Prescription drug · ANDA
Fluoxetine NDC 68645-130
Fluoxetine hydrochloride 20 mg/1 · Capsule · Oral · Legacy Pharmaceutical Packaging, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68645-130-54 | 6864501305468645013054 | 30 CAPSULE in 1 BOTTLE (68645-130-54)Marketed from Jan 25, 2011 |
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
- Capsule
- Route
- Oral
- Labeler
- Legacy Pharmaceutical Packaging, LLCNDC labeler code 68645
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076001
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 68645-130_4c222d2c-813c-5520-e063-6294a90affe6SPL ID 4c222d2c-813c-5520-e063-6294a90affe6SPL set ID b07f9eab-44ac-4667-bd46-52d736daa5d6RxCUI 310384, 310385UNII I9W7N6B1KJUPC 0368645130545
- 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
N468645013054followed by a unit qualifier and the quantityPackage 68645-0130-54. 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 are indicated for the treatment of: Acute treatment of depressive episodes associated with Bipolar I Disor…
Excerpt only. Read the full label for complete information.
About NDC 68645-130
- What is NDC 68645-130?
- 68645-130 is the product NDC for Fluoxetine, Fluoxetine hydrochloride 20 mg/1 capsule, listed with the FDA by Legacy Pharmaceutical Packaging, LLC. It has 1 package NDC, 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?
- Legacy Pharmaceutical Packaging, LLC, NDC labeler code 68645. 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 076001
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 | CapsuleOral | Proficient Rx LP | 63187-233 |
| Fluoxetine | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3752 |
| Fluoxetine | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | Legacy Pharmaceutical Packaging, LLC | 68645-131 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | QPharma Inc | 42708-025 |
| Fluoxetine | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4606 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0924 |
| Fluoxetine | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8093 |
| Fluoxetine | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1048 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4033 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-1619 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | Proficient Rx LP | 71205-178 |
| Fluoxetine | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 50111-647 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 50111-648 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7625 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | Northwind Health Company, LLC | 82868-098 |