Prescription drug · ANDA
Escitalopram Oxalate (Escitalopram) NDC 43602-474
Escitalopram oxalate 10 mg/1 · Tablet · Oral · Ascent Pharmaceuticals, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43602-474-10 | 4360204741043602047410 | 1000 TABLET in 1 BOTTLE (43602-474-10)Marketed from Jul 15, 2025 | |
| 43602-474-30 | 4360204743043602047430 | 30 TABLET in 1 BOTTLE (43602-474-30)Marketed from Jul 15, 2025 |
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
- Route
- Oral
- Labeler
- Ascent Pharmaceuticals, IncNDC labeler code 43602
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215177
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 43602-474_c891ea0b-ed9d-4e75-a529-2b8a651034d2SPL ID c891ea0b-ed9d-4e75-a529-2b8a651034d2SPL set ID 1285841d-d9f8-49c6-9456-bf51c8e37271RxCUI 349332, 351249, 351250UNII 5U85DBW7LOUPC 0343602474306, 0343602475303, 0343602474108, 0343602473101, 0343602473309
- 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
N443602047410followed by a unit qualifier and the quantityPackage 43602-0474-10. 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 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)
Excerpt only. Read the full label for complete information.
About NDC 43602-474
- What is NDC 43602-474?
- 43602-474 is the product NDC for Escitalopram Oxalate (escitalopram), Escitalopram oxalate 10 mg/1 tablet, listed with the FDA by Ascent Pharmaceuticals, Inc. 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?
- Ascent Pharmaceuticals, Inc, NDC labeler code 43602. 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 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 |
| escitalopram oxalate | Escitalopram oxalate 10 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-036 | 82009-0036-10 |
Other NDCs under ANDA 215177
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 5 mg/1 | TabletOral | Ascent Pharmaceuticals, Inc | 43602-473 |
| Escitalopram Oxalateescitalopram | Escitalopram oxalate 20 mg/1 | TabletOral | Ascent Pharmaceuticals, Inc | 43602-475 |