Prescription drug · ANDA
Escitalopram (Escitalopram oxalate) NDC 0615-8475
Escitalopram oxalate 5 mg/1 · Tablet, Film coated · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8475-05 | 0061584750500615847505 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8475-05)Marketed from Aug 10, 2023 | |
| 0615-8475-39 | 0061584753900615847539 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8475-39)Marketed from May 17, 2023 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
- 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 0615-8475_efdc3d31-555b-443b-bdc7-4729675ab6c1SPL ID efdc3d31-555b-443b-bdc7-4729675ab6c1SPL set ID b29ae169-d60b-464a-9763-f1d8d9e0598dRxCUI 349332, 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
N400615847505followed by a unit qualifier and the quantityPackage 00615-8475-05. 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: Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12 to 17 years (1.1) Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (1.2) 1.1 Major Depressive Disorder Escitalopram tablets are 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 incl…
Excerpt only. Read the full label for complete information.
About NDC 0615-8475
- What is NDC 0615-8475?
- 0615-8475 is the product NDC for Escitalopram (escitalopram oxalate), Escitalopram oxalate 5 mg/1 tablet, film coated, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Escitalopram (Escitalopram Oxalate).
- What is the active ingredient?
- Escitalopram oxalate.
- Who is the labeler?
- NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Escitalopram?
- 108 other product NDCs are listed under this name. See all Escitalopram NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Escitalopram products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4171 | 68788-4171-0168788-4171-0368788-4171-06+2 more |
| Escitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0355 | 67046-0355-03 |
| Escitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4567 | 70518-4567-00 |
| escitalopram | Escitalopram oxalate 15 mg/1 | CapsuleOral | Almatica Pharma LLC | 52427-795 | 52427-0795-30 |
| Escitalopram | Escitalopram oxalate 5 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-865 | 60687-0865-01 |
| escitalopram | Escitalopram oxalate 5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4300 | 70518-4300-0070518-4300-01 |
| escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1465 | 67046-1465-03 |
| escitalopram | Escitalopram oxalate 5 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1472 | 67046-1472-03 |
| escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4239 | 70518-4239-0070518-4239-0170518-4239-02+1 more |
| escitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8723 | 68788-8723-0168788-8723-0368788-8723-06+2 more |
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 10 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8476 |
| Escitalopramescitalopram oxalate | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8477 |
| Escitalopramescitalopram oxalate | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | QPharma, Inc. | 42708-077 |
| Escitalopramescitalopram oxalate | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6023 |
| Escitalopramescitalopram oxalate | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6496 |
| Escitalopramescitalopram oxalate | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-147 |
| Escitalopramescitalopram oxalate | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-590 |
| Escitalopramescitalopram oxalate | Escitalopram oxalate 5 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-373 |
| Escitalopramescitalopram oxalate | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-374 |
| 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 | American Health Packaging | 68084-617 |
| Escitalopramescitalopram oxalate | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-618 |
| 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 20 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-311 |
| 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 10 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0375 |