What is NDC 0615-8596?

0615-8596 is the product NDC for Sertraline Hydrochloride, Sertraline hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 2 package NDCs, shown above in 10- and 11-digit form.

NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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 Hydrochloride?

182 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Sertraline Hydrochloride NDC 0615-8596

NDC codes

FDA NDC Directory

Product NDC (as listed)0615-8596Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00615-8596Add 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
0615-8596-05	0061585960500615859605	15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8596-05)Marketed from Nov 18, 2025
0615-8596-39	0061585963900615859639	30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8596-39)Marketed from Nov 18, 2025

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 25 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077670
Marketing start: Feb 6, 2007
Listing expires: Dec 31, 2027
Other FDA classes: Cytochrome P450 2D6 Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 0615-8596_339cfb58-17b5-460a-a7bb-fd5334fbc148SPL ID 339cfb58-17b5-460a-a7bb-fd5334fbc148SPL set ID fd92c8d3-17ec-477c-bc25-e5239c8606acRxCUI 312938, 312940, 312941UNII 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

N400615859605 followed by a unit qualifier and the quantity

Package 00615-8596-05. 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 Jan 23, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Sertraline hydrochloride tablets are 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 tablet 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.

Full label on DailyMed (opens in a new tab)

About NDC 0615-8596

What is NDC 0615-8596?: 0615-8596 is the product NDC for Sertraline Hydrochloride, Sertraline hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Sertraline Hydrochloride.
What is the active ingredient?: Sertraline hydrochloride.
Who is the labeler?: NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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 Hydrochloride?: 182 other product NDCs are listed under this name. See all Sertraline Hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Sertraline Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Sertraline Hydrochloride	Sertraline hydrochloride 150 mg/1	Tablet, Film coatedOral	TRUPHARMA, LLC	52817-223	52817-0223-90
Sertraline Hydrochloride	Sertraline hydrochloride 200 mg/1	Tablet, Film coatedOral	TRUPHARMA, LLC	52817-224	52817-0224-90
Sertraline hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4707	70518-4707-0070518-4707-02
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4151	68788-4151-0168788-4151-0368788-4151-06+1 more
Sertraline Hydrochloride	Sertraline hydrochloride 25 mg/1	TabletOral	Coupler LLC	67046-1181	67046-1181-03
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	Unit Dose Solutions, Inc.	87441-076	87441-0076-01
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	Unit Dose Solutions, Inc.	87441-077	87441-0077-01
Sertraline Hydrochloride	Sertraline hydrochloride 25 mg/1	Tablet, Film coatedOral	Unit Dose Solutions, Inc.	87441-075	87441-0075-01
Sertraline hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1682	67046-1682-03
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0555	67046-0555-03

All 183 Sertraline Hydrochloride NDCs

Other NDCs under ANDA 077670

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

FDA NDC Directory listings under ANDA 077670
Product	Strength	Form · route	Labeler	Product NDC
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7701
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7700
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7661
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7662
Sertraline	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-212
Sertraline Hydrochloride	Sertraline hydrochloride 25 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7699
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	Proficient Rx LP	82804-311
Sertraline Hydrochloride	Sertraline hydrochloride 25 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7698
Sertralinesertraline hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-0989
Sertraline Hydrochloride	Sertraline hydrochloride 25 mg/1	Tablet, Film coatedOral	Unit Dose Solutions, Inc.	87441-075
Sertraline	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-0991
Sertraline	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-3626
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-3570
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-3569
Sertraline	Sertraline hydrochloride 25 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-0938
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8603
Sertraline Hydrochloride	Sertraline hydrochloride 25 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6924
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4518
Sertraline	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-1040
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8604

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