Fluoxetine Hydrochloride NDC 46708-243

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-243Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0243Add 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
46708-243-30	46708024330	30 TABLET, FILM COATED in 1 BOTTLE (46708-243-30)Marketed from Apr 15, 2017
46708-243-31	46708024331	100 TABLET, FILM COATED in 1 BOTTLE (46708-243-31)Marketed from Apr 15, 2017
46708-243-91	46708024391	1000 TABLET, FILM COATED in 1 BOTTLE (46708-243-91)Marketed from Apr 15, 2017

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 — 20 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Alembic Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208698
Marketing start: Apr 15, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 46708-243_563f5910-59e7-46c6-9b3d-d9c9b0efb350SPL ID 563f5910-59e7-46c6-9b3d-d9c9b0efb350SPL set ID 9c5112c0-c721-4086-9a75-3b7f931430bbRxCUI 248642, 313990UNII I9W7N6B1KJUPC 0346708242305
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

N446708024330 followed by a unit qualifier and the quantity

Package 46708-0243-30. 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 Jan 25, 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 Studies (14.1)…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 208698

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

FDA NDC Directory listings under ANDA 208698
Product	Strength	Form · route	Labeler	Product NDC
Fluoxetine Hydrochloride	Fluoxetine hydrochloride 10 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-242
Fluoxetine	Fluoxetine hydrochloride 10 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-242
Fluoxetine	Fluoxetine hydrochloride 20 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-243
Fluoxetine	Fluoxetine hydrochloride 10 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-5930