Prescription drug · ANDA
Escitalopram Oxalate NDC 16571-769
Escitalopram oxalate 5 mg/5mL · Solution · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16571-769-24 | 16571076924 | 240 mL in 1 BOTTLE (16571-769-24)Marketed from Apr 3, 2012 |
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/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079062
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 16571-769_b7140557-3cc1-4c7a-952f-2dca7ae2e9d3SPL ID b7140557-3cc1-4c7a-952f-2dca7ae2e9d3SPL set ID 79fddc2d-2dc2-444f-8fd3-0337090ee744RxCUI 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
N416571076924followed by a unit qualifier and the quantityPackage 16571-0769-24. 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 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 and pediatric patients 7 years of age and older. Escitalopram oral solution is 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 and pediatric patients 7 years and older ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 079062
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 5 mg/5mL | SolutionOral | Aurobindo Pharma Limited | 65862-248 |
- openFDA data updated
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