Prescription drug · ANDA
Escitalopram NDC 50090-5312
Escitalopram oxalate 5 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-5312-0 | 50090531200 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-5312-0)Marketed from Oct 29, 2020 | |
| 50090-5312-1 | 50090531201 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-5312-1)Marketed from Jul 13, 2023 |
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
- Generic name (nonproprietary)
- escitalopram
- Active ingredients
- Escitalopram oxalate — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078032
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 50090-5312_5d70869d-59cb-4cbe-80a1-0b4106c4eab0SPL ID 5d70869d-59cb-4cbe-80a1-0b4106c4eab0SPL set ID 9b0b3c54-5bbc-4db9-9c69-00dac1347f24RxCUI 351249UNII 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
N450090531200followed by a unit qualifier and the quantityPackage 50090-5312-00. 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: • Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12-17 years ( 1.1 ) • Acute Treatment of Generalized Anxiety Disorder (GAD) in adults ( 1.2 ) 1.1 Major Depressive Disorder Escitalopram is indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [ see Clinical Studies ( 14.1 ) ]. A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at le…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078032
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 | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-424 |
| Escitalopram | Escitalopram oxalate 5 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-865 |
| Escitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0355 |
| Escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-451 |
| Escitalopram | Escitalopram oxalate 5 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-449 |
| Escitalopram | Escitalopram oxalate 5 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-116 |
| Escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2317 |
| Escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals, Inc. | 68788-7461 |
| Escitalopram | Escitalopram oxalate 5 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-591 |
| Escitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-592 |
| Escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5248 |
| Escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-593 |
| Escitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4567 |
| Escitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2472 |
| Escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | SOLCO HEALTHCARE US, LLC | 43547-282 |
| Escitalopram | Escitalopram oxalate 5 mg/1 | Tablet, Film coatedOral | SOLCO HEALTHCARE US, LLC | 43547-280 |
| Escitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | SOLCO HEALTHCARE US, LLC | 43547-281 |
| Escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6534 |
| Escitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0320 |
| Escitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-277 |
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