Prescription drug · ANDA
Fluoxetine NDC 63187-233
Fluoxetine hydrochloride 10 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-233-30 | 63187023330 | 30 CAPSULE in 1 BOTTLE (63187-233-30)Marketed from May 22, 2026 | |
| 63187-233-90 | 63187023390 | 90 CAPSULE in 1 BOTTLE (63187-233-90)Marketed from Jan 29, 2002 |
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 — 10 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 076001
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 63187-233_2f9a490f-f385-4bbb-863d-74bc7cd08a9dSPL ID 2f9a490f-f385-4bbb-863d-74bc7cd08a9dSPL set ID 1a2a5194-b793-4c62-a177-040dad38526bRxCUI 310384UNII I9W7N6B1KJUPC 0363187233907
- 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
N463187023330followed by a unit qualifier and the quantityPackage 63187-0233-30. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Fluoxetine Capsules USP are 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 () • Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adult and pediatric patients aged 7 to 17 years () • Acute and maintenance treatment of Bulimia Nervosa in adult patients () • Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients () Fluoxetine Capsules USP and olanzapine in combination for: • Acute treatment of Depressive Episodes Associated with Bipolar I Disorder () 1.1 Major Depressive Disorder Fluoxetine Capsules USP are indicated…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076001
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0924 |
| Fluoxetine | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3752 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | Legacy Pharmaceutical Packaging, LLC | 68645-130 |
| Fluoxetine | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | Legacy Pharmaceutical Packaging, LLC | 68645-131 |
| Fluoxetine | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4606 |
| Fluoxetine | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8093 |
| Fluoxetine | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1048 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | Proficient Rx LP | 71205-178 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | Northwind Health Company, LLC | 82868-098 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7625 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4033 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | QPharma Inc | 42708-025 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-1619 |
| Fluoxetine | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 50111-647 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 50111-648 |