Prescription drug · ANDA
Fluoxetine NDC 43598-566
Fluoxetine hydrochloride 20 mg/1 · Tablet, Film coated · Oral · Dr.Reddy's Laboratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-566-01 | 4359805660143598056601 | 100 TABLET, FILM COATED in 1 BOTTLE (43598-566-01)Marketed from May 8, 2018 | |
| 43598-566-10 | 4359805661043598056610 | 1000 TABLET, FILM COATED in 1 BOTTLE (43598-566-10)Marketed from May 8, 2018 | |
| 43598-566-30 | 4359805663043598056630 | 30 TABLET, FILM COATED in 1 BOTTLE (43598-566-30)Marketed from May 8, 2018 |
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 — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Dr.Reddy's Laboratories Inc.NDC labeler code 43598
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076006
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 43598-566_5d9a91f6-93bc-2002-8876-20139830dbb1SPL ID 5d9a91f6-93bc-2002-8876-20139830dbb1SPL set ID 390c61e6-14dd-4391-45b8-0fb5f4652723RxCUI 248642UNII 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
N443598056601followed by a unit qualifier and the quantityPackage 43598-0566-01. 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 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) 1.1 Major Depressive Disorder Fluoxetine tablets are indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to18 years [see Clinical Stud…
Excerpt only. Read the full label for complete information.
About NDC 43598-566
- What is NDC 43598-566?
- 43598-566 is the product NDC for Fluoxetine, Fluoxetine hydrochloride 20 mg/1 tablet, film coated, listed with the FDA by Dr.Reddy's Laboratories Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fluoxetine.
- What is the active ingredient?
- Fluoxetine hydrochloride.
- Who is the labeler?
- Dr.Reddy's Laboratories Inc., NDC labeler code 43598. 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?
- 200 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) |
|---|---|---|---|---|---|
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | Coupler LLC | 67046-0405 | 67046-0405-03 |
| Fluoxetine | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | Coupler LLC | 67046-1695 | 67046-1695-03 |
| 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 |
Other NDCs under ANDA 076006
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 10 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-112 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-113 |
| Fluoxetine | Fluoxetine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Dr.Reddy's Laboratories Limited | 55111-150 |