What is NDC 71610-425?

71610-425 is the product NDC for Escitalopram, Escitalopram oxalate 20 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Escitalopram?

108 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Escitalopram NDC 71610-425 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-425Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0425Add 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	Copy
71610-425-60	7161004256071610042560	90 TABLET, FILM COATED in 1 BOTTLE (71610-425-60)Marketed from May 8, 2020

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): Escitalopram
Generic name (nonproprietary): escitalopram
Active ingredients: Escitalopram oxalate — 20 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202389
Marketing start: Mar 21, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 71610-425_09b866f0-4435-4d1a-9cc7-c6a5ea487cb0SPL ID 09b866f0-4435-4d1a-9cc7-c6a5ea487cb0SPL set ID 85b2f57e-53f3-4b93-9128-ad74cc34be4cRxCUI 351250UNII 5U85DBW7LO
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

N471610042560 followed by a unit qualifier and the quantity

Package 71610-0425-60. 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 May 20, 2020. This label includes a boxed warning.

Indications (excerpt from the label)

Escitalopram oxalate is a selective serotonin reuptake inhibitor (SSRI) indicated for: Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12 to 17 years ( 1.1 ) Acute Treatment of Generalized Anxiety Disorder (GAD) in adults ( 1.2 ) 1.1 Major Depressive Disorder Escitalopram tablet, is indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [ see Clinical Studies ( 14.1 ) ]. A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-425

What is NDC 71610-425?: 71610-425 is the product NDC for Escitalopram, Escitalopram oxalate 20 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Escitalopram.
What is the active ingredient?: Escitalopram oxalate.
Who is the labeler?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Escitalopram?: 108 other product NDCs are listed under this name. See all Escitalopram 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 Escitalopram NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
escitalopram	Escitalopram oxalate 20 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4171	68788-4171-0168788-4171-0368788-4171-06+2 more
Escitalopram	Escitalopram oxalate 10 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0355	67046-0355-03
Escitalopram	Escitalopram oxalate 10 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4567	70518-4567-00
escitalopram	Escitalopram oxalate 15 mg/1	CapsuleOral	Almatica Pharma LLC	52427-795	52427-0795-30
Escitalopram	Escitalopram oxalate 5 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-865	60687-0865-01
escitalopram	Escitalopram oxalate 5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4300	70518-4300-0070518-4300-01
escitalopram	Escitalopram oxalate 20 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1465	67046-1465-03
escitalopram	Escitalopram oxalate 5 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1472	67046-1472-03
escitalopram	Escitalopram oxalate 20 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4239	70518-4239-0070518-4239-0170518-4239-02+1 more
escitalopram	Escitalopram oxalate 20 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8723	68788-8723-0168788-8723-0368788-8723-06+2 more

All 109 Escitalopram NDCs

Other NDCs under ANDA 202389

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

FDA NDC Directory listings under ANDA 202389
Product	Strength	Form · route	Labeler	Product NDC
Escitalopram	Escitalopram oxalate 10 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-449
Escitalopram	Escitalopram oxalate 20 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals, Inc.	68071-3069
Escitalopram	Escitalopram oxalate 10 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-194
Escitalopram	Escitalopram oxalate 5 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2058
Escitalopram	Escitalopram oxalate 20 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	43063-661
Escitalopram	Escitalopram oxalate 20 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-325
Escitalopram	Escitalopram oxalate 10 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-4915
Escitalopram	Escitalopram oxalate 10 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-344
Escitalopram	Escitalopram oxalate 10 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-149
Escitalopram	Escitalopram oxalate 5 mg/1	Tablet, Film coatedOral	Accord Healthcare Inc.	16729-168
Escitalopram	Escitalopram oxalate 10 mg/1	Tablet, Film coatedOral	Accord Healthcare Inc.	16729-169
Escitalopram	Escitalopram oxalate 20 mg/1	Tablet, Film coatedOral	Accord Healthcare Inc.	16729-170
Escitalopram	Escitalopram oxalate 20 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1002
Escitalopram	Escitalopram oxalate 10 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1030
Escitalopram	Escitalopram oxalate 20 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-236
Escitalopram	Escitalopram oxalate 5 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-766
Escitalopram	Escitalopram oxalate 20 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4985