Prescription drug · ANDA
Fluoxetine (Fluoxetine hydrochloride) NDC 49483-703
Fluoxetine hydrochloride 40 mg/1 · Capsule · Oral · TIME CAP LABORATORIES, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49483-703-01 | 4948307030149483070301 | 100 CAPSULE in 1 BOTTLE (49483-703-01)Marketed from Feb 12, 2022 | |
| 49483-703-03 | 4948307030349483070303 | 30 CAPSULE in 1 BOTTLE (49483-703-03)Marketed from Feb 12, 2022 | |
| 49483-703-50 | 4948307035049483070350 | 500 CAPSULE in 1 BOTTLE (49483-703-50)Marketed from Feb 12, 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 hydrochloride
- Active ingredients
- Fluoxetine hydrochloride — 40 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- TIME CAP LABORATORIES, INC.NDC labeler code 49483
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075465
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 49483-703_22f2136b-5f0f-f6c7-e063-6394a90a907cSPL ID 22f2136b-5f0f-f6c7-e063-6394a90a907cSPL set ID d7a4db7f-cdac-2b36-e053-2995a90a8d64RxCUI 310384, 310385, 313989UNII I9W7N6B1KJUPC 0349483703030, 0349483703504, 0349483702019, 0349483703016, 0349483701012, 0349483702101
- 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
N449483070301followed by a unit qualifier and the quantityPackage 49483-0703-01. 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 and Olanzapine in Combination is indicated for the treatment of: • Acute treatment of depressive episodes associated with Bipolar I…
Excerpt only. Read the full label for complete information.
About NDC 49483-703
- What is NDC 49483-703?
- 49483-703 is the product NDC for Fluoxetine (fluoxetine hydrochloride), Fluoxetine hydrochloride 40 mg/1 capsule, listed with the FDA by TIME CAP LABORATORIES, INC.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fluoxetine (Fluoxetine Hydrochloride).
- What is the active ingredient?
- Fluoxetine hydrochloride.
- Who is the labeler?
- TIME CAP LABORATORIES, INC., NDC labeler code 49483. 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 075465
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 10 mg/1 | CapsuleOral | MARKSANS PHARMA LIMITED | 25000-147 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | MARKSANS PHARMA LIMITED | 25000-148 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 40 mg/1 | CapsuleOral | MARKSANS PHARMA LIMITED | 25000-149 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | TIME CAP LABORATORIES, INC. | 49483-701 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | TIME CAP LABORATORIES, INC. | 49483-702 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 40 mg/1 | CapsuleOral | Northwind Health Company, LLC | 51655-081 |