Fluoxetine NDC 72241-008

NDC codes

FDA NDC Directory

Product NDC (as listed)72241-008Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72241-0008Add 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
72241-008-05	72241000805	100 CAPSULE in 1 BOTTLE (72241-008-05)Marketed from Sep 8, 2021
72241-008-10	72241000810	500 CAPSULE in 1 BOTTLE (72241-008-10)Marketed from Sep 8, 2021
72241-008-11	72241000811	1000 CAPSULE in 1 BOTTLE (72241-008-11)Marketed from Sep 8, 2021
72241-008-22	72241000822	30 CAPSULE in 1 BOTTLE (72241-008-22)Marketed from Sep 8, 2021

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: Modavar Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206993
Marketing start: Sep 8, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 72241-008_f35d566f-6a36-4ba8-8f78-6c1d79900e9aSPL ID f35d566f-6a36-4ba8-8f78-6c1d79900e9aSPL set ID 05b0781b-50e2-4311-bde0-430b96e2ef8eRxCUI 310384, 310385, 313989UNII I9W7N6B1KJUPC 0372241008115, 0372241007224, 0372241008221, 0372241009228
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

N472241000805 followed by a unit qualifier and the quantity

Package 72241-0008-05. 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 Jul 12, 2024. 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 is indicated for the treatment of: • Acute treatment of depressive episodes associated with …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 206993

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

FDA NDC Directory listings under ANDA 206993
Product	Strength	Form · route	Labeler	Product NDC
Fluoxetine	Fluoxetine hydrochloride 20 mg/1	CapsuleOral	Coupler LLC	67046-1670
Fluoxetine	Fluoxetine hydrochloride 10 mg/1	CapsuleOral	PD-Rx Pharmaceuticals, Inc.	72789-557
Fluoxetine	Fluoxetine hydrochloride 10 mg/1	CapsuleOral	Modavar Pharmaceuticals LLC	72241-007
Fluoxetine	Fluoxetine hydrochloride 40 mg/1	CapsuleOral	Modavar Pharmaceuticals LLC	72241-009
Fluoxetine	Fluoxetine hydrochloride 20 mg/1	CapsuleOral	Cadila Pharmaceuticals Limited	71209-041
Fluoxetine	Fluoxetine hydrochloride 10 mg/1	CapsuleOral	Cadila Pharmaceuticals Limited	71209-040
Fluoxetine	Fluoxetine hydrochloride 40 mg/1	CapsuleOral	Cadila Pharmaceuticals Limited	71209-042