Prescription drug · ANDA
Fluoxetine NDC 50111-647
Fluoxetine hydrochloride 10 mg/1 · Capsule · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50111-647-01 | 50111064701 | 100 CAPSULE in 1 BOTTLE (50111-647-01)Marketed from Jan 29, 2002 | |
| 50111-647-02 | 50111064702 | 500 CAPSULE in 1 BOTTLE (50111-647-02)Marketed from Jan 29, 2002 | |
| 50111-647-03 | 50111064703 | 1000 CAPSULE in 1 BOTTLE (50111-647-03)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
- 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 50111-647_424ed364-e023-472f-b113-673e9342a7f1SPL ID 424ed364-e023-472f-b113-673e9342a7f1SPL set ID 06d71a33-5578-4012-b11d-764f45bc1e6aRxCUI 310384, 310385UNII I9W7N6B1KJ
- 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
N450111064701followed by a unit qualifier and the quantityPackage 50111-0647-01. 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 . 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 with Bipolar…
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 | Proficient Rx LP | 63187-233 |
| 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 20 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 50111-648 |