Prescription drug · ANDA
Sertraline Hydrochloride NDC 68071-3951
Sertraline hydrochloride 25 mg/1 · Tablet · Oral · NuCare Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3951-3 | 68071395103 | 30 TABLET in 1 BOTTLE (68071-3951-3)Marketed from Jan 15, 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 — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214790
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 68071-3951_48702222-543d-716a-e063-6394a90a1d4fSPL ID 48702222-543d-716a-e063-6394a90a1d4fSPL set ID 48702ef4-21cd-754e-e063-6394a90af24eRxCUI 312940UNII UTI8907Y6XUPC 0368071395136
- 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
N468071395103followed by a unit qualifier and the quantityPackage 68071-3951-03. 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 selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of: 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 214790
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 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-146 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-145 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-147 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | TabletOral | Ascent Pharmaceuticals, Inc. | 43602-980 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | TabletOral | Ascent Pharmaceuticals, Inc. | 43602-979 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-7691 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | TabletOral | Ascent Pharmaceuticals, Inc. | 43602-981 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-7692 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | TabletOral | A-S Medication Solutions | 50090-7693 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | TabletOral | A-S Medication Solutions | 50090-7694 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc. | 72865-205 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc. | 72865-206 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc. | 72865-207 |