Prescription drug · ANDA
Sertraline Hydrochloride NDC 43602-979
Sertraline hydrochloride 25 mg/1 · Tablet · Oral · Ascent Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43602-979-15 | 43602097915 | 30 TABLET in 1 BOTTLE (43602-979-15)Marketed from May 3, 2021 | |
| 43602-979-16 | 43602097916 | 500 TABLET in 1 BOTTLE (43602-979-16)Marketed from May 3, 2021 |
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 Hydrochloride
- Generic name (nonproprietary)
- sertraline hydrochloride
- Active ingredients
- Sertraline hydrochloride — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Ascent 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 43602-979_91447af3-b3d6-4ffe-8c89-1869a22373baSPL ID 91447af3-b3d6-4ffe-8c89-1869a22373baSPL set ID 056191ca-999a-4c9b-93b9-64db44b8e628RxCUI 312938, 312940, 312941UNII UTI8907Y6XUPC 0343602464055, 0343602462051, 0343602463058, 0010100002194
- 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
N443602097915followed by a unit qualifier and the quantityPackage 43602-0979-15. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 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 | NuCare Pharmaceuticals, Inc. | 68071-3951 |
| 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 |