Prescription drug · NDA
Lexapro (Escitalopram) NDC 0456-2005
Escitalopram oxalate 5 mg/1 · Tablet, Film coated · Oral · Allergan, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0456-2005-01 | 00456200501 | 100 TABLET, FILM COATED in 1 BOTTLE (0456-2005-01)Marketed from Aug 14, 2002 |
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)
- Lexapro
- Generic name (nonproprietary)
- escitalopram
- Active ingredients
- Escitalopram oxalate — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Allergan, Inc.NDC labeler code 0456
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021323
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 0456-2005_9ff46a66-0f97-4a78-9d18-ec576f63bae7SPL ID 9ff46a66-0f97-4a78-9d18-ec576f63bae7SPL set ID 13bb8267-1cab-43e5-acae-55a4d957630aRxCUI 349332, 351249, 351250, 351285, 352272, 352273, 404408, 404420UNII 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
N400456200501followed by a unit qualifier and the quantityPackage 00456-2005-01. 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)
Lexapro 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 and pediatric patients 7 years of age and older. Lexapro 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.
About NDC 0456-2005
- What is NDC 0456-2005?
- 0456-2005 is the product NDC for Lexapro (escitalopram), Escitalopram oxalate 5 mg/1 tablet, film coated, listed with the FDA by Allergan, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lexapro (Escitalopram).
- What is the active ingredient?
- Escitalopram oxalate.
- Who is the labeler?
- Allergan, Inc., NDC labeler code 0456. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lexapro?
- 2 other product NDCs are listed under this name. See all Lexapro NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lexapro products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lexaproescitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Allergan, Inc. | 0456-2010 | 00456-2010-01 |
| Lexaproescitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Allergan, Inc. | 0456-2020 | 00456-2020-01 |
Other NDCs under NDA 021323
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 |
|---|---|---|---|---|
| Lexaproescitalopram | Escitalopram oxalate 10 mg/1 | Tablet, Film coatedOral | Allergan, Inc. | 0456-2010 |
| Lexaproescitalopram | Escitalopram oxalate 20 mg/1 | Tablet, Film coatedOral | Allergan, Inc. | 0456-2020 |