Prescription drug · ANDA
Sertraline Hydrochloride NDC 70710-1949
Sertraline hydrochloride 200 mg/1 · Capsule · Oral · Zydus Pharmaceuticals (USA) Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70710-1949-3 | 70710194903 | 30 CAPSULE in 1 BOTTLE (70710-1949-3)Marketed from Jan 29, 2026 |
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 Hydrochloride
- Generic name (nonproprietary)
- sertraline hydrochloride
- Active ingredients
- Sertraline hydrochloride — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 220275
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 70710-1949_55c2a9d1-6c98-4073-8532-b1f51aa2fda9SPL ID 55c2a9d1-6c98-4073-8532-b1f51aa2fda9SPL set ID 23f1c8c5-032c-4ea9-beb0-ca3a614ba4b6RxCUI 251201, 410584UNII 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
N470710194903followed by a unit qualifier and the quantityPackage 70710-1949-03. 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 capsules are indicated for the treatment of the following [see Clinical Studies ( 14 )] : Major depressive disorder (MDD) in adults Obsessive-compulsive disorder (OCD) in adults and pediatric patients 6 years and older Sertraline hydrochloride capsules are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of ( 1 ): Major depressive disorder (MDD) in adults Obsessive-compulsive disorder (OCD) in adults and pediatric patients 6 years and older
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 220275
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 150 mg/1 | CapsuleOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1948 |
| Sertraline Hydrochloride | Sertraline hydrochloride 200 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 70771-1914 |
| Sertraline Hydrochloride | Sertraline hydrochloride 150 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 70771-1913 |