What is NDC 71335-0415?

71335-0415 is the product NDC for Sertraline Hydrochloride, Sertraline hydrochloride 50 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 9 package NDCs, shown above in 10- and 11-digit form.

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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Sertraline Hydrochloride NDC 71335-0415

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-0415Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-0415Add 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
71335-0415-1	7133504150171335041501	30 TABLET, FILM COATED in 1 BOTTLE (71335-0415-1)Marketed from Mar 7, 2018
71335-0415-2	7133504150271335041502	60 TABLET, FILM COATED in 1 BOTTLE (71335-0415-2)Marketed from Feb 26, 2018
71335-0415-3	7133504150371335041503	90 TABLET, FILM COATED in 1 BOTTLE (71335-0415-3)Marketed from Jun 5, 2018
71335-0415-4	7133504150471335041504	180 TABLET, FILM COATED in 1 BOTTLE (71335-0415-4)Marketed from May 30, 2018
71335-0415-5	7133504150571335041505	100 TABLET, FILM COATED in 1 BOTTLE (71335-0415-5)Marketed from Apr 3, 2024
71335-0415-6	7133504150671335041506	56 TABLET, FILM COATED in 1 BOTTLE (71335-0415-6)Marketed from Apr 3, 2024
71335-0415-7	7133504150771335041507	28 TABLET, FILM COATED in 1 BOTTLE (71335-0415-7)Marketed from Apr 3, 2024
71335-0415-8	7133504150871335041508	120 TABLET, FILM COATED in 1 BOTTLE (71335-0415-8)Marketed from Apr 3, 2024
71335-0415-9	7133504150971335041509	15 TABLET, FILM COATED in 1 BOTTLE (71335-0415-9)Marketed from Apr 3, 2024

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 — 50 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 202825
Marketing start: Feb 9, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2D6 Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 71335-0415_b77be777-f7b7-4f83-ad5e-2dca97a8b2a2SPL ID b77be777-f7b7-4f83-ad5e-2dca97a8b2a2SPL set ID 82a44e20-d0ee-4ed7-9234-24ef4496ac1dRxCUI 312941UNII 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

N471335041501 followed by a unit qualifier and the quantity

Package 71335-0415-01. 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 Apr 3, 2024. 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 is 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 71335-0415

What is NDC 71335-0415?: 71335-0415 is the product NDC for Sertraline Hydrochloride, Sertraline hydrochloride 50 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 9 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
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 100 mg/1	Tablet, Film coatedOral	Unit Dose Solutions, Inc.	87441-076	87441-0076-01
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	Unit Dose Solutions, Inc.	87441-077	87441-0077-01
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 202825

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

FDA NDC Directory listings under ANDA 202825
Product	Strength	Form · route	Labeler	Product NDC
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-738
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-028
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	QPharma, Inc.	42708-092
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-047
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	Accord Healthcare, Inc.	16729-216
Sertraline Hydrochloride	Sertraline hydrochloride 25 mg/1	Tablet, Film coatedOral	Accord Healthcare, Inc.	16729-215
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	Accord Healthcare, Inc.	16729-217
Sertraline Hydrochloride	Sertraline hydrochloride 25 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1078
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0510
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	43063-855
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-651
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-3203