Prescription drug · ANDA
Sertraline hydrochloride NDC 70010-205
Sertraline hydrochloride 100 mg/1 · Tablet, Film coated · Oral · Granules Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70010-205-01 | 70010020501 | 100 TABLET, FILM COATED in 1 BOTTLE (70010-205-01)Marketed from May 15, 2023 | |
| 70010-205-03 | 70010020503 | 30 TABLET, FILM COATED in 1 BOTTLE (70010-205-03)Marketed from May 15, 2023 | |
| 70010-205-05 | 70010020505 | 500 TABLET, FILM COATED in 1 BOTTLE (70010-205-05)Marketed from May 15, 2023 | |
| 70010-205-09 | 70010020509 | 90 TABLET, FILM COATED in 1 BOTTLE (70010-205-09)Marketed from May 15, 2023 | |
| 70010-205-10 | 70010020510 | 1000 TABLET, FILM COATED in 1 BOTTLE (70010-205-10)Marketed from May 15, 2023 | |
| 70010-205-53 | 70010020553 | 3000 TABLET, FILM COATED in 1 BOTTLE (70010-205-53)Marketed from May 15, 2023 | |
| 70010-205-63 | 70010020563 | 8 BLISTER PACK in 1 CARTON (70010-205-63) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from May 15, 2023 |
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 — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078403
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 70010-205_4ec654e4-0bd5-934d-e063-6294a90a218dSPL ID 4ec654e4-0bd5-934d-e063-6294a90a218dSPL set ID 98960cc1-1d44-4d89-b415-7e250cc762ccRxCUI 312938, 312940, 312941UNII UTI8907Y6XUPC 0370010205031, 0370010203037
- 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
N470010020501followed by a unit qualifier and the quantityPackage 70010-0205-01. 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
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.
Other NDCs under ANDA 078403
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 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4707 |
| Sertraline hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1483 |
| Sertraline hydrochloride | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7395 |
| Sertraline hydrochloride | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7396 |
| Sertraline hydrochloride | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Granules Pharmaceuticals Inc. | 70010-203 |
| Sertraline hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Granules Pharmaceuticals Inc. | 70010-204 |
| Sertraline hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 82868-100 |
| Sertraline hydrochloride | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8689 |
| Sertraline hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-988 |
| Sertraline hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4157 |
| Sertraline hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8732 |
| Sertraline hydrochloride | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4171 |
| Sertraline hydrochloride | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2587 |
| Sertraline hydrochloride | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1682 |