantity

Package 59651-0324-30. 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 Jan 25, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Fluoxetine tablets are indicated for the treatment of: Major Depressive Disorder (MDD). The efficacy of fluoxetine in MDD was established in one 5-week trial, three 6-week trials, and one maintenance study in adults. The efficacy of fluoxetine was also established in two 8- to 9-week trials in pediatric patients 8 to 18 years of age [see Clinical Studies (14.1) ]. Obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD). The efficacy of fluoxetine in OCD was demonstrated in two 13-week trials in adults and one 13-week trial in pediatric patients 7 to 17 years of age [see Clinical Studies (14.2) ]. Binge-eating and vomiting behaviors in patients with moderate to severe …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 213265

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

FDA NDC Directory listings under ANDA 213265
Product	Strength	Form · route	Labeler	Product NDC
Fluoxetine	Fluoxetine hydrochloride 60 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	84386-106
Fluoxetine	Fluoxetine hydrochloride 60 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2597