NDC codes

FDA NDC Directory
Product NDC (as listed)68788-6835Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-6835Add 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
68788-6835-16878868350168788683501100 TABLET, FILM COATED in 1 BOTTLE (68788-6835-1)Marketed from Nov 21, 2016
68788-6835-2687886835026878868350228 TABLET, FILM COATED in 1 BOTTLE (68788-6835-2)Marketed from Nov 21, 2016
68788-6835-3687886835036878868350330 TABLET, FILM COATED in 1 BOTTLE (68788-6835-3)Marketed from Nov 21, 2016
68788-6835-6687886835066878868350660 TABLET, FILM COATED in 1 BOTTLE (68788-6835-6)Marketed from Nov 21, 2016
68788-6835-86878868350868788683508120 TABLET, FILM COATED in 1 BOTTLE (68788-6835-8)Marketed from Nov 21, 2016
68788-6835-9687886835096878868350990 TABLET, FILM COATED in 1 BOTTLE (68788-6835-9)Marketed from Nov 21, 2016

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 — 100 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
Listing expires
Other FDA classes
Cytochrome P450 2D6 Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 68788-6835_e62794ba-9527-403c-a0c1-57134cbf63caSPL ID e62794ba-9527-403c-a0c1-57134cbf63caSPL set ID 677c90cd-6527-40cb-a564-571796513fcbRxCUI 312938UNII 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

N468788683501 followed by a unit qualifier and the quantity

Package 68788-6835-01. 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 68788-6835

What is NDC 68788-6835?
68788-6835 is the product NDC for Sertraline Hydrochloride, Sertraline hydrochloride 100 mg/1 tablet, film coated, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 6 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Sertraline HydrochlorideSertraline hydrochloride 150 mg/1Tablet, Film coatedOralTRUPHARMA, LLC52817-22352817-0223-90
Sertraline HydrochlorideSertraline hydrochloride 200 mg/1Tablet, Film coatedOralTRUPHARMA, LLC52817-22452817-0224-90
Sertraline hydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-470770518-4707-0070518-4707-02
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-415168788-4151-0168788-4151-0368788-4151-06+1 more
Sertraline HydrochlorideSertraline hydrochloride 25 mg/1TabletOralCoupler LLC67046-118167046-1181-03
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralUnit Dose Solutions, Inc.87441-07787441-0077-01
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralUnit Dose Solutions, Inc.87441-07687441-0076-01
Sertraline HydrochlorideSertraline hydrochloride 25 mg/1Tablet, Film coatedOralUnit Dose Solutions, Inc.87441-07587441-0075-01
Sertraline hydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralCoupler LLC67046-168267046-1682-03
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralCoupler LLC67046-055567046-0555-03

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
ProductStrengthForm · routeLabelerProduct NDC
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralQuality Care Products LLC55700-362
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6379
Sertraline HydrochlorideSertraline hydrochloride 25 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-1748
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4973
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-088
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4993
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2812
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-092
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralProficient Rx LP71205-205
Sertraline HCLSertraline hydrochloride 50 mg/1Tablet, Film coatedOralDirect_Rx72189-551
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC43353-447
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-612
Sertraline HydrochlorideSertraline hydrochloride 25 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-6437
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-6429
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-2071
Sertraline HydrochlorideSertraline hydrochloride 25 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0808
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-2370
Sertraline HydrochlorideSertraline hydrochloride 25 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4462
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-2080
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2300

Showing 20 of 39.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in