Prescription drug · ANDA
Escitalopram oxalate (Escitalopram) NDC 53401-037
Escitalopram oxalate 10 mg/1 · Tablet, Film coated · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)53401-037Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53401-0037Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53401-037-53 | 5340100375353401003753 | 60 TABLET, FILM COATED in 1 BOTTLE (53401-037-53)Marketed from Sep 16, 2026 | |
| 53401-037-60 | 5340100376053401003760 | 90 TABLET, FILM COATED in 1 BOTTLE (53401-037-60)Marketed from Sep 16, 2026 |
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 — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 53401
- 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 53401-037_5ba20d2d-44af-c5b9-e063-6294a90a7049SPL ID 5ba20d2d-44af-c5b9-e063-6294a90a7049
- 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
N453401003753followed by a unit qualifier and the quantityPackage 53401-0037-53. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 53401-037
- What is NDC 53401-037?
- 53401-037 is the product NDC for Escitalopram oxalate (escitalopram), Escitalopram oxalate 10 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Escitalopram oxalate (Escitalopram).
- What is the active ingredient?
- Escitalopram oxalate.
- Who is the labeler?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 53401. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Escitalopram oxalate?
- 40 other product NDCs are listed under this name. See all Escitalopram oxalate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Escitalopram oxalate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Escitalopram Oxalateescitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4703 | 70518-4703-00 |
| Escitalopram Oxalateescitalopram | Escitalopram oxalate 5 mg/1 | TabletOral | Ascent Pharmaceuticals, Inc | 43602-473 | 43602-0473-1043602-0473-30 |
| Escitalopram Oxalateescitalopram | Escitalopram oxalate 10 mg/1 | TabletOral | Ascent Pharmaceuticals, Inc | 43602-474 | 43602-0474-1043602-0474-30 |
| Escitalopram Oxalateescitalopram | Escitalopram oxalate 20 mg/1 | TabletOral | Ascent Pharmaceuticals, Inc | 43602-475 | 43602-0475-1043602-0475-30 |
| Escitalopram Oxalate | Escitalopram oxalate 20 mg/21 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7200 | 50090-7200-0050090-7200-01 |
| Escitalopram Oxalate | Escitalopram oxalate 20 mg/21 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7201 | 50090-7201-00 |
| Escitalopram Oxalate | Escitalopram oxalate 5 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-149 | 72603-0149-01 |
| Escitalopram Oxalate | Escitalopram oxalate 10 mg/21 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-150 | 72603-0150-01 |
| Escitalopram Oxalate | Escitalopram oxalate 20 mg/21 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-151 | 72603-0151-01 |
| escitalopram oxalate | Escitalopram oxalate 5 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-035 | 82009-0035-10 |
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 | 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 |
| Escitalopram Oxalateescitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4703 |
| Escitalopram oxalateescitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-534 |
| 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 20 mg/1 | Tablet, Film coatedOral | Exelan Pharmaceuticals Inc. | 76282-251 |