Prescription drug · ANDA
fluoxetine hydrochloride NDC 63629-2197
Fluoxetine hydrochloride 10 mg/1 · Tablet, Coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-2197-1 | 63629219701 | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (63629-2197-1)Marketed from Aug 22, 2016 |
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 hydrochloride
- Generic name (nonproprietary)
- fluoxetine hydrochloride
- Active ingredients
- Fluoxetine hydrochloride — 10 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203836
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 63629-2197_39664421-6993-4496-b666-0afdec138766SPL ID 39664421-6993-4496-b666-0afdec138766SPL set ID fb0608d9-1ae3-43be-8a20-e9f34e955862RxCUI 313990UNII 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
N463629219701followed by a unit qualifier and the quantityPackage 63629-2197-01. 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 is a selective serotonin reuptake inhibitor indicated for: Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years (1.1) Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adults and pediatric patients aged 7 to 17 years (1.2) Acute and maintenance treatment of Bulimia Nervosa in adult patients (1.3) Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients (1.4) Indication Adult Pediatric MDD (2.1) 20 mg/day in am (initial dose) 10 to 20 mg/day (initial dose) OCD (2.2) 20 mg/day in am (initial dose) 10 mg/day (initial dose) Bulimia Nervosa (2.3) 60 mg/day in am Panic Disor…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203836
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 hydrochloride | Fluoxetine hydrochloride 10 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 63629-2198 |
| fluoxetine hydrochloride | Fluoxetine hydrochloride 20 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 63629-2200 |
| fluoxetine hydrochloride | Fluoxetine hydrochloride 10 mg/1 | Tablet, CoatedOral | Par Health USA, LLC | 49884-335 |
| fluoxetine hydrochloride | Fluoxetine hydrochloride 20 mg/1 | Tablet, CoatedOral | Par Health USA, LLC | 49884-336 |
| fluoxetine hydrochloride | Fluoxetine hydrochloride 10 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 63629-8989 |
| fluoxetine hydrochloride | Fluoxetine hydrochloride 20 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 63629-8990 |
| fluoxetine hydrochloride | Fluoxetine hydrochloride 10 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 72162-1494 |
| fluoxetine hydrochloride | Fluoxetine hydrochloride 20 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 72162-1495 |