Prescription drug · ANDA
Fluoxetine NDC 70518-4576
Fluoxetine hydrochloride 20 mg/1 · Capsule · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4576-0 | 7051845760070518457600 | 30 CAPSULE in 1 BLISTER PACK (70518-4576-0)Marketed from Feb 17, 2026 |
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
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078619
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 70518-4576_5baf473a-7199-d2b1-e063-6394a90a0374SPL ID 5baf473a-7199-d2b1-e063-6394a90a0374
- 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
N470518457600followed by a unit qualifier and the quantityPackage 70518-4576-00. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 70518-4576
- What is NDC 70518-4576?
- 70518-4576 is the product NDC for Fluoxetine, Fluoxetine hydrochloride 20 mg/1 capsule, listed with the FDA by REMEDYREPACK INC.. 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?
- REMEDYREPACK INC., NDC labeler code 70518. 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 60 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 84386-106 | 84386-0106-30 |
Other NDCs under ANDA 078619
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 20 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7346 |
| Fluoxetine | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | Northwind Health Company, LLC | 82868-105 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-400 |
| Fluoxetine | Fluoxetine hydrochloride 40 mg/1 | CapsuleOral | American Health Packaging | 68002-105 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-399 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 40 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-401 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | Unit Dose Solutions, Inc. | 87441-031 |
| Fluoxetine | Fluoxetine hydrochloride 40 mg/1 | CapsuleOral | NorthStar Rx LLC | 72603-490 |
| Fluoxetine | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | NorthStar Rx LLC | 72603-488 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | NorthStar Rx LLC | 72603-489 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7952 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-0745 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7951 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-2638 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 40 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 43063-993 |
| Fluoxetine | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | Coupler LLC | 67046-1695 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-0417 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 40 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-194 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-192 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-193 |
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