Prescription drug · ANDA
Escitalopram NDC 71335-1002
Escitalopram oxalate 20 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1002-1 | 71335100201 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1002-1)Marketed from Dec 20, 2018 | |
| 71335-1002-2 | 71335100202 | 28 TABLET, FILM COATED in 1 BOTTLE (71335-1002-2)Marketed from Jan 29, 2025 | |
| 71335-1002-3 | 71335100203 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1002-3)Marketed from Nov 19, 2018 | |
| 71335-1002-4 | 71335100204 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1002-4)Marketed from Nov 30, 2018 | |
| 71335-1002-5 | 71335100205 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1002-5)Marketed from Jan 29, 2025 | |
| 71335-1002-6 | 71335100206 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1002-6)Marketed from May 10, 2023 | |
| 71335-1002-7 | 71335100207 | 45 TABLET, FILM COATED in 1 BOTTLE (71335-1002-7)Marketed from Jan 29, 2025 | |
| 71335-1002-8 | 71335100208 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-1002-8)Marketed from Jan 29, 2025 |
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 — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202389
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-1002_aa0ac792-8761-4f81-b6a4-79239182c731SPL ID aa0ac792-8761-4f81-b6a4-79239182c731SPL set ID d143ec01-9445-42d5-a259-b0b5a7f9445fRxCUI 351250UNII 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
N471335100201followed by a unit qualifier and the quantityPackage 71335-1002-01. 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 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 ( 1 ) Escitalopram tablet 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202389
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 20 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-325 |
| Escitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-344 |
| Escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3069 |
| Escitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1030 |
| Escitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-149 |
| Escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-236 |
| Escitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4915 |
| Escitalopram | Escitalopram oxalate 5 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-766 |
| Escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-661 |
| Escitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-194 |
| Escitalopram | Escitalopram oxalate 5 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-168 |
| Escitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-169 |
| Escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-170 |
| Escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-425 |
| Escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4985 |
| Escitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-449 |
| Escitalopram | Escitalopram oxalate 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2058 |