Prescription drug · NDA
sertraline HCl (sertraline hydrochloride) NDC 52427-672
Sertraline hydrochloride 200 mg/1 · Capsule · Oral · Almatica Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52427-672-30 | 52427067230 | 30 CAPSULE in 1 BOTTLE (52427-672-30)Marketed from Nov 1, 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 HCl
- Generic name (nonproprietary)
- sertraline hydrochloride
- Active ingredients
- Sertraline hydrochloride — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Almatica Pharma LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 215133
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 52427-672_fee38eb1-855e-a3c0-c707-8665f61fb400SPL ID fee38eb1-855e-a3c0-c707-8665f61fb400SPL set ID 8c8bcba9-eaeb-aa44-f9ea-b580de55a439RxCUI 251201, 410584UNII UTI8907Y6XUPC 0352427664304, 0352427672309
- 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
N452427067230followed by a unit qualifier and the quantityPackage 52427-0672-30. 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.
Other NDCs under NDA 215133
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 | Alvogen, Inc. | 47781-951 |
| sertraline hydrochloride | Sertraline hydrochloride 200 mg/1 | CapsuleOral | Alvogen, Inc. | 47781-962 |
| sertraline HClsertraline hydrochloride | Sertraline hydrochloride 150 mg/1 | CapsuleOral | Almatica Pharma LLC | 52427-664 |