Prescription drug · ANDA

Escitalopram NDC 71205-344

Escitalopram oxalate 10 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)71205-344Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71205-0344Add 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
71205-344-30712050344307120503443030 TABLET, FILM COATED in 1 BOTTLE (71205-344-30)Marketed from Nov 1, 2019
71205-344-60712050344607120503446060 TABLET, FILM COATED in 1 BOTTLE (71205-344-60)Marketed from Nov 1, 2019
71205-344-90712050344907120503449090 TABLET, FILM COATED in 1 BOTTLE (71205-344-90)Marketed from Nov 1, 2019

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 — 10 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Proficient Rx LPNDC labeler code 71205
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202389
Marketing start
Listing expires
Other FDA classes
Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 71205-344_9980335c-66da-49de-9880-c06f298c6eb1SPL ID 9980335c-66da-49de-9880-c06f298c6eb1SPL set ID 2fb28a40-037a-49a0-b418-6c6841885cf4RxCUI 349332UNII 5U85DBW7LOUPC 0371205344603
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

N471205034430 followed by a unit qualifier and the quantity

Package 71205-0344-30. 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)

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,…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71205-344

What is NDC 71205-344?
71205-344 is the product NDC for Escitalopram, Escitalopram oxalate 10 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, 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?
Proficient Rx LP, NDC labeler code 71205. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
escitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-417168788-4171-0168788-4171-0368788-4171-06+2 more
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralCoupler LLC67046-035567046-0355-03
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-456770518-4567-00
escitalopramEscitalopram oxalate 15 mg/1CapsuleOralAlmatica Pharma LLC52427-79552427-0795-30
EscitalopramEscitalopram oxalate 5 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-86560687-0865-01
escitalopramEscitalopram oxalate 5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-430070518-4300-0070518-4300-01
escitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralCoupler LLC67046-146567046-1465-03
escitalopramEscitalopram oxalate 5 mg/1Tablet, Film coatedOralCoupler LLC67046-147267046-1472-03
escitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-423970518-4239-0070518-4239-0170518-4239-02+1 more
escitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-872368788-8723-0168788-8723-0368788-8723-06+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
ProductStrengthForm · routeLabelerProduct NDC
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-449
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-3069
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-425
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-194
EscitalopramEscitalopram oxalate 5 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2058
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-661
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralProficient Rx LP71205-325
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-4915
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-149
EscitalopramEscitalopram oxalate 5 mg/1Tablet, Film coatedOralAccord Healthcare Inc.16729-168
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralAccord Healthcare Inc.16729-169
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralAccord Healthcare Inc.16729-170
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1002
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1030
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-236
EscitalopramEscitalopram oxalate 5 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-766
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4985

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