Fluoxetine NDC 62135-730

NDC codes

FDA NDC Directory

Product NDC (as listed)62135-730Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62135-0730Add 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
62135-730-24	62135073024	2 TRAY in 1 BOX (62135-730-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-730-45)Marketed from May 23, 2024
62135-730-41	62135073041	120 mL in 1 BOTTLE (62135-730-41)Marketed from Sep 27, 2023

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: Liquid
Route: Oral
Labeler: Chartwell RX, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076458
Marketing start: May 14, 2004
Listing expires: Dec 31, 2027
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 62135-730_4a16df46-6bfb-37c2-e063-6394a90a9525SPL ID 4a16df46-6bfb-37c2-e063-6394a90a9525SPL set ID cac17277-3481-4661-935f-efc48fff534cRxCUI 310386UNII I9W7N6B1KJUPC 0362135730413
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

N462135073024 followed by a unit qualifier and the quantity

Package 62135-0730-24. 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 Feb 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)

Other NDCs under ANDA 076458

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

FDA NDC Directory listings under ANDA 076458
Product	Strength	Form · route	Labeler	Product NDC
Fluoxetine	Fluoxetine hydrochloride 20 mg/5mL	LiquidOral	Chartwell Governmental & Specialty RX, LLC	68999-730