What is NDC 0615-8612?

0615-8612 is the product NDC for Fluoxetine, Fluoxetine hydrochloride 40 mg/1 capsule, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 2 package NDCs, shown above in 10- and 11-digit form.

NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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 0615-8612 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0615-8612Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00615-8612Add 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
0615-8612-05	0061586120500615861205	15 CAPSULE in 1 BLISTER PACK (0615-8612-05)Marketed from Apr 7, 2026
0615-8612-39	0061586123900615861239	30 CAPSULE in 1 BLISTER PACK (0615-8612-39)Marketed from Apr 7, 2026

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 40 mg/1
Dosage form: Capsule
Route: Oral
Labeler: NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078619
Marketing start: Jul 11, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 0615-8612_e6352f3d-7ecb-4aa5-8192-176316a63786SPL ID e6352f3d-7ecb-4aa5-8192-176316a63786SPL set ID faf4bc0c-bf65-4a65-8f08-3d800185d6a8RxCUI 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

N400615861205 followed by a unit qualifier and the quantity

Package 00615-8612-05. 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 Apr 15, 2026. 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 capsules and Olanzapine in Combination are 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)

About NDC 0615-8612

What is NDC 0615-8612?: 0615-8612 is the product NDC for Fluoxetine, Fluoxetine hydrochloride 40 mg/1 capsule, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 2 package NDCs, 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?: NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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 078619

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

FDA NDC Directory listings under ANDA 078619
Product	Strength	Form · route	Labeler	Product NDC
Fluoxetinefluoxetine hydrochloride	Fluoxetine hydrochloride 10 mg/1	CapsuleOral	BluePoint Laboratories	68001-399
Fluoxetine	Fluoxetine hydrochloride 40 mg/1	CapsuleOral	American Health Packaging	68002-105
Fluoxetine	Fluoxetine hydrochloride 20 mg/1	CapsuleOral	Unit Dose Solutions, Inc.	87441-031
Fluoxetinefluoxetine hydrochloride	Fluoxetine hydrochloride 20 mg/1	CapsuleOral	BluePoint Laboratories	68001-400
Fluoxetinefluoxetine hydrochloride	Fluoxetine hydrochloride 40 mg/1	CapsuleOral	BluePoint Laboratories	68001-401
Fluoxetine	Fluoxetine hydrochloride 20 mg/1	CapsuleOral	NorthStar Rx LLC	72603-489
Fluoxetine	Fluoxetine hydrochloride 10 mg/1	CapsuleOral	NorthStar Rx LLC	72603-488
Fluoxetine	Fluoxetine hydrochloride 20 mg/1	CapsuleOral	A-S Medication Solutions	50090-7951
Fluoxetine	Fluoxetine hydrochloride 40 mg/1	CapsuleOral	NorthStar Rx LLC	72603-490
Fluoxetinefluoxetine hydrochloride	Fluoxetine hydrochloride 20 mg/1	CapsuleOral	A-S Medication Solutions	50090-0745
Fluoxetinefluoxetine hydrochloride	Fluoxetine hydrochloride 40 mg/1	CapsuleOral	PD-Rx Pharmaceuticals, Inc.	43063-993
Fluoxetine	Fluoxetine hydrochloride 20 mg/1	CapsuleOral	A-S Medication Solutions	50090-7952
Fluoxetinefluoxetine hydrochloride	Fluoxetine hydrochloride 20 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-0417
Fluoxetinefluoxetine hydrochloride	Fluoxetine hydrochloride 20 mg/1	CapsuleOral	Cardinal Health 107, LLC	55154-2638
Fluoxetine	Fluoxetine hydrochloride 10 mg/1	CapsuleOral	Coupler LLC	67046-1695
Fluoxetinefluoxetine hydrochloride	Fluoxetine hydrochloride 20 mg/1	CapsuleOral	Aurobindo Pharma Limited	65862-193
Fluoxetinefluoxetine hydrochloride	Fluoxetine hydrochloride 10 mg/1	CapsuleOral	Aurobindo Pharma Limited	65862-192
Fluoxetinefluoxetine hydrochloride	Fluoxetine hydrochloride 40 mg/1	CapsuleOral	Aurobindo Pharma Limited	65862-194
Fluoxetinefluoxetine hydrochloride	Fluoxetine hydrochloride 40 mg/1	CapsuleOral	Northwind Health Company, LLC	51655-981
Fluoxetinefluoxetine hydrochloride	Fluoxetine hydrochloride 40 mg/1	CapsuleOral	A-S Medication Solutions	50090-6064

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