Prescription drug · ANDA

Escitalopram NDC 71205-782

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

NDC codes

FDA NDC Directory
Product NDC (as listed)71205-782Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71205-0782Add 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
71205-782-307120507823030 TABLET, FILM COATED in 1 BOTTLE (71205-782-30)Marketed from Mar 28, 2023
71205-782-607120507826060 TABLET, FILM COATED in 1 BOTTLE (71205-782-60)Marketed from Mar 28, 2023
71205-782-907120507829090 TABLET, FILM COATED in 1 BOTTLE (71205-782-90)Marketed from Mar 28, 2023

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 078032
Marketing start
Listing expires
Other FDA classes
Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 71205-782_3e3de8ea-b96b-456b-9336-69380fd2d058SPL ID 3e3de8ea-b96b-456b-9336-69380fd2d058SPL set ID 3e3de8ea-b96b-456b-9336-69380fd2d058RxCUI 349332UNII 5U85DBW7LOUPC 0371205782900
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

N471205078230 followed by a unit qualifier and the quantity

Package 71205-0782-30. 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 is a selective serotonin reuptake inhibitor (SSRI) indicated for: • Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12-17 years ( 1.1 ) • Acute Treatment of Generalized Anxiety Disorder (GAD) in adults ( 1.2 ) 1.1 Major Depressive Disorder Escitalopram 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 includes at le…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71205-782

What is NDC 71205-782?
71205-782 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 078032

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

FDA NDC Directory listings under ANDA 078032
ProductStrengthForm · routeLabelerProduct NDC
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralQPharma, Inc.42708-155
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralQPharma, Inc.42708-163
EscitalopramEscitalopram oxalate 5 mg/1Tablet, Film coatedOralSOLCO HEALTHCARE US, LLC43547-280
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralSOLCO HEALTHCARE US, LLC43547-281
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralSOLCO HEALTHCARE US, LLC43547-282
EscitalopramEscitalopram oxalate 5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5312
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6190
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6191
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6534
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6897
EscitalopramEscitalopram oxalate 5 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-116
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-277
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-284
EscitalopramEscitalopram oxalate 5 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-865
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralCoupler LLC67046-0355
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralRedPharm Drug, Inc.67296-1421
EscitalopramEscitalopram oxalate 5 mg/1Tablet, Film coatedOralBluePoint Laboratories68001-591
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralBluePoint Laboratories68001-592
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralBluePoint Laboratories68001-593
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-5248

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