Prescription drug · ANDA
Sertraline NDC 23155-757
Sertraline hydrochloride 25 mg/1 · Tablet, Film coated · Oral · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 23155-757-03 | 23155075703 | 30 TABLET, FILM COATED in 1 BOTTLE (23155-757-03)Marketed from Feb 23, 2023 | |
| 23155-757-05 | 23155075705 | 500 TABLET, FILM COATED in 1 BOTTLE (23155-757-05)Marketed from Feb 23, 2023 | |
| 23155-757-09 | 23155075709 | 90 TABLET, FILM COATED in 1 BOTTLE (23155-757-09)Marketed from Feb 23, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
- 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 23155-757_5079a5d2-af51-4bac-aaad-75653da2aa97SPL ID 5079a5d2-af51-4bac-aaad-75653da2aa97SPL set ID 444ca054-e450-4c10-a31b-71ad43946cb8RxCUI 312938, 312940, 312941UNII UTI8907Y6XUPC 0323155757057, 0323155758054, 0323155759051, 0323155759037, 0323155758030
- 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
N423155075703followed by a unit qualifier and the quantityPackage 23155-0757-03. 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Sertraline hydrochloride tablets are indicated for the treatment of the following [ See Clinical Studies ( 14 ) ]: • Major depressive disorder (MDD) • Obsessive-compulsive disorder (OCD) • Panic disorder (PD) • Posttraumatic stress disorder (PTSD) • Social anxiety disorder (SAD) • Premenstrual dysphoric disorder (PMDD) Sertraline hydrochloride tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of ( 1 ): • Major depressive disorder (MDD) • Obsessive-compulsive disorder (OCD) • Panic disorder (PD) • Posttraumatic stress disorder (PTSD) • Social anxiety disorder (SAD) • Premenstrual dysphoric disorder (PMDD)
Excerpt only. Read the full label for complete information.
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 | Bryant Ranch Prepack | 71335-2659 |
| 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 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3115 |
| Sertraline | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-683 |
| 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 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2411 |
| Sertraline | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4425 |
| Sertraline | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4183 |