Prescription drug · ANDA
Sertraline NDC 71610-818
Sertraline hydrochloride 50 mg/1 · Tablet, Film coated · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-818-15 | 7161008181571610081815 | 15 TABLET, FILM COATED in 1 BOTTLE (71610-818-15)Marketed from Apr 12, 2024 | |
| 71610-818-30 | 7161008183071610081830 | 30 TABLET, FILM COATED in 1 BOTTLE (71610-818-30)Marketed from Jul 17, 2025 | |
| 71610-818-45 | 7161008184571610081845 | 45 TABLET, FILM COATED in 1 BOTTLE (71610-818-45)Marketed from Apr 4, 2024 | |
| 71610-818-60 | 7161008186071610081860 | 90 TABLET, FILM COATED in 1 BOTTLE (71610-818-60)Marketed from Jun 20, 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 — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
- 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 71610-818_3a7784f8-edc2-8cb2-e063-6294a90a8cdcSPL ID 3a7784f8-edc2-8cb2-e063-6294a90a8cdcSPL set ID 1548faf9-8625-f871-e063-6394a90a931fRxCUI 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
N471610081815followed by a unit qualifier and the quantityPackage 71610-0818-15. 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.
About NDC 71610-818
- What is NDC 71610-818?
- 71610-818 is the product NDC for Sertraline, Sertraline hydrochloride 50 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sertraline.
- What is the active ingredient?
- Sertraline hydrochloride.
- Who is the labeler?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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?
- 31 other product NDCs are listed under this name. See all Sertraline NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sertraline 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 | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4183 | 68788-4183-0168788-4183-0368788-4183-06+1 more |
| Sertraline | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-683 | 60760-0683-90 |
| Sertraline | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4425 | 70518-4425-00 |
| Sertraline | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8669 | 68788-8669-0168788-8669-0268788-8669-03+3 more |
| Sertraline | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-768 | 50268-0768-15 |
| Sertraline | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-769 | 50268-0769-15 |
| Sertraline | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-770 | 50268-0770-15 |
| Sertraline | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-757 | 23155-0757-0323155-0757-0523155-0757-09 |
| Sertraline | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-758 | 23155-0758-0323155-0758-0523155-0758-09+1 more |
| Sertraline | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-759 | 23155-0759-0323155-0759-0523155-0759-09 |
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 | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-769 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-033 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-754 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-345 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-4687 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-4692 |
| 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 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | TabletOral | American Health Packaging | 60687-253 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | TabletOral | Proficient Rx LP | 63187-767 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | TabletOral | Proficient Rx LP | 63187-795 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | TabletOral | Proficient Rx LP | 63187-859 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | TabletOral | Coupler LLC | 67046-1181 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4658 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | TabletOral | Legacy Pharmaceutical Packaging, LLC | 68645-521 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | TabletOral | Legacy Pharmaceutical Packaging, LLC | 68645-522 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | TabletOral | Legacy Pharmaceutical Packaging, LLC | 68645-523 |
| 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 100 mg/1 | TabletOral | Cipla USA Inc. | 69097-835 |
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