Prescription drug · NDA
Zoloft (Sertraline hydrochloride) NDC 58151-601
Sertraline hydrochloride 20 mg/mL · Solution, Concentrate · Oral · Viatris Specialty LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58151-601-35 | 5815106013558151060135 | 1 BOTTLE, DROPPER in 1 CARTON (58151-601-35) / 60 mL in 1 BOTTLE, DROPPERMarketed from Nov 21, 2024 |
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)
- Zoloft
- Generic name (nonproprietary)
- sertraline hydrochloride
- Active ingredients
- Sertraline hydrochloride — 20 mg/mL
- Dosage form
- Solution, Concentrate
- Route
- Oral
- Labeler
- Viatris Specialty LLCNDC labeler code 58151
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020990
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 58151-601_fd27d2f5-1ade-4dbf-b2d2-bb98daf7da3aSPL ID fd27d2f5-1ade-4dbf-b2d2-bb98daf7da3aSPL set ID fda754f6-d0f3-4dce-a17a-927d64f912f7RxCUI 208149, 208161, 212233, 312938, 312940, 312941, 861064, 861066UNII 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
N458151060135followed by a unit qualifier and the quantityPackage 58151-0601-35. 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)
ZOLOFT 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) ZOLOFT is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of ( 1 ): • Major depressive disorder (MDD) • Obsessive-compulsive disorder (OCD) • Panic disorder (PD) • Posttraumatic stress disorder (PTSD) • Social anxiety disorder (SAD) • Premenstrual dysphoric disorder (PMDD)
Excerpt only. Read the full label for complete information.
About NDC 58151-601
- What is NDC 58151-601?
- 58151-601 is the product NDC for Zoloft (sertraline hydrochloride), Sertraline hydrochloride 20 mg/mL solution, concentrate, listed with the FDA by Viatris Specialty LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zoloft (Sertraline hydrochloride).
- What is the active ingredient?
- Sertraline hydrochloride.
- Who is the labeler?
- Viatris Specialty LLC, NDC labeler code 58151. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zoloft?
- 3 other product NDCs are listed under this name. See all Zoloft NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zoloft products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zoloftsertraline hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Viatris Specialty LLC | 58151-575 | 58151-0575-8858151-0575-93 |
| Zoloftsertraline hydrochloride | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Viatris Specialty LLC | 58151-574 | 58151-0574-93 |
| Zoloftsertraline hydrochloride | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Viatris Specialty LLC | 58151-576 | 58151-0576-8858151-0576-93 |
Other NDCs under NDA 020990
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 20 mg/mL | Solution, ConcentrateOral | Mylan Pharmaceuticals Inc. | 59762-0067 |