Prescription drug · ANDA
Sertraline hydrochloride NDC 70518-4707
Sertraline hydrochloride 100 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4707-0 | 7051847070070518470700 | 100 POUCH in 1 BOX (70518-4707-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4707-1)Marketed from Jul 21, 2026 | |
| 70518-4707-2 | 7051847070270518470702 | 100 POUCH in 1 BOX (70518-4707-2) / 1 TABLET, FILM COATED in 1 POUCH (70518-4707-3)Marketed from Sep 23, 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)
- Sertraline hydrochloride
- Generic name (nonproprietary)
- sertraline hydrochloride
- Active ingredients
- Sertraline hydrochloride — 100 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 078403
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 70518-4707_5c2b456c-2e05-d383-e063-6294a90aeaa3SPL ID 5c2b456c-2e05-d383-e063-6294a90aeaa3
- 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
N470518470700followed by a unit qualifier and the quantityPackage 70518-4707-00. 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 70518-4707
- What is NDC 70518-4707?
- 70518-4707 is the product NDC for Sertraline hydrochloride, Sertraline hydrochloride 100 mg/1 tablet, film coated, listed with the FDA by REMEDYREPACK INC.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sertraline hydrochloride.
- 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 hydrochloride?
- 182 other product NDCs are listed under this name. See all Sertraline hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sertraline hydrochloride 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 Hydrochloride | Sertraline hydrochloride 150 mg/1 | Tablet, Film coatedOral | TRUPHARMA, LLC | 52817-223 | 52817-0223-90 |
| Sertraline Hydrochloride | Sertraline hydrochloride 200 mg/1 | Tablet, Film coatedOral | TRUPHARMA, LLC | 52817-224 | 52817-0224-90 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4151 | 68788-4151-0168788-4151-0368788-4151-06+1 more |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | TabletOral | Coupler LLC | 67046-1181 | 67046-1181-03 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-076 | 87441-0076-01 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-077 | 87441-0077-01 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-075 | 87441-0075-01 |
| Sertraline hydrochloride | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1682 | 67046-1682-03 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0555 | 67046-0555-03 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0554 | 67046-0554-03 |
Other NDCs under ANDA 078403
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 hydrochloride | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7395 |
| Sertraline hydrochloride | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7396 |
| Sertraline hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-988 |
| Sertraline hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1483 |
| Sertraline hydrochloride | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1682 |
| Sertraline hydrochloride | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8689 |
| Sertraline hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8732 |
| Sertraline hydrochloride | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Granules Pharmaceuticals Inc. | 70010-203 |
| Sertraline hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Granules Pharmaceuticals Inc. | 70010-204 |
| Sertraline hydrochloride | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Granules Pharmaceuticals Inc. | 70010-205 |
| Sertraline hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4157 |
| Sertraline hydrochloride | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4171 |
| Sertraline hydrochloride | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2587 |
| Sertraline hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 82868-100 |