Prescription drug · ANDA
Escitalopram NDC 51655-149
Escitalopram oxalate 10 mg/1 · Tablet, Film coated · Oral · Northwind Health Company, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51655-149-26 | 51655014926 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-149-26)Marketed from Feb 9, 2022 | |
| 51655-149-52 | 51655014952 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-149-52)Marketed from May 7, 2021 |
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
- Active ingredients
- Escitalopram oxalate — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- 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 51655-149_48c3f3e4-25a2-6aa7-e063-6394a90a0057SPL ID 48c3f3e4-25a2-6aa7-e063-6394a90a0057SPL set ID d9ba6c65-22bd-10c4-e053-2995a90ada2eRxCUI 349332UNII 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
N451655014926followed by a unit qualifier and the quantityPackage 51655-0149-26. 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 | Bryant Ranch Prepack | 71335-1002 |
| 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 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 |
- openFDA data updated
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