Prescription drug · ANDA
Fluoxetine (fluoxetine hydrochloride) NDC 17224-171
Fluoxetine hydrochloride 10 mg/1 · Capsule · Oral · Calvin Scott & Co., Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 17224-171-21 | 17224017121 | 21 CAPSULE in 1 BOTTLE (17224-171-21)Marketed from Mar 16, 2015 | |
| 17224-171-30 | 17224017130 | 30 CAPSULE in 1 BOTTLE (17224-171-30)Marketed from Mar 16, 2015 |
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 — 10 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Calvin Scott & Co., Inc.
- 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 17224-171_f709b80f-6425-790e-e053-6394a90a17fcSPL ID f709b80f-6425-790e-e053-6394a90a17fcSPL set ID 3453755b-3ed6-47a3-b4c7-c64758e7784cRxCUI 310384UNII 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
N417224017121followed by a unit qualifier and the quantityPackage 17224-0171-21. 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.
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 40 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2221 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6702 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0923 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | Calvin Scott & Co., Inc. | 17224-174 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | Coupler LLC | 67046-2083 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 40 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7899 |
| Fluoxetine HCL | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | Direct_rx | 72189-656 |
| 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 | Medsource Pharmaceuticals | 45865-174 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-545 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1033 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 40 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1482 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 40 mg/1 | CapsuleOral | Coupler LLC | 67046-0552 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 40 mg/1 | CapsuleOral | Proficient Rx LP | 63187-361 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-2275 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | Proficient Rx LP | 71205-974 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | Proficient Rx LP | 71205-975 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-5240 |
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