Prescription drug · ANDA
Escitalopram (escitalopram oxalate) NDC 51672-1348
Escitalopram oxalate 5 mg/5mL · Solution · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51672-1348-1 | 51672134801 | 1 BOTTLE in 1 CARTON (51672-1348-1) / 240 mL in 1 BOTTLEMarketed from May 3, 2012 | |
| 51672-1348-8 | 51672134808 | 1 BOTTLE in 1 CARTON (51672-1348-8) / 120 mL in 1 BOTTLEMarketed from May 3, 2012 | |
| 51672-1348-9 | 51672134809 | 1 BOTTLE in 1 CARTON (51672-1348-9) / 480 mL in 1 BOTTLEMarketed from May 3, 2012 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 oxalate
- Active ingredients
- Escitalopram oxalate — 5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079121
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 51672-1348_38e51a59-5806-77a6-e063-6394a90af6c6SPL ID 38e51a59-5806-77a6-e063-6394a90af6c6SPL set ID c871d3fe-5ca2-410c-976d-9ec4b72c878fRxCUI 351285UNII 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
N451672134801followed by a unit qualifier and the quantityPackage 51672-1348-01. 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 oral solution 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 oral solution 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 functi…
Excerpt only. Read the full label for complete information.