Sertraline Hydrochloride NDC 65862-224

NDC codes

FDA NDC Directory

Product NDC (as listed)65862-224Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65862-0224Add 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
65862-224-20	65862022420	1 BOTTLE, PLASTIC in 1 CARTON (65862-224-20) / 60 mL in 1 BOTTLE, PLASTICMarketed from Oct 31, 2008
65862-224-60	65862022460	1 BOTTLE in 1 CARTON (65862-224-60) / 60 mL in 1 BOTTLEMarketed from Oct 31, 2008

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 Hydrochloride
Generic name (nonproprietary): sertraline hydrochloride
Active ingredients: Sertraline hydrochloride — 20 mg/mL
Dosage form: Solution, Concentrate
Route: Oral
Labeler: Aurobindo Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078861
Marketing start: Oct 31, 2008
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2D6 Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 65862-224_9bab5466-564e-4ce9-a139-0eb1ae02b6d1SPL ID 9bab5466-564e-4ce9-a139-0eb1ae02b6d1SPL set ID 01800452-c353-4235-a66a-214048752e74RxCUI 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

N465862022420 followed by a unit qualifier and the quantity

Package 65862-0224-20. 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 Mar 21, 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 ANDA 078861

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

FDA NDC Directory listings under ANDA 078861
Product	Strength	Form · route	Labeler	Product NDC
Sertraline Hydrochloride	Sertraline hydrochloride 20 mg/mL	SolutionOral	NorthStar Rx LLC	16714-601
Sertraline Hydrochloride	Sertraline hydrochloride 20 mg/mL	Solution, ConcentrateOral	Rising Pharma Holdings, Inc.	64980-409