Prescription drug · ANDA

Escitalopram NDC 72189-449

Escitalopram oxalate 5 mg/1 · Tablet, Film coated · Oral · Direct_Rx

NDC codes

FDA NDC Directory
Product NDC (as listed)72189-449Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72189-0449Add 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
72189-449-307218904493030 TABLET, FILM COATED in 1 BOTTLE (72189-449-30)Marketed from Mar 20, 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 — 5 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Direct_Rx
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 72189-449_2c4db59b-4a03-c45c-e063-6294a90ab0ffSPL ID 2c4db59b-4a03-c45c-e063-6294a90ab0ffSPL set ID f75aabf8-f4a1-acd1-e053-6294a90ab9a6RxCUI 351249UNII 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

N472189044930 followed by a unit qualifier and the quantity

Package 72189-0449-30. 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)

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 least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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 5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5312
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralDirect_Rx72189-424
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 coatedOralDirect_Rx72189-451
EscitalopramEscitalopram oxalate 5 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-116
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2317
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals, Inc.68788-7461
EscitalopramEscitalopram oxalate 5 mg/1Tablet, Film coatedOralBluePoint Laboratories68001-591
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralBluePoint Laboratories68001-592
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-5248
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralBluePoint Laboratories68001-593
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4567
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2472
EscitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralSOLCO HEALTHCARE US, LLC43547-282
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 coatedOralA-S Medication Solutions50090-6534
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0320
EscitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-277

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