Prescription drug · ANDA
Sertraline NDC 72162-2411
Sertraline hydrochloride 100 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-2411-0 | 7216224110072162241100 | 1000 TABLET, FILM COATED in 1 BOTTLE (72162-2411-0)Marketed from Oct 30, 2024 | |
| 72162-2411-1 | 7216224110172162241101 | 100 TABLET, FILM COATED in 1 BOTTLE (72162-2411-1)Marketed from Oct 30, 2024 | |
| 72162-2411-5 | 7216224110572162241105 | 500 TABLET, FILM COATED in 1 BOTTLE (72162-2411-5)Marketed from Oct 30, 2024 |
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
- Generic name (nonproprietary)
- sertraline
- Active ingredients
- Sertraline hydrochloride — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 72162
- 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 72162-2411_f2da9a9d-f2dd-474e-a81e-dfbecd4d78b9SPL ID f2da9a9d-f2dd-474e-a81e-dfbecd4d78b9SPL set ID e0adb991-ec4e-4cd1-b54e-6d8c731a1d59RxCUI 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
N472162241100followed by a unit qualifier and the quantityPackage 72162-2411-00. 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.
About NDC 72162-2411
- What is NDC 72162-2411?
- 72162-2411 is the product NDC for Sertraline, Sertraline hydrochloride 100 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 3 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?
- Bryant Ranch Prepack, NDC labeler code 72162. 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 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 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-757 |
| 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 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 50 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-683 |
| Sertraline | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4183 |
| Sertraline | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4425 |
| Sertraline | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2659 |
| Sertraline | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3115 |