NDC codes

FDA NDC Directory
Product NDC (as listed)71335-2587Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-2587Add 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
71335-2587-1713352587017133525870130 TABLET, FILM COATED in 1 BOTTLE (71335-2587-1)Marketed from Apr 7, 2025
71335-2587-2713352587027133525870260 TABLET, FILM COATED in 1 BOTTLE (71335-2587-2)Marketed from Apr 7, 2025
71335-2587-3713352587037133525870390 TABLET, FILM COATED in 1 BOTTLE (71335-2587-3)Marketed from Apr 7, 2025
71335-2587-47133525870471335258704180 TABLET, FILM COATED in 1 BOTTLE (71335-2587-4)Marketed from Apr 7, 2025
71335-2587-5713352587057133525870528 TABLET, FILM COATED in 1 BOTTLE (71335-2587-5)Marketed from Apr 7, 2025
71335-2587-67133525870671335258706120 TABLET, FILM COATED in 1 BOTTLE (71335-2587-6)Marketed from Apr 7, 2025
71335-2587-77133525870771335258707100 TABLET, FILM COATED in 1 BOTTLE (71335-2587-7)Marketed from Apr 7, 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
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078403
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2D6 Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 71335-2587_07ab345f-dcf3-4305-aa31-7a2280cd7b8cSPL ID 07ab345f-dcf3-4305-aa31-7a2280cd7b8cSPL set ID 9c0a7f78-9cac-4e82-b971-f3f9758f8a0cRxCUI 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

N471335258701 followed by a unit qualifier and the quantity

Package 71335-2587-01. 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 71335-2587

What is NDC 71335-2587?
71335-2587 is the product NDC for Sertraline hydrochloride, Sertraline hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 7 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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 100 mg/1Tablet, Film coatedOralUnit Dose Solutions, Inc.87441-07687441-0076-01
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralUnit Dose Solutions, Inc.87441-07787441-0077-01
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 078403

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

FDA NDC Directory listings under ANDA 078403
ProductStrengthForm · routeLabelerProduct NDC
Sertraline hydrochlorideSertraline hydrochloride 25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7395
Sertraline hydrochlorideSertraline hydrochloride 25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7396
Sertraline hydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralST. MARY'S MEDICAL PARK PHARMACY60760-988
Sertraline hydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralCoupler LLC67046-1483
Sertraline hydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralCoupler LLC67046-1682
Sertraline hydrochlorideSertraline hydrochloride 25 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8689
Sertraline hydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8732
Sertraline hydrochlorideSertraline hydrochloride 25 mg/1Tablet, Film coatedOralGranules Pharmaceuticals Inc.70010-203
Sertraline hydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralGranules Pharmaceuticals Inc.70010-204
Sertraline hydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralGranules Pharmaceuticals Inc.70010-205
Sertraline hydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4157
Sertraline hydrochlorideSertraline hydrochloride 25 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4171
Sertraline hydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4707
Sertraline hydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC82868-100

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