Prescription drug · ANDA
Escitalopram Oxalate NDC 33342-037
Escitalopram oxalate 10 mg/21 · Tablet, Film coated · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-037-11 | 33342003711 | 100 TABLET, FILM COATED in 1 BOTTLE (33342-037-11)Marketed from Sep 11, 2012 | |
| 33342-037-12 | 33342003712 | 100 TABLET, FILM COATED in 1 CARTON (33342-037-12)Marketed from Sep 11, 2012 | |
| 33342-037-15 | 33342003715 | 500 TABLET, FILM COATED in 1 BOTTLE (33342-037-15)Marketed from Sep 9, 2015 |
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 — 10 mg/21
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202210
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 33342-037_53210109-53db-4d08-8ea4-be60e5597cafSPL ID 53210109-53db-4d08-8ea4-be60e5597cafSPL set ID 24b43cb4-1a26-44a2-b1d8-a40239eb5c7cRxCUI 349332, 351249, 351250UNII 5U85DBW7LOUPC 0333342036155, 0333342037152, 0333342037114, 0333342038159, 0333342038111, 0333342036117
- 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
N433342003711followed by a unit qualifier and the quantityPackage 33342-0037-11. 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 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. 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 information. Escitalopram tablets 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202210
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/1 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-036 |
| Escitalopram Oxalate | Escitalopram oxalate 20 mg/21 | Tablet, Film coatedOral | Macleods Pharmaceuticals Limited | 33342-038 |
| Escitalopram Oxalate | Escitalopram oxalate 20 mg/21 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7200 |
| Escitalopram Oxalate | Escitalopram oxalate 20 mg/21 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7201 |
| Escitalopram Oxalate | Escitalopram oxalate 10 mg/21 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-150 |
| Escitalopram Oxalate | Escitalopram oxalate 5 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-149 |
| Escitalopram Oxalate | Escitalopram oxalate 20 mg/21 | Tablet, Film coatedOral | NorthStar RxLLC | 72603-151 |