Sertraline hydrochloride NDC 59762-0067

NDC codes

FDA NDC Directory

Product NDC (as listed)59762-0067Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59762-0067Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
59762-0067-1	59762006701	1 BOTTLE, DROPPER in 1 CARTON (59762-0067-1) / 60 mL in 1 BOTTLE, DROPPERMarketed from May 15, 2018

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 hydrochloride
Generic name (nonproprietary): sertraline hydrochloride
Active ingredients: Sertraline hydrochloride — 20 mg/mL
Dosage form: Solution, Concentrate
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 020990
Marketing start: May 15, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2D6 Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 59762-0067_a0edcebe-af2d-463c-aad8-fa5fb77f0828SPL ID a0edcebe-af2d-463c-aad8-fa5fb77f0828SPL set ID 1a58062b-e635-431a-908d-2651c6a4a21cRxCUI 861064UNII 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

N459762006701 followed by a unit qualifier and the quantity

Package 59762-0067-01. 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 Sep 15, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Sertraline hydrochloride oral solution 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) Sertraline hydrochloride oral solution 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 020990

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 020990
Product	Strength	Form · route	Labeler	Product NDC
Zoloftsertraline hydrochloride	Sertraline hydrochloride 20 mg/mL	Solution, ConcentrateOral	Viatris Specialty LLC	58151-601