Fluoxetine NDC 71205-188

NDC codes

FDA NDC Directory

Product NDC (as listed)71205-188Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71205-0188Add 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
71205-188-30	71205018830	30 CAPSULE in 1 BOTTLE (71205-188-30)Marketed from Jan 1, 2019
71205-188-60	71205018860	60 CAPSULE in 1 BOTTLE (71205-188-60)Marketed from Jan 1, 2019
71205-188-90	71205018890	90 CAPSULE in 1 BOTTLE (71205-188-90)Marketed from Jan 1, 2019

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 — 40 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Proficient Rx LP
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075452
Marketing start: Jan 30, 2002
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 71205-188_9c7dbd85-1235-4b6f-98df-deec21ca815bSPL ID 9c7dbd85-1235-4b6f-98df-deec21ca815bSPL set ID 5ebf287e-fc95-4a2c-a496-62c7cf6cbf38RxCUI 313989UNII I9W7N6B1KJUPC 0371205188306
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

N471205018830 followed by a unit qualifier and the quantity

Package 71205-0188-30. 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 Oct 1, 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 are indicated for the treatment of: • Acute treatment of depressive episodes associated wi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 075452

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

FDA NDC Directory listings under ANDA 075452
Product	Strength	Form · route	Labeler	Product NDC
Fluoxetine	Fluoxetine hydrochloride 40 mg/1	CapsuleOral	Teva Pharmaceuticals USA, Inc.	0093-7198