Prescription drug · ANDA
Sertraline NDC 68788-8669
Sertraline hydrochloride 100 mg/1 · Tablet, Film coated · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8669-1 | 68788866901 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-8669-1)Marketed from May 20, 2024 | |
| 68788-8669-2 | 68788866902 | 28 TABLET, FILM COATED in 1 BOTTLE (68788-8669-2)Marketed from May 20, 2024 | |
| 68788-8669-3 | 68788866903 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8669-3)Marketed from May 20, 2024 | |
| 68788-8669-6 | 68788866906 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8669-6)Marketed from May 20, 2024 | |
| 68788-8669-8 | 68788866908 | 120 TABLET, FILM COATED in 1 BOTTLE (68788-8669-8)Marketed from May 20, 2024 | |
| 68788-8669-9 | 68788866909 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8669-9)Marketed from May 20, 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077670
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 68788-8669_562f7d5b-44ac-4564-a713-221f3584d7c5SPL ID 562f7d5b-44ac-4564-a713-221f3584d7c5
- 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
N468788866901followed by a unit qualifier and the quantityPackage 68788-8669-01. 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
The FDA listing for this product does not reference a label (SPL) set.
Other NDCs under ANDA 077670
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 | A-S Medication Solutions | 50090-7661 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7662 |
| Sertraline | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-212 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3110 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8596 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-3569 |
| Sertraline | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3626 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-3570 |
| Sertraline | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0938 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6924 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4518 |
| Sertraline | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1040 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6925 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7698 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7699 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7700 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7701 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6926 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-075 |
| Sertraline | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-0991 |
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