Fluoxetine (fluoxetine hydrochloride) NDC 50228-638

NDC codes

FDA NDC Directory

Product NDC (as listed)50228-638Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50228-0638Add 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
50228-638-10	50228063810	1000 TABLET in 1 BOTTLE (50228-638-10)Marketed from Sep 11, 2025
50228-638-30	50228063830	30 TABLET in 1 BOTTLE (50228-638-30)Marketed from Sep 11, 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): Fluoxetine
Generic name (nonproprietary): fluoxetine hydrochloride
Active ingredients: Fluoxetine hydrochloride — 60 mg/1
Dosage form: Tablet
Route: Oral
Labeler: ScieGen Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211282
Marketing start: Sep 11, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 50228-638_3e89095f-77b2-4fde-e063-6294a90a1ff3SPL ID 3e89095f-77b2-4fde-e063-6294a90a1ff3SPL set ID 3e8912e2-2a0c-5047-e063-6294a90a7e32RxCUI 1190110UNII I9W7N6B1KJ
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

N450228063810 followed by a unit qualifier and the quantity

Package 50228-0638-10. 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 Aug 31, 2025. 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 211282

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

FDA NDC Directory listings under ANDA 211282
Product	Strength	Form · route	Labeler	Product NDC
Fluoxetinefluoxetine hydrochloride	Fluoxetine hydrochloride 60 mg/1	TabletOral	ScieGen Pharmaceuticals, Inc.	50228-422