Fluoxetine Hydrochloride NDC 70954-600

NDC codes

FDA NDC Directory

Product NDC (as listed)70954-600Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70954-0600Add 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
70954-600-10	70954060010	120 mL in 1 BOTTLE, PLASTIC (70954-600-10)Marketed from Nov 9, 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 Hydrochloride
Generic name (nonproprietary): fluoxetine hydrochloride
Active ingredients: Fluoxetine hydrochloride — 20 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: ANI Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216448
Marketing start: Nov 9, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 70954-600_0f4f464b-d8a7-400c-ab63-f0510ba8b982SPL ID 0f4f464b-d8a7-400c-ab63-f0510ba8b982SPL set ID 1ffe57c3-6f70-4075-aacb-d87a3990fdeaRxCUI 310386UNII I9W7N6B1KJUPC 0370954600107
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

N470954060010 followed by a unit qualifier and the quantity

Package 70954-0600-10. 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 Jan 5, 2026. 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)