Fluoxetine (fluoxetine hydrochloride) NDC 51655-081

NDC codes

FDA NDC Directory

Product NDC (as listed)51655-081Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51655-0081Add 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
51655-081-26	51655008126	90 CAPSULE in 1 BOTTLE, PLASTIC (51655-081-26)Marketed from Oct 4, 2022

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 — 40 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Northwind Health Company, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075465
Marketing start: Oct 4, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 51655-081_46ddcd42-e20e-656c-e063-6294a90a7e5fSPL ID 46ddcd42-e20e-656c-e063-6294a90a7e5fSPL set ID f2a48124-0790-51c2-e053-2a95a90aa1afRxCUI 313989UNII 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

N451655008126 followed by a unit qualifier and the quantity

Package 51655-0081-26. 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 Dec 26, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Fluoxetine capsules are indicated for the treatment of: • Acute and maintenance treatment of Major Depressive Disorder [ see Clinical Studies (14.1) ]. • Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [ see Clinical Studies (14.2) ]. • Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [ see Clinical Studies (14.3) ]. • Acute treatment of Panic Disorder, with or without agoraphobia [ see Clinical Studies (14.4) ]. Fluoxetine and Olanzapine in Combination is indicated for the treatment of: • Acute treatment of depressive episodes associated with Bipolar I…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 075465

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

FDA NDC Directory listings under ANDA 075465
Product	Strength	Form · route	Labeler	Product NDC
Fluoxetinefluoxetine hydrochloride	Fluoxetine hydrochloride 10 mg/1	CapsuleOral	MARKSANS PHARMA LIMITED	25000-147
Fluoxetinefluoxetine hydrochloride	Fluoxetine hydrochloride 20 mg/1	CapsuleOral	MARKSANS PHARMA LIMITED	25000-148
Fluoxetinefluoxetine hydrochloride	Fluoxetine hydrochloride 40 mg/1	CapsuleOral	MARKSANS PHARMA LIMITED	25000-149
Fluoxetinefluoxetine hydrochloride	Fluoxetine hydrochloride 40 mg/1	CapsuleOral	TIME CAP LABORATORIES, INC.	49483-703
Fluoxetinefluoxetine hydrochloride	Fluoxetine hydrochloride 10 mg/1	CapsuleOral	TIME CAP LABORATORIES, INC.	49483-701
Fluoxetinefluoxetine hydrochloride	Fluoxetine hydrochloride 20 mg/1	CapsuleOral	TIME CAP LABORATORIES, INC.	49483-702