What is NDC 84386-106?

84386-106 is the product NDC for Fluoxetine, Fluoxetine hydrochloride 60 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Aurobindo Pharma Limited, NDC labeler code 84386. 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 84386-106 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)84386-106Labeler and product segments. Claims need a package NDC.

Product NDC at billing width84386-0106Add 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
84386-106-30	8438601063084386010630	30 TABLET, FILM COATED in 1 BOTTLE (84386-106-30)Marketed from Jan 15, 2026

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 — 60 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Aurobindo Pharma LimitedNDC labeler code 84386
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213265
Marketing start: Jan 15, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 84386-106_bed68a4a-234d-4871-b61a-90bc7e10f61eSPL ID bed68a4a-234d-4871-b61a-90bc7e10f61eSPL set ID a9ed97dd-8041-4a02-889c-dcb8b2805f36RxCUI 1190110UNII I9W7N6B1KJUPC 0384386106304
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

N484386010630 followed by a unit qualifier and the quantity

Package 84386-0106-30. 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 Jul 15, 2026. 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)

About NDC 84386-106

What is NDC 84386-106?: 84386-106 is the product NDC for Fluoxetine, Fluoxetine hydrochloride 60 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. 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?: Aurobindo Pharma Limited, NDC labeler code 84386. 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

Other NDCs under ANDA 213265

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

FDA NDC Directory listings under ANDA 213265
Product	Strength	Form · route	Labeler	Product NDC
Fluoxetine	Fluoxetine hydrochloride 60 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2597