Prescription drug · NDA
sertraline HCl (Sertraline hydrochloride) NDC 52427-664
Sertraline hydrochloride 150 mg/1 · Capsule · Oral · Almatica Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52427-664-30 | 5242706643052427066430 | 30 CAPSULE in 1 BOTTLE (52427-664-30)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 — 150 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Almatica Pharma LLCNDC labeler code 52427
- 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 52427-664_f6e110f6-643d-ced3-d401-b91dd9f1f3b0SPL ID f6e110f6-643d-ced3-d401-b91dd9f1f3b0
- 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
N452427066430followed by a unit qualifier and the quantityPackage 52427-0664-30. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 52427-664
- What is NDC 52427-664?
- 52427-664 is the product NDC for sertraline HCl (sertraline hydrochloride), Sertraline hydrochloride 150 mg/1 capsule, listed with the FDA by Almatica Pharma LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- sertraline HCl (Sertraline hydrochloride).
- What is the active ingredient?
- Sertraline hydrochloride.
- Who is the labeler?
- Almatica Pharma LLC, NDC labeler code 52427. 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 | Sertraline hydrochloride 200 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-2791 | 69238-2791-01 |
| 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 200 mg/1 | CapsuleOral | Almatica Pharma LLC | 52427-672 | 52427-0672-30 |
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 HClsertraline hydrochloride | Sertraline hydrochloride 200 mg/1 | CapsuleOral | Almatica Pharma LLC | 52427-672 |
| sertraline hydrochloride | Sertraline hydrochloride 150 mg/1 | CapsuleOral | Alvogen, Inc. | 47781-951 |
| sertraline hydrochloride | Sertraline hydrochloride 200 mg/1 | CapsuleOral | Alvogen, Inc. | 47781-962 |