What is NDC 55111-150?

55111-150 is the product NDC for Fluoxetine, Fluoxetine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Dr.Reddy's Laboratories Limited. It has 5 package NDCs, shown above in 10- and 11-digit form.

Dr.Reddy's Laboratories Limited, NDC labeler code 55111. 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 55111-150 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)55111-150Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55111-0150Add 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
55111-150-01	5511101500155111015001	100 TABLET, FILM COATED in 1 BOTTLE (55111-150-01)Marketed from Sep 30, 2016
55111-150-05	5511101500555111015005	500 TABLET, FILM COATED in 1 BOTTLE (55111-150-05)Marketed from Sep 30, 2016
55111-150-10	5511101501055111015010	1000 TABLET, FILM COATED in 1 BOTTLE (55111-150-10)Marketed from Sep 30, 2016
55111-150-30	5511101503055111015030	30 TABLET, FILM COATED in 1 BOTTLE (55111-150-30)Marketed from Sep 30, 2016
55111-150-78	5511101507855111015078	10 BLISTER PACK in 1 CARTON (55111-150-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-150-79)Marketed from Sep 30, 2016

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 — 10 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Dr.Reddy's Laboratories LimitedNDC labeler code 55111
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076006
Marketing start: Sep 30, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 55111-150_ec5088cd-9e68-ba14-e274-7e3935c87f17SPL ID ec5088cd-9e68-ba14-e274-7e3935c87f17SPL set ID 11544dea-2f5e-1536-584a-5d1f37a99770RxCUI 313990UNII 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

N455111015001 followed by a unit qualifier and the quantity

Package 55111-0150-01. 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 31, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Fluoxetine is a a selective serotonin reuptake inhibitor indicated for: Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years (1.1) Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adults and pediatric patients aged 7 to 17 years (1.2) Acute and maintenance treatment of Bulimia Nervosa in adult patients (1.3) Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients (1.4) 1.1 Major Depressive Disorder Fluoxetine tablets are indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to18 years [see Clinical Stud…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 55111-150

What is NDC 55111-150?: 55111-150 is the product NDC for Fluoxetine, Fluoxetine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Dr.Reddy's Laboratories Limited. It has 5 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?: Dr.Reddy's Laboratories Limited, NDC labeler code 55111. 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 076006

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

FDA NDC Directory listings under ANDA 076006
Product	Strength	Form · route	Labeler	Product NDC
Fluoxetine	Fluoxetine hydrochloride 10 mg/1	Tablet, Film coatedOral	NorthStar Rx LLC	16714-112
Fluoxetine	Fluoxetine hydrochloride 20 mg/1	Tablet, Film coatedOral	NorthStar Rx LLC	16714-113
Fluoxetine	Fluoxetine hydrochloride 20 mg/1	Tablet, Film coatedOral	Dr.Reddy's Laboratories Inc.	43598-566