Prescription drug · ANDA
Fluoxetine NDC 70518-3752
Fluoxetine hydrochloride 10 mg/1 · Capsule · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-3752-0 | 70518375200 | 30 CAPSULE in 1 BLISTER PACK (70518-3752-0)Marketed from Jun 8, 2023 |
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 — 10 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- REMEDYREPACK 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 70518-3752_4f830563-ed78-a516-e063-6394a90a1ca1SPL ID 4f830563-ed78-a516-e063-6394a90a1ca1SPL set ID a1b40d46-5233-49d7-9833-762cb6999012RxCUI 310384UNII 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
N470518375200followed by a unit qualifier and the quantityPackage 70518-3752-00. 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 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 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 | NuCare Pharmaceuticals,Inc. | 68071-4033 |
| 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 |