NDC codes

FDA NDC Directory
Product NDC (as listed)68788-4183Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-4183Add 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 NDC11-digit (billing)PackageCopy
68788-4183-16878841830168788418301100 TABLET, FILM COATED in 1 BOTTLE (68788-4183-1)Marketed from Aug 20, 2026
68788-4183-3687884183036878841830330 TABLET, FILM COATED in 1 BOTTLE (68788-4183-3)Marketed from Aug 20, 2026
68788-4183-6687884183066878841830660 TABLET, FILM COATED in 1 BOTTLE (68788-4183-6)Marketed from Aug 20, 2026
68788-4183-9687884183096878841830990 TABLET, FILM COATED in 1 BOTTLE (68788-4183-9)Marketed from Aug 20, 2026

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
Generic name (nonproprietary)
sertraline
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 076465
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2D6 Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 68788-4183_957ba196-0b9b-4cda-bd15-28357ced8d2fSPL ID 957ba196-0b9b-4cda-bd15-28357ced8d2fSPL set ID 957ba196-0b9b-4cda-bd15-28357ced8d2fRxCUI 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

N468788418301 followed by a unit qualifier and the quantity

Package 68788-4183-01. 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 . 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 68788-4183

What is NDC 68788-4183?
68788-4183 is the product NDC for Sertraline, 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.
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?
31 other product NDCs are listed under this name. See all Sertraline 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 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
SertralineSertraline hydrochloride 50 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-68360760-0683-90
SertralineSertraline hydrochloride 25 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-442570518-4425-00
SertralineSertraline hydrochloride 100 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-866968788-8669-0168788-8669-0268788-8669-03+3 more
SertralineSertraline hydrochloride 25 mg/1Tablet, Film coatedOralAvPAK50268-76850268-0768-15
SertralineSertraline hydrochloride 50 mg/1Tablet, Film coatedOralAvPAK50268-76950268-0769-15
SertralineSertraline hydrochloride 100 mg/1Tablet, Film coatedOralAvPAK50268-77050268-0770-15
SertralineSertraline hydrochloride 25 mg/1Tablet, Film coatedOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-75723155-0757-0323155-0757-0523155-0757-09
SertralineSertraline hydrochloride 50 mg/1Tablet, Film coatedOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-75823155-0758-0323155-0758-0523155-0758-09+1 more
SertralineSertraline hydrochloride 100 mg/1Tablet, Film coatedOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-75923155-0759-0323155-0759-0523155-0759-09
SertralineSertraline hydrochloride 25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-761450090-7614-0050090-7614-01

All 32 Sertraline NDCs

Other NDCs under ANDA 076465

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

FDA NDC Directory listings under ANDA 076465
ProductStrengthForm · routeLabelerProduct NDC
SertralineSertraline hydrochloride 25 mg/1Tablet, Film coatedOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-757
SertralineSertraline hydrochloride 50 mg/1Tablet, Film coatedOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-758
SertralineSertraline hydrochloride 100 mg/1Tablet, Film coatedOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-759
SertralineSertraline hydrochloride 25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7614
SertralineSertraline hydrochloride 25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7615
SertralineSertraline hydrochloride 50 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-683
SertralineSertraline hydrochloride 25 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4425
SertralineSertraline hydrochloride 25 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2659
SertralineSertraline hydrochloride 100 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-3115
SertralineSertraline hydrochloride 100 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-2411

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