Prescription drug · ANDA
Sertraline HCl (Sertraline) NDC 69238-2791
Sertraline hydrochloride 200 mg/1 · Capsule · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-2791-1 | 6923827910169238279101 | 30 CAPSULE in 1 BOTTLE (69238-2791-1)Marketed from Feb 2, 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 HCl
- Generic name (nonproprietary)
- sertraline
- Active ingredients
- Sertraline hydrochloride — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals NY LLCNDC labeler code 69238
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219655
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 69238-2791_8d3cc874-a2eb-4977-862b-b09fdf66992aSPL ID 8d3cc874-a2eb-4977-862b-b09fdf66992aSPL set ID a5c49e6e-b8e0-4a75-99e6-b88e323ce653RxCUI 251201, 410584UNII UTI8907Y6XUPC 0369238279115, 0369238278910
- 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
N469238279101followed by a unit qualifier and the quantityPackage 69238-2791-01. 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 (HCl) Capsules is 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 (HCl) Capsules is 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.
About NDC 69238-2791
- What is NDC 69238-2791?
- 69238-2791 is the product NDC for Sertraline HCl (sertraline), Sertraline hydrochloride 200 mg/1 capsule, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sertraline HCl (Sertraline).
- What is the active ingredient?
- Sertraline hydrochloride.
- Who is the labeler?
- Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. 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 HCl?
- 8 other product NDCs are listed under this name. See all Sertraline HCl NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sertraline HCl 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 HClsertraline hydrochloride | Sertraline hydrochloride 150 mg/1 | CapsuleOral | Umedica Laboratories USA Inc. | 60290-070 | 60290-0070-01 |
| Sertraline HClsertraline hydrochloride | Sertraline hydrochloride 200 mg/1 | CapsuleOral | Umedica Laboratories USA Inc. | 60290-071 | 60290-0071-01 |
| Sertraline HClsertraline | Sertraline hydrochloride 150 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-2789 | 69238-2789-01 |
| Sertraline HClsertraline hydrochloride | Sertraline hydrochloride 150 mg/1 | CapsuleOral | Biocon Pharma Inc. | 70377-128 | 70377-0128-11 |
| Sertraline HClsertraline hydrochloride | Sertraline hydrochloride 200 mg/1 | CapsuleOral | Biocon Pharma Inc. | 70377-129 | 70377-0129-11 |
| Sertraline HCL | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-551 | 72189-0551-3072189-0551-90 |
| sertraline HClsertraline hydrochloride | Sertraline hydrochloride 150 mg/1 | CapsuleOral | Almatica Pharma LLC | 52427-664 | 52427-0664-30 |
| sertraline HClsertraline hydrochloride | Sertraline hydrochloride 200 mg/1 | CapsuleOral | Almatica Pharma LLC | 52427-672 | 52427-0672-30 |
Other NDCs under ANDA 219655
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 HClsertraline | Sertraline hydrochloride 150 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-2789 |