Prescription drug · ANDA
Fluoxetine (fluoxetine hydrochloride) NDC 50090-7232
Fluoxetine hydrochloride 40 mg/1 · Capsule · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-7232-0 | 50090723200 | 90 CAPSULE in 1 BOTTLE (50090-7232-0)Marketed from Aug 26, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 40 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078619
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 50090-7232_19fd63e7-d4bf-46c7-b13e-9cab103447b9SPL ID 19fd63e7-d4bf-46c7-b13e-9cab103447b9SPL set ID 2f302db0-1c88-44cf-8258-3c1c60afb5a4RxCUI 313989UNII 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
N450090723200followed by a unit qualifier and the quantityPackage 50090-7232-00. 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 I…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078619
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 20 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-0417 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 40 mg/1 | CapsuleOral | Northwind Health Company, LLC | 51655-981 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 83209-192 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | NorthStar Rx LLC | 16714-721 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-192 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-193 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | NorthStar Rx LLC | 16714-720 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | QPharma Inc | 42708-182 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 40 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-194 |
| Fluoxetine | Fluoxetine hydrochloride 40 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7914 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 40 mg/1 | CapsuleOral | NorthStar Rx LLC | 16714-722 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 83209-721 |
| Fluoxetine | Fluoxetine hydrochloride 40 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7915 |
| Fluoxetine | Fluoxetine hydrochloride 40 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-554 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | QPharma Inc | 42708-200 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | QUALLENT PHARMACEUTICALS HEALTH LLC | 82009-100 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | QUALLENT PHARMACEUTICALS HEALTH LLC | 82009-101 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 40 mg/1 | CapsuleOral | QUALLENT PHARMACEUTICALS HEALTH LLC | 82009-102 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7951 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7952 |
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