Prescription drug · ANDA
Sertraline NDC 71610-769
Sertraline hydrochloride 100 mg/1 · Tablet, Film coated · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-769-15 | 71610076915 | 15 TABLET, FILM COATED in 1 BOTTLE (71610-769-15)Marketed from Jan 17, 2024 | |
| 71610-769-30 | 71610076930 | 30 TABLET, FILM COATED in 1 BOTTLE (71610-769-30)Marketed from Mar 7, 2024 | |
| 71610-769-45 | 71610076945 | 45 TABLET, FILM COATED in 1 BOTTLE (71610-769-45)Marketed from Jan 17, 2024 | |
| 71610-769-53 | 71610076953 | 60 TABLET, FILM COATED in 1 BOTTLE (71610-769-53)Marketed from Jan 17, 2024 | |
| 71610-769-60 | 71610076960 | 90 TABLET, FILM COATED in 1 BOTTLE (71610-769-60)Marketed from Jan 17, 2024 | |
| 71610-769-73 | 71610076973 | 135 TABLET, FILM COATED in 1 BOTTLE (71610-769-73)Marketed from Jan 17, 2024 | |
| 71610-769-80 | 71610076980 | 180 TABLET, FILM COATED in 1 BOTTLE (71610-769-80)Marketed from Jan 17, 2024 |
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 — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077397
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 71610-769_13679124-92cd-bffa-e063-6394a90a219cSPL ID 13679124-92cd-bffa-e063-6394a90a219cSPL set ID 7be6a62e-0e85-47c8-8793-b41c51c2557fRxCUI 312938UNII 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
N471610076915followed by a unit qualifier and the quantityPackage 71610-0769-15. 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 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 tablets are 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 077397
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 | Quallent Pharmaceuticals Health LLC | 82009-049 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0328 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-050 |
| Sertraline | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-818 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | TabletOral | Legacy Pharmaceutical Packaging, LLC | 68645-522 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | TabletOral | Legacy Pharmaceutical Packaging, LLC | 68645-521 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-033 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | TabletOral | Legacy Pharmaceutical Packaging, LLC | 68645-523 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4658 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | TabletOral | Cipla USA Inc. | 69097-835 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | TabletOral | Cipla USA Inc. | 69097-833 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | TabletOral | Cipla USA Inc. | 69097-834 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4307 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | TabletOral | Proficient Rx LP | 63187-767 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-4692 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-4687 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | TabletOral | Proficient Rx LP | 63187-795 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-886 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | TabletOral | American Health Packaging | 60687-231 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | TabletOral | American Health Packaging | 60687-242 |
Showing 20 of 26.