Prescription drug · ANDA
Sertraline NDC 70518-4425
Sertraline hydrochloride 25 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4425-0 | 7051844250070518442500 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4425-0)Marketed from Aug 5, 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)
- Sertraline
- Generic name (nonproprietary)
- sertraline
- Active ingredients
- Sertraline hydrochloride — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076465
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 70518-4425_5b2562a8-5323-14ca-e063-6294a90a136fSPL ID 5b2562a8-5323-14ca-e063-6294a90a136f
- 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
N470518442500followed by a unit qualifier and the quantityPackage 70518-4425-00. 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 70518-4425
- What is NDC 70518-4425?
- 70518-4425 is the product NDC for Sertraline, Sertraline hydrochloride 25 mg/1 tablet, film coated, 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?
- Sertraline.
- What is the active ingredient?
- Sertraline 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 Sertraline?
- 31 other product NDCs are listed under this name. See all Sertraline NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sertraline products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sertraline | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4183 | 68788-4183-0168788-4183-0368788-4183-06+1 more |
| Sertraline | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-683 | 60760-0683-90 |
| Sertraline | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8669 | 68788-8669-0168788-8669-0268788-8669-03+3 more |
| Sertraline | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-768 | 50268-0768-15 |
| Sertraline | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-769 | 50268-0769-15 |
| Sertraline | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-770 | 50268-0770-15 |
| Sertraline | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-757 | 23155-0757-0323155-0757-0523155-0757-09 |
| Sertraline | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-758 | 23155-0758-0323155-0758-0523155-0758-09+1 more |
| Sertraline | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-759 | 23155-0759-0323155-0759-0523155-0759-09 |
| Sertraline | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7614 | 50090-7614-0050090-7614-01 |
Other NDCs under ANDA 076465
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 |
|---|---|---|---|---|
| Sertraline | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-757 |
| Sertraline | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-758 |
| Sertraline | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-759 |
| Sertraline | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7614 |
| Sertraline | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7615 |
| Sertraline | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-683 |
| Sertraline | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4183 |
| Sertraline | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2659 |
| Sertraline | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3115 |
| Sertraline | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2411 |