Sertraline Hydrochloride NDC 50228-467

NDC codes

FDA NDC Directory

Product NDC (as listed)50228-467Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50228-0467Add 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
50228-467-05	50228046705	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50228-467-05)Marketed from May 8, 2023
50228-467-30	50228046730	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50228-467-30)Marketed from May 8, 2023
50228-467-90	50228046790	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50228-467-90)Marketed from May 8, 2023

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 — 25 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: ScieGen Pharmaceuticals Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076442
Marketing start: May 8, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2D6 Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 50228-467_09a95635-597e-d608-e063-6294a90a203fSPL ID 09a95635-597e-d608-e063-6294a90a203fSPL set ID 10b9cae4-b452-4abb-866a-9f9d2568f212RxCUI 312938, 312940, 312941UNII UTI8907Y6XUPC 0350228469302, 0350228468305, 0350228469906, 0350228468053, 0350228467056, 0350228467308, 0350228469050, 0350228468909, 0350228467902
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

N450228046705 followed by a unit qualifier and the quantity

Package 50228-0467-05. 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 Nov 8, 2023. 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 tablets are 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 076442

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

FDA NDC Directory listings under ANDA 076442
Product	Strength	Form · route	Labeler	Product NDC
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	ScieGen Pharmaceuticals Inc	50228-468
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	ScieGen Pharmaceuticals Inc	50228-469