What is NDC 68788-4045?

68788-4045 is the product NDC for Sertraline Hydrochloride, Sertraline hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 68788-4045

NDC codes

FDA NDC Directory

Product NDC (as listed)68788-4045Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68788-4045Add 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
68788-4045-1	6878840450168788404501	100 TABLET, FILM COATED in 1 BOTTLE (68788-4045-1)Marketed from Oct 17, 2025
68788-4045-3	6878840450368788404503	30 TABLET, FILM COATED in 1 BOTTLE (68788-4045-3)Marketed from Oct 17, 2025
68788-4045-6	6878840450668788404506	60 TABLET, FILM COATED in 1 BOTTLE (68788-4045-6)Marketed from Oct 17, 2025
68788-4045-9	6878840450968788404509	90 TABLET, FILM COATED in 1 BOTTLE (68788-4045-9)Marketed from Oct 17, 2025

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 — 25 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077206
Marketing start: Oct 17, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2D6 Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 68788-4045_8f5a71b2-2821-46a0-ac65-28d9b2db73ecSPL ID 8f5a71b2-2821-46a0-ac65-28d9b2db73ecSPL set ID 8f5a71b2-2821-46a0-ac65-28d9b2db73ecRxCUI 312940UNII 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

N468788404501 followed by a unit qualifier and the quantity

Package 68788-4045-01. 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 Oct 17, 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 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)

About NDC 68788-4045

What is NDC 68788-4045?: 68788-4045 is the product NDC for Sertraline Hydrochloride, Sertraline hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 4 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?: Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 50 mg/1	Tablet, Film coatedOral	Unit Dose Solutions, Inc.	87441-077	87441-0077-01
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	Unit Dose Solutions, Inc.	87441-076	87441-0076-01
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 077206

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

FDA NDC Directory listings under ANDA 077206
Product	Strength	Form · route	Labeler	Product NDC
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	Quality Care Products LLC	55700-362
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6379
Sertraline Hydrochloride	Sertraline hydrochloride 25 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-1748
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4973
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-088
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4993
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-2812
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-092
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-205
Sertraline HCL	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-551
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	43353-447
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-612
Sertraline Hydrochloride	Sertraline hydrochloride 25 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-6437
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-6429
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-2071
Sertraline Hydrochloride	Sertraline hydrochloride 25 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0808
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2370
Sertraline Hydrochloride	Sertraline hydrochloride 25 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4462
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-2080
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-6835

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