What is NDC 71656-089?

71656-089 is the product NDC for Fluoxetine, Fluoxetine hydrochloride 20 mg/5mL solution, listed with the FDA by Saptalis Pharmaceuticals, LLC.. It has 1 package NDC, shown above in 10- and 11-digit form.

Saptalis Pharmaceuticals, LLC., NDC labeler code 71656. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Fluoxetine?

200 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Fluoxetine NDC 71656-089 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71656-089Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71656-0089Add 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
71656-089-04	7165600890471656008904	120 mL in 1 BOTTLE (71656-089-04)Marketed from Jun 20, 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
Active ingredients: Fluoxetine hydrochloride — 20 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Saptalis Pharmaceuticals, LLC.NDC labeler code 71656
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075525
Marketing start: Jun 20, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 71656-089_38420669-08b4-a3e4-e063-6294a90a4573SPL ID 38420669-08b4-a3e4-e063-6294a90a4573SPL set ID 4527c502-b28c-449f-ad2d-7daf21563cfaRxCUI 310386UNII 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

N471656008904 followed by a unit qualifier and the quantity

Package 71656-0089-04. 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 Jun 23, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Fluoxetine is 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 monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depr…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71656-089

What is NDC 71656-089?: 71656-089 is the product NDC for Fluoxetine, Fluoxetine hydrochloride 20 mg/5mL solution, listed with the FDA by Saptalis Pharmaceuticals, LLC.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Fluoxetine.
What is the active ingredient?: Fluoxetine hydrochloride.
Who is the labeler?: Saptalis Pharmaceuticals, LLC., NDC labeler code 71656. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Fluoxetine?: 200 other product NDCs are listed under this name. See all Fluoxetine NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Fluoxetine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Fluoxetinefluoxetine hydrochloride	Fluoxetine hydrochloride 20 mg/1	CapsuleOral	Coupler LLC	67046-0405	67046-0405-03
Fluoxetine	Fluoxetine hydrochloride 10 mg/1	CapsuleOral	Coupler LLC	67046-1695	67046-1695-03
Fluoxetine	Fluoxetine hydrochloride 40 mg/1	CapsuleOral	American Health Packaging	68002-105	68002-0105-01
Fluoxetine	Fluoxetine hydrochloride 20 mg/1	CapsuleOral	Unit Dose Solutions, Inc.	87441-031	87441-0031-01
Fluoxetinefluoxetine hydrochloride	Fluoxetine hydrochloride 40 mg/1	CapsuleOral	Coupler LLC	67046-0552	67046-0552-03
Fluoxetinefluoxetine hydrochloride	Fluoxetine hydrochloride 10 mg/1	CapsuleOral	Coupler LLC	67046-2083	67046-2083-03
Fluoxetine	Fluoxetine hydrochloride 10 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4611	70518-4611-00
Fluoxetine	Fluoxetine hydrochloride 20 mg/1	CapsuleOral	Coupler LLC	67046-1670	67046-1670-03
Fluoxetine	Fluoxetine hydrochloride 10 mg/1	CapsuleOral	Northwind Health Company, LLC	82868-105	82868-0105-3082868-0105-90
Fluoxetine	Fluoxetine hydrochloride 20 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4576	70518-4576-00

All 201 Fluoxetine NDCs