Prescription drug · ANDA
Escitalopram oxalate (escitalopram) NDC 71610-534
Escitalopram oxalate 20 mg/1 · Tablet, Film coated · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-534-60 | 71610053460 | 90 TABLET, FILM COATED in 1 BOTTLE (71610-534-60)Marketed from Mar 9, 2021 |
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 oxalate
- Generic name (nonproprietary)
- escitalopram
- Active ingredients
- Escitalopram oxalate — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078604
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 71610-534_2b8bb776-9f66-415a-b869-aded0e844450SPL ID 2b8bb776-9f66-415a-b869-aded0e844450SPL set ID 900b7a2f-23e7-4c78-bd6e-549bbe09883eRxCUI 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
N471610053460followed by a unit qualifier and the quantityPackage 71610-0534-60. 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 to 17 years ( 1.1 ) • Acute Treatment of Generalized Anxiety Disorder (GAD) in adults ( 1.2 ) 1.1 Major Depressive Disorder Escitalopram Tablets, USP 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078604
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Escitalopram oxalateescitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 53401-037 |
| Escitalopram Oxalateescitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4703 |
| Escitalopram oxalateescitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Exelan Pharmaceuticals Inc. | 76282-251 |
| Escitalopram oxalateescitalopram | Escitalopram oxalate 5 mg/1 | Tablet, Film coatedOral | Exelan Pharmaceuticals Inc. | 76282-249 |
| Escitalopram oxalateescitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Exelan Pharmaceuticals Inc. | 76282-250 |
| Escitalopram Oxalateescitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Legacy Pharmaceutical Packaging, LLC | 68645-519 |
| Escitalopram Oxalateescitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Legacy Pharmaceutical Packaging, LLC | 68645-520 |
| Escitalopram Oxalateescitalopram | Escitalopram oxalate 5 mg/1 | Tablet, Film coatedOral | Cipla USA Inc. | 69097-847 |
| Escitalopram Oxalateescitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Cipla USA Inc. | 69097-848 |
| Escitalopram Oxalateescitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Cipla USA Inc. | 69097-849 |