Prescription drug · ANDA
Fluoxetine (Fluoxetine hydrochloride) NDC 70518-1174
Fluoxetine hydrochloride 10 mg/1 · Capsule · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-1174-2 | 70518117402 | 30 CAPSULE in 1 BOTTLE, PLASTIC (70518-1174-2)Marketed from Aug 27, 2025 |
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 hydrochloride
- Active ingredients
- Fluoxetine hydrochloride — 10 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 70518-1174_55b529c8-63f8-9549-e063-6294a90aa6e5SPL ID 55b529c8-63f8-9549-e063-6294a90aa6e5SPL set ID 32afb28a-dc4c-4a7e-9701-1825f805e7dfRxCUI 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
N470518117402followed by a unit qualifier and the quantityPackage 70518-1174-02. 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.
About NDC 70518-1174
- What is NDC 70518-1174?
- 70518-1174 is the product NDC for Fluoxetine (fluoxetine hydrochloride), Fluoxetine hydrochloride 10 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 (Fluoxetine Hydrochloride).
- 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?
- 193 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) |
|---|---|---|---|---|---|
| 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 |
| Fluoxetine | Fluoxetine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 84386-104 | 84386-0104-0184386-0104-30 |
| 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 | Northwind Health Company, LLC | 51655-100 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-0745 |
| Fluoxetine | Fluoxetine hydrochloride 40 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-900 |
| Fluoxetine | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-898 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-899 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6065 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4576 |
| Fluoxetine | Fluoxetine hydrochloride 40 mg/1 | CapsuleOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8612 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 40 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6064 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 40 mg/1 | CapsuleOral | American Health Packaging | 60687-659 |
| Fluoxetine | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | Northwind Health Company, LLC | 82868-105 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 40 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1145 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 40 mg/1 | CapsuleOral | CouplerLLC | 67046-1580 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 40 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 43063-993 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 10 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7345 |
| 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 40 mg/1 | CapsuleOral | NorthStar Rx LLC | 72603-490 |
| Fluoxetinefluoxetine hydrochloride | Fluoxetine hydrochloride 40 mg/1 | CapsuleOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8183 |
| Fluoxetine | Fluoxetine hydrochloride 20 mg/1 | CapsuleOral | Unit Dose Solutions, Inc. | 87441-031 |
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