Fluoxetine HCl NDC 64380-900

NDC codes

FDA NDC Directory

Product NDC (as listed)64380-900Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64380-0900Add 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
64380-900-04	64380090004	30 TABLET in 1 BOTTLE (64380-900-04)Marketed from Nov 8, 2024

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 HCl
Generic name (nonproprietary): fluoxetine hcl
Active ingredients: Fluoxetine — 60 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Strides Pharma Science Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212683
Marketing start: Nov 8, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 64380-900_adcbffe8-9a0c-421a-9a18-21faac0207ebSPL ID adcbffe8-9a0c-421a-9a18-21faac0207ebSPL set ID d09a5026-b3eb-403f-bf31-d5991a81a8ceRxCUI 1190110UNII 01K63SUP8DUPC 0364380900047
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

N464380090004 followed by a unit qualifier and the quantity

Package 64380-0900-04. 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 Dec 16, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Fluoxetine tablets are indicated for the treatment of: Major Depressive Disorder (MDD). The efficacy of fluoxetine tablets in MDD was established in one 5-week trial, three 6-week trials, and one maintenance study in adults. The efficacy of fluoxetine tablets was also established in two 8- to 9-week trials in pediatric patients 8 to 18 years of age [see Clinical Studies (14.1)]. Obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD). The efficacy of fluoxetine tablets in OCD was demonstrated in two 13-week trials in adults and one 13-week trial in pediatric patients 7 to 17 years of age [see Clinical Studies (14.2)]. Binge-eating and vomiting behaviors in patients wi…

Excerpt only. Read the full label for complete information.

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