Fluoxetine Hydrochloride NDC 68180-998

NDC codes

FDA NDC Directory

Product NDC (as listed)68180-998Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68180-0998Add 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
68180-998-01	68180099801	100 TABLET in 1 BOTTLE (68180-998-01)Marketed from Aug 7, 2019
68180-998-06	68180099806	30 TABLET in 1 BOTTLE (68180-998-06)Marketed from Aug 7, 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 Hydrochloride
Generic name (nonproprietary): fluoxetine hydrochloride
Active ingredients: Fluoxetine hydrochloride — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Lupin Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211653
Marketing start: Aug 7, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 68180-998_71041a6b-43e4-415c-a1a6-dbd55a09a0d6SPL ID 71041a6b-43e4-415c-a1a6-dbd55a09a0d6SPL set ID dd659085-c32d-4d35-9d4b-bafa2a93f1fbRxCUI 248642, 313990UNII I9W7N6B1KJUPC 0368180998068, 0368180999065
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

N468180099801 followed by a unit qualifier and the quantity

Package 68180-0998-01. 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 is 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 is indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to 18 years [see Clinical Studi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 211653

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

FDA NDC Directory listings under ANDA 211653
Product	Strength	Form · route	Labeler	Product NDC
Fluoxetine Hydrochloride	Fluoxetine hydrochloride 20 mg/1	TabletOral	Lupin Pharmaceuticals, Inc.	68180-999