Prescription drug · ANDA
Fluoxetine NDC 55111-150
Fluoxetine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Dr.Reddy's Laboratories Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55111-150-01 | 55111015001 | 100 TABLET, FILM COATED in 1 BOTTLE (55111-150-01)Marketed from Sep 30, 2016 | |
| 55111-150-05 | 55111015005 | 500 TABLET, FILM COATED in 1 BOTTLE (55111-150-05)Marketed from Sep 30, 2016 | |
| 55111-150-10 | 55111015010 | 1000 TABLET, FILM COATED in 1 BOTTLE (55111-150-10)Marketed from Sep 30, 2016 | |
| 55111-150-30 | 55111015030 | 30 TABLET, FILM COATED in 1 BOTTLE (55111-150-30)Marketed from Sep 30, 2016 | |
| 55111-150-78 | 55111015078 | 10 BLISTER PACK in 1 CARTON (55111-150-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-150-79)Marketed from Sep 30, 2016 |
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
- Tablet, Film coated
- Route
- Oral
- 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 55111-150_ec5088cd-9e68-ba14-e274-7e3935c87f17SPL ID ec5088cd-9e68-ba14-e274-7e3935c87f17SPL set ID 11544dea-2f5e-1536-584a-5d1f37a99770RxCUI 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
N455111015001followed by a unit qualifier and the quantityPackage 55111-0150-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 20 mg/1 | Tablet, Film coatedOral | Dr.Reddy's Laboratories Inc. | 43598-566 |