Prescription drug · ANDA
Fluoxetine (Fluoxetine hydrochloride) NDC 53401-024
Fluoxetine hydrochloride 20 mg/1 · Capsule · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53401-024-92 | 53401002492 | 270 CAPSULE in 1 BOTTLE (53401-024-92)Marketed from Aug 3, 2026 |
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 hydrochloride
- Active ingredients
- Fluoxetine hydrochloride — 20 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 53401
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204597
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 53401-024_583c5021-2949-7db4-e063-6294a90ae7dcSPL ID 583c5021-2949-7db4-e063-6294a90ae7dcSPL set ID 583c5021-2948-7db4-e063-6294a90ae7dcRxCUI 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
N453401002492followed by a unit qualifier and the quantityPackage 53401-0024-92. 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 is 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 and Olanzapine in Combination is indicated for the treatment of: Acute treatment of depressive episodes associated with Bipolar I Disorder. Treatment…
Excerpt only. Read the full label for complete information.
About NDC 53401-024
- What is NDC 53401-024?
- 53401-024 is the product NDC for Fluoxetine (fluoxetine hydrochloride), Fluoxetine hydrochloride 20 mg/1 capsule, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fluoxetine (Fluoxetine Hydrochloride).
- What is the active ingredient?
- Fluoxetine hydrochloride.
- Who is the labeler?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 53401. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fluoxetine?
- 193 other product NDCs are listed under this name. See all Fluoxetine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fluoxetine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fluoxetine | Fluoxetine hydrochloride 40 mg/1 | CapsuleOral | American Health Packaging | 68002-105 | 68002-0105-01 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | Unit Dose Solutions, Inc. | 87441-031 | 87441-0031-01 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 40 mg/1 | CapsuleOral | Coupler LLC | 67046-0552 | 67046-0552-03 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | Coupler LLC | 67046-2083 | 67046-2083-03 |
| Fluoxetine | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4611 | 70518-4611-00 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | Coupler LLC | 67046-1670 | 67046-1670-03 |
| Fluoxetine | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | Northwind Health Company, LLC | 82868-105 | 82868-0105-3082868-0105-90 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4576 | 70518-4576-00 |
| Fluoxetine | Fluoxetine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 84386-104 | 84386-0104-0184386-0104-30 |
| Fluoxetine | Fluoxetine hydrochloride 60 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 84386-106 | 84386-0106-30 |
Other NDCs under ANDA 204597
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 |
|---|---|---|---|---|
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | Calvin Scott & Co., Inc. | 17224-171 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | Calvin Scott & Co., Inc. | 17224-174 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | Vensun Pharmaceuticals, Inc. | 42543-725 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | Vensun Pharmaceuticals, Inc. | 42543-726 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 40 mg/1 | CapsuleOral | Vensun Pharmaceuticals, Inc. | 42543-727 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | Medsource Pharmaceuticals | 45865-174 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 40 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-5678 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6193 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6574 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6702 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7225 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7226 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 40 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7899 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc. | 50228-113 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc. | 50228-114 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 40 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc. | 50228-115 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | Northwind Health Company, LLC | 51655-274 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | Northwind Health Company, LLC | 51655-314 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-311 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 40 mg/1 | CapsuleOral | Proficient Rx LP | 63187-361 |
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