Prescription drug · ANDA
Fluoxetine NDC 68071-4033
Fluoxetine hydrochloride 20 mg/1 · Capsule · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-4033-1 | 68071403301 | 15 CAPSULE in 1 BOTTLE (68071-4033-1)Marketed from Aug 7, 2017 | |
| 68071-4033-2 | 68071403302 | 20 CAPSULE in 1 BOTTLE (68071-4033-2)Marketed from Aug 7, 2017 | |
| 68071-4033-3 | 68071403303 | 30 CAPSULE in 1 BOTTLE (68071-4033-3)Marketed from Aug 7, 2017 | |
| 68071-4033-5 | 68071403305 | 56 CAPSULE in 1 BOTTLE (68071-4033-5)Marketed from Aug 7, 2017 | |
| 68071-4033-6 | 68071403306 | 60 CAPSULE in 1 BOTTLE (68071-4033-6)Marketed from Aug 7, 2017 | |
| 68071-4033-8 | 68071403308 | 28 CAPSULE in 1 BOTTLE (68071-4033-8)Marketed from Aug 7, 2017 | |
| 68071-4033-9 | 68071403309 | 90 CAPSULE in 1 BOTTLE (68071-4033-9)Marketed from Aug 7, 2017 |
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
- Generic name (nonproprietary)
- fluoxetine
- Active ingredients
- Fluoxetine hydrochloride — 20 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.
- 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 68071-4033_1d7a47ee-fcdb-167d-e063-6294a90a8323SPL ID 1d7a47ee-fcdb-167d-e063-6294a90a8323SPL set ID 5631bb72-798a-6efc-e054-00144ff8d46cRxCUI 310385UNII I9W7N6B1KJUPC 0368071403336
- 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
N468071403301followed by a unit qualifier and the quantityPackage 68071-4033-01. 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 capsules and Olanzapine in Combination are indicated for the treatment of: Acute treatment of depressive episodes associated with Bipolar…
Excerpt only. Read the full label for complete information.
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 20 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0924 |
| 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 20 mg/1 | CapsuleOral | Legacy Pharmaceutical Packaging, LLC | 68645-130 |
| Fluoxetine | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | Legacy Pharmaceutical Packaging, LLC | 68645-131 |
| Fluoxetine | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4606 |
| 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 | Proficient Rx LP | 71205-178 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | Northwind Health Company, LLC | 82868-098 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7625 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | QPharma Inc | 42708-025 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-1619 |
| 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 |