Prescription drug · ANDA
Escitalopram Oxalate (escitalopram) NDC 70518-4703
Escitalopram oxalate 10 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4703-0 | 70518470300 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4703-0)Marketed from Jul 19, 2026 |
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 Oxalate
- Generic name (nonproprietary)
- escitalopram
- Active ingredients
- Escitalopram oxalate — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- 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 70518-4703_570a3feb-2dd7-46e9-e063-6394a90a5537SPL ID 570a3feb-2dd7-46e9-e063-6394a90a5537SPL set ID 4508226c-5623-41d3-8916-5f94ffdb8839RxCUI 349332UNII 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
N470518470300followed by a unit qualifier and the quantityPackage 70518-4703-00. 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 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 ) Escitalopram Tablets, USP 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 and LEXAPRO (escitalopram) oral solution. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that …
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 20 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-534 |
| 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 |