Prescription drug · ANDA
Finjozy (Sertraline hydrochloride) NDC 58657-275
Sertraline hydrochloride 75 mg/1 · Tablet · Oral · Method Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58657-275-30 | 5865702753058657027530 | 30 TABLET in 1 BOTTLE (58657-275-30)Marketed from Oct 15, 2026 |
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)
- Finjozy
- Generic name (nonproprietary)
- sertraline hydrochloride
- Active ingredients
- Sertraline hydrochloride — 75 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Method Pharmaceuticals LLCNDC labeler code 58657
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214790
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 58657-275_5f6333aa-cec7-a179-e063-6294a90a06f3SPL ID 5f6333aa-cec7-a179-e063-6294a90a06f3SPL set ID 5ee98411-5a83-3045-e063-6394a90ad76aUNII UTI8907Y6XUPC 0358657275303
- 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
N458657027530followed by a unit qualifier and the quantityPackage 58657-0275-30. 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)
FINJOZY is 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) FINJOZY is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of (1): Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Post-traumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD)
Excerpt only. Read the full label for complete information.
About NDC 58657-275
- What is NDC 58657-275?
- 58657-275 is the product NDC for Finjozy (sertraline hydrochloride), Sertraline hydrochloride 75 mg/1 tablet, listed with the FDA by Method Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Finjozy (Sertraline hydrochloride).
- What is the active ingredient?
- Sertraline hydrochloride.
- Who is the labeler?
- Method Pharmaceuticals LLC, NDC labeler code 58657. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Finjozy?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 214790
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 | TabletOral | A-S Medication Solutions | 50090-7693 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | TabletOral | A-S Medication Solutions | 50090-7694 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | TabletOral | Ascent Pharmaceuticals, Inc. | 43602-981 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | TabletOral | Ascent Pharmaceuticals, Inc. | 43602-979 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | TabletOral | Ascent Pharmaceuticals, Inc. | 43602-980 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-7692 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-7691 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc. | 72865-205 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc. | 72865-206 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc. | 72865-207 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3951 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-145 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-146 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-147 |