What is NDC 50111-648?

50111-648 is the product NDC for Fluoxetine, Fluoxetine hydrochloride 20 mg/1 capsule, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

Teva Pharmaceuticals USA, Inc., NDC labeler code 50111. 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 50111-648 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50111-648Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50111-0648Add 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
50111-648-01	5011106480150111064801	100 CAPSULE in 1 BOTTLE (50111-648-01)Marketed from Jan 29, 2002
50111-648-02	5011106480250111064802	500 CAPSULE in 1 BOTTLE (50111-648-02)Marketed from Jan 29, 2002
50111-648-03	5011106480350111064803	1000 CAPSULE in 1 BOTTLE (50111-648-03)Marketed from Jan 29, 2002
50111-648-44	5011106484450111064844	2000 CAPSULE in 1 BOTTLE (50111-648-44)Marketed from Jan 29, 2002

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/1
Dosage form: Capsule
Route: Oral
Labeler: Teva Pharmaceuticals USA, Inc.NDC labeler code 50111
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076001
Marketing start: Jan 29, 2002
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 50111-648_424ed364-e023-472f-b113-673e9342a7f1SPL ID 424ed364-e023-472f-b113-673e9342a7f1SPL set ID 06d71a33-5578-4012-b11d-764f45bc1e6aRxCUI 310384, 310385UNII 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

N450111064801 followed by a unit qualifier and the quantity

Package 50111-0648-01. 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 Aug 1, 2023. 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50111-648

What is NDC 50111-648?: 50111-648 is the product NDC for Fluoxetine, Fluoxetine hydrochloride 20 mg/1 capsule, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 4 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?: Teva Pharmaceuticals USA, Inc., NDC labeler code 50111. 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 076001

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

FDA NDC Directory listings under ANDA 076001
Product	Strength	Form · route	Labeler	Product NDC
Fluoxetine	Fluoxetine hydrochloride 10 mg/1	CapsuleOral	Proficient Rx LP	63187-233
Fluoxetine	Fluoxetine hydrochloride 10 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-3752
Fluoxetine	Fluoxetine hydrochloride 20 mg/1	CapsuleOral	Legacy Pharmaceutical Packaging, LLC	68645-130
Fluoxetine	Fluoxetine hydrochloride 10 mg/1	CapsuleOral	Legacy Pharmaceutical Packaging, LLC	68645-131
Fluoxetine	Fluoxetine hydrochloride 20 mg/1	CapsuleOral	QPharma Inc	42708-025
Fluoxetine	Fluoxetine hydrochloride 10 mg/1	CapsuleOral	NuCare Pharmaceuticals,Inc.	68071-4606
Fluoxetine	Fluoxetine hydrochloride 20 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-0924
Fluoxetine	Fluoxetine hydrochloride 10 mg/1	CapsuleOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8093
Fluoxetine	Fluoxetine hydrochloride 10 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-1048
Fluoxetine	Fluoxetine hydrochloride 20 mg/1	CapsuleOral	NuCare Pharmaceuticals,Inc.	68071-4033
Fluoxetine	Fluoxetine hydrochloride 20 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-1619
Fluoxetine	Fluoxetine hydrochloride 20 mg/1	CapsuleOral	Proficient Rx LP	71205-178
Fluoxetine	Fluoxetine hydrochloride 10 mg/1	CapsuleOral	Teva Pharmaceuticals USA, Inc.	50111-647
Fluoxetine	Fluoxetine hydrochloride 20 mg/1	CapsuleOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-7625
Fluoxetine	Fluoxetine hydrochloride 20 mg/1	CapsuleOral	Northwind Health Company, LLC	82868-098