Prescription drug · ANDA
Sertraline Hydrochloride NDC 0615-8596
Sertraline hydrochloride 25 mg/1 · Tablet, Film coated · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8596-05 | 00615859605 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8596-05)Marketed from Nov 18, 2025 | |
| 0615-8596-39 | 00615859639 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8596-39)Marketed from Nov 18, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 Hydrochloride
- Generic name (nonproprietary)
- sertraline hydrochloride
- 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 077670
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 0615-8596_339cfb58-17b5-460a-a7bb-fd5334fbc148SPL ID 339cfb58-17b5-460a-a7bb-fd5334fbc148SPL set ID fd92c8d3-17ec-477c-bc25-e5239c8606acRxCUI 312938, 312940, 312941UNII UTI8907Y6X
- 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
N400615859605followed by a unit qualifier and the quantityPackage 00615-8596-05. 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 tablet is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of ( 1 ): Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Post-traumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD)
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077670
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 50 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7661 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7662 |
| Sertraline | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-212 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3110 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-3569 |
| Sertraline | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3626 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-3570 |
| Sertraline | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0938 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6924 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4518 |
| Sertraline | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1040 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6925 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7698 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7699 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7700 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7701 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6926 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-075 |
| Sertraline | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-0991 |
| Sertralinesertraline hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-0989 |
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