Prescription drug · ANDA
Escitalopram (escitalopram oxalate) NDC 72789-311
Escitalopram oxalate 20 mg/1 · Tablet, Film coated · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-311-30 | 72789031130 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-311-30)Marketed from Jul 11, 2023 | |
| 72789-311-90 | 72789031190 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-311-90)Marketed from Mar 16, 2023 |
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
- Generic name (nonproprietary)
- escitalopram oxalate
- Active ingredients
- Escitalopram oxalate — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090432
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 72789-311_56d52e53-44f0-8328-e063-6394a90abe19SPL ID 56d52e53-44f0-8328-e063-6394a90abe19SPL set ID 517a551a-6f60-4b8d-9341-63a41baff12dRxCUI 351250UNII 5U85DBW7LOUPC 0372789311906
- 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
N472789031130followed by a unit qualifier and the quantityPackage 72789-0311-30. 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 and pediatric patients 7 years of age and older. Escitalopram oxalate 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 and pediatric patients 7 years and older ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090432
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 |
|---|---|---|---|---|
| Escitalopramescitalopram oxalate | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6023 |
| Escitalopramescitalopram oxalate | Escitalopram oxalate 5 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8475 |
| Escitalopramescitalopram oxalate | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8476 |
| Escitalopramescitalopram oxalate | Escitalopram oxalate 5 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-721 |
| Escitalopramescitalopram oxalate | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-722 |
| Escitalopramescitalopram oxalate | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-723 |
| Escitalopramescitalopram oxalate | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-147 |
| Escitalopramescitalopram oxalate | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-374 |
| Escitalopramescitalopram oxalate | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-617 |
| Escitalopramescitalopram oxalate | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8477 |
| Escitalopramescitalopram oxalate | Escitalopram oxalate 5 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-373 |
| Escitalopramescitalopram oxalate | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-618 |
| Escitalopramescitalopram oxalate | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-375 |
| Escitalopramescitalopram oxalate | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6496 |
| Escitalopramescitalopram oxalate | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-168 |
| Escitalopramescitalopram oxalate | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-193 |
| Escitalopramescitalopram oxalate | Escitalopram oxalate 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-9687 |
| Escitalopramescitalopram oxalate | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0375 |
| Escitalopramescitalopram oxalate | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | QPharma, Inc. | 42708-077 |
| Escitalopramescitalopram oxalate | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-590 |