Prescription drug · ANDA
Fluoxetine NDC 71209-040
Fluoxetine hydrochloride 10 mg/1 · Capsule · Oral · Cadila Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71209-040-01 | 71209004001 | 30 CAPSULE in 1 BOTTLE (71209-040-01)Marketed from Dec 15, 2022 | |
| 71209-040-05 | 71209004005 | 100 CAPSULE in 1 BOTTLE (71209-040-05)Marketed from Dec 15, 2022 | |
| 71209-040-10 | 71209004010 | 500 CAPSULE in 1 BOTTLE (71209-040-10)Marketed from Dec 15, 2022 | |
| 71209-040-11 | 71209004011 | 1000 CAPSULE in 1 BOTTLE (71209-040-11)Marketed from Dec 15, 2022 |
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 206993
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 71209-040_1922c101-5662-4952-9ac2-6470bbfd5ad3SPL ID 1922c101-5662-4952-9ac2-6470bbfd5ad3SPL set ID 9651816f-58f5-4bf8-8183-6f3d84d36b5cRxCUI 310384, 310385, 313989UNII I9W7N6B1KJUPC 0371209041119, 0371209040013, 0371209042109, 0371209042055, 0371209041010, 0371209040051, 0371209041058, 0371209042017
- 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
N471209004001followed by a unit qualifier and the quantityPackage 71209-0040-01. 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 is indicated for the treatment of: • Acute treatment of depressive episodes associated with …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206993
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 | Coupler LLC | 67046-1670 |
| Fluoxetine | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-557 |
| Fluoxetine | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | Modavar Pharmaceuticals LLC | 72241-007 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | Modavar Pharmaceuticals LLC | 72241-008 |
| Fluoxetine | Fluoxetine hydrochloride 40 mg/1 | CapsuleOral | Modavar Pharmaceuticals LLC | 72241-009 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | Cadila Pharmaceuticals Limited | 71209-041 |
| Fluoxetine | Fluoxetine hydrochloride 40 mg/1 | CapsuleOral | Cadila Pharmaceuticals Limited | 71209-042 |