Prescription drug · ANDA

Escitalopram NDC 72189-438

Escitalopram oxalate 20 mg/1 · Tablet · Oral · Direct_Rx

NDC codes

FDA NDC Directory
Product NDC (as listed)72189-438Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72189-0438Add 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
72189-438-307218904383030 TABLET in 1 BOTTLE (72189-438-30)Marketed from Mar 13, 2023
72189-438-907218904389090 TABLET in 1 BOTTLE (72189-438-90)Marketed from Mar 13, 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 — 20 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Direct_Rx
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090939
Marketing start
Listing expires
Other FDA classes
Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 72189-438_2c4d7dfd-fbd4-516b-e063-6394a90add1bSPL ID 2c4d7dfd-fbd4-516b-e063-6394a90add1bSPL set ID f6cacd68-0f55-deb9-e053-6294a90aa266RxCUI 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

N472189043830 followed by a unit qualifier and the quantity

Package 72189-0438-30. 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 tablets are 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 th…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090939

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

FDA NDC Directory listings under ANDA 090939
ProductStrengthForm · routeLabelerProduct NDC
escitalopramEscitalopram oxalate 5 mg/1Tablet, Film coatedOralTorrent Pharmaceuticals Limited13668-135
escitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6427
escitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralTorrent Pharmaceuticals Limited13668-136
escitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralTorrent Pharmaceuticals Limited13668-137
escitalopram oxalateEscitalopram oxalate 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0322
escitalopram oxalateEscitalopram oxalate 5 mg/1TabletOralProficient Rx LP71205-313
escitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2903
escitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-2240
escitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-2241
escitalopramEscitalopram oxalate 5 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-2242
escitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2960
escitalopram oxalateEscitalopram oxalate 20 mg/1TabletOralBryant Ranch Prepack71335-0685
escitalopram oxalateEscitalopram oxalate 10 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8371
escitalopram oxalateEscitalopram oxalate 10 mg/1TabletOralProficient Rx LP71205-792
escitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-6893
escitalopram oxalateEscitalopram oxalate 10 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-761
escitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-7288
escitalopramEscitalopram oxalate 20 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-4171
escitalopramEscitalopram oxalate 10 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6426
escitalopram oxalateEscitalopram oxalate 10 mg/1TabletOralQuallent Pharmaceuticals Health LLC82009-036

Showing 20 of 22.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in