What is NDC 50268-824?

50268-824 is the product NDC for Sertraline Hydrochloride, Sertraline hydrochloride 50 mg/1 tablet, film coated, listed with the FDA by AvPAK. It has 1 package NDC, shown above in 10- and 11-digit form.

AvPAK, NDC labeler code 50268. 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 50268-824

NDC codes

FDA NDC Directory

Product NDC (as listed)50268-824Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50268-0824Add 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
50268-824-15	5026808241550268082415	50 BLISTER PACK in 1 BOX (50268-824-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-824-11)Marketed from Oct 9, 2025

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 — 50 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: AvPAKNDC labeler code 50268
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077670
Marketing start: Oct 9, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2D6 Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 50268-824_40be57d9-2746-0f89-e063-6394a90af4f1SPL ID 40be57d9-2746-0f89-e063-6394a90af4f1SPL set ID 40be43b2-649b-0928-e063-6394a90a3b48RxCUI 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

N450268082415 followed by a unit qualifier and the quantity

Package 50268-0824-15. 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 Oct 9, 2025. 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 50268-824

What is NDC 50268-824?: 50268-824 is the product NDC for Sertraline Hydrochloride, Sertraline hydrochloride 50 mg/1 tablet, film coated, listed with the FDA by AvPAK. It has 1 package NDC, 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?: AvPAK, NDC labeler code 50268. 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	Sertraline hydrochloride 25 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-5848
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7830
Sertraline	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8669
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4590
Sertraline	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7295
Sertraline	Sertraline hydrochloride 25 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-478
Sertraline Hydrochloride	Sertraline hydrochloride 25 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4606
Sertraline	Sertraline hydrochloride 25 mg/1	Tablet, Film coatedOral	AvPAK	50268-768
Sertraline	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	AvPAK	50268-769
Sertraline	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	AvPAK	50268-770
Sertraline	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-055
Sertraline	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-1617
Sertraline	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-3534
Sertraline Hydrochloride	Sertraline hydrochloride 25 mg/1	Tablet, Film coatedOral	AvPAK	50268-823
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	AvPAK	50268-825
Sertraline	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	Quality Care Products, LLC	55700-225
Sertraline Hydrochloride	Sertraline hydrochloride 25 mg/1	Tablet, Film coatedOral	Lupin Pharmaceuticals, Inc.	68180-978
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4151
Sertraline	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-0153
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	Lupin Pharmaceuticals, Inc.	68180-986

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