Prescription drug · ANDA
Escitalopram Oxalate NDC 65162-019
Escitalopram oxalate 5 mg/1 · Tablet, Film coated · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-019-03 | 65162001903 | 30 TABLET, FILM COATED in 1 BOTTLE (65162-019-03)Marketed from May 17, 2017 | |
| 65162-019-09 | 65162001909 | 90 TABLET, FILM COATED in 1 BOTTLE (65162-019-09)Marketed from May 17, 2017 | |
| 65162-019-11 | 65162001911 | 1000 TABLET, FILM COATED in 1 BOTTLE (65162-019-11)Marketed from May 17, 2017 | |
| 65162-019-50 | 65162001950 | 500 TABLET, FILM COATED in 1 BOTTLE (65162-019-50)Marketed from May 17, 2017 |
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 oxalate
- Active ingredients
- Escitalopram oxalate — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205619
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 65162-019_058fe58a-fa86-459a-b79a-ac337913bc7eSPL ID 058fe58a-fa86-459a-b79a-ac337913bc7eSPL set ID 8704d062-fa91-4224-9dec-41664d20ee6bRxCUI 349332, 351249, 351250UNII 5U85DBW7LOUPC 0365162021035, 0365162020038
- 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
N465162001903followed by a unit qualifier and the quantityPackage 65162-0019-03. 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 tablets are indicated for the treatment of: major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older. generalized anxiety disorder (GAD) in adults. Additional pediatric use information is approved for AbbVie Inc.’s LEXAPRO (escitalopram) tablets. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Escitalopram tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for the: treatment of major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older. (1) treatment of generalized anxiety disorder (GAD) in adults. (1)
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205619
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 Oxalate | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals of New York LLC | 53746-021 |
| Escitalopram Oxalate | Escitalopram oxalate 5 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals of New York LLC | 53746-019 |
| Escitalopram Oxalate | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals of New York LLC | 53746-020 |
| Escitalopram Oxalate | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals LLC | 65162-020 |
| Escitalopram Oxalate | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Amneal Pharmaceuticals LLC | 65162-021 |